Página Nct de ensaios clínicos

Clinical Trial Results:
Comparison of the immunogenicity and safety of a combined adsorbed low dose diphtheria, tetanus and inactivated poliomyelitis vaccine (REVAXIS®) with a combined diphtheria, tetanus and inactivated poliomyelitis vaccine (DT Polio®) when given as a booster dose at 6 years of age.

Summary
EudraCT number
 2005-001446-16
Trial protocol
 FR  
Global end of trial date
16 Jan 2008

Results information
Results version number
 v1(current)
This version publication date
27 Apr 2016
First version publication date
29 May 2015
Other versions

Trial information

 Close Top of page
Trial identification
Sponsor protocol code
F05-TdI-301
Additional study identifiers
ISRCTN number
 -
US NCT number
 NCT00447525
WHO universal trial number (UTN)
 -
Sponsors
Sponsor organisation name
Sanofi Pasteur MSD S.N.C.
Sponsor organisation address
162 avenue Jean Jaurès - CS 50712, Lyon Cedex 07, France, 69367
Public contact
Clinical Trials Disclosure, Sanofi Pasteur MSD S.N.C, ClinicalTrialsDisclosure@spmsd.com
Scientific contact
Clinical Trials Disclosure, Sanofi Pasteur MSD S.N.C, ClinicalTrialsDisclosure@spmsd.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
16 Jan 2008
Is this the analysis of the primary completion data?
No
Global end of trial reached?
Yes
Global end of trial date
16 Jan 2008
Was the trial ended prematurely?
No
General information about the trial
Main objective of the trial
To demonstrate that the Diphtheria seroprotection response (defined as anti-diphtheria antibody titre (SN) ≥0.1 IU/mL), the Tetanus seroprotection response (defined as an anti-tetanus antibody titre (EIA) ≥0.1 IU/mL), and the Poliomyelitis type 1, 2 & 3 seroprotection responses (defined as an anti-poliovirus antibody type 1, 2 & 3 titre (SN) ≥8 (1/dil)) 1 month (28 to 35 days) after a single dose of REVAXIS® (dT-IPV vaccine) is non inferior to the Diphtheria, Tetanus and Poliomyelitis type 1, 2 & 3 seroprotection responses 1 month after a single dose of DT Polio® (DT-IPV vaccine) when given as a second booster to healthy 6 year-old children who received 3-dose primary series within the first 6 months of life and a first booster at 16-18 months of life (+/-2 months) including DT-IPV vaccine.
Protection of trial subjects
Subjects in the study received a single dose of the study vaccine or comparator vaccine supplied in a pre-filled 0.5 mL syringe that was administered by qualified study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After each vaccination, subjects were also kept under observation for 20 minutes to ensure their safety. Appropriate equipment were also available on site in case of any immediate allergic reactions.
Background therapy
 Children were previously vaccinated with 3 doses of a diphtheria, tetanus and poliomyelitis containing vaccine given alone or in combination within the first 6 months of life and a booster dose of a diphtheria, tetanus and poliomyelitis containing vaccine given alone or in combination at 16-18 months of life (+/-2 months).
Evidence for comparator
 The comparator group (DT Polio Group) was added in order to answer the study objective. Indeed, this study was designed to provide comparative data of the immunogenicity and the safety of REVAXIS versus DT Polio when given as a booster dose at 6 years of age. DT Polio was a reference vaccine licensed and recommended as diphtheria, tetanus and poliovirus booster at 6 years of age in France.
Actual start date of recruitment
24 Jan 2007
Long term follow-up planned
No
Independent data monitoring committee (IDMC) involvement?
No
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled
France: 760
Worldwide total number of subjects
760
EEA total number of subjects
760
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)
0
Children (2-11 years)
760
Adolescents (12-17 years)
0
Adults (18-64 years)
0
From 65 to 84 years
0
85 years and over
0

Subject disposition

 Close Top of page
Recruitment
Recruitment details
 Study participants were recruited for the study between 24 January 2007 and 10 December 2007 in 71 active centres in France.

Pre-assignment
Screening details
 788 subjects were screened in this study. 760 subjects were randomised. 759 subjects met all inclusion criteria and none of the non-inclusion criteria. 758 subjects were vaccinated and completed the study.

Period 1
Period 1 title
Overall trial (overall period)
Is this the baseline period?
 Yes
Allocation method
Randomised - controlled
Blinding used
 Not blinded
Blinding implementation details
Blinding is not applicable as this study was an open-label study.

Arms
Are arms mutually exclusive
Yes

Arm title
 REVAXIS Group
Arm description
 Participants received a single dose of REVAXIS (diphtheria, tetanus and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)).
Arm type
 Experimental

Investigational medicinal product name
REVAXIS®
Investigational medicinal product code
Other name
Pharmaceutical forms
Suspension for injection in pre-filled syringe
Routes of administration
Intramuscular use
Dosage and administration details
One 0.5 mL dose (intramuscular, deltoid) at 6 years of age.

Arm title
 DT Polio Group
Arm description
 Participants received a single dose of DT Polio (diphtheria, tetanus and inactivated poliovirus vaccine).
Arm type
 Active comparator

Investigational medicinal product name
DT Polio®
Investigational medicinal product code
Other name
Pharmaceutical forms
Suspension for injection in pre-filled syringe
Routes of administration
Intramuscular use
Dosage and administration details
One 0.5 mL dose (intramuscular, deltoid) at 6 years of age.

Number of subjects in period 1
REVAXIS Group DT Polio Group
Started
384
376
Vaccinated
383
375
Completed
383
375
Not completed
1
1
     Protocol deviation
1
-
     Consent withdrawn by subject
-
1

Baseline characteristics

 Close Top of page
Baseline characteristics reporting groups
Reporting group title
REVAXIS Group
Reporting group description
 Participants received a single dose of REVAXIS (diphtheria, tetanus and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)).

Reporting group title
DT Polio Group
Reporting group description
 Participants received a single dose of DT Polio (diphtheria, tetanus and inactivated poliovirus vaccine).

Reporting group values
 REVAXIS Group DT Polio Group Total
Number of subjects
 384 376 760
Age categorical
Units: Subjects
    Children (2-11 years)
 384 376 760
Age continuous
Age in years at vaccination (1 missing value in the REVAXIS group)
Units: years
    arithmetic mean (standard deviation)
 6.4 ± 0.3 6.4 ± 0.3 -
Gender categorical
Female and male
Units: Subjects
    Female
 182 180 362
    Male
 202 196 398
Weight continuous
Weight in kg at vaccination
Units: kg
    arithmetic mean (standard deviation)
 22.4 ± 3.6 22.6 ± 3.8 -
Height continuous
Height in cm at vaccination
Units: cm
    arithmetic mean (standard deviation)
 119 ± 5.3 119.2 ± 5.5 -

End points

 Close Top of page
End points reporting groups
Reporting group title
REVAXIS Group
Reporting group description
 Participants received a single dose of REVAXIS (diphtheria, tetanus and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)).

Reporting group title
DT Polio Group
Reporting group description
 Participants received a single dose of DT Polio (diphtheria, tetanus and inactivated poliovirus vaccine).

Primary: Seroprotection against diphtheria (SN), tetanus (EIA), and polio 1, 2 & 3 (SN) one month after one dose of REVAXIS vaccine or DT Polio vaccine

 Close Top of page
End point title
 Seroprotection against diphtheria (SN), tetanus (EIA), and polio 1, 2 & 3 (SN) one month after one dose of REVAXIS vaccine or DT Polio vaccine
End point description
On day 0 (D0), study participants were blood sampled and then received 1 dose of study or comparator vaccine. One month later (i.e., 28 to 35 days post vaccination), study participants were blood sampled. Antibody titres were measured using seroneutralisation method (SN) for diphtheria and polio 1, 2 & 3, enzyme immunoassay (EIA) for diphtheria and tetanus. Seroprotection was defined as a titre ≥0.10 IU/mL for diphtheria (SN), ≥0.10 IU/mL for tetanus (EIA), ≥8 (1/dil) for polio 1, 2 & 3 (SN). Analysis was done on the Per Protocol set. Note: (N=***, ***) represents the number of assessed subjects in the REVAXIS and DT Polio groups, respectively.
End point type
Primary
End point timeframe
One month (28 to 35 days) after vaccination.
End point values
 REVAXIS Group DT Polio Group
Number of subjects analysed
284
283
Units: Percentage of subjects
number (confidence interval 95%)
    Anti-Diphtheria ≥0.10 IU/mL (SN) (N=284, 283)
98.6 (96.4 to 99.6)
99.3 (97.5 to 99.9)
    Anti-Tetanus ≥0.10 IU/mL (EIA) (N=284, 283)
99.6 (98.1 to 100)
100 (98.7 to 100)
    Anti-Polio 1 ≥8 (1/dil) (SN) (N=284, 283)
100 (98.7 to 100)
100 (98.7 to 100)
    Anti-Polio 2 ≥8 (1/dil) (SN) (N=284, 283)
100 (98.7 to 100)
100 (98.7 to 100)
    Anti-Polio 3 ≥8 (1/dil) (SN) (N=284, 282)
100 (98.7 to 100)
100 (98.7 to 100)
Statistical analysis title
 Non-inferiority analysis for diphtheria (SN)
Statistical analysis description
The estimate of the difference between groups in the diphtheria, tetanus and poliomyelitis type 1, 2 & 3 seroprotection rates was calculated with their two-sided 95% confidence interval (CI). If all lower bounds of the 95% CIs of the difference were higher than -5 % (i.e the non-inferiority margin) it was concluded that the REVAXIS Group was non-inferior to the DT Polio Group. Analysis was done on the Per Protocol set.
Comparison groups
REVAXIS Group v DT Polio Group
Number of subjects included in analysis
567
Analysis specification
Pre-specified
Analysis type
 non-inferiority [1]
Method
 Wilson score method without CC
Parameter type
 Difference in percentages of subjects
Point estimate
-0.7
Confidence interval
     level
 95%
     sides
2-sided
     lower limit
 -2.9
     upper limit
 1.3
Notes
[1] - The immune response of REVAXIS vaccine was considered as non-inferior to DT Polio vaccine if the lower bound of the 2-sided 95% CI of the difference in the percentages of subjects with antibody titres ≥0.10 IU/mL for diphtheria (SN) was greater than -5%. CI was based on the Wilson score method without continuity correction (CC).
Statistical analysis title
 Non inferiority analysis for tetanus (EIA)
Statistical analysis description
The estimate of the difference between groups in the diphtheria, tetanus and poliomyelitis type 1, 2 & 3 seroprotection rates was calculated with their two-sided 95% confidence interval (CI). If all lower bounds of the 95% CIs of the difference were higher than -5 % (i.e the non-inferiority margin) it was concluded that the REVAXIS Group was non-inferior to the DT Polio Group. Analysis was done on the Per Protocol set.
Comparison groups
REVAXIS Group v DT Polio Group
Number of subjects included in analysis
567
Analysis specification
Pre-specified
Analysis type
 non-inferiority [2]
Method
 Wilson score method without CC
Parameter type
 Difference in percentages of subjects
Point estimate
-0.4
Confidence interval
     level
 95%
     sides
2-sided
     lower limit
 -2
     upper limit
 1
Notes
[2] - The immune response of REVAXIS vaccine was considered as non-inferior to DT Polio vaccine if the lower bound of the 2-sided 95% CI of the difference in the percentages of subjects with antibody titres ≥0.10 IU/mL for tetanus (EIA) was greater than -5%. CI was based on the Wilson score method without continuity correction (CC).
Statistical analysis title
 Non inferiority analysis for Polio 1 (SN)
Statistical analysis description
The estimate of the difference between groups in the diphtheria, tetanus and poliomyelitis type 1, 2 & 3 seroprotection rates was calculated with their two-sided 95% confidence interval (CI). If all lower bounds of the 95% CIs of the difference were higher than -5 % (i.e the non-inferiority margin) it was concluded that the REVAXIS Group was non-inferior to the DT Polio Group. Analysis was done on the Per Protocol set.
Comparison groups
REVAXIS Group v DT Polio Group
Number of subjects included in analysis
567
Analysis specification
Pre-specified
Analysis type
 non-inferiority [3]
Method
 Wilson score method without CC
Parameter type
 Difference in percentages of subjects
Point estimate
0
Confidence interval
     level
 95%
     sides
2-sided
     lower limit
 -1.3
     upper limit
 1.3
Notes
[3] - The immune response of REVAXIS vaccine was considered as non-inferior to DT Polio vaccine if the lower bound of the 2-sided 95% CI of the difference in the percentages of subjects with antibody titres ≥8 (1/dil for polio 1 (SN) was greater than -5%. CI was based on the Wilson score method without continuity correction (CC).
Statistical analysis title
 Non inferiority analysis for Polio 2 (SN)
Statistical analysis description
The estimate of the difference between groups in the diphtheria, tetanus and poliomyelitis type 1, 2 & 3 seroprotection rates was calculated with their two-sided 95% confidence interval (CI). If all lower bounds of the 95% CIs of the difference were higher than -5 % (i.e the non-inferiority margin) it was concluded that the REVAXIS Group was non-inferior to the DT Polio Group. Analysis was done on the Per Protocol set.
Comparison groups
REVAXIS Group v DT Polio Group
Number of subjects included in analysis
567
Analysis specification
Pre-specified
Analysis type
 non-inferiority [4]
Method
 Wilson score method without CC
Parameter type
 Difference in percentages of subjects
Point estimate
0
Confidence interval
     level
 95%
     sides
2-sided
     lower limit
 -1.3
     upper limit
 1.3
Notes
[4] - The immune response of REVAXIS vaccine was considered as non-inferior to DT Polio vaccine if the lower bound of the 2-sided 95% CI of the difference in the percentages of subjects with antibody titres ≥8 (1/dil) for polio 2 (SN) was greater than -5%. CI was based on the Wilson score method without continuity correction (CC).
Statistical analysis title
 Non inferiority analysis for Polio 3 (SN)
Statistical analysis description
The estimate of the difference between groups in the diphtheria, tetanus and poliomyelitis type 1, 2 & 3 seroprotection rates was calculated with their two-sided 95% confidence interval (CI). If all lower bounds of the 95% CIs of the difference were higher than -5 % (i.e the non-inferiority margin) it was concluded that the REVAXIS Group was non-inferior to the DT Polio Group. Analysis was done on the Per Protocol set.
Comparison groups
REVAXIS Group v DT Polio Group
Number of subjects included in analysis
567
Analysis specification
Pre-specified
Analysis type
 non-inferiority [5]
Method
 Wilson score method without CC
Parameter type
 Difference in percentages of subjects
Point estimate
0
Confidence interval
     level
 95%
     sides
2-sided
     lower limit
 -1.3
     upper limit
 1.3
Notes
[5] - The immune response of REVAXIS vaccine was considered as non-inferior to DT Polio vaccine if the lower bound of the 2-sided 95% CI of the difference in the percentages of subjects with antibody titres ≥8 (1/dil) for polio 3 (SN) was greater than -5%. CI was based on the Wilson score method without continuity correction (CC).

Secondary: Geometric Mean Titres of anti-diphtheria, anti-tetanus and anti-polio 1, 2 & 3 antibodies one month after one dose of REVAXIS vaccine or DT Polio vaccine

 Close Top of page
End point title
 Geometric Mean Titres of anti-diphtheria, anti-tetanus and anti-polio 1, 2 & 3 antibodies one month after one dose of REVAXIS vaccine or DT Polio vaccine
End point description
On day 0 (D0), study participants were blood sampled and then received 1 dose of study or comparator vaccine. One month later (28 to 35 days, i.e., post vaccination), study participants were blood sampled. Antibody titres were measured using seroneutralisation method (SN) for diphtheria and polio 1, 2 & 3, enzyme immunoassay (EIA) for diphtheria and tetanus. Antibody titres are expressed in IU/mL for diphtheria (SN), for diphtheria (EIA), and for tetanus (EIA), and 1/dil for polio 1, 2 & 3 (SN). Analysis was done on the Per Protocol set. Note: (N=***, ***) represents the number of assessed subjects in the REVAXIS and DT Polio groups, respectively.
End point type
Secondary
End point timeframe
One month (28 to 35 days) after vaccination.
End point values
 REVAXIS Group DT Polio Group
Number of subjects analysed
284
283
Units: Titres
geometric mean (confidence interval 95%)
    Anti-Diphtheria (SN) (N=284, 283)
3.71 (3.14 to 4.38)
23.32 (19.52 to 27.85)
    Anti-Diphtheria (EIA) (N=284, 281)
1.9 (1.65 to 2.19)
8.31 (7.24 to 9.54)
    Anti-Tetanus (EIA) (N=284, 283)
9.38 (8.33 to 10.56)
13.87 (12.21 to 15.76)
    Anti-Polio 1 (SN) (N=284, 283)
4776.77 (4093.41 to 5574.21)
7705.41 (6681.88 to 8885.73)
    Anti-Polio 2 (SN) (N=284, 283)
5715.35 (4919.35 to 6640.16)
4534.24 (3931.99 to 5228.73)
    Anti-Polio 3 (SN) (N=284, 282)
6015.97 (5138.41 to 7043.41)
2248.5 (1906.62 to 2651.69)
No statistical analyses for this end point

Secondary: Response rates for diphtheria (SN & EIA) and tetanus (EIA) one month after one dose of REVAXIS vaccine or DT Polio vaccine

 Close Top of page
End point title
 Response rates for diphtheria (SN & EIA) and tetanus (EIA) one month after one dose of REVAXIS vaccine or DT Polio vaccine
End point description
On day 0 (D0), study participants were blood sampled and then received 1 dose of study or comparator vaccine. One month later (28 to 35 days, i.e., post vaccination), study participants were blood sampled. Antibody titres were measured using seroneutralisation method (SN) for diphtheria and polio 1, 2 & 3, enzyme immunoassay (EIA) for diphtheria and tetanus. Thresholds were defined as titres ≥1.0 IU/mL for diphtheria (SN), ≥0.10 IU/mL and ≥1.0 IU/mL for diphtheria (EIA), ≥1.0 IU/mL for tetanus (EIA). Analysis was done on the Per Protocol set. Note: (N=***, ***) represents the number of assessed subjects in the REVAXIS and DT Polio groups, respectively.
End point type
Secondary
End point timeframe
One month (28 to 35 days) after vaccination.
End point values
 REVAXIS Group DT Polio Group
Number of subjects analysed
284
283
Units: Percentage of subjects
number (confidence interval 95%)
    Anti-Diphtheria ≥1.0 IU/mL (SN) (N=284, 283)
85.9 (81.3 to 89.7)
98.6 (96.4 to 99.6)
    Anti-Diphtheria ≥0.1 IU/mL (EIA) (N=284, 281)
98.6 (96.4 to 99.6)
99.6 (98 to 100)
    Anti-Diphtheria ≥1.0 IU/mL (EIA) (N=284, 281)
71.1 (65.5 to 76.3)
95 (91.8 to 97.2)
    Anti-Tetanus ≥1.0 IU/mL (EIA) (N=284, 283)
98.6 (96.4 to 99.6)
97.5 (95 to 99)
No statistical analyses for this end point

Secondary: Geometric Mean of (individual) Titres Ratios of anti-diphtheria, anti-tetanus and anti-polio 1, 2 & 3 antibodies one month after one dose of REVAXIS vaccine or DT Polio vaccine

 Close Top of page
End point title
 Geometric Mean of (individual) Titres Ratios of anti-diphtheria, anti-tetanus and anti-polio 1, 2 & 3 antibodies one month after one dose of REVAXIS vaccine or DT Polio vaccine
End point description
On day 0 (D0), study participants were blood sampled and then received 1 dose of study or comparator vaccine. One month later (28 to 35 days, i.e., post vaccination), study participants were blood sampled. Antibody titres were measured using seroneutralisation method (SN) for diphtheria and polio 1, 2 & 3, enzyme immunoassay (EIA) for diphtheria and tetanus. Individual post (D28) / pre (D0) antibody titre ratios were measured for diphtheria, tetanus and polio 1, 2 & 3. Analysis was done on the Per Protocol set. Note: (N=***, ***) represents the number of assessed subjects in the REVAXIS and DT Polio groups, respectively.
End point type
Secondary
End point timeframe
One month (28 to 35 days) after vaccination.
End point values
 REVAXIS Group DT Polio Group
Number of subjects analysed
284
283
Units: Not applicable
geometric mean (confidence interval 95%)
    Anti-Diphtheria (SN) (N=284, 283)
58.62 (47.59 to 72.2)
307.62 (247.53 to 382.31)
    Anti-Diphtheria (EIA) (N=284, 280)
27.79 (23.75 to 32.52)
112.23 (97.28 to 129.47)
    Anti-Tetanus (EIA) (N=284, 283)
38.7 (33.37 to 44.89)
58.95 (51.61 to 67.32)
    Anti-Polio 1 (SN) (N=283, 282)
63.52 (49.07 to 82.23)
121.98 (93.58 to 159.02)
    Anti-Polio 2 (SN) (N=284, 283)
56.92 (44.28 to 73.17)
54.11 (42 to 69.71)
    Anti-Polio 3 (SN) (N=284, 282)
51.51 (40.26 to 65.89)
23.68 (18.88 to 29.68)
No statistical analyses for this end point

Secondary: Summary of safety (D0-D28)

 Close Top of page
End point title
 Summary of safety (D0-D28)
End point description
Adverse events (AEs) were reported onto the diary card by the parent(s) or legal representative: - From day 0 (D0) to D7 for solicited injection-site adverse reactions (ISRs: injection site pain, erythema, and swelling) and solicited systemic AEs (headache, myalgia, pyrexia); - From D0 to Visit 2 for unsolicited (spontaneously reported) ISRs and systemic AEs. AEs at injection sites were always considered as related to vaccine (Injection-Site Reactions (ISRs)). The investigator had to assess whether systemic AEs were related or not to the vaccine. All (related and unrelated) are displayed here. Descriptive analysis was done on the Safety Analysis set. One subject was randomised in the DT Polio Group but received REVAXIS vaccine. The subject was thus included in the REVAXIS Group in the Safety Analysis set, which therefore included 384 subjects in the REVAXIS group, and 374 subjects in the DT Polio Group.
End point type
Secondary
End point timeframe
One month (28 to 35 days) after vaccination.
End point values
 REVAXIS Group DT Polio Group
Number of subjects analysed
384
374
Units: Percentage of subjects
number (not applicable)
    D0 to D28, any AE
83.1
85.6
    D0 to D7, any AE
82.6
84.2
    D0 to D7, ISR
76
78.6
    D0 to D7, solicited ISR
76
78.6
    D0 to D7, unsolicited ISR
3.4
5.6
    D0 to D7, systemic AE
42.4
40.9
    D0 to D7, solicited systemic AE
35.4
36.4
    D0 to D7, unsolicited systemic AE
12.2
12.3
    D0 to D7, vaccine-related systemic AE
33.3
34
    D0 to D7, vaccine-related solicited systemic AE
31.3
32.9
    D0 to D7, vaccine-related unsolicited systemic AE
3.1
2.9
    D8 to D28, any AE
10.7
11
    D8 to D28, ISR
0
0
    D8 to D28, systemic AE
10.7
11
    D8 to D28, vaccine-related systemic AE
1.3
0.5
No statistical analyses for this end point

Secondary: Proportion of subjects reporting solicited injection-site reactions from D0 to D7 after one dose of REVAXIS vaccine or DT Polio vaccine

 Close Top of page
End point title
 Proportion of subjects reporting solicited injection-site reactions from D0 to D7 after one dose of REVAXIS vaccine or DT Polio vaccine
End point description
Solicited injection-site adverse reactions (ISRs: injection-site pain, injection-site erythema, and injection-site swelling) were reported onto the diary card by the parent(s) or legal representative from day 0 (D0) to D7. AEs at injection sites were always considered as related to vaccine (Injection-Site Reactions (ISRs)). Descriptive analysis was done on the Safety Analysis set.
End point type
Secondary
End point timeframe
One month (28 to 35 days) after vaccination
End point values
 REVAXIS Group DT Polio Group
Number of subjects analysed
384
374
Units: Percentage of subjects
number (not applicable)
    Injection site erythema
40.9
47.1
    Injection site pain
69.8
69.8
    Injection site swelling
32.3
37.4
No statistical analyses for this end point

Secondary: Proportion of subjects reporting solicited systemic adverse events and reactions from D0 to D7 after one dose of REVAXIS vaccine or DT Polio vaccine

 Close Top of page
End point title
 Proportion of subjects reporting solicited systemic adverse events and reactions from D0 to D7 after one dose of REVAXIS vaccine or DT Polio vaccine
End point description
Solicited systemic adverse events (AEs: headache, myalgia, pyrexia) were reported onto the diary card by the parent(s) or legal representative from day 0 (D0) to D7. The investigator had to assess whether systemic AEs were related or not to the vaccine. All (related and unrelated) are displayed here. Pyrexia was defined in this study as an oral temperature of 37.5°C or over. From D0 to D7, temperature values were captured in the diary card. In case of an oral temperature of 37.5°C or over at D7, the maximum temperature value of the event was also captured. From D0 to D7, temperature had to be measured once daily at the same time every day, preferably in the evening, and at the time of any apparent fever. At any time during the study, the highest observed temperature of the day had to be recorded in the diary card. Descriptive analysis was done on the Safety Analysis set.
End point type
Secondary
End point timeframe
One month (28 to 35 days) after vaccination
End point values
 REVAXIS Group DT Polio Group
Number of subjects analysed
384
374
Units: Percentage of subjects
number (not applicable)
    Headache (all)
15.1
19.3
    Headache (related)
12.2
16.6
    Myalgia (all)
21.4
17.9
    Myalgia (related)
19.3
17.1
    Pyrexia (all)
11.2
14.4
    Pyrexia (related)
9.6
11.2
No statistical analyses for this end point

Adverse events

 Close Top of page
Adverse events information
Timeframe for reporting adverse events
Adverse event (AE) data were collected from Day 0 (D0) to Visit 2 (D28 to D35). Solicited AEs (collected from D0 to D7) are detailed in the "End points" section. Unsolicited AEs (collected from D0 to D28) are detailed in this section.
Adverse event reporting additional description
One subject was randomised in the DT Polio Group but received REVAXIS vaccine. The subject was thus included in the REVAXIS Group in the Safety Analysis set, which therefore included 384 subjects in the REVAXIS group, and 374 subjects in the DT Polio Group.
Assessment type
 Non-systematic
Dictionary used for adverse event reporting
Dictionary name
 MedDRA
Dictionary version
9.1
Reporting groups
Reporting group title
REVAXIS Group
Reporting group description
 Participants received a single dose of REVAXIS (diphtheria, tetanus and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)). The number of subjects reporting at least 1 unsolicited ISR or AE with incidence ≥1% are presented hereafter. If each unsolicited ISR or AE with incidence ≥1% was reported by a different subject, the number of subjects reporting at least 1 unsolicited ISR or AE with incidence ≥1% would have been 67.

Reporting group title
DT Polio Group
Reporting group description
 Participants received a single dose of DT Polio (diphtheria, tetanus and inactivated poliovirus vaccine). The number of subjects reporting at least 1 unsolicited ISR or AE with incidence ≥1% are presented hereafter. If each unsolicited ISR or AE with incidence ≥1% was reported by a different subject, the number of subjects reporting at least 1 unsolicited ISR or AE with incidence ≥1% would have been 59.

Serious adverse events
 REVAXIS Group DT Polio Group
Total subjects affected by serious adverse events
     subjects affected / exposed
0 / 384 (0.00%)
1 / 374 (0.27%)
     number of deaths (all causes)
0
0
     number of deaths resulting from adverse events
0
0
Surgical and medical procedures
Nose fracture
Additional description: Subject 9500002 experienced accidental severe nose fracture 14 days after receiving one dose of DT Polio vaccine. He was hospitalised to treat the fracture by surgery. SAE assessed as unrelated with the study vaccine.
     subjects affected / exposed
0 / 384 (0.00%)
1 / 374 (0.27%)
     occurrences causally related to treatment / all
0 / 0
0 / 1
     deaths causally related to treatment / all
0 / 0
0 / 0
Frequency threshold for reporting non-serious adverse events: 1%
Non-serious adverse events
 REVAXIS Group DT Polio Group
Total subjects affected by non serious adverse events
     subjects affected / exposed
67 / 384 (17.45%)
59 / 374 (15.78%)
Respiratory, thoracic and mediastinal disorders
D0-D7, Cough
     subjects affected / exposed
8 / 384 (2.08%)
6 / 374 (1.60%)
     occurrences all number
8
6
D8-D28, Cough
     subjects affected / exposed
6 / 384 (1.56%)
3 / 374 (0.80%)
     occurrences all number
7
3
Nervous system disorders
D8-D28, Headache
     subjects affected / exposed
5 / 384 (1.30%)
2 / 374 (0.53%)
     occurrences all number
6
2
General disorders and administration site conditions
D8-D28, Pyrexia
     subjects affected / exposed
6 / 384 (1.56%)
4 / 374 (1.07%)
     occurrences all number
7
4
D0-D7, Pruritus
     subjects affected / exposed
5 / 384 (1.30%)
11 / 374 (2.94%)
     occurrences all number
5
11
Gastrointestinal disorders
D0-D7, Abdominal pain
     subjects affected / exposed
4 / 384 (1.04%)
8 / 374 (2.14%)
     occurrences all number
4
8
D0-D7, Vomiting
     subjects affected / exposed
4 / 384 (1.04%)
4 / 374 (1.07%)
     occurrences all number
4
4
Infections and infestations
D8-D28, Ear infection
     subjects affected / exposed
3 / 384 (0.78%)
7 / 374 (1.87%)
     occurrences all number
3
7
D8-D28, Gastroenteritis
     subjects affected / exposed
1 / 384 (0.26%)
4 / 374 (1.07%)
     occurrences all number
1
4
D8-D28, Nasopharyngitis
     subjects affected / exposed
5 / 384 (1.30%)
0 / 374 (0.00%)
     occurrences all number
5
0
D0-D7, Rhinitis
     subjects affected / exposed
7 / 384 (1.82%)
5 / 374 (1.34%)
     occurrences all number
7
5
D8-D28, Pharyngitis
     subjects affected / exposed
5 / 384 (1.30%)
2 / 374 (0.53%)
     occurrences all number
5
2
D0-D7, Tonsillitis
     subjects affected / exposed
4 / 384 (1.04%)
1 / 374 (0.27%)
     occurrences all number
4
1
D8-D28, Tonsillitis
     subjects affected / exposed
4 / 384 (1.04%)
2 / 374 (0.53%)
     occurrences all number
4
2

More information

 Close Top of page

Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? Yes
Date
Amendment
06 Mar 2007
Administrative changes
31 May 2007
Extension of the recruitment period for 4 additional months
13 Jul 2007
Opening of 6 new sites and closure of 6 inactive sites

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

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

3
Se inscrever