The aim of the study is to assess the safety \& immunogenicity of a pandemic influenza vaccine administered at 2 different time points. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value
Timeframe: At Day 0
Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value
Timeframe: At Month 6
Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value
Timeframe: At Month 6 + 7 Days
Number of Subjects With H5N1 Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value
Timeframe: At Month 6 + 21 Days
Geometric Mean Titers (GMTs) of H5N1 HI Antibodies
Timeframe: At Day 0
Geometric Mean Titers (GMTs) of H5N1 HI Antibodies
Timeframe: At Month 6
Geometric Mean Titers (GMTs) of H5N1 HI Antibodies
Timeframe: At Month 6 + 7 Days
Geometric Mean Titers (GMTs) of H5N1 HI Antibodies
Timeframe: At Month 6 + 21 Days
Seroconversion Factor for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Timeframe: At Month 6
Seroconversion Factor for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Timeframe: At Month 6 + 7 Days
Seroconversion Factor for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Timeframe: At Month 6 + 21 Days
Number of Seroconverted Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Timeframe: At Month 6
Number of Seroconverted Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Timeframe: At Month 6 + 7 Days
Number of Seroconverted Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Timeframe: At Month 6 + 21 Days
Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Timeframe: At Day 0
Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Timeframe: At Month 6
Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Timeframe: At Month 6 + 7 Days
Number of Seroprotected Subjects for H5N1 Haemagglutination-inhibition (HI) Antibodies Against 2 Strains of Influenza Disease
Timeframe: At Month 6 + 21 Days
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses, up to 6/12 months + 7 days
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses, up to 12 months + 7 days
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Timeframe: During the 30-day (Days 0-29) post-primary vaccination period (Month 6 + 30 days)
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Timeframe: During the 30-day (Days 0-29) post-booster vaccination period (Month 12 + 30 days)
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Timeframe: During the entire study period (Day 0 to Month 18)
Number of Subjects With Serious Adverse Events (SAEs)
Timeframe: During the entire study period (Day 0 to Month 18)
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease
Timeframe: At Month 6 + 7 Days
Number of Booster Seroconverted Subjects Against 2 Strains of Influenza Disease
Timeframe: At Month 6 + 21 days
Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease
Timeframe: At Month 6 + 7 Days
Booster Factor of H5N1 HI Antibodies Against 2 Strains of Influenza Disease
Timeframe: At Month 6 + 21 Days