Primary Outcome Measures:
- Frequencies of adverse events (AEs) and serious adverse events (SAEs) solicited in clinic, via Memory Aids and phone calls, and targeted physical evaluations [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Proportion of subjects in each vaccine group achieving a Day 28 post vaccination serum titer HAI antibody titer of 40 or greater for each vaccine antigen. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
- Proportion of subjects in each vaccine group achieving a Day 28 post vaccination serum titer HAI antibody titer of 40 or greater for each vaccine antigen. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Geometric mean titers (GMTs) of serum antibodies against vaccine antigens in each vaccine group 28 days after vaccination [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Proportion of subjects in each vaccine group who experience culture-positive CDC ILI and/or culture-positive respiratory illness during the 2007-2008 influenza epidemic season [ Time Frame: influenza season ] [ Designated as safety issue: No ]
The study is a modified double-blind, randomized, controlled, Phase III multi-center clinical trial designed to evaluate the safety and reactogenicity of FluBlOk and the immunogenicity, efficacy and effectiveness of FluBlOk and TIV in healthy adults aged 50 to 64. Subjects will be stratified according to receipt of influenza vaccine during the 2006-07 season (yes/no) and then randomized within the two strata to receive either FluBlOk or TIV as noted in the table below. Subjects and staff will be blinded to the vaccine administered. FluBlOk will be evaluated for safety and reactogenicity and for immunogenicity (measured by HAI antibody titers at Day 0 and 28), efficacy and effectiveness. Subjects will be given a memory aid to record reactogenicity events during the week after immunization. Reactogenicity data from Day 0 to Day 7 will be collected by phone call 8-10 days following vaccination. Reactogenic symptoms persisting beyond day 7 will be recorded as AEs. Subjects will be encouraged to report illnesses that may be compatible with influenza, and will otherwise be contacted bi-weekly by telephone during the influenza season to identify subjects who are experiencing flu like symptoms. NS/TSs will be obtained and cultured for influenza from those who have CDC-ILI or ILI symptoms.