drugset / Trial / NCT01636102

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

NCT01636102

Phase 2 Completed 126 enrolled Novartis Vaccines
NaSingle-groupOpen-labelPrevention

Summary

To evaluate the safety of a single intramuscular (IM) injection of trivalent nonadjuvated influenza study vaccine, formulation 2012/2013, in adult and 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 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
2012-07
Completion
2012-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Agrippal Vaccine 0.5 ml Intramuscular

Indications