Clinical Trial Results:
A phase II, open, study to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined DTPa-HBV-IPV/Hib vaccine when administered as a booster dose to children aged 16-20 months, previously primed with GSK Biologicals’ combined DSSITGDPa-HBV-IPV/Hib vaccine, containing diphtheria toxoid from the Statens Serum Institute (SSI) of Denmark and tetanus toxoid from GSK Biologicals’ Kft [GD] or with GSK Biologicals licensed DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) in the primary vaccination study DTPa-HBV-IPV-116 (106786)
Summary
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EudraCT number |
2007-005343-16 |
Trial protocol |
FI |
Global end of trial date |
18 Aug 2008
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Results information
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Results version number |
v3(current) |
This version publication date |
12 May 2023
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First version publication date |
28 Jun 2015
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Other versions |
v1 (removed from public view) , v2 |
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 |
111344
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00627458 | ||
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 2089-904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, 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 |
29 Mar 2009
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
18 Aug 2008
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Global end of trial reached? |
Yes
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Global end of trial date |
18 Aug 2008
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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 assess the immunogenicity of the DSSITGDPa-HBV-IPV/Hib vaccine (preservative-free or preservative-containing), in terms of persistence of the antibodies to all vaccine antigens at the time of the booster vaccination.
To assess the immunogenicity of a booster dose of DTPa-HBV-IPV/Hib vaccine given after primary vaccination with the DSSITGDPa-HBV-IPV/Hib vaccine (preservative-free or preservative-containing), in terms of response to all vaccine antigens.
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Protection of trial subjects |
All subjects were supervised after vaccination/product administration with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
19 Feb 2008
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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 |
Finland: 403
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Worldwide total number of subjects |
403
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EEA total number of subjects |
403
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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) |
403
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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 |
- | ||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms. | ||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall period
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Infanrix Hexa PF Group | ||||||||||||||||||||||||||||
Arm description |
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. | ||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||
Investigational medicinal product name |
Preservative-free Infanrix hexa
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Investigational medicinal product code |
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Other name |
DSSI-TGD-Pa-HBV-IPV/Hib
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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 received one vaccine dose administered intramuscularly into the anterolateral quadrant of the right thigh.
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Investigational medicinal product name |
Infanrix hexa
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Investigational medicinal product code |
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Other name |
DTPa-HBV-IPV/Hib
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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 received one booster dose of study vaccine, intramuscularly into the anterolateral right thigh.
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Arm title
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Infanrix Hexa PC Group | ||||||||||||||||||||||||||||
Arm description |
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. | ||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||
Investigational medicinal product name |
Preservative-containing Infanrix hexa
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Investigational medicinal product code |
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Other name |
DSSI-TGD-Pa-HBV-IPV/Hib
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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 received one vaccine dose administered intramuscularly into the anterolateral quadrant of the right thigh.
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Investigational medicinal product name |
Infanrix hexa
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Investigational medicinal product code |
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Other name |
DTPa-HBV-IPV/Hib
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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 received one booster dose of study vaccine, intramuscularly into the anterolateral right thigh.
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Arm title
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Control Group | ||||||||||||||||||||||||||||
Arm description |
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. | ||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||
Investigational medicinal product name |
Licensed Infanrix hexa
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Investigational medicinal product code |
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Other name |
DTPa-HBV-IPV/Hib
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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 received one vaccine dose administered intramuscularly into the anterolateral quadrant of the right thigh, in the primary phase and one booster dose of the same vaccine in the booster phase.
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Baseline characteristics reporting groups
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Reporting group title |
Infanrix Hexa PF Group
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Reporting group description |
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Infanrix Hexa PC Group
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Reporting group description |
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control Group
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Reporting group description |
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Infanrix Hexa PF Group
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Reporting group description |
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. | ||
Reporting group title |
Infanrix Hexa PC Group
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Reporting group description |
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. | ||
Reporting group title |
Control Group
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Reporting group description |
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. |
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End point title |
Number of seroprotected subjects against diphtheria (D) and tetanus (T) toxoids [1] [2] | |||||||||||||||
End point description |
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
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End point type |
Primary
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End point timeframe |
Before the booster administration (At Month 0)
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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. [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Infanrix Hexa PF Group and the Infanrix Hexa PC Group. |
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No statistical analyses for this end point |
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End point title |
Number of seroprotected subjects against Hepatitis B surface antigen (HBs) [3] [4] | |||||||||||||||
End point description |
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL). Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
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End point type |
Primary
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End point timeframe |
Before the booster vaccination (At Month 0)
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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. [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Infanrix Hexa PF Group and the Infanrix Hexa PC Group. |
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No statistical analyses for this end point |
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End point title |
Number of seroprotected subjects against Poliovirus type 1, type 2 and type 3 [5] [6] | ||||||||||||||||||
End point description |
A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
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End point type |
Primary
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End point timeframe |
Before the booster vaccination (At Month 0)
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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. [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Infanrix Hexa PF Group and the Infanrix Hexa PC Group. |
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No statistical analyses for this end point |
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End point title |
Number of seroprotected subjects against pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN) [7] [8] | ||||||||||||||||||
End point description |
A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
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End point type |
Primary
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End point timeframe |
Before the booster vaccination (At Month 0)
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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. [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Infanrix Hexa PF Group and the Infanrix Hexa PC Group. |
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No statistical analyses for this end point |
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End point title |
Anti-D and anti-T antibody concentrations [9] [10] | ||||||||||||||||||
End point description |
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
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End point type |
Primary
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End point timeframe |
Before the booster vaccination (At Month 0)
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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. [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Infanrix Hexa PF Group and the Infanrix Hexa PC Group. |
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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 [11] [12] | |||||||||||||||||||||
End point description |
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
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End point type |
Primary
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End point timeframe |
Before the booster vaccination (At Month 0)
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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. [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Infanrix Hexa PF Group and the Infanrix Hexa PC Group. |
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No statistical analyses for this end point |
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End point title |
Anti-HBs antibody concentrations [13] [14] | ||||||||||||
End point description |
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
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End point type |
Primary
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End point timeframe |
Before the booster vaccination (At Month 0)
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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. [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Infanrix Hexa PF Group and the Infanrix Hexa PC Group. |
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No statistical analyses for this end point |
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End point title |
Anti-poliovirus type 1, type 2 and type 3 antibody titers [15] [16] | |||||||||||||||||||||
End point description |
Antibody titers were presented as geometric mean titers (GMTs).
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
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End point type |
Primary
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End point timeframe |
Before the booster vaccination (At Month 0)
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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. [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Infanrix Hexa PF Group and the Infanrix Hexa PC Group. |
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No statistical analyses for this end point |
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End point title |
Anti-PRP antibody concentrations [17] [18] | ||||||||||||
End point description |
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL).
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
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End point type |
Primary
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End point timeframe |
Before the booster vaccination (At Month 0)
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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. [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Infanrix Hexa PF Group and the Infanrix Hexa PC Group. |
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No statistical analyses for this end point |
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End point title |
Number of subjects with a vaccine response to PT, FHA and PR [19] [20] | ||||||||||||||||||||||||||||||||||||
End point description |
Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) [i.e. with concentrations lower than (<) the cut-off value] or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) [i.e. with concentrations greater than (>) the cut-off value).
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
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End point type |
Primary
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End point timeframe |
One month after the booster vaccination (At Month 1)
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Notes [19] - 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. [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Infanrix Hexa PF Group and the Infanrix Hexa PC Group. |
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No statistical analyses for this end point |
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End point title |
Number of seroprotected subjects against polyribosyl-ribitol-phosphate (PRP) [21] [22] | |||||||||||||||
End point description |
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL). Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
|
|||||||||||||||
End point type |
Primary
|
|||||||||||||||
End point timeframe |
Before the booster vaccination (At Month 0)
|
|||||||||||||||
Notes [21] - 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. [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Infanrix Hexa PF Group and the Infanrix Hexa PC Group. |
||||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Number of seroprotected subjects against diphtheria (D) and tetanus (T) toxoids [23] [24] | |||||||||||||||
End point description |
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
|
|||||||||||||||
End point type |
Primary
|
|||||||||||||||
End point timeframe |
One month after the booster vaccination (At Month 1)
|
|||||||||||||||
Notes [23] - 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. [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Infanrix Hexa PF Group and the Infanrix Hexa PC Group. |
||||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Number of seroprotected subjects against Hepatitis B surface antigen (HBs) [25] [26] | |||||||||||||||
End point description |
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
|
|||||||||||||||
End point type |
Primary
|
|||||||||||||||
End point timeframe |
One month after the booster vaccination (At Month 1)
|
|||||||||||||||
Notes [25] - 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. [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Infanrix Hexa PF Group and the Infanrix Hexa PC Group. |
||||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Number of seroprotected subjects against Poliovirus type 1, type 2 and type 3 [27] [28] | ||||||||||||||||||
End point description |
A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
|
||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||
End point timeframe |
One month after the booster vaccination (At Month 1)
|
||||||||||||||||||
Notes [27] - 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. [28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Infanrix Hexa PF Group and the Infanrix Hexa PC Group. |
|||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Number of seroprotected subjects against pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN) [29] [30] | ||||||||||||||||||
End point description |
A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
|
||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||
End point timeframe |
One month after the booster vaccination (At Month 1)
|
||||||||||||||||||
Notes [29] - 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. [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Infanrix Hexa PF Group and the Infanrix Hexa PC Group. |
|||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Number of seroprotected subjects against polyribosyl-ribitol-phosphate (PRP) [31] [32] | |||||||||||||||
End point description |
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
|
|||||||||||||||
End point type |
Primary
|
|||||||||||||||
End point timeframe |
One month after the booster vaccination (At Month 1)
|
|||||||||||||||
Notes [31] - 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. [32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Infanrix Hexa PF Group and the Infanrix Hexa PC Group. |
||||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Anti-D and anti-T antibody concentrations [33] [34] | ||||||||||||||||||
End point description |
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
|
||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||
End point timeframe |
One month after the booster vaccination (At Month 1)
|
||||||||||||||||||
Notes [33] - 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. [34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Infanrix Hexa PF Group and the Infanrix Hexa PC Group. |
|||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Anti-PT, anti-FHA and anti-PRN antibody concentrations [35] [36] | |||||||||||||||||||||
End point description |
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
|
|||||||||||||||||||||
End point type |
Primary
|
|||||||||||||||||||||
End point timeframe |
One month after the booster vaccination (At Month 1)
|
|||||||||||||||||||||
Notes [35] - 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. [36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Infanrix Hexa PF Group and the Infanrix Hexa PC Group. |
||||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Anti-HBs antibody concentrations [37] [38] | ||||||||||||
End point description |
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
One month after the booster vaccination (At Month 1)
|
||||||||||||
Notes [37] - 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. [38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Infanrix Hexa PF Group and the Infanrix Hexa PC Group. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Anti-poliovirus type 1, type 2 and type 3 antibody titers [39] [40] | |||||||||||||||||||||
End point description |
Antibody titers were presented as geometric mean titers (GMTs).
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
|
|||||||||||||||||||||
End point type |
Primary
|
|||||||||||||||||||||
End point timeframe |
One month after the booster vaccination (At Month 1)
|
|||||||||||||||||||||
Notes [39] - 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. [40] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Infanrix Hexa PF Group and the Infanrix Hexa PC Group. |
||||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Anti-PRP antibody concentrations [41] [42] | ||||||||||||
End point description |
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
|
||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
One month after the booster vaccination (At Month 1)
|
||||||||||||
Notes [41] - 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. [42] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Infanrix Hexa PF Group and the Infanrix Hexa PC Group. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of subjects with any solicited local symptoms | ||||||||||||||||||||||||
End point description |
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with their symptoms sheet filled in.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
During the 4-day (Days 0–3) follow-up period after the booster vaccination
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||
End point title |
Number of subjects with any solicited general symptoms | ||||||||||||||||||||||||||||
End point description |
Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature equal to or above (≥) 38.0 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with their symptoms sheet filled in.
|
||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||
End point timeframe |
During the 4-day (Days 0–3) follow-up period after the booster vaccination
|
||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Number of subjects with unsolicited adverse events (AEs) | ||||||||||||||||
End point description |
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
During the 31-day (Day 0–30) follow-up period after the booster vaccination
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Number of subjects with serious adverse events (SAEs) | ||||||||||||||||
End point description |
Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
From Month 0 to Month 1, during the entire study period
|
||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Number of subjects reporting concomitant medications | ||||||||||||||||||||
End point description |
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
During the 4-day (Days 0-3) follow-up period after the booster vaccination
|
||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||
End point title |
Number of seroprotected subjects against diphtheria (D) and tetanus (T) toxoids [43] | ||||||||||||||
End point description |
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
|
||||||||||||||
End point type |
Secondary
|
||||||||||||||
End point timeframe |
Before (Month 0) and one month after (Month 1) the booster vaccination
|
||||||||||||||
Notes [43] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Control Group. |
|||||||||||||||
|
|||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||
End point title |
Number of seroprotected subjects against Hepatitis B surface antigen (HBs) [44] | ||||||||||||||
End point description |
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
|
||||||||||||||
End point type |
Secondary
|
||||||||||||||
End point timeframe |
Before (Month 0) and one month after (Month 1) the booster vaccination
|
||||||||||||||
Notes [44] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Control Group. |
|||||||||||||||
|
|||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Number of seroprotected subjects against Poliovirus type 1, type 2 and type 3 [45] | ||||||||||||||||||
End point description |
A seroprotected subject was defined as a subject with anti-polio 1, 2 and 3 antibody titers ≥ the value of 8.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Before (Month 0) and one month after (Month 1) the booster vaccination
|
||||||||||||||||||
Notes [45] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Control Group. |
|||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Number of seroprotected subjects against PT, FHA and PRN [46] | ||||||||||||||||||
End point description |
A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Before (Month 0) and one month after (Month 1) the booster vaccination
|
||||||||||||||||||
Notes [46] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Control Group. |
|||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||
End point title |
Anti-D and anti-T antibody concentrations [47] | ||||||||||||||||
End point description |
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Before (Month 0) and one month after (Month 1) the booster vaccination
|
||||||||||||||||
Notes [47] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Control Group. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Anti-PT, anti-FHA, anti-PRN antibody concentrations [48] | ||||||||||||||||||||
End point description |
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
The analysis was performed on the Total Vaccinated Cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Before (Month 0) and one month after (Month 1) the booster vaccination
|
||||||||||||||||||||
Notes [48] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Control Group. |
|||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Anti-HBs antibody concentrations [49] | ||||||||||||
End point description |
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Before (Month 0) and one month after (Month 1) the booster vaccination
|
||||||||||||
Notes [49] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Control Group. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||
End point title |
Anti-poliovirus type 1, type 2 and type 3 antibody titers [50] | ||||||||||||||||||||
End point description |
Antibody titers were presented as geometric mean titers (GMTs).
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
|
||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||
End point timeframe |
Before (Month 0) and one month after (Month 1) the booster vaccination
|
||||||||||||||||||||
Notes [50] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Control Group. |
|||||||||||||||||||||
|
|||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Anti-PRP antibody concentrations [51] | ||||||||||||
End point description |
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Before (Month 0) and one month after (Month 1) the booster vaccination
|
||||||||||||
Notes [51] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Control Group. |
|||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of subjects with a vaccine response to PT, FHA and PR [52] | ||||||||||||||||||||||||
End point description |
Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) (i.e. with concentrations < cut-off value) or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) (i.e. with concentrations > cut-off value).
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
One month after the booster dose (At Month 1)
|
||||||||||||||||||||||||
Notes [52] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Control Group. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||
End point title |
Number of seroprotected subjects against polyribosyl-ribitol-phosphate (PRP) [53] | ||||||||||||||
End point description |
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
|
||||||||||||||
End point type |
Secondary
|
||||||||||||||
End point timeframe |
Before (Month 0) and one month after (Month 1) the booster vaccination
|
||||||||||||||
Notes [53] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint is only reporting values for the Control Group. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Solicited symptoms: during the 4-day (Days 0–3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0–30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
10.1
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Reporting groups
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Reporting group title |
Infanrix Hexa PF Group
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Reporting group description |
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control Group
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Reporting group description |
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Infanrix Hexa PC Group
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Reporting group description |
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Notes [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event for this phase was performed solely on subjects with their symptom sheets completed. [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event for this phase was performed solely on subjects with their symptom sheets completed. [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: Assessment for this event for this phase was performed solely on subjects with their symptom sheets completed.zs [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: Assessment for this event for this phase was performed solely on subjects with their symptom sheets completed. [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: Assessment for this event for this phase was performed solely on subjects with their symptom sheets completed. [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: Assessment for this event for this phase was performed solely on subjects with their symptom sheets completed. [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: Assessment for this event for this phase was performed solely on subjects with their symptom sheets completed. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |