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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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