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A Phase 3 Study to Assess the Immunogenicity, Safety, and Consistency of Lot Manufacture of Ross River Virus (RRV) Vaccine in Healthy Male and Female Subjects 16 Years of Age and Older
The purpose of the study is to verify the safety and adequacy of the immune response produced by a 2.5 µg, adjuvanted (aluminium hydroxide) dose of Ross River Virus (RRV) vaccine and to demonstrate the consistency of manufacture of 3 separate lots of RRV vaccine.
Details
| Lead sponsor | Alachua Government Services, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 1968 |
| Start date | 2011-04 |
| Completion | 2012-10 |
Conditions
- Prophylaxis of Ross River Virus Infection
Interventions
- Ross River Virus Vaccine
Primary outcomes
- Immune response measured by Ross River Vaccine (RRV)-specific neutralizing titer 21 days after the 3rd vaccination as determined by RRV microneutralization (μNT) assay — 21 days after 3rd vaccination
- Rate of subjects with a RRV-specific neutralizing titer — 21 days after 3rd vaccination
Rate of subjects with a RRV-specific neutralizing titer 21 days after the third vaccination as determined by RRV microneutralization (μNT) assay - Frequency and severity of injection site and systemic reactions within 7 days of any study vaccination — Within 7 days of any study vaccination
Countries
Australia