A Study to Demonstrate the Non-Inferiority of Influenza Vaccine Candidate, Compared With Fluarix™ Administered Intramuscularly in Elderly Aged 60 Years Old and Above
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 1,220
- Locations
- 18
- Primary Endpoint
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus
Study Overview
Brief Summary
The purpose of this study is to evaluate the immune response and safety of influenza vaccine candidate with or without adjuvant compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.
Detailed Description
Subjects will be randomized into 3 groups and will be followed for 6 months with 4 scheduled contacts per subjects. The immune response will be evaluated at days 0, 21 and 180 after vaccination. The safety evaluation will involve follow-up of solicited local and general signs and symptoms, unsolicited adverse events and serious adverse events.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
GSK1247446A-AS03 Group
Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Intervention: Candidate Influenza Vaccine GSK1247446A - 2 different formulations (Biological)
GSK1247446A Group
Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Intervention: Candidate Influenza Vaccine GSK1247446A - 2 different formulations (Biological)
Fluarix Group
Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Intervention: FluarixTM (Biological)
Outcomes
Primary Outcomes
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus
Time Frame: At Days 0 and 21 post-vaccination
Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia, A/New York and B/Malaysia. The reference seropositivity cut-off value was ≥ 1:10.
Secondary Outcomes
- Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus(At Day 180 post-vaccination.)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms.(During the 7-day (Days 0-6) follow-up period after vaccination)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.(During the 7-day (Days 0-6) follow up period after vaccination)
- Number of Subjects With Unsolicited Adverse Events (AEs).(During the 30-day (Days 0-29) follow-up period after vaccination)
- Number of Subjects With Any and Related Serious Adverse Events (SAEs)(During the entire study period (Day 0 to Day 180))