This Phase 3 study evaluates the safety, immunogenicity and lot-to lot consistency of 3 lots of aH5N1c vaccine for pandemic avian influenza, in approximately 2394 healthy adults ≥18 years of age receiving the vaccine and 797 healthy adults receiving placebo. Subjects were randomized in a 3:1 ratio to receive either aH5N1c vaccine or saline placebo. Enrollment was stratified by age: 18 to \<65 years of age and ≥65 years of age, to allow adequate safety assessment of the entire age spectrum.
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Primary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 43 by Lot
Timeframe: Day 1, Day 43
Primary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 at Day 43 by Age Cohort
Timeframe: Day 1, Day 43
Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination
Timeframe: Day 1 to Day 7
Percentages of Subjects With Any Unsolicited AEs Reported Through 21 Day After Vaccination
Timeframe: Day 1 to Day 43
Percentages of Subjects Reporting SAEs, AESIs, NOCD, AEs Leading to Vaccine/Study Withdrawal, and Medically Attended AEs, and Concomitant Medications Associated With These Events as Collected From Day 1 to Day 387, by Vaccine Group.
Timeframe: Day 1 to Day 387