drugset / Trial / NCT01752881

Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2012-2013, in Non-Elderly Adult and Elderly Subjects

NCT01752881 ↗

Phase 4 Completed 130 enrolled Adimmune Corporation
NaSingle-groupOpen-labelPrevention

Summary

The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HAI) at three weeks post immunization in non-elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).

Timeline

Start
2012-08
Primary completion
2012-08
Completion
2012-09

Drugs

EvaluationDrugModalityDoseRoute
Subject AdimFlu-S Vaccine 0.5 ml Intramuscular

Indications