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Clinical Trial Results:
A phase IIIb, observer-blind, controlled study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine or Prevenar when given as a booster dose between 12-18 months of age in children previously vaccinated in the primary study 10PN-PD-DIT-012 (107007) with either GSK Biologicals’ 10-valent pneumococcal conjugate vaccine or Prevenar.

Summary
EudraCT number
 2006-005891-41
Trial protocol
 PL  
Global end of trial date
07 Oct 2008

Results information
Results version number
 v1(current)
This version publication date
16 Mar 2016
First version publication date
17 Jun 2015
Other versions

Trial information

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Trial identification
Sponsor protocol code
109509
Additional study identifiers
ISRCTN number
 -
US NCT number
 NCT00547248
WHO universal trial number (UTN)
 -
Sponsors
Sponsor organisation name
GlaxoSmithKline Biologicals
Sponsor organisation address
Rue de l’Institut 89, Rixensart, Belgium, B-1330
Public contact
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
Scientific contact
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
Paediatric regulatory details
Is trial part of an agreed paediatric investigation plan (PIP)
No
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
No
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
Yes
Results analysis stage
Analysis stage
Final
Date of interim/final analysis
09 Feb 2009
Is this the analysis of the primary completion data?
No
Global end of trial reached?
Yes
Global end of trial date
07 Oct 2008
Was the trial ended prematurely?
No
General information about the trial
Main objective of the trial
To demonstrate that a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine(10Pn-PD-DiT) is non-inferior to Prevenar(7Pn) when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines, in terms of post-immunization booster reactions with rectal fever > 39.0°C in children at 12 to 18 months of age. Criteria for safety: Non-inferiority will be demonstrated if one can rule out an increase, in terms of percentage of subjects with rectal fever >39.0°C (10Pn-PD-DiT group as compared to Prevenar group), above 5% + half the incidence in the control group (= the null hypothesis) as shown by an one-sided P-value < 2.5%.
Protection of trial subjects
All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up from the time the subject consents to participate in the study until she/he is discharged. As with all injectable vaccines, Tritanrix™-HepB should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects. Tritanrix™-HepB should under no circumstances be administered intravenously.
Background therapy
 -
Evidence for comparator
 -
Actual start date of recruitment
22 Oct 2007
Long term follow-up planned
Yes
Long term follow-up rationale
 Safety
Long term follow-up duration
 6 Months
Independent data monitoring committee (IDMC) involvement?
No
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled
Philippines: 373
Country: Number of subjects enrolled
Poland: 383
Worldwide total number of subjects
756
EEA total number of subjects
383
Number of subjects enrolled per age group
In utero
0
Preterm newborn - gestational age
0
Newborns (0-27 days)
0
Infants and toddlers (28 days-23 months)
756
Children (2-11 years)
0
Adolescents (12-17 years)
0
Adults (18-64 years)
0
From 65 to 84 years
0
85 years and over
0

Subject disposition

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Recruitment
Recruitment details
 -

Pre-assignment
Screening details
 During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Period 1
Period 1 title
Overall period
Is this the baseline period?
 Yes
Allocation method
Non-randomised - controlled
Blinding used
 Double blind
Roles blinded
 Subject, Investigator, Monitor, Carer, Assessor
Blinding implementation details
The study was conducted in an observer-blind/double-blind fashion. Due to the different appearance of the 10Pn-PD-DiT and Prevenar vaccines, a different person than the one who administered the vaccines, performed the safety assessments in order to keep the study double-blind. In addition, the Clinical Report and the Individual Data Listings of the primary vaccination study 10PN-PD-DIT-012 were not shared with the Investigator before the booster study was over.

Arms
Are arms mutually exclusive
Yes

Arm title
 10PnEPI Group
Arm description
 Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of 10Pn-PD-DiT vaccine, co-administered with DTPw-HBV/Hib and OPV vaccines at 12-18 months of age.
Arm type
 Experimental

Investigational medicinal product name
Pneumococcal conjugate vaccine GSK1024850A
Investigational medicinal product code
Other name
10Pn-PD-DiT vaccine
Pharmaceutical forms
Injection
Routes of administration
Intramuscular use
Dosage and administration details
1 booster dose administered in the right thigh or deltoid at 12-18 months of age

Investigational medicinal product name
Tritanrix™-HepB
Investigational medicinal product code
Other name
DTPw-HBV
Pharmaceutical forms
Injection
Routes of administration
Intramuscular use
Dosage and administration details
1 dose administered in the left thigh or deltoid at 12-18 months of age, recombined with Hiberix.

Investigational medicinal product name
Hiberix™
Investigational medicinal product code
Other name
Hib vaccine
Pharmaceutical forms
Injection
Routes of administration
Intramuscular use
Dosage and administration details
Reconstituted with Tritanrix-HepB before injection, 1-dose administered in the left thigh or deltoid at 12-18 months of age.

Investigational medicinal product name
Polio Sabin™
Investigational medicinal product code
Other name
OPV vaccine
Pharmaceutical forms
Oral suspension
Routes of administration
Oral use
Dosage and administration details
1 dose at 12-18 months of age

Arm title
 7PnEPI Group
Arm description
 Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the 7Pn vaccine, co-administered with DTPw-HBV/Hib and OPV at 12-18 months of age.
Arm type
 Experimental

Investigational medicinal product name
Prevenar™
Investigational medicinal product code
Other name
7Pn vaccine
Pharmaceutical forms
Injection
Routes of administration
Intramuscular use
Dosage and administration details
1 booster dose administered in the right thigh or deltoid at 12-18 months of age

Investigational medicinal product name
Tritanrix™-HepB
Investigational medicinal product code
Other name
DTPw-HBV
Pharmaceutical forms
Injection
Routes of administration
Intramuscular use
Dosage and administration details
1 dose administered in the left thigh or deltoid at 12-18 months of age, recombined with Hiberix.

Investigational medicinal product name
Hiberix™
Investigational medicinal product code
Other name
Hib vaccine
Pharmaceutical forms
Injection
Routes of administration
Intramuscular use
Dosage and administration details
Reconstituted with Tritanrix-HepB before injection, 1-dose administered in the left thigh or deltoid at 12-18 months of age.

Investigational medicinal product name
Polio Sabin™
Investigational medicinal product code
Other name
OPV vaccine
Pharmaceutical forms
Oral suspension
Routes of administration
Oral use
Dosage and administration details
1 dose at 12-18 months of age

Arm title
 10Pn246 Group
Arm description
 Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of 10Pn-PD-DiT vaccine co-administered with DTPw-HBV/Hib and IPV vaccines at 12-18 months of age
Arm type
 Experimental

Investigational medicinal product name
Pneumococcal conjugate vaccine GSK1024850A
Investigational medicinal product code
Other name
10Pn-PD-DiT vaccine
Pharmaceutical forms
Injection
Routes of administration
Intramuscular use
Dosage and administration details
1 booster dose administered in the right thigh or deltoid at 12-18 months of age

Investigational medicinal product name
Tritanrix™-HepB
Investigational medicinal product code
Other name
DTPw-HBV
Pharmaceutical forms
Injection
Routes of administration
Intramuscular use
Dosage and administration details
1 dose administered in the left thigh or deltoid at 12-18 months of age, recombined with Hiberix.

Investigational medicinal product name
Hiberix™
Investigational medicinal product code
Other name
Hib vaccine
Pharmaceutical forms
Injection
Routes of administration
Intramuscular use
Dosage and administration details
Reconstituted with Tritanrix-HepB before injection, 1-dose administered in the left thigh or deltoid at 12-18 months of age.

Investigational medicinal product name
Poliorix™
Investigational medicinal product code
Other name
IPV vaccine
Pharmaceutical forms
Injection
Routes of administration
Intramuscular use
Dosage and administration details
1 dose administered in the lower left thigh or deltoid at 12-18 months of age

Arm title
 7Pn246 Group
Arm description
 Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the 7Pn vaccine, co-administered with DTPw-HBV/Hib and IPV at 12-18 months of age.
Arm type
 Experimental

Investigational medicinal product name
Prevenar™
Investigational medicinal product code
Other name
7Pn vaccine
Pharmaceutical forms
Injection
Routes of administration
Intramuscular use
Dosage and administration details
1 booster dose administered in the right thigh or deltoid at 12-18 months of age

Investigational medicinal product name
Tritanrix™-HepB
Investigational medicinal product code
Other name
DTPw-HBV
Pharmaceutical forms
Injection
Routes of administration
Intramuscular use
Dosage and administration details
1 dose administered in the left thigh or deltoid at 12-18 months of age, recombined with Hiberix.

Investigational medicinal product name
Hiberix™
Investigational medicinal product code
Other name
Hib vaccine
Pharmaceutical forms
Injection
Routes of administration
Intramuscular use
Dosage and administration details
Reconstituted with Tritanrix-HepB before injection, 1-dose administered in the left thigh or deltoid at 12-18 months of age.

Investigational medicinal product name
Poliorix™
Investigational medicinal product code
Other name
IPV vaccine
Pharmaceutical forms
Injection
Routes of administration
Intramuscular use
Dosage and administration details
1 dose administered in the lower left thigh or deltoid at 12-18 months of age

Number of subjects in period 1
10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Started
280
93
285
98
Completed
280
93
275
96
Not completed
0
0
10
2
     Protocol deviation
-
-
-
1
     Migrated/moved from study area
-
-
2
-
     Consent withdrawn by subject
-
-
7
1
     Protocol deviation
-
-
1
-

Baseline characteristics

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Baseline characteristics reporting groups
Reporting group title
10PnEPI Group
Reporting group description
 Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of 10Pn-PD-DiT vaccine, co-administered with DTPw-HBV/Hib and OPV vaccines at 12-18 months of age.

Reporting group title
7PnEPI Group
Reporting group description
 Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the 7Pn vaccine, co-administered with DTPw-HBV/Hib and OPV at 12-18 months of age.

Reporting group title
10Pn246 Group
Reporting group description
 Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of 10Pn-PD-DiT vaccine co-administered with DTPw-HBV/Hib and IPV vaccines at 12-18 months of age

Reporting group title
7Pn246 Group
Reporting group description
 Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the 7Pn vaccine, co-administered with DTPw-HBV/Hib and IPV at 12-18 months of age.

Reporting group values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group Total
Number of subjects
 280 93 285 98 756
Age categorical
Units: Subjects
    In utero
 0
    Preterm newborn infants (gestational age < 37 wks)
 0
    Newborns (0-27 days)
 0
    Infants and toddlers (28 days-23 months)
 0
    Children (2-11 years)
 0
    Adolescents (12-17 years)
 0
    Adults (18-64 years)
 0
    From 65-84 years
 0
    85 years and over
 0
Age continuous
Units: months
    arithmetic mean (standard deviation)
 16.2 ± 0.66 16.2 ± 0.59 17.2 ± 0.84 17.2 ± 0.88 -
Gender categorical
Units: Subjects
    Female
 133 43 134 43 353
    Male
 147 50 151 55 403

End points

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End points reporting groups
Reporting group title
10PnEPI Group
Reporting group description
 Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of 10Pn-PD-DiT vaccine, co-administered with DTPw-HBV/Hib and OPV vaccines at 12-18 months of age.

Reporting group title
7PnEPI Group
Reporting group description
 Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the 7Pn vaccine, co-administered with DTPw-HBV/Hib and OPV at 12-18 months of age.

Reporting group title
10Pn246 Group
Reporting group description
 Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of 10Pn-PD-DiT vaccine co-administered with DTPw-HBV/Hib and IPV vaccines at 12-18 months of age

Reporting group title
7Pn246 Group
Reporting group description
 Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the 7Pn vaccine, co-administered with DTPw-HBV/Hib and IPV at 12-18 months of age.

Subject analysis set title
10pn group
Subject analysis set type
 Sub-group analysis
Subject analysis set description
10pn epi+ 10pn246

Subject analysis set title
7pn group
Subject analysis set type
 Sub-group analysis
Subject analysis set description
7pnepi +7pn246

Primary: Number of subjects reporting rectal temperature above (>) 39.0 degree Celsius (°C)

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End point title
 Number of subjects reporting rectal temperature above (>) 39.0 degree Celsius (°C)
End point description
Fever was measured as rectal temperature. Assessment of occurrences of fever > 39.0 °C was performed after booster vaccination of 10Pn-PD-DiT or 7Pn vaccine.
End point type
Primary
End point timeframe
Within 4-day (Days 0-3) after booster vaccination.
End point values
 10pn group 7pn group
Number of subjects analysed
558
189
Units: Subjects
    Fever > 39.0°C
64
20
Statistical analysis title
 Non-inferiority of 10Pnvs7Pn vaccine after Booster
Statistical analysis description
to demonstrate that a booster dose of 10Pn-PD-DiT vaccine administered at 12-18 months of age after a primary vaccination (either at 6-10-14 weeks or at 2-4-6 months of age), is non-inferior to 7Pn in terms of the incidence of rectal fever >39.0°C, when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines.Towards this, standardized asymptotic 95% confidence interval (CI) for the difference [10Pn minus 7Pn] in terms of percentages of subjects reporting rectal fever >39.0°C was computed.
Comparison groups
10pn group v 7pn group
Number of subjects included in analysis
747
Analysis specification
Pre-specified
Analysis type
 non-inferiority [1]
P-value
 > 0.001 [2]
Method
 Philips’ statistical test
Parameter type
 Difference in percentage
Point estimate
0.89
Confidence interval
     level
 95%
     sides
2-sided
     lower limit
 -4.82
     upper limit
 5.59
Notes
[1] - Non-inferiority was demonstrated if the difference in terms of incidence of post-immunization febrile reactions (rectal temperature > 39.0°C) in 10Pn-PD-DiT vaccine minus 7Pn did not exceed the pre-defined clinically acceptable threshold of 5% + half the incidence in 7Pn.
[2] - Phillips’ statistical test, an extension of Farrington and Manning's methods, allows the inferiority limit (i.e. the tolerated absolute difference) to vary with the underlying failures rates. Observed P-value < 0.001.

Secondary: Number of subjects with any and Grade 3 solicited local symptoms

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End point title
 Number of subjects with any and Grade 3 solicited local symptoms
End point description
Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). “Any” is defined as incidence of the specified symptom regardless of intensity.
End point type
Secondary
End point timeframe
Within 4-day (Days 0-3) after booster vaccination
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
280
93
278
96
Units: Subjects
    Any Pain
203
66
248
77
    Grade 3 Pain
40
20
117
39
    Any Redness
107
37
197
66
    Grade 3 Redness
8
3
35
11
    Any Swelling
92
32
158
52
    Grade 3 Swelling
21
9
34
8
No statistical analyses for this end point

Secondary: Number of subjects with any and Grade 3 solicited general symptoms

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End point title
 Number of subjects with any and Grade 3 solicited general symptoms
End point description
Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. “Any” is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.
End point type
Secondary
End point timeframe
Within 4-day (Days 0-3) after booster vaccination
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
280
93
278
96
Units: Subjects
    Any Drowsiness
90
32
190
66
    Grade 3 Drowsiness
5
1
7
2
    Any Fever
138
51
215
65
    Grade 3 Fever
0
0
1
0
    Any Irritability
173
64
243
79
    Grade 3 Irritability
12
3
40
5
    Any Loss of appetite
97
28
184
57
    Grade 3 Loss of appetite
8
1
13
1
No statistical analyses for this end point

Secondary: Number of subjects with unsolicited adverse events (AEs)

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End point title
 Number of subjects with unsolicited adverse events (AEs)
End point description
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. “Any” is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
End point type
Secondary
End point timeframe
Within 31-day (Days 0-30) after booster vaccination
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
280
93
285
98
Units: Subjects
    Any AE(s)
25
9
106
35
No statistical analyses for this end point

Secondary: Number of subjects with serious adverse events (SAEs)

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End point title
 Number of subjects with serious adverse events (SAEs)
End point description
End point type
Secondary
End point timeframe
Throughout the active phase of the study (Month 0 to Month 1)
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
280
93
285
98
Units: Subjects
    Any SAE(s)
2
0
5
2
No statistical analyses for this end point

Secondary: Number of subjects with serious adverse events (SAEs)

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End point title
 Number of subjects with serious adverse events (SAEs)
End point description
End point type
Secondary
End point timeframe
Throughout the entire study period starting from the beginning of the booster phase (Month 0) up to the end of the 6-month safety follow-up period.
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
280
93
285
98
Units: Subjects
    Any SAE(s)
6
1
14
5
No statistical analyses for this end point

Secondary: Number of subjects with anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations above or equal to (≥) 0.20 microgram per milliliter (µg/mL)

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End point title
 Number of subjects with anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations above or equal to (≥) 0.20 microgram per milliliter (µg/mL)
End point description
End point type
Secondary
End point timeframe
Prior to and one month after the booster dose of 10Pn-PD-DiT or 7Pn vaccine
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
136
43
130
44
Units: Subjects
    Anti-1, Pre-booster [N=136;42;128;40]
100
2
64
2
    Anti-1, Post-booster [N=136;42;125;43]
136
3
125
2
    Anti-4, Pre-booster [N=135;43;130;42]
113
25
78
23
    Anti-4, Post-booster [N=136;43;125;43]
136
43
125
43
    Anti-5, Pre-booster [N=135;42;129;42]
118
7
98
3
    Anti-5, Post-booster [N=136;43;125;43]
136
8
124
3
    Anti-6B, Pre-booster [N=135;43;129;44]
113
24
90
27
    Anti-6B, Post-booster [N=136;42;125;43]
134
42
122
41
    Anti-7F, Pre-booster [N=135;43;130;42]
128
7
118
1
    Anti-7F, Post-booster [N=136;43;125;43]
136
9
125
1
    Anti-9V, Pre-booster [N=135;42;130;44]
132
40
116
42
    Anti-9V, Post-booster [N=136;43;125;43]
136
43
125
43
    Anti-14, Pre-booster [N=134;43;130;43]
126
42
111
40
    Anti-14, Post-booster [N=136;43;125;43]
135
43
125
43
    Anti-18C, Pre-booster [N=135;43;130;44]
130
36
111
35
    Anti-18C, Post-booster [N=136;43;125;43]
136
43
125
43
    Anti-19F, Pre-booster [N=135;43;130;44]
129
11
121
22
    Anti-19F, Post-booster [N=136;43;125;43]
136
43
123
43
    Anti-23F, Pre-booster [N=133;43;130;44]
123
32
89
40
    Anti-23F, Post-booster [N=136;43;125;43]
135
42
123
42
No statistical analyses for this end point

Secondary: Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations

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End point title
 Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations
End point description
Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥0.05 microgram per milliliter (µg/mL).
End point type
Secondary
End point timeframe
Prior to and one month after the booster dose of 10Pn-PD-DiT or 7Pn vaccine
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
136
43
130
44
Units: µg/mL
geometric mean (confidence interval 95%)
    Anti-1, Pre-booster [N=136;42;128;40]
0.35 (0.29 to 0.42)
0.03 (0.03 to 0.04)
0.19 (0.16 to 0.22)
0.04 (0.03 to 0.05)
    Anti-1, Post-booster [N=136;42;125;43]
10.8 (9.22 to 12.66)
0.04 (0.03 to 0.05)
2.14 (1.8 to 2.55)
0.04 (0.03 to 0.05)
    Anti-4, Pre-booster [N=135;43;130;42]
0.55 (0.45 to 0.67)
0.34 (0.25 to 0.45)
0.27 (0.22 to 0.33)
0.24 (0.19 to 0.3)
    Anti-4, Post-booster [N=136;43;125;43]
13.16 (11.43 to 15.14)
11.84 (8.74 to 16.04)
4.21 (3.61 to 4.91)
6.86 (5.39 to 8.73)
    Anti-5, Pre-booster [N=135;42;129;42]
0.55 (0.47 to 0.64)
0.06 (0.04 to 0.09)
0.4 (0.34 to 0.47)
0.04 (0.03 to 0.05)
    Anti-5, Post-booster [N=136;43;125;43]
14.59 (12.53 to 16.99)
0.09 (0.06 to 0.13)
2.54 (2.11 to 3.06)
0.05 (0.04 to 0.06)
    Anti-6B, Pre-booster [N=135;43;129;44]
0.66 (0.54 to 0.8)
0.38 (0.22 to 0.65)
0.34 (0.28 to 0.41)
0.34 (0.2 to 0.59)
    Anti-6B, Post-booster [N=136;42;125;43]
7.02 (5.83 to 8.45)
9.08 (6.5 to 12.7)
2.31 (1.93 to 2.75)
6.28 (4.18 to 9.44)
    Anti-7F, Pre-booster [N=135;43;130;42]
0.9 (0.77 to 1.04)
0.05 (0.03 to 0.07)
0.58 (0.51 to 0.67)
0.03 (0.03 to 0.04)
    Anti-7F, Post-booster [N=136;43;125;43]
12.52 (11.09 to 14.13)
0.06 (0.04 to 0.1)
4.14 (3.61 to 4.74)
0.03 (0.03 to 0.04)
    Anti-9V, Pre-booster [N=135;42;130;44]
1.16 (0.98 to 1.37)
0.77 (0.59 to 0.99)
0.59 (0.5 to 0.7)
0.58 (0.47 to 0.71)
    Anti-9V, Post-booster [N=136;43;125;43]
14.42 (12.44 to 16.7)
20.31 (15.44 to 26.71)
4.63 (4 to 5.36)
13.6 (11.12 to 16.62)
    Anti-14, Pre-booster [N=134;43;130;43]
1.32 (1.07 to 1.63)
1.83 (1.26 to 2.66)
0.84 (0.66 to 1.07)
1.04 (0.75 to 1.43)
    Anti-14, Post-booster [N=136;43;125;43]
17.07 (14.12 to 20.64)
27.42 (20.96 to 35.86)
5.93 (4.97 to 7.09)
15.51 (12.14 to 19.82)
    Anti-18C, Pre-booster [N=135;43;130;44]
1.43 (1.2 to 1.71)
0.42 (0.32 to 0.55)
0.63 (0.52 to 0.77)
0.4 (0.3 to 0.53)
    Anti-18C, Post-booster [N=136;43;125;43]
39.59 (34.04 to 46.05)
12.07 (9.23 to 15.79)
10.49 (8.81 to 12.49)
9.92 (7.74 to 12.71)
    Anti-19F, Pre-booster [N=135;43;130;44]
1.33 (1.08 to 1.64)
0.16 (0.1 to 0.26)
0.99 (0.81 to 1.22)
0.35 (0.2 to 0.61)
    Anti-19F, Post-booster [N=136;43;125;43]
21.25 (18.07 to 24.98)
6.61 (4.9 to 8.92)
12.23 (9.89 to 15.13)
6.01 (4.75 to 7.6)
    Anti-23F, Pre-booster [N=133;43;130;44]
0.94 (0.76 to 1.16)
0.41 (0.26 to 0.64)
0.33 (0.27 to 0.4)
0.62 (0.43 to 0.91)
    Anti-23F, Post-booster [N=136;43;125;43]
13.47 (11.38 to 15.94)
14.78 (9.45 to 23.11)
3.16 (2.61 to 3.83)
10.77 (7.19 to 16.12)
No statistical analyses for this end point

Secondary: Opsonophagocytic activity (OPA) titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F

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End point title
 Opsonophagocytic activity (OPA) titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
End point description
Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8
End point type
Secondary
End point timeframe
Prior to and one month after the booster dose of 10Pn-PD-DiT or 7Pn vaccine
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
136
43
125
37
Units: Titers
geometric mean (confidence interval 95%)
    OPA Anti-1, Pre-booster [N=134;43;122;37]
13.2 (10.2 to 16.9)
4.6 (3.9 to 5.4)
8.5 (7 to 10.5)
4.7 (3.8 to 5.8)
    OPA Anti-1, Post-booster [N=134;43;120;37]
1571.6 (1210.7 to 2040)
4.9 (4.1 to 5.8)
161.4 (120.7 to 215.9)
5.4 (4 to 7.4)
    OPA Anti-4, Pre-booster [N=127;42;114;33]
40.5 (27.6 to 59.2)
18.5 (10 to 34.2)
12.5 (8.9 to 17.4)
12.4 (6.7 to 22.8)
    OPA Anti-4, Post-booster [N=134;43;119;35]
5035.8 (4214 to 6017.8)
4783.5 (3432 to 6667.2)
2498.7 (2103.3 to 2968.4)
4812.5 (3167.8 to 7311.3)
    OPA Anti-5, Pre-booster [N=133;43;119;36]
19.8 (16 to 24.7)
4.2 (3.8 to 4.6)
10.9 (8.8 to 13.6)
4.5 (3.7 to 5.5)
    OPA Anti-5, Post-booster [N=130;43;117;36]
1135.8 (928.5 to 1389.6)
4.9 (3.9 to 6)
149.1 (115.4 to 192.5)
4.3 (3.8 to 4.8)
    OPA Anti-6B, Pre-booster [N=132;43;124;37]
97.8 (61.5 to 155.5)
56.6 (21.3 to 150.1)
9.9 (7.2 to 13.5)
23.3 (9.1 to 60.1)
    OPA Anti-6B, Post-booster [N=136;43;120;35]
2896.8 (2247.5 to 3733.8)
9302.7 (7187.3 to 12040.8)
405.3 (267.4 to 614.3)
3547.1 (1500.7 to 8384.5)
    OPA Anti-7F, Pre-booster [N=135;41;116;31]
2278.4 (1803.1 to 2879)
378.8 (136.9 to 1048)
796.3 (582.2 to 1089.1)
63.6 (21.3 to 190.1)
    OPA Anti-7F, Post-booster [N=136;40;122;24]
12484 (10750.7 to 14496.8)
1407.7 (694.6 to 2852.9)
6436.1 (5507.6 to 7521)
90.6 (25.2 to 325.5)
    OPA Anti-9V, Pre-booster [N=136;42;122;37]
788 (655.1 to 947.8)
666.8 (482.1 to 922.2)
380.2 (313.1 to 461.7)
247.5 (164.9 to 371.3)
    OPA Anti-9V, Post-booster [N=134;42;121;35]
4842 (4122.7 to 5686.9)
7387.8 (5429.2 to 10052.9)
3499.9 (2950.8 to 4151.3)
6881.4 (4883.6 to 9696.4)
    OPA Anti-14, Pre-booster [N=130;42;106;31]
298.4 (220.1 to 404.7)
337.2 (207 to 549.2)
179.6 (127.4 to 253.2)
236.6 (132.6 to 422.2)
    OPA Anti-14, Post-booster [N=132;42;120;36]
3579.7 (2966.3 to 4319.9)
4097.3 (3019.2 to 5560.2)
1961.3 (1630 to 2359.8)
2939.5 (2022.3 to 4272.7)
    OPA Anti-18C, Pre-booster [N=129;42;121;37]
19.8 (15.2 to 25.9)
4.5 (3.9 to 5.2)
7.8 (6.5 to 9.4)
4.5 (4 to 5.2)
    OPA Anti-18C, Post-booster [N=134;43;115;36]
2417.2 (1989.9 to 2936.2)
966.5 (607.1 to 1538.6)
694 (532.9 to 903.7)
612.1 (338.4 to 1107)
    OPA Anti-19F, Pre-booster [N=135;43;125;37]
58.6 (45.2 to 76)
7.3 (4.5 to 11.8)
33.3 (25.7 to 43.2)
11.1 (6 to 20.6)
    OPA Anti-19F, Post-booster [N=136;42;122;37]
2016 (1609 to 2526)
473.2 (263.5 to 849.9)
1059.8 (808.2 to 1389.7)
471 (270 to 821.8)
    OPA Anti-23F, Pre-booster [N=136;43;118;36]
948.9 (688.4 to 1308.2)
661.9 (312.5 to 1402)
301.8 (198.4 to 459)
790.6 (326.8 to 1912.6)
    OPA Anti-23F, Post-booster [N=136;43;121;37]
7456.2 (6301.9 to 8822)
23177.9 (13235.9 to 40587.7)
3427.3 (2727.7 to 4306.3)
19943.3 (13473.1 to 29520.5)
No statistical analyses for this end point

Secondary: Antibody concentrations to protein D (Anti-PD)

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End point title
 Antibody concentrations to protein D (Anti-PD)
End point description
Seropositivity status, defined as anti-PD antibody concentrations >=100 ELISA units per milliliter (EL.U/mL)
End point type
Secondary
End point timeframe
Prior to and one month after the booster dose of 10Pn-PD-DiT or 7Pn vaccine
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
135
43
128
43
Units: EL.U/mL
geometric mean (confidence interval 95%)
    Anti-PD, Pre-booster [N=132;43;128;43]
573.1 (495.7 to 662.6)
136.8 (102 to 183.3)
526.8 (427.4 to 649.3)
73.8 (58.4 to 93.2)
    Anti-PD, Post-booster [N= 135;43;125;43]
4973.9 (4280.2 to 5780)
124.1 (92.8 to 166)
2769.6 (2308.5 to 3322.7)
91.6 (72 to 116.7)
No statistical analyses for this end point

Secondary: Antibody concentrations against pneumococcal cross-reactive serotypes 6A and 19A

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End point title
 Antibody concentrations against pneumococcal cross-reactive serotypes 6A and 19A
End point description
Seropositivity status, defined as anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations >=0.05 microgram per milliliter (µg/mL).
End point type
Secondary
End point timeframe
Prior to and one month after the booster dose of 10Pn-PD-DiT or 7Pn vaccine
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
136
43
130
44
Units: µg/mL
geometric mean (confidence interval 95%)
    Anti-6A, Pre-booster [N=135;43;130;43]
0.46 (0.36 to 0.6)
0.24 (0.14 to 0.4)
0.12 (0.1 to 0.14)
0.13 (0.08 to 0.2)
    Anti-6A, Post-booster [N=136;43;125;43]
4.07 (3.09 to 5.36)
4.57 (2.92 to 7.17)
0.84 (0.65 to 1.08)
2.54 (1.65 to 3.93)
    Anti-19A, Pre-booster [N=134;43;130;44]
0.24 (0.19 to 0.3)
0.08 (0.05 to 0.12)
0.16 (0.12 to 0.2)
0.06 (0.04 to 0.08)
    Anti-19A, Post-booster [N=136;43;125;43]
3.22 (2.46 to 4.21)
0.58 (0.37 to 0.91)
1.75 (1.27 to 2.43)
0.38 (0.25 to 0.58)
No statistical analyses for this end point

Secondary: Opsonophagocytic activity (OPA) against pneumococcal cross-reactive serotypes 6A and 19A

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End point title
 Opsonophagocytic activity (OPA) against pneumococcal cross-reactive serotypes 6A and 19A
End point description
Seropositivity status, defined as Opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A >=8
End point type
Secondary
End point timeframe
Prior to and one month after the booster dose of 10Pn-PD-DiT or 7Pn vaccine
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
134
43
123
36
Units: Titers
geometric mean (confidence interval 95%)
    OPA Anti-6A Pre-booster [N=117;39;108;32]
113.6 (73.6 to 175.4)
191.4 (89.7 to 408.2)
46.8 (30.8 to 71.1)
42.2 (19.3 to 92.1)
    OPA Anti-6A Post-booster [N=133;43;109;32]
882.8 (665.9 to 1170.3)
2563.8 (1689.9 to 3889.4)
369.7 (258.5 to 528.8)
1394.5 (827.9 to 2348.9)
    OPA Anti-19A Pre-booster [N=134;43;123;36]
5.3 (4.5 to 6.3)
5.1 (3.6 to 7.3)
5.3 (4.5 to 6.2)
4.4 (3.6 to 5.3)
    OPA Anti-19A Post-booster [N=133;40;115;32]
89.3 (58.9 to 135.4)
8.7 (5.4 to 14.2)
70.7 (45.3 to 110.4)
20.3 (8.8 to 46.8)
No statistical analyses for this end point

Secondary: Number of subjects with anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 µg/mL

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End point title
 Number of subjects with anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 µg/mL
End point description
End point type
Secondary
End point timeframe
Prior to and one month after the booster dose of 10Pn-PD-DiT or 7Pn vaccine
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
136
43
130
44
Units: Subjects
    Anti-1, Pre-booster [N=136;42;128;40]
135
7
122
8
    Anti-1, Post-booster [N=136;42;125;43]
136
11
125
9
    Anti-4, Pre-booster [N=135;43;130;42]
134
43
126
42
    Anti-4, Post-booster [N=136;43;125;43]
136
43
125
43
    Anti-5, Pre-booster [N=135;42;129;42]
135
18
128
13
    Anti-5, Post-booster [N=136;43;125;43]
136
31
125
20
    Anti-6B, Pre-booster [N=135;43;129;44]
132
40
127
39
    Anti-6B, Post-booster [N=136;42;125;43]
135
42
124
42
    Anti-7F, Pre-booster [N=135;43;130;42]
135
13
130
8
    Anti-7F, Post-booster [N=136;43;125;43]
136
17
125
11
    Anti-9V, Pre-booster [N=135;42;130;44]
135
42
130
44
    Anti-9V, Post-booster [N=136;43;125;43]
136
43
125
43
    Anti-14, Pre-booster [N=134;43;130;43]
134
42
130
43
    Anti-14, Post-booster [N=136;43;125;43]
136
43
125
43
    Anti-18C, Pre-booster [N=135;43;130;44]
135
43
129
44
    Anti-18C, Post-booster [N=136;43;125;43]
136
43
125
43
    Anti-19F, Pre-booster [N=135;43;130;44]
134
37
129
43
    Anti-19F, Post-booster [N=136;43;125;43]
136
43
124
43
    Anti-23F, Pre-booster [N=133;43;130;44]
132
40
125
43
    Anti-23F, Post-booster [N=136;43;125;43]
136
42
124
42
No statistical analyses for this end point

Secondary: Number of subjects with opsonophagocytic activity (OPA) titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ 8

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End point title
 Number of subjects with opsonophagocytic activity (OPA) titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ 8
End point description
End point type
Secondary
End point timeframe
Prior to and one month after the booster dose of 10Pn-PD-DiT or 7Pn vaccine
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
136
43
125
37
Units: Subjects
    OPA Anti-1, Pre-booster [N=134;43;122;37]
61
3
45
3
    OPA Anti-1, Post-booster [N=134;43;120;37]
134
5
114
5
    OPA Anti-4, Pre-booster [N=127;42;114;33]
83
20
39
12
    OPA Anti-4, Post-booster [N=134;43;119;35]
134
43
119
35
    OPA Anti-5, Pre-booster [N=133;43;119;36]
94
1
56
2
    OPA Anti-5, Post-booster [N=130;43;117;36]
130
4
114
1
    OPA Anti-6B, Pre-booster [N=132;43;124;37]
93
21
34
14
    OPA Anti-6B, Post-booster [N=136;43;120;35]
134
43
106
32
    OPA Anti-7F, Pre-booster [N=135;41;116;31]
133
28
109
15
    OPA Anti-7F, Post-booster [N=136;40;122;24]
136
36
122
13
    OPA Anti-9V, Pre-booster [N=136;42;122;37]
135
42
121
36
    OPA Anti-9V, Post-booster [N=134;42;121;35]
134
42
121
35
    OPA Anti-14, Pre-booster [N=130;42;106;31]
119
39
93
29
    OPA Anti-14, Post-booster [N=132;42;120;36]
132
42
120
36
    OPA Anti-18C, Pre-booster [N=129;42;121;37]
84
3
42
4
    OPA Anti-18C, Post-booster [N=134;43;115;36]
133
42
114
36
    OPA Anti-19F, Pre-booster [N=135;43;125;37]
117
7
96
12
    OPA Anti-19F, Post-booster [N=136;42;122;37]
135
39
118
36
    OPA Anti-23F, Pre-booster [N=136;43;118;36]
130
37
99
30
    OPA Anti-23F, Post-booster [N=136;43;121;37]
136
42
120
37
No statistical analyses for this end point

Secondary: Number of subjects with concentrations of antibodies against cross-reactive pneumococcal serotypes 6A and 19A ≥ 0.05 μg/mL

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End point title
 Number of subjects with concentrations of antibodies against cross-reactive pneumococcal serotypes 6A and 19A ≥ 0.05 μg/mL
End point description
End point type
Secondary
End point timeframe
Prior to and one month after the booster dose of 10Pn-PD-DiT or 7Pn vaccine
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
136
43
130
44
Units: Subjects
    Anti-6A, Pre-booster [N=135;43;130;43]
128
37
105
33
    Anti-6A, Post-booster [N=136;43;125;43]
133
42
125
42
    Anti-19A, Pre-booster [N=134;43;130;44]
124
25
105
27
    Anti-19A, Post-booster [N=136;43;125;43]
135
42
119
42
No statistical analyses for this end point

Secondary: Number of subjects with opsonophagocytic activity (OPA) against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8

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End point title
 Number of subjects with opsonophagocytic activity (OPA) against pneumococcal cross-reactive serotypes 6A and 19A ≥ 8
End point description
End point type
Secondary
End point timeframe
Prior to and one month after the booster dose of 10Pn-PD-DiT or 7Pn vaccine
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
134
43
123
36
Units: Subjects
    OPA Anti-6A Pre-booster [N=117;39;108;32]
82
30
63
19
    OPA Anti-6A Post-booster [N=133;43;109;32]
127
43
97
32
    OPA Anti-19A Pre-booster [N=134;43;123;36]
14
2
11
1
    OPA Anti-19A Post-booster [N=133;40;115;32]
92
11
74
12
No statistical analyses for this end point

Secondary: Number of subjects with antibody concentrations against protein D (Anti-PD) ≥ 100 ELISA units per milliliter (EL.U/mL).

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End point title
 Number of subjects with antibody concentrations against protein D (Anti-PD) ≥ 100 ELISA units per milliliter (EL.U/mL).
End point description
End point type
Secondary
End point timeframe
Prior to and one month after the booster dose of 10Pn-PD-DiT or 7Pn vaccine
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
135
43
128
43
Units: Subjects
    Anti-PD, Pre-booster [N=132;43;128;43]
131
28
117
11
    Anti-PD, Post-booster [N= 135;43;125;43]
135
23
125
19
No statistical analyses for this end point

Secondary: Anti-diphtheria (Anti-DT) and anti-tetanus toxoids (Anti-TT) antibody concentrations

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End point title
 Anti-diphtheria (Anti-DT) and anti-tetanus toxoids (Anti-TT) antibody concentrations
End point description
Seroprotection status, defined as anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations >= 0.1 IU/mL
End point type
Secondary
End point timeframe
Prior to and one month after the booster vaccination of DTPw-HBV/Hib + OPV or IPV
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
65
25
62
24
Units: IU/mL
geometric mean (confidence interval 95%)
    Anti-DT, Pre-booster [N=65;25;62;24]
0.258 (0.209 to 0.319)
0.17 (0.118 to 0.243)
0.188 (0.153 to 0.231)
0.126 (0.088 to 0.179)
    Anti-DT, Post-booster [N=65;25;59;24]
7.829 (6.339 to 9.671)
4.768 (3.699 to 6.145)
8.463 (7.11 to 10.074)
4.876 (3.503 to 6.787)
    Anti-TT, Pre-booster [N= 65;25;62;24]
0.735 (0.629 to 0.858)
0.455 (0.314 to 0.66)
0.568 (0.432 to 0.748)
0.525 (0.29 to 0.951)
    Anti-TT, Post-booster [N= 65;25;59;24]
20.979 (18.359 to 23.972)
9.703 (8.173 to 11.518)
12.171 (9.772 to 15.16)
6.719 (4.598 to 9.819)
No statistical analyses for this end point

Secondary: Anti-polyribosyl-ribitol-phosphate (Anti-PRP) antibody concentrations

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End point title
 Anti-polyribosyl-ribitol-phosphate (Anti-PRP) antibody concentrations
End point description
Seroprotection status, defined as anti-PRP antibody concentrations ≥0.15 µg/mL and ≥1.0 µg/mL
End point type
Secondary
End point timeframe
Prior to and one month after the booster vaccination of DTPw-HBV/Hib + OPV or IPV
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
65
25
62
24
Units: µg/mL
geometric mean (confidence interval 95%)
    Anti-PRP, Pre-booster [N=65;25;62;24]
5.335 (3.578 to 7.953)
6.433 (2.93 to 14.124)
1.03 (0.745 to 1.423)
0.894 (0.57 to 1.401)
    Anti-PRP, Post-booster [N=65;25;59;24]
106.004 (79.937 to 140.572)
89.376 (55.131 to 144.891)
53.386 (34.817 to 81.858)
33.656 (19.464 to 58.198)
No statistical analyses for this end point

Secondary: Anti-Bordetella pertussis (BPT) antibody concentrations

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End point title
 Anti-Bordetella pertussis (BPT) antibody concentrations
End point description
Seropositivity status, defined as anti-BPT antibody concentrations ≥15 EL.U/mL
End point type
Secondary
End point timeframe
Prior to and one month after the booster vaccination of DTPw-HBV/Hib + OPV or IPV
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
65
25
62
24
Units: EL.U/mL
geometric mean (confidence interval 95%)
    Anti-BPT, Pre-booster [N=65;25;62;24]
12.88 (10.86 to 15.28)
12.46 (9.32 to 16.65)
9.54 (8.34 to 10.91)
10 (8.21 to 12.19)
    Anti-BPT, Post-booster [N=65;25;59;24]
139.51 (123.26 to 157.89)
133.45 (110.33 to 161.4)
121.73 (103.16 to 143.64)
121.76 (91.81 to 161.47)
No statistical analyses for this end point

Secondary: Anti-hepatitis B surface antigen (HBs) antibody concentrations

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End point title
 Anti-hepatitis B surface antigen (HBs) antibody concentrations
End point description
Seroprotection status, defined as anti-HBs antibody concentrations ≥10 mIU/mL.
End point type
Secondary
End point timeframe
Prior to and one month after the booster vaccination of DTPw-HBV/Hib + OPV or IPV
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
69
21
64
19
Units: mIU/mL
geometric mean (confidence interval 95%)
    Anti-HBs, Pre-booster [N=69;21;64;19]
30 (21.1 to 42.8)
23.4 (11.5 to 47.7)
97.9 (77 to 124.5)
113 (55.1 to 231.7)
    Anti-HBs, Post-booster [N=69;21;62;19]
1220.5 (790.6 to 1884)
1098.1 (358.4 to 3364.9)
4428.7 (2980.3 to 6581)
3188.6 (1171.7 to 8677.1)
No statistical analyses for this end point

Secondary: Anti-polio type 1, 2 and 3 antibody titers

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End point title
 Anti-polio type 1, 2 and 3 antibody titers
End point description
Seroprotection status, defined as anti-polio type 1, anti-polio type 2 and anti-polio type 3 antibody titers ≥8
End point type
Secondary
End point timeframe
Prior to and one month after the booster vaccination of DTPw-HBV/Hib + OPV or IPV
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
69
21
64
20
Units: Titers
geometric mean (confidence interval 95%)
    Anti-Polio 1, Pre-booster [N=69;21;63;20]
329.1 (214.9 to 504.1)
269 (114.8 to 630.3)
46.5 (33.6 to 64.4)
51.1 (28.4 to 91.9)
    Anti-Polio 1, Post-booster [N=69;21;63;19]
854.6 (573.5 to 1273.5)
426.9 (166.2 to 1096.7)
932.5 (770.5 to 1128.6)
727.3 (512.9 to 1059.9)
    Anti-Polio 2, Pre-booster [N=69;21;64;20]
222.6 (171.8 to 288.3)
210.4 (115.4 to 383.6)
50.2 (36.9 to 68.2)
60.8 (33.4 to 110.8)
    Anti-Polio 2, Post-booster [N=69;21;63;19]
716.9 (487.6 to 1054.1)
689.1 (304.8 to 1557.9)
1195.7 (977.8 to 1462.2)
1206.6 (737 to 1975.4)
    Anti-Polio 3, Pre-booster [N=69;21;64;20]
102.2 (73.9 to 141.5)
38.4 (20.3 to 72.9)
51.8 (37.4 to 71.7)
71.1 (36.2 to 139.5)
    Anti-Polio 3, Post-booster [N=69;21;63;19]
232.7 (159.6 to 339.4)
190.4 (78.2 to 463.6)
1464.2 (1128 to 1900.6)
1346.2 (857.6 to 2113.2)
No statistical analyses for this end point

Secondary: Number of subjects with Anti-Bordetella pertussis (BPT) with concentrations ≥ 15 EL.U/mL

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End point title
 Number of subjects with Anti-Bordetella pertussis (BPT) with concentrations ≥ 15 EL.U/mL
End point description
End point type
Secondary
End point timeframe
Prior to and one month after the booster vaccination of DTPw-HBV/Hib + OPV or IPV
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
65
25
62
24
Units: Subjects
    Anti-BPT, Pre-booster [N=65;25;62;24]
28
10
12
7
    Anti-BPT, Post-booster [N=65;25;59;24]
65
25
59
24
No statistical analyses for this end point

Secondary: Number of subjects with anti-diphtheria (Anti-DT) and anti-tetanus toxoids (Anti-TT) antibody concentrations ≥ 0.1 mili-international units per mililiter (mIU/mL)

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End point title
 Number of subjects with anti-diphtheria (Anti-DT) and anti-tetanus toxoids (Anti-TT) antibody concentrations ≥ 0.1 mili-international units per mililiter (mIU/mL)
End point description
End point type
Secondary
End point timeframe
Prior to and one month after the booster vaccination of DTPw-HBV/Hib + OPV or IPV
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
65
25
62
24
Units: Subjects
    Anti-DT, Pre-booster [N=65;25;62;24]
56
18
49
15
    Anti-DT, Post-booster [N=65;25;59;24]
65
25
59
24
    Anti-TT, Pre-booster [N= 65;25;62;24]
65
24
60
23
    Anti-TT, Post-booster [N= 65;25;59;24]
65
25
58
24
No statistical analyses for this end point

Secondary: Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration ≥ 0.15 µg/mL

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End point title
 Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration ≥ 0.15 µg/mL
End point description
End point type
Secondary
End point timeframe
Prior to and one month after the booster vaccination of DTPw-HBV/Hib + OPV or IPV
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
65
25
62
24
Units: Subjects
    Anti-PRP, Pre-booster [N=65;25;62;24]
65
25
58
23
    Anti-PRP, Post-booster [N=65;25;59;24]
65
25
59
24
No statistical analyses for this end point

Secondary: Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration ≥ 1.0 µg/mL

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End point title
 Number of subjects with anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentration ≥ 1.0 µg/mL
End point description
End point type
Secondary
End point timeframe
Prior to and one month after the booster vaccination of DTPw-HBV/Hib + OPV or IPV
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
65
25
62
24
Units: Subjects
    Anti-PRP, Pre-booster [N=65;25;62;24]
56
22
32
12
    Anti-PRP, Post-booster [N=65;25;59;24]
65
25
57
24
No statistical analyses for this end point

Secondary: Number of subjects with anti-hepatitis B surface antigen (HBs) antibody concentrations ≥ 10 mIU/mL

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End point title
 Number of subjects with anti-hepatitis B surface antigen (HBs) antibody concentrations ≥ 10 mIU/mL
End point description
End point type
Secondary
End point timeframe
Prior to and one month after the booster vaccination of DTPw-HBV/Hib + OPV or IPV
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
69
21
64
19
Units: Subjects
    Anti-HBs, Pre-booster [N=69;21;64;19]
53
13
63
19
    Anti-HBs, Post-booster [N=69;21;62;19]
68
19
62
19
No statistical analyses for this end point

Secondary: Number of subjects with anti-polio type 1, 2 and 3 (Anti-Polio 1, 2 and 3) antibody titers ≥ 8

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End point title
 Number of subjects with anti-polio type 1, 2 and 3 (Anti-Polio 1, 2 and 3) antibody titers ≥ 8
End point description
End point type
Secondary
End point timeframe
Prior to and one month after the booster vaccination of DTPw-HBV/Hib + OPV or IPV
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
69
21
64
20
Units: Subjects
    Anti-Polio 1, Pre-booster [N=69;21;63;20]
64
19
56
19
    Anti-Polio 1, Post-booster [N=69;21;63;19]
68
19
63
19
    Anti-Polio 2, Pre-booster [N=69;21;64;20]
69
21
59
19
    Anti-Polio 2, Post-booster [N=69;21;63;19]
69
21
63
19
    Anti-Polio 3, Pre-booster [N=69;21;64;20]
65
17
61
18
    Anti-Polio 3, Post-booster [N=69;21;63;19]
66
20
63
19
No statistical analyses for this end point

Secondary: Number of subjects with vaccine response to Anti-Bordetella pertussis (BPT)

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End point title
 Number of subjects with vaccine response to Anti-Bordetella pertussis (BPT)
End point description
Vaccine response for anti-BPT, defined as the appearance of antibodies (i.e. concentrations ≥ 15 EL.U/mL) in subjects seronegative at pre-vaccination (i.e. with concentrations < 15 EL.U/mL), or at least 2-fold increase of pre-vaccination antibody concentrations in those who were initially seropositive at pre-vaccination (i.e. with concentrations ≥ 15 EL.U/mL).
End point type
Secondary
End point timeframe
Prior to and one month after the booster vaccination of DTPw-HBV/Hib + OPV or IPV
End point values
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Number of subjects analysed
37
15
48
16
Units: Subjects
    Anti-BPT, S- [N=37;15;48;16]
37
15
48
16
    Anti-BPT, S+ [N=28;10;11;7]
27
8
11
7
No statistical analyses for this end point

Adverse events

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Adverse events information
Timeframe for reporting adverse events
Solicited local and general symptoms during the 4-day and Unsolicited AEs during the 31-day after booster vaccination; SAEs: throughout the entire study period from the beginning of the booster phase up to the end of the 6-month safety follow-up period
Adverse event reporting additional description
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
Assessment type
 Non-systematic
Dictionary used for adverse event reporting
Dictionary name
 MedDRA
Dictionary version
11.1
Reporting groups
Reporting group title
10PnEPI Group
Reporting group description
 -

Reporting group title
7PnEPI Group
Reporting group description
 -

Reporting group title
10Pn246 Group
Reporting group description
 -

Reporting group title
7Pn246 Group
Reporting group description
 -

Serious adverse events
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Total subjects affected by serious adverse events
     subjects affected / exposed
6 / 280 (2.14%)
1 / 93 (1.08%)
14 / 285 (4.91%)
5 / 98 (5.10%)
     number of deaths (all causes)
0
1
0
0
     number of deaths resulting from adverse events
Injury, poisoning and procedural complications
Internal injury
     subjects affected / exposed
0 / 280 (0.00%)
1 / 93 (1.08%)
0 / 285 (0.00%)
0 / 98 (0.00%)
     occurrences causally related to treatment / all
0 / 0
0 / 1
0 / 0
0 / 0
     deaths causally related to treatment / all
0 / 0
0 / 1
0 / 0
0 / 0
Thermal burn
     subjects affected / exposed
0 / 280 (0.00%)
0 / 93 (0.00%)
1 / 285 (0.35%)
0 / 98 (0.00%)
     occurrences causally related to treatment / all
0 / 0
0 / 0
0 / 1
0 / 0
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
     subjects affected / exposed
0 / 280 (0.00%)
1 / 93 (1.08%)
0 / 285 (0.00%)
0 / 98 (0.00%)
     occurrences causally related to treatment / all
0 / 0
0 / 1
0 / 0
0 / 0
     deaths causally related to treatment / all
0 / 0
0 / 1
0 / 0
0 / 0
Hepatoblastoma
     subjects affected / exposed
0 / 280 (0.00%)
0 / 93 (0.00%)
1 / 285 (0.35%)
0 / 98 (0.00%)
     occurrences causally related to treatment / all
0 / 0
0 / 0
0 / 1
0 / 0
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Blood and lymphatic system disorders
Anaemia
     subjects affected / exposed
0 / 280 (0.00%)
0 / 93 (0.00%)
0 / 285 (0.00%)
1 / 98 (1.02%)
     occurrences causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 1
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Hypoglobulinaemia
     subjects affected / exposed
0 / 280 (0.00%)
0 / 93 (0.00%)
0 / 285 (0.00%)
1 / 98 (1.02%)
     occurrences causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 1
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Lymphadenitis
     subjects affected / exposed
0 / 280 (0.00%)
0 / 93 (0.00%)
0 / 285 (0.00%)
1 / 98 (1.02%)
     occurrences causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 1
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
     subjects affected / exposed
0 / 280 (0.00%)
1 / 93 (1.08%)
0 / 285 (0.00%)
0 / 98 (0.00%)
     occurrences causally related to treatment / all
0 / 0
0 / 1
0 / 0
0 / 0
     deaths causally related to treatment / all
0 / 0
0 / 1
0 / 0
0 / 0
Nervous system disorders
Febrile convulsion
     subjects affected / exposed
3 / 280 (1.07%)
0 / 93 (0.00%)
1 / 285 (0.35%)
0 / 98 (0.00%)
     occurrences causally related to treatment / all
0 / 3
0 / 0
0 / 1
0 / 0
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
General disorders and administration site conditions
Pyrexia
     subjects affected / exposed
0 / 280 (0.00%)
0 / 93 (0.00%)
1 / 285 (0.35%)
0 / 98 (0.00%)
     occurrences causally related to treatment / all
0 / 0
0 / 0
1 / 1
0 / 0
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Gastrointestinal disorders
Diarrhoea
     subjects affected / exposed
0 / 280 (0.00%)
0 / 93 (0.00%)
1 / 285 (0.35%)
1 / 98 (1.02%)
     occurrences causally related to treatment / all
0 / 0
0 / 0
0 / 1
0 / 1
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Enterocolitis haemorrhagic
     subjects affected / exposed
0 / 280 (0.00%)
0 / 93 (0.00%)
0 / 285 (0.00%)
1 / 98 (1.02%)
     occurrences causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 1
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Intussusception
     subjects affected / exposed
0 / 280 (0.00%)
0 / 93 (0.00%)
0 / 285 (0.00%)
1 / 98 (1.02%)
     occurrences causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 1
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Metabolism and nutrition disorders
Dehydration
     subjects affected / exposed
1 / 280 (0.36%)
0 / 93 (0.00%)
0 / 285 (0.00%)
0 / 98 (0.00%)
     occurrences causally related to treatment / all
0 / 1
0 / 0
0 / 0
0 / 0
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Infections and infestations
Gastroenteritis
     subjects affected / exposed
1 / 280 (0.36%)
0 / 93 (0.00%)
5 / 285 (1.75%)
2 / 98 (2.04%)
     occurrences causally related to treatment / all
0 / 1
0 / 0
0 / 5
0 / 2
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Pneumonia
     subjects affected / exposed
1 / 280 (0.36%)
0 / 93 (0.00%)
3 / 285 (1.05%)
1 / 98 (1.02%)
     occurrences causally related to treatment / all
0 / 1
0 / 0
0 / 3
0 / 1
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Bronchitis
     subjects affected / exposed
1 / 280 (0.36%)
0 / 93 (0.00%)
2 / 285 (0.70%)
0 / 98 (0.00%)
     occurrences causally related to treatment / all
0 / 1
0 / 0
0 / 2
0 / 0
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Pharyngitis
     subjects affected / exposed
0 / 280 (0.00%)
0 / 93 (0.00%)
3 / 285 (1.05%)
0 / 98 (0.00%)
     occurrences causally related to treatment / all
0 / 0
0 / 0
1 / 3
0 / 0
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Gastroenteritis rotavirus
     subjects affected / exposed
0 / 280 (0.00%)
0 / 93 (0.00%)
2 / 285 (0.70%)
0 / 98 (0.00%)
     occurrences causally related to treatment / all
0 / 0
0 / 0
0 / 2
0 / 0
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Amoebiasis
     subjects affected / exposed
1 / 280 (0.36%)
0 / 93 (0.00%)
0 / 285 (0.00%)
0 / 98 (0.00%)
     occurrences causally related to treatment / all
0 / 1
0 / 0
0 / 0
0 / 0
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Clostridium difficile colitis
     subjects affected / exposed
0 / 280 (0.00%)
0 / 93 (0.00%)
0 / 285 (0.00%)
1 / 98 (1.02%)
     occurrences causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 1
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Infectious mononucleosis
     subjects affected / exposed
0 / 280 (0.00%)
0 / 93 (0.00%)
1 / 285 (0.35%)
0 / 98 (0.00%)
     occurrences causally related to treatment / all
0 / 0
0 / 0
0 / 1
0 / 0
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Infestation
     subjects affected / exposed
0 / 280 (0.00%)
0 / 93 (0.00%)
0 / 285 (0.00%)
1 / 98 (1.02%)
     occurrences causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 1
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Nasopharyngitis
     subjects affected / exposed
0 / 280 (0.00%)
0 / 93 (0.00%)
1 / 285 (0.35%)
0 / 98 (0.00%)
     occurrences causally related to treatment / all
0 / 0
0 / 0
0 / 1
0 / 0
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Otitis media
     subjects affected / exposed
0 / 280 (0.00%)
0 / 93 (0.00%)
1 / 285 (0.35%)
0 / 98 (0.00%)
     occurrences causally related to treatment / all
0 / 0
0 / 0
0 / 1
0 / 0
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Pneumonia mycoplasmal
     subjects affected / exposed
0 / 280 (0.00%)
0 / 93 (0.00%)
1 / 285 (0.35%)
0 / 98 (0.00%)
     occurrences causally related to treatment / all
0 / 0
0 / 0
0 / 1
0 / 0
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Rotavirus infection
     subjects affected / exposed
0 / 280 (0.00%)
0 / 93 (0.00%)
1 / 285 (0.35%)
0 / 98 (0.00%)
     occurrences causally related to treatment / all
0 / 0
0 / 0
0 / 1
0 / 0
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Tonsillitis
     subjects affected / exposed
0 / 280 (0.00%)
0 / 93 (0.00%)
1 / 285 (0.35%)
0 / 98 (0.00%)
     occurrences causally related to treatment / all
0 / 0
0 / 0
0 / 1
0 / 0
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Urinary tract infection
     subjects affected / exposed
1 / 280 (0.36%)
0 / 93 (0.00%)
0 / 285 (0.00%)
0 / 98 (0.00%)
     occurrences causally related to treatment / all
0 / 1
0 / 0
0 / 0
0 / 0
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Wound
     subjects affected / exposed
1 / 280 (0.36%)
0 / 93 (0.00%)
0 / 285 (0.00%)
0 / 98 (0.00%)
     occurrences causally related to treatment / all
0 / 1
0 / 0
0 / 0
0 / 0
     deaths causally related to treatment / all
0 / 0
0 / 0
0 / 0
0 / 0
Frequency threshold for reporting non-serious adverse events: 5%
Non-serious adverse events
 10PnEPI Group 7PnEPI Group 10Pn246 Group 7Pn246 Group
Total subjects affected by non serious adverse events
     subjects affected / exposed
203 / 280 (72.50%)
66 / 93 (70.97%)
248 / 285 (87.02%)
79 / 98 (80.61%)
General disorders and administration site conditions
Pain
alternative assessment type: Systematic
     subjects affected / exposed [1]
203 / 280 (72.50%)
66 / 93 (70.97%)
248 / 278 (89.21%)
77 / 96 (80.21%)
     occurrences all number
203
66
248
77
Redness
alternative assessment type: Systematic
     subjects affected / exposed [2]
107 / 280 (38.21%)
37 / 93 (39.78%)
197 / 278 (70.86%)
66 / 96 (68.75%)
     occurrences all number
107
37
197
66
Swelling
alternative assessment type: Systematic
     subjects affected / exposed [3]
92 / 280 (32.86%)
32 / 93 (34.41%)
158 / 278 (56.83%)
52 / 96 (54.17%)
     occurrences all number
92
32
158
52
Drowsiness
alternative assessment type: Systematic
     subjects affected / exposed [4]
90 / 280 (32.14%)
32 / 93 (34.41%)
190 / 278 (68.35%)
66 / 96 (68.75%)
     occurrences all number
90
32
190
66
Fever (Rectally)
alternative assessment type: Systematic
     subjects affected / exposed [5]
138 / 280 (49.29%)
51 / 93 (54.84%)
215 / 278 (77.34%)
65 / 96 (67.71%)
     occurrences all number
138
51
215
65
Irritability
alternative assessment type: Systematic
     subjects affected / exposed [6]
173 / 280 (61.79%)
64 / 93 (68.82%)
243 / 278 (87.41%)
79 / 96 (82.29%)
     occurrences all number
173
64
243
79
Loss of appetite
alternative assessment type: Systematic
     subjects affected / exposed [7]
97 / 280 (34.64%)
28 / 93 (30.11%)
184 / 278 (66.19%)
57 / 96 (59.38%)
     occurrences all number
97
28
184
57
Infections and infestations
Gastroenteritis
     subjects affected / exposed
6 / 280 (2.14%)
3 / 93 (3.23%)
10 / 285 (3.51%)
5 / 98 (5.10%)
     occurrences all number
6
3
10
5
Nasopharyngitis
     subjects affected / exposed
0 / 280 (0.00%)
0 / 93 (0.00%)
15 / 285 (5.26%)
5 / 98 (5.10%)
     occurrences all number
0
0
15
5
Pharyngitis
     subjects affected / exposed
0 / 280 (0.00%)
0 / 93 (0.00%)
5 / 285 (1.75%)
6 / 98 (6.12%)
     occurrences all number
0
0
5
6
Rhinitis
     subjects affected / exposed
3 / 280 (1.07%)
2 / 93 (2.15%)
11 / 285 (3.86%)
5 / 98 (5.10%)
     occurrences all number
3
2
11
5
Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: The analysis of the solicited symptom included only subjects with documented data.
[2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: The analysis of the solicited symptom included only subjects with documented data.
[3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: The analysis of the solicited symptom included only subjects with documented data.
[4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: The analysis of the solicited symptom included only subjects with documented data.
[5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: The analysis of the solicited symptom included only subjects with documented data.
[6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: The analysis of the solicited symptom included only subjects with documented data.
[7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: The analysis of the solicited symptom included only subjects with documented data.

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Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? Yes
Date
Amendment
14 Mar 2008
The protocol was amended to plan for an interim analysis on final cleaned safety and reactogenicity data. This allowed providing to the authorities additional safety and reactogenicity data of a booster dose of GSK Biologicals’ 10Pn-PD-DiT vaccine co-administered with a DTPw-combined vaccine.

Interruptions (globally)
Were there any global interruptions to the trial? No

Limitations and caveats
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
None reported

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