Influenza Clinical Trial
Official title:
A Randomized, Double Blind, Multicentre Study to Evaluate Safety and Immunogenicity of Four Fluval AB-Like Influenza Vaccines With 3.5 μgHA, 6 μgHA, 9 μgHA Or 15 μgHA Of A/H1N1, A/H3N2 and B Influenza Antigens in Adult and Elderly Subjects
The purpose of this study is to determine the immunogenicity, tolerability and dose-effect relationship of one 0.5 mL intramuscular (IM) injection of four FLUVAL AB-like trivalent influenza vaccines containing either 3.5μgHA, 6μgHA,9μgHA or 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens in adults and elderly people.
Primary immunogenicity objectives
- To assess immunogenicity of one 0.5 mL intramuscular (IM) injection of four FLUVAL
AB-like trivalent influenza vaccines containing either 3.5μgHA, 6μgHA, 9μgHA or 15μgHA
of seasonal A/H1N1, A/H3N2 and B influenza antigens, as measured by haemagglutination
inhibition (HI) test 21 days after vaccination in compliance with the requirements of
the current European Union recommendations as determined in CPMP/BWP/214/96.
- To determine dose-effect relationship between one 0.5 mL IM injection of four FLUVAL
AB-like trivalent influenza vaccines containing either 3.5μgHA, 6μgHA, 9μgHA or 15μgHA
of seasonal A/H1N1, A/H3N2 and B influenza antigens and immune response provoked 21
days after vaccination in terms of pre- and postimmunization HA titers as measured by
HI test.
Secondary immunogenicity objectives
- To assess immunogenicity of one 0.5 mL IM injection of four FLUVAL AB-like trivalent
influenza vaccines containing either 3.5μgHA, 6μgHA, 9μgHA or 15μgHA of seasonal
A/H1N1, A/H3N2 and B influenza antigens, as measured by HI test 14 days after
vaccination in compliance with the requirements of the current European Union
recommendations as determined in CPMP/BWP/214/96.
- To find the highest dose of FLUVAL AB-like trivalent influenza vaccine among 3.5μgHA,
6μgHA and 9μgHA the response of which differs from that of dose 15μgHA in terms of
post-immunization HA titers as measured by HI test 21 days after vaccination.
- To find the highest dose of FLUVAL AB-like trivalent influenza vaccine among 3.5μgHA,
6μgHA and 9μgHA the response of which differs from that of dose 15μgHA in terms of
post-immunization HA titers as measured by HI test 14 days after vaccination.
- To find the highest dose of FLUVAL AB-like trivalent influenza vaccine among 3.5μgHA,
6μgHA and 9μgHA the response of which differs from that of dose 15μgHA in terms of the
percentage of subjects achieving seroconversion or significant increase in antibody
titer at day 21 after vaccination.
- To find the highest dose of FLUVAL AB-like trivalent influenza vaccine among 3.5μgHA,
6μgHA and 9μgHA the response of which differs from that of dose 15μgHA in terms of the
percentage of subjects achieving seroconversion or significant increase in antibody
titer at day 14 after vaccination.
- To find the highest dose of FLUVAL AB-like trivalent influenza vaccine among 3.5μgHA,
6μgHA and 9μgHA the response of which differs from that of dose 15μgHA in terms of Day
21/Day 0 geometric mean titer ratios (GMTRs) as determined by HI.
- To find the highest dose of FLUVAL AB-like trivalent influenza vaccine among 3.5μgHA,
6μgHA and 9μgHA the response of which differs from that of dose 15μgHA in terms of Day
14/Day 0 geometric mean titer ratios (GMTRs) as determined by HI.
Safety and tolerability objective
- To evaluate the safety of the administration of one 0.5 mL IM injection of four FLUVAL
AB-like trivalent influenza vaccines containing either 3.5μgHA, 6μgHA,9μgHA or 15μgHA
of seasonal A/H1N1, A/H3N2 and B influenza antigens.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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