Clinical Trial Results:
A phase III, open-label, randomised multicentre study to evaluate the immunogenicity and safety of a booster dose of GlaxoSmithKline Biologicals’ dTpa-IPV vaccine (Boostrix Polio) compared with Sanofi Pasteur MSD’s dTpa-IPV vaccine (Repevax), when co-administered with GSK Biologicals’ MMR vaccine (Priorix) in 3 and 4-year-old healthy children.
Summary
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EudraCT number |
2009-012202-39 |
Trial protocol |
GB |
Global end of trial date |
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Results information
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Results version number |
v2 |
This version publication date |
08 Jul 2016
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First version publication date |
06 Jun 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 |
111763
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01245049 | ||
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, 0044 2089904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 0044 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) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000500-PIP01-08 | ||
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 |
Interim
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Date of interim/final analysis |
27 Mar 2012
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
27 Mar 2012
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Global end of trial reached? |
No
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General information about the trial
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Main objective of the trial |
• To demonstrate that GSK Biologicals’ dTpa-IPV vaccine is non-inferior to Sanofi Pasteur MSD’s dTpa-IPV vaccine in terms of percentages of subjects with immune response to the diphtheria, tetanus and polio antigens, one month after booster vaccination.
• To demonstrate that GSK Biologicals’ dTpa-IPV vaccine given as a single booster dose in this study is non-inferior to GSK Biologicals’ DTPa vaccine (Infanrix) given as a primary series in the German household contact study APV-039 in terms of anti-PT, anti-FHA and anti-PRN geometric mean concentrations (GMCs), one month after booster vaccination.
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Protection of trial subjects |
The vaccine was administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may have occurred following an intramuscular administration to these subjects. Firm pressure was applied to the injection site (without rubbing) for at least two minutes.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
06 Apr 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 |
United Kingdom: 385
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Worldwide total number of subjects |
385
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EEA total number of subjects |
385
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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) |
0
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Children (2-11 years) |
385
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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 trial (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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Boostrix Polio Group | ||||||||||||||||||||||||
Arm description |
Subjects received 1 booster dose of Boostrix Polio vaccine co-administered with Priorix. | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Boostrix Polio
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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 |
1 dose of Boostrix™ Polio co-administered with Priorix™.
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Investigational medicinal product name |
Priorix™
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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 |
1 dose of Boostrix™ Polio co-administered with Priorix™.
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Arm title
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Repevax Group | ||||||||||||||||||||||||
Arm description |
Subjects received 1 booster dose of Repevax vaccine co-administered with Priorix vaccine. | ||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||
Investigational medicinal product name |
Repevax™
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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 |
1 dose of Repevax™ Polio co-administered with Priorix™.
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Investigational medicinal product name |
Priorix™
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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 |
1 dose of Repevax™ co-administered with Priorix™.
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Baseline characteristics reporting groups
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Reporting group title |
Boostrix Polio Group
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Reporting group description |
Subjects received 1 booster dose of Boostrix Polio vaccine co-administered with Priorix. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Repevax Group
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Reporting group description |
Subjects received 1 booster dose of Repevax vaccine co-administered with Priorix vaccine. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Boostrix Polio Group
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Reporting group description |
Subjects received 1 booster dose of Boostrix Polio vaccine co-administered with Priorix. | ||
Reporting group title |
Repevax Group
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Reporting group description |
Subjects received 1 booster dose of Repevax vaccine co-administered with Priorix vaccine. |
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End point title |
Number of subjects with a booster response to diphtheria (D) and tetanus (T) antibodies | |||||||||||||||
End point description |
Booster response was defined as:
For initially seronegative subjects, antibody concentrations at least four times the assay cut-off;
For initially seropositive subjects, an increase in antibody concentrations of at least four times the Pre booster vaccination concentration.
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End point type |
Primary
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End point timeframe |
One month after booster vaccination
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Statistical analysis title |
Non-inferiority in terms of booster response to D | |||||||||||||||
Comparison groups |
Boostrix Polio Group v Repevax Group
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Number of subjects included in analysis |
267
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [1] | |||||||||||||||
Method |
Standardized asymptotic | |||||||||||||||
Parameter type |
Percentage difference | |||||||||||||||
Point estimate |
0.56
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Confidence interval |
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level |
95% | |||||||||||||||
sides |
2-sided
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lower limit |
-3.55 | |||||||||||||||
upper limit |
3.14 | |||||||||||||||
Notes [1] - To assess the Non-inferiority of the Boostrix Polio Group compared to the Repevax Group in terms of booster response to diphtheria, standardized asymptotic 95% CI for the groups’difference [Repevax Group minus Boostrix Polio Group] was computed. Non-inferiority criterion: Upper limit of the 95% CI of the groups’ difference in booster response rate ≤10%. |
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Statistical analysis title |
Non-inferiority in terms of booster response to T | |||||||||||||||
Comparison groups |
Boostrix Polio Group v Repevax Group
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Number of subjects included in analysis |
267
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [2] | |||||||||||||||
Method |
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Parameter type |
Percentage difference | |||||||||||||||
Point estimate |
1.7
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Confidence interval |
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level |
95% | |||||||||||||||
sides |
2-sided
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lower limit |
-2.43 | |||||||||||||||
upper limit |
4.9 | |||||||||||||||
Notes [2] - To assess the Non-inferiority of the Boostrix Polio Group compared to the Repevax Group in terms of booster response to tetanus, standardized asymptotic 95% CI for the groups’ difference [Repevax Group minus Boostrix Polio Group] was computed. Non-inferiority criterion: Upper limit of the 95% CI of the groups’ difference in booster response rate ≤10% |
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End point title |
Concentrations for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) [3] | ||||||||||||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Before (PRE) and one month after (POST) the booster vaccination
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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 scope of this primary end point was descriptive, 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-Polio type 1, 2 and 3 antibody titers | ||||||||||||||||||||||||||||||
End point description |
Results for the one month after (POST) booster vaccination timepoint were the primary outcome.
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End point type |
Primary
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End point timeframe |
Prior to (PRE) and one month after (POST) booster vaccination
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Statistical analysis title |
Immune response difference to anti-Polio 1 antigen | ||||||||||||||||||||||||||||||
Comparison groups |
Boostrix Polio Group v Repevax Group
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Number of subjects included in analysis |
241
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [4] | ||||||||||||||||||||||||||||||
Method |
ANCOVA | ||||||||||||||||||||||||||||||
Parameter type |
Difference in adjusted GMT ratio | ||||||||||||||||||||||||||||||
Point estimate |
0.91
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Confidence interval |
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level |
95% | ||||||||||||||||||||||||||||||
sides |
2-sided
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lower limit |
0.65 | ||||||||||||||||||||||||||||||
upper limit |
1.28 | ||||||||||||||||||||||||||||||
Notes [4] - Non-inferiority in terms of response to the poliovirus types 1, 2 and 3 was demonstrated if the upper limit of the 95% confidence interval (CI) on the ratio of geometric mean titres (GMTs) [Repevax Group divided by Boostrix-Polio Group] was ≤ 2. |
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Statistical analysis title |
Immune response difference to anti-Polio 2 antigen | ||||||||||||||||||||||||||||||
Comparison groups |
Boostrix Polio Group v Repevax Group
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Number of subjects included in analysis |
241
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [5] | ||||||||||||||||||||||||||||||
Method |
ANCOVA | ||||||||||||||||||||||||||||||
Parameter type |
Difference in adjusted GMT ratio | ||||||||||||||||||||||||||||||
Point estimate |
0.78
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Confidence interval |
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level |
95% | ||||||||||||||||||||||||||||||
sides |
2-sided
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lower limit |
0.54 | ||||||||||||||||||||||||||||||
upper limit |
1.12 | ||||||||||||||||||||||||||||||
Notes [5] - Non-inferiority in terms of response to the poliovirus types 1, 2 and 3 was demonstrated if the upper limit of the 95% confidence interval (CI) on the ratio of geometric mean titres (GMTs) [Repevax Group divided by Boostrix-Polio Group] was ≤ 2. |
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Statistical analysis title |
Immune response difference to anti-Polio 3 antigen | ||||||||||||||||||||||||||||||
Comparison groups |
Boostrix Polio Group v Repevax Group
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Number of subjects included in analysis |
241
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [6] | ||||||||||||||||||||||||||||||
Method |
ANCOVA | ||||||||||||||||||||||||||||||
Parameter type |
Difference in adjusted GMT ratio | ||||||||||||||||||||||||||||||
Point estimate |
1.3
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Confidence interval |
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level |
95% | ||||||||||||||||||||||||||||||
sides |
2-sided
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lower limit |
0.93 | ||||||||||||||||||||||||||||||
upper limit |
1.84 | ||||||||||||||||||||||||||||||
Notes [6] - Non-inferiority in terms of response to the poliovirus types 1, 2 and 3 was demonstrated if the upper limit of the 95% confidence interval (CI) on the ratio of geometric mean titres (GMTs) [Repevax Group divided by Boostrix-Polio Group] was ≤ 2. |
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End point title |
Number of seropositive subjects for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) | |||||||||||||||||||||||||||
End point description |
A seropositive subject for anti-PT, anti-FHA and anti-PRN was a subject whose antibody concentration was ≥ 5 EL.U/mL.
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End point type |
Secondary
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End point timeframe |
Before (PRE) and one month after (POST) the booster vaccination
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No statistical analyses for this end point |
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End point title |
Number of seroprotected subjects for anti-D and anti-T | |||||||||||||||||||||
End point description |
A seroprotected subject was defined a subject with antibody concentrations ≥ 0.1 international units per millilitre (IU/mL).
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End point type |
Secondary
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End point timeframe |
Before (PRE) and one month after (POST) the booster vaccination.
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No statistical analyses for this end point |
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End point title |
Concentrations for anti-D and anti-T | ||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Before (PRE) and one month after (POST) the booster vaccination.
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No statistical analyses for this end point |
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End point title |
Number of seroconverted subjects for anti-measles | |||||||||||||||
End point description |
A converted subject was defined an initially seronegative subject with antibody concentrations ≥ 150 milli-international units per millilitre (mIU/mL).
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End point type |
Secondary
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End point timeframe |
Before (PRE) and one month after (POST) the booster vaccination
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No statistical analyses for this end point |
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End point title |
Number of seroconverted subjects for anti-mumps | |||||||||||||||
End point description |
A converted subject was defined an initially seronegative subject with antibody concentrations ≥ 231 units per millilitre (U/mL).
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End point type |
Secondary
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End point timeframe |
Before (PRE) and one month after (POST) the booster vaccination
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No statistical analyses for this end point |
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End point title |
Number of subjects with a booster response to PT, FHA and PRN antibodies | ||||||||||||||||||
End point description |
Booster response was defined as:
For initially seronegative subjects, antibody concentrations at least four times the assay cut-off;
For initially seropositive subjects, an increase in antibody concentrations of at least four times the Pre booster vaccination concentration.
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End point type |
Secondary
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End point timeframe |
One month after the booster vaccination
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No statistical analyses for this end point |
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End point title |
Number of subjects with solicited local symptoms | ||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
During the 4-day (Days 0-3) follow-up period after booster vaccination
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No statistical analyses for this end point |
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End point title |
Number of subjects with solicited general symptoms | |||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
During the 4-day (Days 0-3) follow-up period after booster vaccination
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No statistical analyses for this end point |
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End point title |
Number of subjects with unsolicited adverse events (AEs) | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
During the 31-day (Days 0-30) follow-up period after booster vaccination
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No statistical analyses for this end point |
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End point title |
Number of subjects with serious adverse events (SAEs) | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
During the entire study period
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No statistical analyses for this end point |
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End point title |
Number of subjects with anti-measles antibody concentrations ≥ 150 milli-international units per millilitre (mIU/mL) | |||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Prior to (PRE) and one month after (POST) booster vaccination
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No statistical analyses for this end point |
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End point title |
Number of subjects with anti-mumps antibody concentrations ≥ 231 units per millilitre (U/mL) | |||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Prior to (PRE) and one month after (POST) booster vaccination
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No statistical analyses for this end point |
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End point title |
Number of subjects with anti-rubella antibody concentrations ≥ 4 international units per millilitre (IU/mL) | |||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Prior to (PRE) and one month after (POST) booster vaccination
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No statistical analyses for this end point |
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End point title |
Anti-Mumps antibody concentrations | ||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Prior to (PRE) and one month after (POST) booster vaccination
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No statistical analyses for this end point |
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End point title |
Anti-measles antibody concentrations | ||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Prior to (PRE) and one month after (POST) booster vaccination
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No statistical analyses for this end point |
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End point title |
Anti-rubella antibody concentrations | ||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Prior to (PRE) and one month after (POST) booster vaccination
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No statistical analyses for this end point |
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End point title |
Number of subjects with booster response for anti- Polio 1, 2 and 3 antigens | ||||||||||||||||||
End point description |
Booster response defined as:
For initially seronegative subjects, antibody titers at least four times the cut-off (post-vaccination titer ≥ 32);
For initially seropositive subjects, an increase in antibody titers of at least four times the Pre booster vaccination titer.
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End point type |
Secondary
|
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End point timeframe |
At one month after (POST) booster vaccination
|
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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 local and general symptoms: during the 4 day- (Day 0-Day 3) after vaccination;
- Unsolicited adverse events: during the 31 day (Day 0-Day 30) after vaccination;
- Serious adverse event from the booster dose up to study end.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
14.1
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Reporting groups
|
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Reporting group title |
Repevax Group
|
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Reporting group description |
Subjects received 1 booster dose of Repevax vaccine co-administered with Priorix vaccine. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Boostrix Polio Group
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Reporting group description |
Subjects received 1 booster dose of Boostrix Polio vaccine co-administered with Priorix. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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: The analysis was performed on the Total vaccinated cohort, only 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: The analysis was performed on the Total vaccinated cohort, only 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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed. [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 on the Total vaccinated cohort, only 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: The analysis was performed on the Total vaccinated cohort, only 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: The analysis was performed on the Total vaccinated cohort, only 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: The analysis was performed on the Total vaccinated cohort, only 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 |