Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok

GMTs of anti-influenza antibodies were measured using a single radial immunodiffusion (SRID) assay for 3 strains: A/Solomon Islands \[H1N1\], A/Wisconsin \[H3N2\], and B/Malaysia. Titers were expressed in terms of 1/dilution.

Time frame: Day 28 post vaccination

Population: Analysis was done on evaluable population that included all participants who had met the study entry criteria and had titers taken at Baseline (Day 0) and after vaccination (Day 28). Data for this outcome measure was planned to be collected and analyzed for each FluBlok lot separately and not planned to be collected for placebo, as pre-specified in protocol.

Solicited reaction (reactogenicity event) was an adverse event (AE) that was pre-listed in electronic case report form(eCRF), considered to be related to vaccination and recorded by participant by means of memory aid. Injection sites reaction included pain,bruising,redness,swelling. Pain and bruising:Grade0: didn't have it at all; Grade1: noticed it, but it didn't interfere with usual activities at all; Grade2: had it, and it was bad enough to prevent a significant part of usual activities; Grade3: had it, and it prevented most or all of normal activities, or had to see a doctor for prescription medicine, Redness and swelling: participants measured largest diameter of any injection site reaction and grade them from 0 to 3, where Grade0: measured less than(\<)10 milliliters(mm); Grade1: larger than or equal to(\>=) 10mm and \<20mm; Grade 2: \>=20mm and \<50mm; Grade3: \>=50mm. Participants with multiple symptoms in same category were counted once per category using symptom with maximum grade

Time frame: Within 7 days post vaccination

Population: Analysis was performed on safety population.

Solicited reaction (reactogenicity event) was an AE that was pre-listed in eCRF, considered to be related to vaccination recorded by the participant by means of a memory aid between the day of vaccination (Day 0) and Day 7 post vaccination. Systemic events included fever, fatigue, shivering, joint pain, muscle pain, headache, and nausea. Fever: \>=100.4 degree Fahrenheit (ºF) to \<101.1ºF; \>=101.2ºF to \<102.2ºF; \>=102.2ºF; Fatigue, shivering, joint pain, muscle pain, headache and nausea: Grade 0: didn't have it at all; Grade 1: noticed it, but it didn't interfere with usual activities at all; Grade 2: had it, and it was bad enough to prevent a significant part of usual activities; and Grade 3: had it, and it prevented most or all of normal activities, or had to see a doctor for prescription medicine. Participants with multiple symptoms in the same category were counted once per category using the symptom with the maximum grade.

Time frame: Within 7 days post vaccination

Population: Analysis was performed on safety population.

An AE was defined as any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a study vaccine, whether or not considered to be related to the study vaccine. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination, ascertained during follow-up visit or telephone contact up to (and including) the Day 28 contact, whether reported spontaneously by the participant or in response to general questions about current or interim health status.

Time frame: From Day 0 (post-vaccination) through Day 28 post vaccination

Population: Analysis was performed on safety population.

CDC-defined ILI was defined as fever (body temperature \>=100ºF oral accompanied by cough and/or sore throat, on the same day or on consecutive days) due to strains represented in the vaccine.

Time frame: 14 days post vaccination through and up to 6 months

Population: Analysis was performed on safety population.

Anti-influenza antibodies were measured using an HAI assay for 3 strains: A/Solomon Islands \[H1N1\], A/Wisconsin \[H3N2\] and B/Malaysia. Seroconversion was defined as a post-vaccination titer of \>=1:40 in participants with undetectable baseline antibody (HI titer = \<1:10) or a \>=4-fold rise in antibody in participants with a baseline titer of \>=1:10, with the achievement of post-vaccination titer of at least 1:40.

Time frame: 28 days post vaccination

Population: Analysis was performed on evaluable population. Data for this outcome measure was not planned to be collected and analyzed for placebo group, as pre-specified in protocol.

Anti-influenza antibodies were measured using an HAI assay for 3 strains: A/Solomon Islands \[H1N1\], A/Wisconsin \[H3N2\] and B/Malaysia. Seroprotection was defined as a post-vaccination HAI antibody titer of \>=1:40.

Time frame: 28 days post vaccination

Population: Analysis was performed on evaluable population. Data for this outcome measure was not planned to be collected and analyzed for placebo group, as pre-specified in protocol.