drugset / Trial / NCT01651104

Safety and Immunogenicity of a Trivalent Influenza Vaccine When Administered to Elderly Subjects

NCT01651104

Phase 2 Completed 63 enrolled Novartis Vaccines
NaSingle-groupOpen-labelPrevention

Summary

To evaluate the safety of a single intramuscular (IM) injection of trivalent adjuvanted influenza study vaccine, formulation 2012/2013, in elderly subjects and the antibody response to each influenza vaccine antigen, as measured by single radial hemolysis (SRH) and hemagglutination inhibition (HI) at approximately 21 days postimmunization in 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 Fluad Vaccine 0.5 ml Intramuscular

Indications