Clinical Trial Results:
A phase II, double-blind, multicentre study to evaluate the safety and immunogenicity of a booster dose of new formulations of GlaxoSmithKline Biologicals’ combined DTPa-HBV-IPV/Hib vaccine in healthy toddlers, previously primed with three doses of the same vaccine in study 113948 (DTPA-HBV-IPV-124 PRI).
Summary
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EudraCT number |
2011-000876-33 |
Trial protocol |
FI Outside EU/EEA |
Global end of trial date |
12 Nov 2012
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Results information
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Results version number |
v2 |
This version publication date |
11 Aug 2016
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First version publication date |
01 Feb 2015
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Other versions |
v1 , v3 |
Version creation reason |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
114843
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01453998 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
GlaxoSmithKline Biologicals
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Sponsor organisation address |
Rue de l’Institut 89, Rixensart, Belgium, B-1330
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Public contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
02 May 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
12 Nov 2012
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Global end of trial reached? |
Yes
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Global end of trial date |
12 Nov 2012
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To demonstrate that the immunogenicity of at least one DTPa-HBV-IPV/Hib formulation is non-inferior to the licensed formulation in terms of seroprotection rates to diphtheria, tetanus, hepatitis B, poliovirus types 1, 2 and 3 and PRP antigens and in terms of antibody geometric mean concentrations (GMCs) for pertussis antigens one month after the booster dose.
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Protection of trial subjects |
As with all injectable vaccines, appropriate medical treatment was always readily available in case of anaphylactic reactions following the administration of the vaccine.
For this reason, the vaccinee remained under medical supervision for 30 minutes after vaccination.
DTPa vaccination was administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may have occured following an intramuscular administration to these subjects.
DTPa vaccination was under no circumstances administered intravenously.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
14 Oct 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Dominican Republic: 248
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Country: Number of subjects enrolled |
Finland: 409
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Worldwide total number of subjects |
657
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EEA total number of subjects |
409
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
657
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
A total of 272 subjects were enrolled in the study before the second protocol amendment and total of 385 after the amendment. After amendment 2, all subjects yet to receive a booster dose of a GSK217744 formulation, were administered the Infanrix hexa™ vaccine. | ||||||||||||||||||||
Pre-assignment
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Screening details |
A total of 272 subjects were enrolled in the study before the second protocol amendment and total of 385 after the amendment. After amendment 2, all subjects yet to receive a booster dose of a GSK217744 formulation, were administered the Infanrix hexa™ vaccine. | ||||||||||||||||||||
Period 1
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Period 1 title |
Before Protocol Amendment 2
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Is this the baseline period? |
No | ||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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GSK217744 Group 1 | ||||||||||||||||||||
Arm description |
Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
Prevenar 13®
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
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Investigational medicinal product name |
Biological: GSK217744
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively
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Arm title
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GSK217744 Group 2 | ||||||||||||||||||||
Arm description |
Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
Prevenar 13®
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
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Investigational medicinal product name |
GSK217744
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
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Arm title
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Infanrix hexa Group | ||||||||||||||||||||
Arm description |
Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
Infanrix hexa™
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
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Investigational medicinal product name |
Prevenar 13®
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
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Period 2
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Period 2 title |
After Protocol Amendment 2
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Is this the baseline period? |
Yes [1] | ||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||||
Arms
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Are arms mutually exclusive |
No
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Arm title
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GSK217744 Group 1 | ||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
infanrix hexa™
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Single dose, licensed formulation, intramuscular into the right side of the thigh
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Investigational medicinal product name |
Prevenar 13®
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Single co-administered dose, intramuscular into the left side of the thigh
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Investigational medicinal product name |
GSK217744
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Single dose, licensed formulation, intramuscular into the right side of the thigh
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Arm title
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GSK217744 Group 2 | ||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
Infanrix hexa™
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Single dose, licensed formulation, intramuscular into the right side of the thigh
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Arm title
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Infanrix hexa Group | ||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||
Investigational medicinal product name |
Infanrix hexa™
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Single dose, licensed formulation, intramuscular into the right side of the thigh
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Notes [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period. Justification: A total of 272 subjects were enrolled in the study before the second protocol amendment and total of 385 were enrolled after the amendment, hence the second period was the baseline. |
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Baseline characteristics reporting groups [1]
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Reporting group title |
GSK217744 Group 1
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
GSK217744 Group 2
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Infanrix hexa Group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same. Justification: A total of 272 subjects were enrolled in the study before the second protocol amendment and total of 385 were enrolled after the amendment. |
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End points reporting groups
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Reporting group title |
GSK217744 Group 1
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Reporting group description |
Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. | ||
Reporting group title |
GSK217744 Group 2
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Reporting group description |
Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. | ||
Reporting group title |
Infanrix hexa Group
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Reporting group description |
Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. | ||
Reporting group title |
GSK217744 Group 1
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Reporting group description |
- | ||
Reporting group title |
GSK217744 Group 2
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Reporting group description |
- | ||
Reporting group title |
Infanrix hexa Group
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Reporting group description |
- |
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End point title |
Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies. [1] | ||||||||||||||||||||
End point description |
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
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End point type |
Primary
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End point timeframe |
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
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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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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No statistical analyses for this end point |
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End point title |
Number of seroprotected subjects for anti-polyribosyl-ribitol phosphate (anti-PRP) [2] | ||||||||||||||||
End point description |
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
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End point type |
Primary
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End point timeframe |
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
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Notes [2] - 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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No statistical analyses for this end point |
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End point title |
Concentrations for anti-PRP antibodies [3] | ||||||||||||||||||||
End point description |
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.
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End point type |
Primary
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End point timeframe |
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
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Notes [3] - 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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No statistical analyses for this end point |
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End point title |
Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies [4] | ||||||||||||||||||||
End point description |
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
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End point type |
Primary
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End point timeframe |
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
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Notes [4] - 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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No statistical analyses for this end point |
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End point title |
Anti-Pertussis toxoid (anti-PT), anti-Filamentous haemagglutinin (anti-FHA), anti-Pertactin (anti-PRN) antibody concentrations [5] | ||||||||||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
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Notes [5] - 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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No statistical analyses for this end point |
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End point title |
Anti-PT, Anti-FHA, anti-PRN antibody concentrations [6] | ||||||||||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
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Notes [6] - 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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No statistical analyses for this end point |
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End point title |
Number of subjects anti-PT, anti-FHA, anti-PRN antibody concentrations equal to or above (≥) the cut-off value of 5 ELISA units per millilitre (EL.U/mL) [7] | ||||||||||||||||||||||||
End point description |
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End point type |
Primary
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||||||||||||||||||||||||
End point timeframe |
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
|
||||||||||||||||||||||||
Notes [7] - 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of subjects anti-PT, anti-FHA, anti-PRN antibody concentrations ≥ the cut-off value of 5 EL.U/mL [8] | ||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
|
||||||||||||||||||||||||
Notes [8] - 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Anti-Hepatitis B (anti-HBs) antibody concentrations [9] | ||||||||||||||||||||
End point description |
|||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||
End point timeframe |
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
|
||||||||||||||||||||
Notes [9] - 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
|||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Number of seroprotected subjects against anti-HBs antigens [10] | ||||||||||||||||
End point description |
A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
|
||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
|
||||||||||||||||
Notes [10] - 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Anti-HBs antibody concentrations [11] | ||||||||||||||||||||
End point description |
|||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||
End point timeframe |
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
|
||||||||||||||||||||
Notes [11] - 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
|||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Number of seroprotected subjects against anti-HBs antigens [12] | ||||||||||||||||
End point description |
A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
|
||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
|
||||||||||||||||
Notes [12] - 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||
End point title |
Anti-Polio virus type 1, 2 and 3 (anti-Polio 1, anti-Polio 2 and anti-Polio 3) antibody titers [13] | ||||||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||
End point timeframe |
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
|
||||||||||||||||||||||||||||
Notes [13] - 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
|||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of seroprotected subjects against Polio type 1, 2 and 3 antigens [14] | ||||||||||||||||||||||||
End point description |
A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
|
||||||||||||||||||||||||
Notes [14] - 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||
End point title |
Anti-Polio 1, anti-Polio 2 and anti-Polio 3 antibody titers [15] | ||||||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||
End point timeframe |
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
|
||||||||||||||||||||||||||||
Notes [15] - 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
|||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of seroprotected subjects against anti-Polio 1, 2 and 3 [16] | ||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
|
||||||||||||||||||||||||
Notes [16] - 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Anti- polyribosyl-ribitol phosphate (anti-PRP) antibody concentrations [17] | ||||||||||||||||||||
End point description |
|||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||
End point timeframe |
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
|
||||||||||||||||||||
Notes [17] - 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
|||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Number of seroprotected subjects against anti-PRP antigens [18] | ||||||||||||||||
End point description |
A seroprotected subject was a subject whose antibody concentration was greater than or equal to ≥ 0.15 μg/mL
|
||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
|
||||||||||||||||
Notes [18] - 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 analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||
End point title |
Concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies. | ||||||||||||||||||||||||||||||||
End point description |
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
|
||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||
End point timeframe |
Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
|
||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||
End point title |
Concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies | ||||||||||||||||||||||||||||||||
End point description |
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
|
||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||
End point timeframe |
Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
|
||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of seropositive subjects for anti-pneumococcal (anti-PNE) serotypes. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Concentrations for anti-PNE antibodies. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of seropositive subjects for anti-pneumococcal (anti-PNE) serotypes | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Concentrations for anti-PNE antibodies. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of subjects reporting any solicited local symptoms. | ||||||||||||||||||||||||
End point description |
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||
End point title |
Number of subjects reporting any solicited general symptoms. | ||||||||||||||||||||||||||||
End point description |
Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.
|
||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||
End point timeframe |
During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Number of subjects reporting any unsolicited adverse events (AEs). | ||||||||||||||||
End point description |
An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled before protocol amendment 2)
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Number of subjects reporting any serious adverse events (SAEs). | ||||||||||||||||
End point description |
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
During the entire study period (Days 0-30). (subjects enrolled before protocol amendment 2)
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of subjects reporting any solicited local symptoms | ||||||||||||||||||||||||
End point description |
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||
End point title |
Number of subjects reporting any solicited general symptoms | ||||||||||||||||||||||||||||
End point description |
Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.
|
||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||
End point timeframe |
During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Number of subjects reporting any unsolicited adverse events (AEs) | ||||||||||||||||
End point description |
An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled after protocol amendment 2)
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Number of subjects reporting any serious adverse events (SAEs) | ||||||||||||||||
End point description |
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
During the entire study period (Days 0-30). (subjects enrolled after protocol amendment 2)
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Number of seroprotected subjects against Anti-D/Anti-T antigens | ||||||||||||||||||||
End point description |
|||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
|
||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Number of seroprotected subjects against Anti-D/Anti-T antigens | ||||||||||||||||||||
End point description |
|||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Before (PRE) booster vaccination period (subjects enrolled before protocol amendment 2)
|
||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||
End point title |
Anti-PT, Anti-FHA, anti-PRN antibody concentrations | ||||||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||
End point timeframe |
Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||
End point title |
Anti-PT, Anti-FHA, anti-PRN antibody concentrations | ||||||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||
End point timeframe |
Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of subjects anti-PT, anti-FHA, anti-PRN antibody concentrations ≥ the cut-off value of 5 EL.U/mL | ||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of subjects anti-PT, anti-FHA, anti-PRN antibody concentrations ≥ the cut-off value of 5 EL.U/mL | ||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Anti-Hepatitis B (anti-HBs) antibody concentrations | ||||||||||||||||||||
End point description |
|||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
|
||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Number of seroprotected subjects against anti-HBs antigens | ||||||||||||||||
End point description |
A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Anti-HBs antibody concentrations | ||||||||||||||||||||
End point description |
|||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
|
||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Number of seroprotected subjects against anti-HBs antigens | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||
End point title |
Anti-Polio virus type 1, 2 and 3 (anti-Polio 1, anti-Polio 2 and anti-Polio 3) antibody titers | ||||||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||
End point timeframe |
Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of seroprotected subjects against Polio type 1, 2 and 3 antigens | ||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||
End point title |
Anti-Polio 1, anti-Polio 2 and anti-Polio 3 antibody titers | ||||||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||
End point timeframe |
Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of seroprotected subjects against anti-Polio 1, 2 and 3 | ||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Concentrations for anti-PRP antibodies | ||||||||||||||||||||
End point description |
|||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
|
||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Number of seroprotected subjects for anti-PRP | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Anti- polyribosyl-ribitol phosphate (anti-PRP) antibody concentrations | ||||||||||||||||||||
End point description |
|||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
|
||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Number of seroprotected subjects against anti-PRP antigens | ||||||||||||||||
End point description |
|||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of subjects with booster response to anti-pertussis antigens (anti-PT, anti-FHA and anti-PRN) | ||||||||||||||||||||||||
End point description |
Booster response defined as :
– For initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month after booster vaccination
– For initially seropositive subjects, antibody concentration at Post-booster ≥ 2 fold the pre-vaccination antibody concentration
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of subjects with booster response to anti-pertussis antigens (anti-PT, anti-FHA and anti-PRN) | ||||||||||||||||||||||||
End point description |
Booster response defined as :
– For initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month after booster vaccination
– For initially seropositive subjects, antibody concentration at Post-booster ≥ 2 fold the pre-vaccination antibody concentration
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
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Timeframe for reporting adverse events |
Solicited symptoms: 4-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Days 0-30).
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
As there were no SAEs reported before protocol amendment 2, the number of subjects at risk for each reported SAE was the total number of subjects enrolled after the protocol amendment. The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
GSK217744 Group 2
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
GSK217744 Group 1
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Infanrix hexa Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed separately on subjects enrolled after protocol amendment 2, corresponding to a total number of 385. [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: The analysis was performed separately on subjects enrolled after protocol amendment 2, corresponding to a total number of 385. |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Notes [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 was performed separately on subjects enrolled after protocol amendment 2, corresponding to a total number of 385. [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 was performed separately on subjects enrolled after protocol amendment 2, corresponding to a total number of 385. [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 was performed separately on subjects enrolled after protocol amendment 2, corresponding to a total number of 385. [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 was performed separately on subjects enrolled after protocol amendment 2, corresponding to a total number of 385. [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 was performed separately on subjects enrolled after protocol amendment 2, corresponding to a total number of 385. [8] - 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 was performed separately on subjects enrolled after protocol amendment 2, corresponding to a total number of 385. [9] - 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 was performed separately on subjects enrolled after protocol amendment 2, corresponding to a total number of 385. [10] - 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 was performed separately on subjects enrolled before protocol amendment 2, corresponding to a total number of 272. [11] - 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 was performed separately on subjects enrolled before protocol amendment 2, corresponding to a total number of 272. [12] - 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 was performed separately on subjects enrolled before protocol amendment 2, corresponding to a total number of 272. [13] - 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 was performed separately on subjects enrolled before protocol amendment 2, corresponding to a total number of 272. [14] - 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 was performed separately on subjects enrolled before protocol amendment 2, corresponding to a total number of 272. [15] - 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 was performed separately on subjects enrolled before protocol amendment 2, corresponding to a total number of 272. [16] - 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 was performed separately on subjects enrolled before protocol amendment 2, corresponding to a total number of 272. [17] - 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 was performed separately on subjects enrolled before protocol amendment 2, corresponding to a total number of 272. [18] - 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 was performed separately on subjects enrolled before protocol amendment 2, corresponding to a total number of 272. [19] - 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 was performed separately on subjects enrolled before protocol amendment 2, corresponding to a total number of 272. [20] - 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 was performed separately on subjects enrolled before protocol amendment 2, corresponding to a total number of 272. [21] - 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 was performed separately on subjects enrolled after protocol amendment 2, corresponding to a total number of 385. [22] - 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 was performed separately on subjects enrolled before protocol amendment 2, corresponding to a total number of 272. [23] - 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 was performed separately on subjects enrolled before protocol amendment 2, corresponding to a total number of 272. [24] - 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 was performed separately on subjects enrolled before protocol amendment 2, corresponding to a total number of 272. [25] - 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 was performed separately on subjects enrolled before protocol amendment 2, corresponding to a total number of 272. |
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
03 Oct 2011 |
1. At the discretion of GSK Biologicals, pneumococcal testing may be done at a GSK Biologicals laboratory or the World Health Organisation (WHO) reference laboratory. Since the 22F-inhibition ELISA assay used at the WHO reference laboratory has a different assay cut-off, different thresholds are mentioned in the statistical analysis description. The threshold for the 22F-inhibition non-GSK ELISA assay performed at the WHO reference laboratory is 0.35 µg/ml.
2. In order to simplify study management activities, the subjects will be given new treatment numbers in the present booster study.
3. Exploratory statistical comparisons will be based on 97.5% CI instead of 95% to be aligned with the study objective criteria.
|
||
12 Apr 2012 |
1. Due to the increased incidence of fever observed with the new formulations of the DTPa-HBV-IPV/Hib vaccine in the primary vaccination study 113948 (DTPa-HBV-IPV-124), all subjects yet to receive a booster dose in the present study will be administered the licensed formulation of Infanrix hexa.
2. Because the safety and immunogenicity of commercial vaccines administered after Formulation A or Formulation B is unknown, this study will continue to ensure the safety of the subjects and adequate immune responses to the booster dose of Infanrix hexa.
3. SBIR will be used to allocate new treatment numbers corresponding to Infanrix hexa vaccine to all newly enrolled subjects after amendment 2.
4. After amendment 2, all subjects will receive Infanrix hexa. Accordingly less than half of the subjects can contribute to the initial study objectives leading to a study power lower than 50%. For this reason, separate analyses of the cohort enrolled pre and post amendment will be performed. These analyses will be descriptive without study group comparisons. |
||
15 May 2012 |
At the European Medicines Agency’s (EMA) request, GSK Biologicals has updated its procedure for emergency unblinding during the conduct of a clinical study. According to the revised procedure, the responsibility and the decision to break the treatment code in emergency situations resides solely with the investigator and consequently, the investigator will have full authority to break the treatment code. |
||
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 |