A Randomized, Open Label, Single Center, Dose- and Regimen-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Children and Adults Ages 3 to 64 Years
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 784
- Locations
- 1
- Primary Endpoint
- Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age
Study Overview
Brief Summary
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children, adolescents, and adults.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 64 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Children, adolescents, and adults 3 to 64 years of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.
Exclusion Criteria
- •History of serious disease.
- •History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
- •Known or suspected impairment/alteration of immune function.
- •Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.
- •For additional entry criteria, please refer to protocol.
Outcomes
Primary Outcomes
Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age
Time Frame: Day 1 to day 387
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer \>1:40 or a prevaccination HI titer \>1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS).
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age
Time Frame: Day 1 to day 387
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer \>1:40 or a prevaccination HI titer \>1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. Analyses were performed on the Per-Protocol set (PPS).
Secondary Outcomes
- Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years(7 days and 21 days after each vaccination)
- Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years(Day 1 to day 387)
- HI GMRs, in 3 to <9 Years and 9 to 17 Years(Day 1 to day 387)
- Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age(7 days after each vaccination)
- Age Distribution at Baseline(Baseline)
- HI GMR, in Adults 18 to 64 Years(Day 1 to day 387)
- Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age(7 days after each vaccination)
- Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age(7 days after each vaccination)