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A Phase II Study in Healthy Adult and Elderly Populations to Assess the Safety and Immunogenicity of a CSL H1N1 Influenza Vaccine Administered at Different Dose Levels Given With and Without GlaxoSmithKline AS03 Adjuvant
The purpose of this study is to see how the body reacts to different strengths of the H1N1 flu shot when it is given with or without an "adjuvant." An adjuvant is a substance that may cause the body to produce more antibodies when it is given with a vaccine. This study will also compare how age affects the body's response to the H1N1 flu shot. In this study, 3 strengths of the H1N1 flu shot will be tested combined with an adjuvant. In addition, 2 strengths of the H1N1 flu shot will be tested without adjuvant. Two H1N1 flu shots of the same strength, with or without adjuvant, will be given about 3 weeks apart. Participants will include up to 800 healthy adults, approximately 500 individuals ages 18-64 and 250 individuals greater than or equal to age 65. Study procedures include: physical exam, blood samples, completing a memory aid to record vaccine side effects, medications and daily oral temperature. Participants will be involved in study related procedures for up to 13 months.
Details
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 2 |
| Status | WITHDRAWN |
| Completion | 2010-11 |
Conditions
- Influenza
Interventions
- AS03
- Inactivated H1N1 Vaccine
Primary outcomes
- Safety: occurrence of safety laboratory adverse events (AEs). — Days 0, 8-10, 21 and 29.
- Safety: occurrence of vaccine-associated serious adverse events (SAEs). — Throughout the course of the study.
- Immunogenicity: proportion of subjects, stratified by age, achieving a serum HAI antibody titer of 1:40 or greater, against influenza H1N1 2009 virus at Day 21 following a single dose of H1N1 vaccine combined with or without AS03 adjuvant. — Day 21.
- Immunogenicity: proportion of subjects, stratified by age, with 4-fold or greater hemagglutination inhibition (HAI) antibody titer increases against influenza H1N1 2009 virus at Day 21 following a single dose of H1N1 vaccine with or without AS03. — Day 21.
- Safety: occurrence of solicited local and systemic adverse events (AEs). — Within 8 days post vaccination (Day 0-7).