Clinical Trial Results:
A phase II, randomized, observer blind, multicenter study to evaluate the safety and immunogenicity of a single low dose of AS03-adjuvanted, Quebec- or Dresden- manufactured monovalent A/California/7/2009 (H1N1)v-like vaccine in children 3 to less than 10 years old
Summary
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EudraCT number |
2011-003512-23 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
31 Jan 2011
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Results information
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Results version number |
v1 |
This version publication date |
18 Apr 2016
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First version publication date |
23 Jul 2015
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Other versions |
v2 |
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 |
114495
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01161160 | ||
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, 44 2089904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
09 May 2011
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
23 Aug 2010
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Jan 2011
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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 whether vaccination with 1 dose of 0.9 µg monovalent A/California/7/2009 (H1N1)v-like HA antigen produced in Quebec adjuvanted with AS03B and 1 dose of monovalent A/California/7/2009 (H1N1)v-like HA antigen produced in Dresden adjuvanted with AS03B; results in an immune response to the vaccine-homologous virus that meets or exceeds the U.S Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) and the European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP) guidance targets for pandemic vaccine serocon-version rate (SCR), rate of induction of vaccine-homologous reciprocal hemagglutination inhibition (HI) titers >= 40 (potential seroprotection rate [SPR]) and geo-metric mean fold rise (GMFR) 21 days after vaccination in children 3 to < 10 years of age.
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Protection of trial subjects |
All subjects were supervised closely for at least 30 minutes following vaccination 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. Subjects were followed-up from the time the subject consents to participate in the study until she/he is discharged.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
25 Jul 2010
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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 |
Philippines: 102
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Country: Number of subjects enrolled |
Thailand: 107
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Worldwide total number of subjects |
209
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EEA total number of subjects |
0
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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) |
209
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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 Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind [1] | ||||||||||||
Roles blinded |
Subject, Assessor | ||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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FluQ half Goup | ||||||||||||
Arm description |
Subjects received 1 half-pediatric dose of FluQ vaccine at Day 0 | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Arepanrix™
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Investigational medicinal product code |
GSK2340274A
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Other name |
Q-PAN H1N1-AS03 (FluQ)
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Pharmaceutical forms |
Emulsion for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
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Arm title
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FluD half Group | ||||||||||||
Arm description |
Subjects received 1 half-pediatric dose of FluD vaccine at Day 0 | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Pandemrix™
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Investigational medicinal product code |
GSK2340272A
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Other name |
D-PAN H1N1-AS03 (FluD)
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Pharmaceutical forms |
Emulsion for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
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Arm title
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FluQ Group | ||||||||||||
Arm description |
Subjects received 1 pediatric dose of FluQ vaccine at Day 0 | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Arepanrix™
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Investigational medicinal product code |
GSK2340274A
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Other name |
Q-PAN H1N1-AS03 (FluD)
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Pharmaceutical forms |
Emulsion for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
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Notes [1] - The roles blinded appear to be inconsistent with a double blind trial. Justification: This is an observer-blind study which means that during the course of the study, the vaccine recipient (subject) and those responsible for the evaluation of any study endpoint, were all unaware of which vaccine was administered to a particular subject. To do so, vaccine preparation and vaccination was done by authorized medical personnel who did not participate in any of the study clinical evaluation (i.e. assessor). |
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Baseline characteristics reporting groups
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Reporting group title |
FluQ half Goup
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Reporting group description |
Subjects received 1 half-pediatric dose of FluQ vaccine at Day 0 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
FluD half Group
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Reporting group description |
Subjects received 1 half-pediatric dose of FluD vaccine at Day 0 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
FluQ Group
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Reporting group description |
Subjects received 1 pediatric dose of FluQ vaccine at Day 0 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
FluQ half Goup
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Reporting group description |
Subjects received 1 half-pediatric dose of FluQ vaccine at Day 0 | ||
Reporting group title |
FluD half Group
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Reporting group description |
Subjects received 1 half-pediatric dose of FluD vaccine at Day 0 | ||
Reporting group title |
FluQ Group
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Reporting group description |
Subjects received 1 pediatric dose of FluQ vaccine at Day 0 |
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End point title |
Number of seroconverted subjects for HI antibodies against Flu A/CAL/7/09 H1N1 strain [1] [2] | ||||||||||||
End point description |
Seroconversion rate (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titre < 10 and a post-vaccination reciprocal titre ≥ 40, or a pre-vaccination reciprocal HI titre ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titre against the vaccine virus.
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End point type |
Primary
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End point timeframe |
At Day 21
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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. The CBER Criteria were fulfilled for this study if after vaccination in FluQ half and FluD half groups: - the lower limit (LL) of the 95% confidence interval (CI) for SCR was >40%, - the LL of the 95% CI for SPR was >70%. The CHMP Criteria were fulfilled if: – the point estimate for SCR is >40%, – the post-vaccination point estimate for SPR is >70% – the point estimate for GMFR was >2.5 [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 outcome measure specifically covers the results of the subjects that received the FluQ half or FluD half pediatric vaccine (i.e. FluQ half Group and FluD half Group). |
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No statistical analyses for this end point |
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End point title |
Number of seroprotected subjects for HI antibodies against Flu A/CAL/7/09 H1N1 strain [3] [4] | |||||||||||||||
End point description |
A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection.
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End point type |
Primary
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End point timeframe |
At Day 0 and Day 21
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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. The CBER Criteria were fulfilled for this study if after vaccination in FluQ half and FluD half groups: - the lower limit (LL) of the 95% confidence interval (CI) for SCR was >40%, - the LL of the 95% CI for SPR was >70%. The CHMP Criteria were fulfilled if: – the point estimate for SCR is >40%, – the post-vaccination point estimate for SPR is >70% – the point estimate for GMFR was >2.5 [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 outcome measure specifically covers the results of the subjects that received the FluQ half or FluD half pediatric vaccine (i.e. FluQ half Group and FluD half Group). |
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No statistical analyses for this end point |
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End point title |
Seroconversion factor for HI antibodies against Flu A/CAL/7/09 H1N1 strain [5] [6] | |||||||||||||||
End point description |
Seroconversion factors [as known as Geometric Mean Fold Rise (GMFR)] were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.
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End point type |
Primary
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End point timeframe |
At day 21
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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. The CBER Criteria were fulfilled for this study if after vaccination in FluQ half and FluD half groups: - the lower limit (LL) of the 95% confidence interval (CI) for SCR was >40%, - the LL of the 95% CI for SPR was >70%. The CHMP Criteria were fulfilled if: – the point estimate for SCR is >40%, – the post-vaccination point estimate for SPR is >70% – the point estimate for GMFR was >2.5 [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 outcome measure specifically covers the results of the subjects that received the FluQ half or FluD half pediatric vaccine (i.e. FluQ half Group and FluD half Group). |
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No statistical analyses for this end point |
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End point title |
Number of seroconverted subjects for HI antibodies against Flu A/CAL/7/09 H1N1 strain | ||||||||||||||||
End point description |
Seroconversion rate (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titre < 10 and a post-vaccination reciprocal titre ≥ 40, or a pre-vaccination reciprocal HI titre ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titre against the vaccine virus.
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End point type |
Secondary
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End point timeframe |
At Day 182
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No statistical analyses for this end point |
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End point title |
Number of seroprotected subjects for HI antibodies against Flu A/CAL/7/09 H1N1 strain | ||||||||||||||||||||
End point description |
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
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End point type |
Secondary
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End point timeframe |
At Day 0 and Day 182
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No statistical analyses for this end point |
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End point title |
Seroconversion factor for HI antibodies against Flu A/CAL/7/09 H1N1 strain | ||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At Day 182
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No statistical analyses for this end point |
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End point title |
Number of subjects with HI antibody titers against Flu A/CAL/7/09 ≥ 1:10 | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At Day 21
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No statistical analyses for this end point |
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End point title |
HI antibody titres against Flu A/CAL/7/09 H1N1 strain | ||||||||||||||||||||
End point description |
Antibody titres were expressed as Geometric mean titers (GMTs).
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End point type |
Secondary
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End point timeframe |
At Day 21
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Statistical analysis title |
Adjusted ratios Flu A/CAL/7/09 H1N1.HA antibodies | ||||||||||||||||||||
Statistical analysis description |
To demonstrate immunological equivalence of HA antigen adjuvanted with AS03B manufactured in Quebec (FluQ) and HA antigen adjuvanted with AS03B manufactured in Dresden (FluD), 21 days after vaccination.
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Comparison groups |
FluQ half Goup v FluD half Group
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Number of subjects included in analysis |
151
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Analysis specification |
Pre-specified
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Analysis type |
equivalence [7] | ||||||||||||||||||||
Method |
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Parameter type |
Adjusted GMT ratio | ||||||||||||||||||||
Point estimate |
0.96
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Confidence interval |
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level |
95% | ||||||||||||||||||||
sides |
2-sided
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lower limit |
0.73 | ||||||||||||||||||||
upper limit |
1.26 | ||||||||||||||||||||
Notes [7] - Equivalence criteria were fulfilled if the 2-sided 95% confidence limits on the geometric mean titre (GMT) ratio was within the interval 0.5 to 2.0. |
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End point title |
Number of subjects with HI antibody titers against Flu A/CAL/7/09 ≥ 1:10 | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At Day 182
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No statistical analyses for this end point |
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End point title |
HI antibody titres against Flu A/CAL/7/09 H1N1 strain | ||||||||||||||||||||
End point description |
Antibody titers were expressed as GMTs.
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End point type |
Secondary
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End point timeframe |
At Day 182
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No statistical analyses for this end point |
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End point title |
Number of subjects reporting any and grade 3 solicited local Adverse events (AEs) | ||||||||||||||||||||||||||||||||||||
End point description |
Any was defined as occurrence of any local symptom regardless of their intensity grade. Grade 3 redness and swelling = >100 millimeter (mm) and grade 3 pain = Cried when limb is moved/spontaneously painful.
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End point type |
Secondary
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End point timeframe |
During a 7-day (Days 0-6) post-vaccination period
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No statistical analyses for this end point |
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End point title |
Number of subjects reporting any, grade 3 and related solicited general AEs aged 3 years to 5 years | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (Fever = axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature equal to or above (≥) 39.0°C.
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End point type |
Secondary
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End point timeframe |
During the 7-day (Days 0-6) post-vaccination
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No statistical analyses for this end point |
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End point title |
Number of subjects reporting solicited general symptoms on subjects aged 6 years to 10 years | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever (Fever = axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature equal to or above (≥) 39.0°C.
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End point type |
Secondary
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End point timeframe |
During the 7-day (Days 0-6) post-vaccination
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No statistical analyses for this end point |
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End point title |
Number of subjects with medically-attended adverse events (MAEs) | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Up to Day 21
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No statistical analyses for this end point |
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End point title |
Number of subjects with MAEs | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
During the entire study period (Day 0 to Day 182)
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No statistical analyses for this end point |
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End point title |
Number of subjects with potential immune-mediated diseases (pIMDs) | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Up to Day 21
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No statistical analyses for this end point |
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End point title |
Number of subjects with pIMDs | ||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
During the entire study period (Day 0 to Day 182)
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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 |
An AE is 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.
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End point type |
Secondary
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End point timeframe |
Within the 21-day (Days 0-20) post-vaccination period
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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 |
An AE is 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.
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End point type |
Secondary
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End point timeframe |
Within the 42-day (Days 0-41) post-vaccination period
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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 |
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
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End point type |
Secondary
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End point timeframe |
Up to 21 days after 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 |
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
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End point type |
Secondary
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End point timeframe |
During the entire study period (Days 0 - 182)
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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 |
SAEs: Day 0 to 182; Unsolicted AEs: During the 42-day (Days 0-41) post-vaccination period; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period.
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Adverse event reporting additional description |
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
13.1
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Reporting groups
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Reporting group title |
FluQ half Goup
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Reporting group description |
Subjects received 1 half-pediatric dose of FluQ vaccine at Day 0 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
FluD half Group
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Reporting group description |
Subjects received 1 half-pediatric dose of FluD vaccine at Day 0 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
FluQ Group
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Reporting group description |
Subjects received 1 pediatric dose of FluQ vaccine at Day 0 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively). [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 Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively). [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 Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively). [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 Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively). [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 Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively). [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 Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively). [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 Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively). [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively). [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively). [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively). [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively). [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively). |
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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 |