Clinical Trial Results:
Safety and Immunogenicity of the Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Children Aged 3 to 8 Years
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Summary
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EudraCT number |
2011-005374-33 |
Trial protocol |
FI |
Global end of trial date |
25 Jun 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
10 Feb 2016
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First version publication date |
17 Jul 2015
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Other versions |
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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 |
GQM02
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
U1111-1127-7425 | ||
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Sponsors
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Sponsor organisation name |
Sanofi Pasteur SA
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Sponsor organisation address |
2, avenue Pont Pasteur, F-69367 Lyon Cedex 07, France,
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Public contact |
Director, Clinical Development, Sanofi Pasteur SA, +33 (4) 37 37 58 50, stephanie.pepin@sanofipasteur.com
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Scientific contact |
Director, Clinical Development, Sanofi Pasteur SA, +33 (4) 37 37 58 50, stephanie.pepin@sanofipasteur.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-001254-PIP01-11 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
02 Sep 2014
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
25 Jun 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To demonstrate non-inferiority of antibody (Ab) responses induced by QIV compared with the TIV.
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Protection of trial subjects |
Only subjects that met all the study inclusion and none of the exclusion criteria were randomized and vaccinated in the study. Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment was also available on site in case of any immediate allergic reactions.
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Background therapy |
Not applicable | ||
Evidence for comparator |
Not applicable | ||
Actual start date of recruitment |
12 Sep 2013
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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: 154
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Country: Number of subjects enrolled |
Poland: 288
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Country: Number of subjects enrolled |
Mexico: 600
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Country: Number of subjects enrolled |
Taiwan: 200
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Worldwide total number of subjects |
1242
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EEA total number of subjects |
442
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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) |
1242
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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 |
Study subjects were enrolled from 12 September 2013 to 13 November 2013 in 11 clinical centers in Finland, 4 in Mexico, 4 in Poland, and 3 in Taiwan. | ||||||||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
A total of 1242 subjects who met all the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated. | ||||||||||||||||||||||||||||||||
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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 |
Double blind | ||||||||||||||||||||||||||||||||
Roles blinded |
Investigator, Subject | ||||||||||||||||||||||||||||||||
Blinding implementation details |
This study was blinded to the Investigator and subjects. The code could be broken by the Investigator in the event of a SAE and if identification of the vaccine received could influence SAE treatment (Responsible Medical Officer was to be notified first) by calling the IVRS/IWRS system and by the GPV department for reporting to Health authorities in the case of an SAE as described in International Conference on Harmonisation (only for the subject in question).
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Quadrivalent influenza vaccine (QIV) | ||||||||||||||||||||||||||||||||
Arm description |
Children aged 3-8 years who received one dose of quadrivalent influenza vaccine (QIV) and if previously unvaccinated, a second dose of vaccine was administered on Day 28. | ||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Quadrivalent influenza vaccine (split-virion, inactivated) (QIV)
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Investigational medicinal product code |
481
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL dose, intramuscular (IM) to be injected into the deltoid muscle or deep subcutaneous (SC), one dose on Day 0 and if previously unvaccinated, a second dose of vaccine was administered on Day 28.
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Arm title
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TIV1 | ||||||||||||||||||||||||||||||||
Arm description |
Children aged 3-8 years who received one dose of trivalent influenza vaccine that contained the B strain from the Victoria lineage (TIV1) and if previously unvaccinated, a second dose of vaccine was administered on Day 28. | ||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||
Investigational medicinal product name |
TIV1 (split-virion, inactivated)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL dose, intramuscular (IM) to be injected into the deltoid muscle or deep subcutaneous (SC), one dose on Day 0 and if previously unvaccinated, a second dose of vaccine was administered on Day 28.
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Arm title
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TIV2 | ||||||||||||||||||||||||||||||||
Arm description |
Children aged 3-8 years who received one dose of trivalent influenza vaccine containing the B strain from the Yamagata lineage (TIV2) and if previously unvaccinated, a second dose of vaccine was administered on Day 28. | ||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||
Investigational medicinal product name |
TIV2 (split-virion, inactivated)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL dose, intramuscular (IM) to be injected into the deltoid muscle or deep subcutaneous (SC), one dose on Day 0 and if previously unvaccinated, a second dose of vaccine was administered on Day 28.
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Baseline characteristics reporting groups
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Reporting group title |
Quadrivalent influenza vaccine (QIV)
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Reporting group description |
Children aged 3-8 years who received one dose of quadrivalent influenza vaccine (QIV) and if previously unvaccinated, a second dose of vaccine was administered on Day 28. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
TIV1
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Reporting group description |
Children aged 3-8 years who received one dose of trivalent influenza vaccine that contained the B strain from the Victoria lineage (TIV1) and if previously unvaccinated, a second dose of vaccine was administered on Day 28. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
TIV2
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Reporting group description |
Children aged 3-8 years who received one dose of trivalent influenza vaccine containing the B strain from the Yamagata lineage (TIV2) and if previously unvaccinated, a second dose of vaccine was administered on Day 28. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Quadrivalent influenza vaccine (QIV)
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Reporting group description |
Children aged 3-8 years who received one dose of quadrivalent influenza vaccine (QIV) and if previously unvaccinated, a second dose of vaccine was administered on Day 28. | ||
Reporting group title |
TIV1
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Reporting group description |
Children aged 3-8 years who received one dose of trivalent influenza vaccine that contained the B strain from the Victoria lineage (TIV1) and if previously unvaccinated, a second dose of vaccine was administered on Day 28. | ||
Reporting group title |
TIV2
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Reporting group description |
Children aged 3-8 years who received one dose of trivalent influenza vaccine containing the B strain from the Yamagata lineage (TIV2) and if previously unvaccinated, a second dose of vaccine was administered on Day 28. | ||
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End point title |
Geometric Mean Titers (GMTs) of Influenza Antibodies Before and After Vaccination with a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route [1] | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method.
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End point type |
Primary
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End point timeframe |
Day 0 (pre-vaccination) and Day 28-Day 56 post-vaccination
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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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects with Seroprotection Against the Influenza Antigens Before or After Vaccination with a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route [2] | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method. Seroprotection was defined as subjects with titers ≥ 40 (1/dil) on D0 and, on D28 or D56.
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End point type |
Primary
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End point timeframe |
Day 0 (pre-vaccination) and Day 28-Day 56 post-vaccination
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects Achieving Seroconversion or Significant increase Against Influenza Antigens After Vaccination with a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route [3] | ||||||||||||||||||||||||||||||||
End point description |
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method. Seroconversion was defined as subjects with pre-vaccination titer < 10 (1/dil) on D0, post-vaccination titer ≥40 (1/dil) or significant increase was for subjects with pre-vaccination titer ≥ 10 (1/dil), ≥ 4-fold increase of the titer after vaccination (post/pre).
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End point type |
Primary
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End point timeframe |
Day 28-Day 56 post-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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||
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End point title |
Geometric Mean Titers (GMTs) of Influenza Antibodies In Primed Subjects Before and After Vaccination with a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route [4] | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method.
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End point type |
Primary
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End point timeframe |
Day 0 (pre-vaccination) and Day 28-Day 56 post-vaccination
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of Primed Subjects with Seroprotection Against the Influenza Antigens Before or After Vaccination with a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route [5] | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method. Seroprotection was defined as subjects with titers ≥ 40 (1/dil) on D0 and, on D28 or D56.
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End point type |
Primary
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End point timeframe |
Day 0 (pre-vaccination) and Day 28-Day 56 post-vaccination
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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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of Primed Subjects Achieving Seroconversion or Significant increase Against Influenza Antigens After Vaccination with a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route [6] | ||||||||||||||||||||||||||||||||
End point description |
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method. Seroconversion was defined as subjects with pre-vaccination titer < 10 (1/dil) on D0, post-vaccination titer ≥40 (1/dil) or significant increase was for subjects with pre-vaccination titer ≥ 10 (1/dil), ≥ 4-fold increase of the titer after vaccination (post/pre).
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End point type |
Primary
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End point timeframe |
Day 28-Day 56 post-vaccination
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| Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||
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End point title |
Geometric Mean Titers (GMTs) of Influenza Antibodies in Unprimed Subjects Before and After Vaccination with a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route [7] | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method.
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End point type |
Primary
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End point timeframe |
Day 0 (pre-vaccination) and Day 28-Day 56 post-vaccination
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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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of Unprimed Subjects with Seroprotection Against the Influenza Antigens Before or After Vaccination with a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route [8] | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method. Seroprotection was defined as subjects with titers ≥ 40 (1/dil) on D0 and, on D28 or D56.
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End point type |
Primary
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End point timeframe |
Day 0 (pre-vaccination) and Day 28-Day 56 post-vaccination
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| Notes [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of Unprimed Subjects Achieving Seroconversion or Significant increase Against Influenza Antigens After Vaccination with a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route [9] | ||||||||||||||||||||||||||||||||
End point description |
Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method. Seroconversion was defined as subjects with pre-vaccination titer < 10 (1/dil) on D0, post-vaccination titer ≥40 (1/dil) or significant increase was for subjects with pre-vaccination titer ≥ 10 (1/dil), ≥ 4-fold increase of the titer after vaccination (post/pre).
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End point type |
Primary
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End point timeframe |
Day 28-Day 56 post-vaccination
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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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||
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End point title |
Geometric Mean Titers (GMTs) of Influenza Antibodies Before and After Vaccination with a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route [10] | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Immunogenicity was evaluated using the virus seroneutralization (SN) method.
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End point type |
Primary
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End point timeframe |
Day 0 (pre-vaccination) and Day 28-Day 56 post-vaccination
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| Notes [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects Reporting Solicited Injection-site or Systemic Reaction After First Vaccination with a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route [11] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited injection site: Pain, Erythema, Swelling, Induration and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 Solicited Injection site reactions: Pain – Incapacitating, unable to perform usual activities; Erythema, Swelling, Induration, and Ecchymosis - ≥50 mm. Grade 3 Solicited systemic reactions: Fever - ≥39˚C; Headache, Malaise, Myalgia, and Shivering – Significant, prevents daily activities.
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End point type |
Primary
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End point timeframe |
Day 0 up to Day 7 post-vaccination
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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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects Reporting Solicited Injection-site or Systemic Reaction After Second Vaccination with a Quadrivalent Influenza Vaccine Administered via the Intramuscular Route [12] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited injection site: Pain, Erythema, Swelling, Induration and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 Solicited Injection site reactions: Pain – Incapacitating, unable to perform usual activities; Erythema, Swelling, Induration, and Ecchymosis - ≥50 mm. Grade 3 Solicited systemic reactions: Fever - ≥39˚C; Headache, Malaise, Myalgia, and Shivering – Significant, prevents daily activities.
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End point type |
Primary
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End point timeframe |
Day 0 up to Day 7 post-vaccination
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| Notes [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
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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 |
Adverse event data were collected from Day 0 (post-vaccination) up to Day 28 post-vaccination.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
14.0
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Reporting groups
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Reporting group title |
Quadrivalent influenza vaccine (QIV)
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Reporting group description |
Children aged 3-8 years who received one dose of quadrivalent influenza vaccine (QIV) and if previously unvaccinated, a second dose of vaccine was administered on Day 28. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
TIV1
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Reporting group description |
Children aged 3-8 years who received one dose of trivalent influenza vaccine that contained the B strain from the Victoria lineage (TIV1) and if previously unvaccinated, a second dose of vaccine was administered on Day 28. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
TIV2
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Reporting group description |
Children aged 3-8 years who received one dose of trivalent influenza vaccine containing the B strain from the Yamagata lineage (TIV2) and if previously unvaccinated, a second dose of vaccine was administered on Day 28. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period. [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: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period. [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: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period. [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: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period. [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: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period. [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: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period. [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: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period. [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: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period. [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: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period. [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: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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27 Jan 2014 |
A first analysis on vaccination period data (D0-D56) was added. |
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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 | |||
