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Immunogenicity and Safety of AdimFlu-S 2011-2012 in Non-Elderly Adult and Elderly Subjects

Influenza Clinical Trial

Official title:
Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2011-2012, in Non-Elderly Adult and Elderly Subjects

Clinical Trial 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 21 days 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).

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01411358
Study type Interventional
Source Adimmune Corporation
Contact
Status Completed
Phase N/A
Start date August 2011
Completion date March 2012
View Details
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