drugset / Trial / NCT01640314

Safety and Immunogenicity of a Cell Derived Subunit Trivalent Nonadjuvated Influenza Study Vaccine in Adults Aged 18 Years and Above

NCT01640314

Phase 3 Completed 126 enrolled Novartis Vaccines
NaSingle-groupOpen-labelPrevention

Summary

The purpose of this study is to evaluate the safety of a single intramuscular (IM) injection of the cell derived subunit trivalent nonadjuvanted influenza vaccine in adult and elderly subjects and the antibody response to each influenza vaccine antigen, as measured by hemagglutination inhibition (HI) at approximately 21 days postimmunization in adult and elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines.

Timeline

Start
2012-07
Primary completion
2012-08
Completion
2012-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Optaflu Vaccine 0.5 ml Intramuscular

Indications