Clinical Trial Page

Clinical Trial Results:
An open, randomized, controlled, phase II study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ 11-valent pneumococcal conjugate vaccine, when administered intramuscularly as a 3, 5, 12 month vaccination schedule, as part of a staggered vaccination schedule

Summary
EudraCT number
 2004-001823-39
Trial protocol
 SE  
Global end of trial date
27 Nov 2012

Results information
Results version number
 v1(current)
This version publication date
22 Dec 2018
First version publication date
22 Dec 2018
Other versions
Summary report(s)
 Cancelled before Active Statement

Trial information

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Trial identification
Sponsor protocol code
103502
Additional study identifiers
ISRCTN number
 -
US NCT number
 -
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
27 Nov 2012
Is this the analysis of the primary completion data?
No
Global end of trial reached?
Yes
Global end of trial date
27 Nov 2012
Was the trial ended prematurely?
Yes
General information about the trial
Main objective of the trial
To assess the immune response post-dose 2 elicited by GSK Biologicals’ candidate 11Pn-PD-DiT vaccine administered according to a 3, 5, 12 month vaccination schedule as part of a staggered vaccination schedule with co-administration of Infanrix™ penta and GSK Biologicals’ candidate HibMenC-TT vaccine at 2, 4 months of age.
Protection of trial subjects
The study was cancelled before active (see attached statement). No patient entered the study, therefore no results / data are available.
Background therapy
 -
Evidence for comparator
 -
Actual start date of recruitment
01 Nov 2004
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
Sweden: 99999
Worldwide total number of subjects
99999
EEA total number of subjects
99999
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)
99999
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
 99999 is "Not applicable" value or 0 participants, the study was cancelled before active. No patient entered the study, therefore no results / data are available.

Pre-assignment
Screening details
 Study cancelled before active (see attached statement)

Period 1
Period 1 title
Cancelled before active period (overall period)
Is this the baseline period?
 Yes
Allocation method
Not applicable
Blinding used
 Not blinded

Arms
Arm title
 No-Arm
Arm description
 -
Arm type
 Experimental

Investigational medicinal product name
GSK Biologicals’ 11-valent Pn-PD-DiT vaccine
Investigational medicinal product code
Other name
Pharmaceutical forms
Solution for suspension for injection
Routes of administration
Intramuscular use
Dosage and administration details
The product was not administered as the study was cancelled before active

Number of subjects in period 1
No-Arm
Started
99999
Completed
0
Not completed
99999
     Study was cancelled before active
99999

Baseline characteristics

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End points

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End points reporting groups
Reporting group title
No-Arm
Reporting group description
 -

Primary: No endpoint results

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End point title
 No endpoint results [1]
End point description
End point type
Primary
End point timeframe
The study was cancelled before active (see attached statement)
Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The study was cancelled before active (see attached statement).
End point values
 No-Arm
Number of subjects analysed
9999
Units: Participants
0
No statistical analyses for this end point

Adverse events

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Adverse events information [1]
Timeframe for reporting adverse events
The study was cancelled before active (see attached statement)
Assessment type
 Systematic
Dictionary used for adverse event reporting
Dictionary name
 MedDRA
Dictionary version
8.0
Frequency threshold for reporting non-serious adverse events: 0%
Notes
[1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
Justification: The study was cancelled before active (see attached statement).

More information

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Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? No

Interruptions (globally)
Were there any global interruptions to the trial? Yes
Date
Interruption
Restart date
27 Nov 2012
The study was cancelled before active (see attached statement).
-

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

Sponsors and Collaborators

Medical Conditions

Drug Interventions

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