Clinical Trial Results:
Safety and immunogenicity of an intramuscular, inactivated, split-virion, pandemic influenza A/H5N1 vaccine in adults and the elderly
Summary
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EudraCT number |
2006-000477-29 |
Trial protocol |
BE GB |
Global end of trial date |
23 Dec 2008
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Feb 2016
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First version publication date |
03 Dec 2014
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Other versions |
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 |
GPA02
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00415129 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Sanofi Pasteur SA
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Sponsor organisation address |
1541, Avenue Marcel Mérieux, Marcy L’Etoile, France, 69280
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Public contact |
Director, Clinical Development, Sanofi Pasteur SA, 1 57 09 57 61 25, sanjay.gurunathan@sanofipasteur.com
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Scientific contact |
Director, Clinical Development, Sanofi Pasteur SA, 1 57 09 57 61 25, sanjay.gurunathan@sanofipasteur.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? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
03 Sep 2009
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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 |
23 Dec 2008
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
• To describe the injection site reactions and systemic safety profile during the 21 days after each of two primary series and one booster (as applicable) intramuscular (IM) injections in two age groups: subjects aged 18 to 60 years (adults) or >60 years (elderly).
• To describe the immune response 21 days after each of two primary series IM injections in two age groups: subjects aged 18 to 60 years and >60 years.
• To describe the antibody persistence at month 6 (all subjects) and months 15 and 22 (subsets of subjects) after the first vaccination in two age groups: subjects aged 18 to 60 years or >60 years.
• To describe the immune response 21 days after a booster vaccination administered at either 6 months (A/Vietnam booster) or 7 and 21 days after a booster vaccination administered at 22 months (A/Indonesia booster) after the first vaccination in two age groups: subjects aged 18 to 60 years or >60 years.
• To describe any serious adverse event during the trial.
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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 were also available on site in case of any immediate allergic reactions.
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Background therapy |
Not applicable | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
16 May 2006
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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: 150
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Country: Number of subjects enrolled |
Belgium: 450
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Worldwide total number of subjects |
600
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EEA total number of subjects |
600
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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) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
390
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From 65 to 84 years |
210
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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 16 May 2006 to 12 June 2006 in 3 clinical centers in Belgium and 1 in the United Kingdom. | |||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
A total of 600 subjects who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated. | |||||||||||||||||||||||||||||||||||
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 |
Not applicable
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Blinding used |
Not blinded | |||||||||||||||||||||||||||||||||||
Blinding implementation details |
Not applicable
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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18-60 years 30μg+Adjuvant | |||||||||||||||||||||||||||||||||||
Arm description |
Subjects aged 18-60 years of age who received two doses of A/H5N1 inactivated, split-virion influenza virus (A/Vietnam 30μg anti-hemagglutination [HA]) with aluminum hydroxide adjuvant 21 days apart as primary series and a booster vaccination at either 6 months (A/Vietnam 7.5μg HA) or 22 months (A/Indonesia 30μg HA plus adjuvant) after the first vaccination or no booster vaccination. | |||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
A/H5N1 inactivated, adjuvanted, split virion influenza vaccine made in embryonated eggs
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Investigational medicinal product code |
402
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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, intramuscular, two doses 21 days apart as primary series and booster at either 6 or 22 months after first vaccination or no booster vaccination.
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Arm title
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18-60 years 7.5μg | |||||||||||||||||||||||||||||||||||
Arm description |
Subjects aged 18-60 years of age who received two doses of A/H5N1 inactivated, split-virion influenza virus (A/Vietnam 7.5μg anti-hemagglutination [HA] ) without adjuvant 21 days apart as primary series and a booster vaccination at 6 months (A/Vietnam 7.5μg HA) after the first vaccination or no booster at 22 months. | |||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
A/H5N1 inactivated, adjuvanted, split virion influenza vaccine made in embryonated eggs
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Investigational medicinal product code |
402
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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, intramuscular, two doses 21 days apart as primary series and booster at either 6 or 22 months after first vaccination or no booster vaccination.
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Arm title
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>60 years 30μg+Adjuvant | |||||||||||||||||||||||||||||||||||
Arm description |
Subjects aged >60 years of age who received two doses of A/H5N1 inactivated, split-virion influenza virus (A/Vietnam 30μg anti-hemagglutination [HA]) with aluminum hydroxide adjuvant 21 days apart as primary series and a booster vaccination at either 6 months (A/Vietnam 7.5μg HA) or 22 months (A/Indonesia 30μg HA plus adjuvant) after the first vaccination or no booster vaccination. | |||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
A/H5N1 inactivated, adjuvanted, split virion influenza vaccine made in embryonated eggs
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Investigational medicinal product code |
402
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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, intramuscular, two doses 21 days apart as primary series and booster at either 6 or 22 months after first vaccination or no booster vaccination.
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Arm title
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>60 years 7.5μg | |||||||||||||||||||||||||||||||||||
Arm description |
Subjects aged >60 years of age who received two doses of A/H5N1 inactivated, split-virion influenza virus (A/Vietnam 7.5μg anti-hemagglutination [HA]) without adjuvant 21 days apart as primary series and a booster vaccination at 6 months (A/Vietnam 7.5μg HA) after the first vaccination or no booster at 22 months. | |||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
A/H5N1 inactivated, adjuvanted, split virion influenza vaccine made in embryonated eggs
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Investigational medicinal product code |
402
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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, intramuscular, two doses 21 days apart as primary series and booster at either 6 or 22 months after first vaccination or no booster vaccination.
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Baseline characteristics reporting groups
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Reporting group title |
18-60 years 30μg+Adjuvant
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Reporting group description |
Subjects aged 18-60 years of age who received two doses of A/H5N1 inactivated, split-virion influenza virus (A/Vietnam 30μg anti-hemagglutination [HA]) with aluminum hydroxide adjuvant 21 days apart as primary series and a booster vaccination at either 6 months (A/Vietnam 7.5μg HA) or 22 months (A/Indonesia 30μg HA plus adjuvant) after the first vaccination or no booster vaccination. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
18-60 years 7.5μg
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Reporting group description |
Subjects aged 18-60 years of age who received two doses of A/H5N1 inactivated, split-virion influenza virus (A/Vietnam 7.5μg anti-hemagglutination [HA] ) without adjuvant 21 days apart as primary series and a booster vaccination at 6 months (A/Vietnam 7.5μg HA) after the first vaccination or no booster at 22 months. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
>60 years 30μg+Adjuvant
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Reporting group description |
Subjects aged >60 years of age who received two doses of A/H5N1 inactivated, split-virion influenza virus (A/Vietnam 30μg anti-hemagglutination [HA]) with aluminum hydroxide adjuvant 21 days apart as primary series and a booster vaccination at either 6 months (A/Vietnam 7.5μg HA) or 22 months (A/Indonesia 30μg HA plus adjuvant) after the first vaccination or no booster vaccination. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
>60 years 7.5μg
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Reporting group description |
Subjects aged >60 years of age who received two doses of A/H5N1 inactivated, split-virion influenza virus (A/Vietnam 7.5μg anti-hemagglutination [HA]) without adjuvant 21 days apart as primary series and a booster vaccination at 6 months (A/Vietnam 7.5μg HA) after the first vaccination or no booster at 22 months. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
18-60 years 30μg+Adjuvant
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Reporting group description |
Subjects aged 18-60 years of age who received two doses of A/H5N1 inactivated, split-virion influenza virus (A/Vietnam 30μg anti-hemagglutination [HA]) with aluminum hydroxide adjuvant 21 days apart as primary series and a booster vaccination at either 6 months (A/Vietnam 7.5μg HA) or 22 months (A/Indonesia 30μg HA plus adjuvant) after the first vaccination or no booster vaccination. | ||
Reporting group title |
18-60 years 7.5μg
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Reporting group description |
Subjects aged 18-60 years of age who received two doses of A/H5N1 inactivated, split-virion influenza virus (A/Vietnam 7.5μg anti-hemagglutination [HA] ) without adjuvant 21 days apart as primary series and a booster vaccination at 6 months (A/Vietnam 7.5μg HA) after the first vaccination or no booster at 22 months. | ||
Reporting group title |
>60 years 30μg+Adjuvant
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Reporting group description |
Subjects aged >60 years of age who received two doses of A/H5N1 inactivated, split-virion influenza virus (A/Vietnam 30μg anti-hemagglutination [HA]) with aluminum hydroxide adjuvant 21 days apart as primary series and a booster vaccination at either 6 months (A/Vietnam 7.5μg HA) or 22 months (A/Indonesia 30μg HA plus adjuvant) after the first vaccination or no booster vaccination. | ||
Reporting group title |
>60 years 7.5μg
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Reporting group description |
Subjects aged >60 years of age who received two doses of A/H5N1 inactivated, split-virion influenza virus (A/Vietnam 7.5μg anti-hemagglutination [HA]) without adjuvant 21 days apart as primary series and a booster vaccination at 6 months (A/Vietnam 7.5μg HA) after the first vaccination or no booster at 22 months. |
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End point title |
Summary of Geometric Mean Titers (GMTs) of Antibody Assayed by HI Horse Erythrocytes Method Against A/Vietnam/1194/2004/NIBRG-14 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [1] | |||||||||||||||||||||||||||||||||||
End point description |
Influenza vaccine antibodies were assessed using the hemagglutination inhibition using horse erythrocytes method.
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End point type |
Primary
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End point timeframe |
Day 0 (pre-vaccination) and Day 21 and Day 42 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 |
Summary of Geometric Mean Titers Ratios (GMTR) Antibody Assayed by HI Horse Erythrocytes Method Against A/Vietnam/1194/2004/NIBRG-14 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [2] | |||||||||||||||||||||||||||||||||||
End point description |
Influenza vaccine antibodies were assessed using the hemagglutination inhibition using horse erythrocytes method. Geometric mean titer ratio is the geometric mean of the individual post-vaccination/pre-vaccination titer of antibodies to the influenza virus antigens.
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End point type |
Primary
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End point timeframe |
Day 0 (pre-vaccination) and Day 21 and Day 42 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 with Antibody Titers <8 (1/dil) Assayed by HI Horse Erythrocytes Method Against A/Vietnam/1194/2004/NIBRG-14 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [3] | |||||||||||||||||||||||||||||||||||
End point description |
Influenza vaccine antibodies were assessed using the hemagglutination inhibition using horse erythrocytes method.
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End point type |
Primary
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End point timeframe |
Day 0 (pre-vaccination) and Day 21 and Day 42 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 |
Percentage of Subjects Achieving Seroconversion or Significant Increase in Antibody Assayed by HI Horse Erythrocytes Method Against A/Vietnam/1194/2004/NIBRG-14 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [4] | ||||||||||||||||||||||||||||||
End point description |
Influenza vaccine antibodies were assessed using the hemagglutination inhibition using horse erythrocytes method. Seroconversion (for subjects with a titer <10 [turkey] or <8 [horse] [1/dil] on Day 0: post-injection titer ≥40 [turkey] or ≥32 [horse] [1/dil]), or significant increase (for subjects with a titer ≥10 [turkey] or ≥8 [horse] [1/dil]: ≥four-fold increase of the titer) at Day 21 and Day 42.
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End point type |
Primary
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End point timeframe |
Day 21 and Day 42 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 |
Summary of Geometric Mean Titers (GMTs) of Antibody Assayed by HI Turkey Erythrocytes Method Against A/Vietnam/1194/2004/NIBRG-14 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [5] | |||||||||||||||||||||||||||||||||||
End point description |
Influenza vaccine antibodies were assessed using the hemagglutination inhibition using turkey erythrocytes method.
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End point type |
Primary
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End point timeframe |
Day 0 (pre-vaccination) and Day 21 and Day 42 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 |
Summary of Geometric Mean Titers Ratios (GMTR) Antibody Assayed by HI Turkey Erythrocytes Method Against A/Vietnam/1194/2004/NIBRG-14 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [6] | |||||||||||||||||||||||||||||||||||
End point description |
Influenza vaccine antibodies were assessed using the hemagglutination inhibition using turkey erythrocytes method. Geometric mean titer ratio is the geometric mean of the individual post-vaccination/pre-vaccination titer of antibodies to the influenza virus antigens.
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End point type |
Primary
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End point timeframe |
Day 0 (pre-vaccination) and Day 21 and Day 42 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 |
Percentage of Subjects with Antibody titers <10 (1/dil) Assayed by HI Turkey Erythrocytes Method Against A/Vietnam/1194/2004/NIBRG-14 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [7] | |||||||||||||||||||||||||||||||||||
End point description |
Influenza vaccine antibodies were assessed using the hemagglutination inhibition using turkey erythrocytes method.
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End point type |
Primary
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End point timeframe |
Day 0 (pre-vaccination) and Day 21 and Day 42 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 Subjects Achieving Seroconversion or Significant Increase in Antibody Assayed by HI Turkey Erythrocytes Method Against A/Vietnam/1194/2004/NIBRG-14 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [8] | ||||||||||||||||||||||||||||||
End point description |
Influenza vaccine antibodies were assessed using the hemagglutination inhibition using turkey erythrocytes method. Seroconversion (for subjects with a titer <10 [turkey] or <8 [horse] [1/dil] on Day 0: post-injection titer ≥40 [turkey] or ≥32 [horse] [1/dil]), or significant increase (for subjects with a titer ≥10 [turkey] or ≥8 [horse] [1/dil]: ≥four-fold increase of the titer) at Day 21 and Day 42.
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End point type |
Primary
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End point timeframe |
Day 21 and Day 42 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. |
|||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||
End point title |
Summary of Geometric Mean Titers (GMTs) of Antibody Assayed Seroneutralization Method Against A/Vietnam/1194/2004/NIBRG-14 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [9] | |||||||||||||||||||||||||||||||||||
End point description |
Influenza vaccine antibodies were assessed using the seroneutralization method.
|
|||||||||||||||||||||||||||||||||||
End point type |
Primary
|
|||||||||||||||||||||||||||||||||||
End point timeframe |
Day 0 (pre-vaccination) and Day 21 and Day 42 post-vaccination
|
|||||||||||||||||||||||||||||||||||
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. |
||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||
End point title |
Summary of Geometric Mean Titers Ratios (GMTR) Antibody Assayed by Seroneutralization Method Against A/Vietnam/1194/2004/NIBRG-14 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [10] | |||||||||||||||||||||||||||||||||||
End point description |
Influenza vaccine antibodies were assessed using the seroneutralization method. Geometric mean titer ratio is the geometric mean of the individual post-vaccination/pre-vaccination titer of antibodies to the influenza virus antigens.
|
|||||||||||||||||||||||||||||||||||
End point type |
Primary
|
|||||||||||||||||||||||||||||||||||
End point timeframe |
Day 0 (pre-vaccination) and Day 21 and Day 42 post-vaccination
|
|||||||||||||||||||||||||||||||||||
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. |
||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||
End point title |
Percentage of Subjects with Antibody titers <20 (1/dil) Assayed by Seroneutralization Method Against A/Vietnam/1194/2004/NIBRG-14 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [11] | |||||||||||||||||||||||||||||||||||
End point description |
Influenza vaccine antibodies were assessed using the seroneutralization method.
|
|||||||||||||||||||||||||||||||||||
End point type |
Primary
|
|||||||||||||||||||||||||||||||||||
End point timeframe |
Day 0 (pre-vaccination) and Day 21 and Day 42 post-vaccination
|
|||||||||||||||||||||||||||||||||||
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. |
||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||
End point title |
Percentage of Subjects with 2- and 4-fold Increase in Antibody titers Assayed by Seroneutralization Method Against A/Vietnam/1194/2004/NIBRG-14 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [12] | ||||||||||||||||||||||||||||||||||||||||
End point description |
Influenza vaccine antibodies were assessed using the seroneutralization method.
|
||||||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 0 (pre-vaccination) and Day 21 and Day 42 post-vaccination
|
||||||||||||||||||||||||||||||||||||||||
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. |
|||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||
End point title |
Summary of Geometric Mean Titers of Antibody (Ab) Assayed by HI Horse Erythrocytes Method Against A/Vietnam/1194/2004/NIBRG-14 (H5N1) Strain In Subjects with Undetectable Ab After Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [13] | |||||||||||||||||||||||||||||||||||
End point description |
Influenza vaccine antibodies were assessed using the hemagglutination inhibition using horse erythrocytes method.
|
|||||||||||||||||||||||||||||||||||
End point type |
Primary
|
|||||||||||||||||||||||||||||||||||
End point timeframe |
Day 0 (pre-vaccination) and Day 21 and Day 42 post-vaccination
|
|||||||||||||||||||||||||||||||||||
Notes [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||
End point title |
Summary of Geometric Mean Titers Ratios Antibody (Ab) Assayed by HI Horse Erythrocytes Method Against A/Vietnam/1194/2004/NIBRG-14 (H5N1) Strain In Subjects with Undetectable Ab After Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [14] | |||||||||||||||||||||||||||||||||||
End point description |
Influenza vaccine antibodies were assessed using the hemagglutination inhibition using horse erythrocytes method. Geometric mean titer ratio is the geometric mean of the individual post-vaccination/pre-vaccination titer of antibodies to the influenza virus antigens.
|
|||||||||||||||||||||||||||||||||||
End point type |
Primary
|
|||||||||||||||||||||||||||||||||||
End point timeframe |
Day 0 (pre-vaccination) and Day 21 and Day 42 post-vaccination
|
|||||||||||||||||||||||||||||||||||
Notes [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||
End point title |
Percentage of Subjects with Undetectable Antibody Achieving Antibody titers <8 (1/dil) Assayed by HI Horse Erythrocytes Method Against A/Vietnam/1194/2004/NIBRG-14 (H5N1) Strain After Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [15] | |||||||||||||||||||||||||||||||||||
End point description |
Influenza vaccine antibodies were assessed using the hemagglutination inhibition using horse erythrocytes method.
|
|||||||||||||||||||||||||||||||||||
End point type |
Primary
|
|||||||||||||||||||||||||||||||||||
End point timeframe |
Day 0 (pre-vaccination) and Day 21 and Day 42 post-vaccination
|
|||||||||||||||||||||||||||||||||||
Notes [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||
End point title |
Percentage of Subjects with Undetectable Antibody (Ab) Achieving Seroconversion/Significant Increase in Ab Assayed by HI Horse Erythrocytes Method Against A/Vietnam/1194/2004/NIBRG-14 (H5N1) Strain After Inactivated Split-Virion, Influenza Vaccine [16] | ||||||||||||||||||||||||||||||
End point description |
Influenza vaccine antibodies were assessed using the hemagglutination inhibition using horse erythrocytes method. Seroconversion (for subjects with a titer <10 [turkey] or <8 [horse] [1/dil] on Day 0: post-injection titer ≥40 [turkey] or ≥32 [horse] [1/dil]), or significant increase (for subjects with a titer ≥10 [turkey] or ≥8 [horse] [1/dil]: ≥four-fold increase of the titer) at Day 21 and Day 42.
|
||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||
End point timeframe |
Day 21 and Day 42 post-vaccination
|
||||||||||||||||||||||||||||||
Notes [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
|||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||
End point title |
Summary of Geometric Mean Titers (GMTs) of Neuraminidase Assay - Anti-neuraminidase Antibody Against A/Vietnam/1194/2004 (H5N1)_RG14 Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [17] | ||||||||||||||||||||||||||||||
End point description |
Influenza vaccine antibodies were assessed using the neuraminidase assay.
|
||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||
End point timeframe |
Day 0 (pre-vaccination) and Day 42 post-vaccination
|
||||||||||||||||||||||||||||||
Notes [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
|||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||
End point title |
Summary of Geometric Mean Titers Assayed by HI Horse Erythrocyte Method of Neuraminidase Assay - Anti-neuraminidase Antibody Against A/Vietnam/1194/2004/NIBRG-14 (H5N1) Strain After Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [18] | ||||||||||||||||||||||||||||||||||||||||
End point description |
Influenza vaccine antibodies were assessed using the hemagglutination inhibition using horse erythrocytes method.
|
||||||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 0 (pre-vaccination) and Day 21, Day 42, and Day 180 post-vaccination
|
||||||||||||||||||||||||||||||||||||||||
Notes [18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
|||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||
End point title |
Percentage of Subjects with Antibody titers <32 (1/dil) Assayed by HI Horse Erythrocytes Method Against A/Vietnam/1194/2004/NIBRG-14 (H5N1) Strain Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [19] | ||||||||||||||||||||||||||||||||||||||||
End point description |
Influenza vaccine antibodies were assessed using the hemagglutination inhibition using horse erythrocytes method.
|
||||||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 0 (pre-vaccination) and Day 21, Day 42, and Day 180 post-vaccination
|
||||||||||||||||||||||||||||||||||||||||
Notes [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
|||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||
End point title |
Summary of Geometric Mean Titers (GMTs) Assayed by Seroneutralization Method – Neutralizing Antibody Against A/Vietnam (H5N1) Strains Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [20] | ||||||||||||||||||||||||||||||||||||||||
End point description |
Influenza vaccine antibodies were assessed using the seroneutralization method. [Day 0 to Day 42]: Neutralizing Antibody (1/dil) against A/Vietnam/1194/2004/NIBRG-14 (H5N1) Strain and [Day 180 to Day 201]: Neutralizing Antibody (1/dil) against rg A/Vietnam/1203/2004 (H5N1) Strain.
|
||||||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 0 (pre-vaccination) and Day 21, Day 42, and Day 180 post-vaccination
|
||||||||||||||||||||||||||||||||||||||||
Notes [20] - 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. |
|||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Percentage of Subjects Reporting Solicited Injection-site or Systemic Reactions within 7 Days After Each Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [21] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited injection site: Pain, Erythema, Swelling, Induration and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 0 up to Day 7 post- each vaccination
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Percentage of Subjects with at Least One Reaction Within 3 Days after Any Vaccine Injection Listed in the EMEA Note for Guidance Strains Following Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [22] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited injection site: Induration and Ecchymosis. Solicited systemic reactions: Fever, Malaise, and Shivering.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 0 up to Day 3 post-each vaccination
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [22] - 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. |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Percentage of Subjects Reporting Solicited Injection-site or Systemic Reactions Within 7 Days after Clade 1 A/Vietnam Booster Vaccine Injection Following Primary Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [23] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited injection site: Pain, Erythema, Swelling, Induration and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 0 up to Day 7 post-vaccination
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome. |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Percentage of Subjects with at least one Reaction within 3 Days after the Clade 1 A/Vietnam Booster Vaccine Injection Listed in the EMEA Note for Guidance Following Primary Vaccination with Inactivated Split-Virion, Pandemic Influenza Vaccine [24] | |||||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited injection site: Induration and Ecchymosis. Solicited systemic reactions: Fever, Malaise, and Shivering.
|
|||||||||||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
|||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 0 up to Day 3 post-vaccination
|
|||||||||||||||||||||||||||||||||||||||||||||
Notes [24] - 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. |
||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Adverse event data were collected from Day 0 (post vaccination) up to Day 7 post vaccination.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
7.1
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
18-60 years 30μg+Ad
|
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Reporting group description |
Subjects aged 18-60 years of age who received two doses of A/H5N1 inactivated, split-virion influenza virus (A/Vietnam 30μg anti-hemagglutination [HA]) with aluminum hydroxide adjuvant 21 days apart as primary series and a booster vaccination at either 6 months (A/Vietnam 7.5μg HA) or 22 months (A/Indonesia 30μg HA plus adjuvant) after the first vaccination or no booster vaccination. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
18-60 years 7.5μg
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Reporting group description |
Subjects aged 18-60 years of age who received two doses of A/H5N1 inactivated, split-virion influenza virus (A/Vietnam 7.5μg anti-hemagglutination [HA] ) without adjuvant 21 days apart as primary series and a booster vaccination at 6 months (A/Vietnam 7.5μg HA) after the first vaccination or no booster at 22 months. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
>60 years 30μg+Ad
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Reporting group description |
Subjects aged >60 years of age who received two doses of A/H5N1 inactivated, split-virion influenza virus (A/Vietnam 30μg anti-hemagglutination [HA]) with aluminum hydroxide adjuvant 21 days apart as primary series and a booster vaccination at either 6 months (A/Vietnam 7.5μg HA) or 22 months (A/Indonesia 30μg HA plus adjuvant) after the first vaccination or no booster vaccination. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
>60 years 7.5μg
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Reporting group description |
Subjects aged >60 years of age who received two doses of A/H5N1 inactivated, split-virion influenza virus (A/Vietnam 7.5μg anti-hemagglutination [HA] ) without adjuvant 21 days apart as primary series and a booster vaccination at 6 months (A/Vietnam 7.5μg HA) after the first vaccination or no booster at 22 months. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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. |
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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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16 Feb 2006 |
Clarification of the timing and type of booster; inclusion of additional subjects aged 18 to 60 years to receive two administrations of the new vaccine strain (Clade 2 A/Indonesia) in order to assess the priming immunogenicity response to this strain and the concomitant production other randomization lists for the Clade 2 A/Indonesia vaccinations and an increase of planned sample size for the analysis; Ethnicity and seasonal influenza vaccination history added to the CRF; Deletion of the Single Radial Hemolysis (SRH) analysis method. |
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06 Sep 2006 |
Modification of the timing of the 12-month (Clade 2 A/Indonesia) booster vaccination and the timing of the assessment for 12-month Antibody persistence. |
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20 Apr 2007 |
Determination of the timing of the Clade 2 A/Indonesia booster in a subset of subjects primed with the 30µgHA+aluminum hydroxide vaccine; Modification of the design of the study regarding the administration of the booster, and the additional subjects included at the time of the Clade 2 A/Indonesia booster; addition of an additional visit 7 days after the Clade 2 A/Indonesia booster for immunogenicity assessment and elimination of the CMI evaluation after booster with the A/Indonesia strain. |
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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 |