drugset / Trial / NCT00775450

Influenza Vaccine Revaccination in Ambulatory Elderly Subjects

NCT00775450 ↗

Phase 2 Completed 807 enrolled Sanofi Pasteur, a Sanofi Company
RandomizedParallel-groupOpen-labelPrevention

Summary

This is a multi-center study designed to evaluate the safety and immunogenicity of a Fluzone revaccination in elderly adults aged ≥ 65 years. Primary Objective: To describe the safety profile for all subjects. Secondary Objective: To describe immunogenicity 28 days following revaccination with one of three Fluzone formulations.

Timeline

Start
2008-10
Primary completion
2009-06
Completion
2009-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Influenza Virus Vaccine USP Trivalent Types A and B Vaccine 0.1 ml Intramuscular
Comparator Influenza Virus Vaccine USP Trivalent Types A and B Vaccine 0.5 ml Intramuscular

Indications