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Immunogenicity and Safety of Two Dosages of the Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in the Elderly Compared With Standard Fluzone® in Adults and Elderly Subjects.
The present formulations are being developed for further study in the elderly population in order to generate additional supporting data. Primary Objective: To demonstrate non-inferiority of post-vaccination immunogenicity of subjects who received either 1 of the 2 investigational formulations of a trivalent inactivated vaccine (TIV) compared to that of the standard Fluzone® in elderly subjects. Secondary Objectives: Immunogenicity To describe the immunogenicity in subjects receiving investigational Fluzone and standard Fluzone®. Safety: To evaluate and describe the safety profile of investigational Fluzone in terms of solicited- and unsolicited adverse events and serious adverse events post-vaccination.
Details
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 2098 |
| Start date | 2007-10 |
| Completion | 2008-11 |
Conditions
- Influenza
- Myxovirus Infection
Interventions
- Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 1)
- Split, Inactivated, Trivalent Influenza Vaccine (Intradermal Formulation 2)
- Split, Inactivated, Trivalent Influenza Vaccine (Standard dose)
- Split, Inactivated, Trivalent Influenza Vaccine (High-dose)
- Split, Inactivated, Trivalent Influenza Vaccine (Standard dose)
Primary outcomes
- Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. — Day 0 and Day 28 post vaccination
Serum antibody titers for the Influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by hemagglutinin inhibition (HAI) assay. - Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine — Day 28 post-vaccination
Seroconversion defined as either a pre-vaccination hemagglutination inhibition (HAI) titer \< 1:10 and a post vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four fold increase at one month post-vaccination. - Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine. — Day 0 and Day 28 post-vaccination
Seroprotection was defined as a Hemagglutination inhibition (HAI) titer ≥ 1:40
Countries
United States