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Study of Safety and Immunogenicity of a Quadrivalent Influenza Vaccine in Healthy Adults Age 65-75 Years

Influenza Clinical Trial

Official title:
Phase 1b/2 Double Blind, Randomized, Placebo Controlled Study of Safety and Immunogenicity of VAX2012Q: A Quadrivalent Influenza Vaccine in Healthy Adults Age 65-75 Years

Clinical Trial Summary

One dose of escalating strengths of an investigational influenza vaccine, VAX2012Q (Quadrivalent Recombinant Hemagglutinin Seasonal Influenza Vaccine), will be evaluated for safety and immunogenicity in healthy adults 65 to 75 years of age in this placebo-controlled study.

Clinical Trial Description

The purpose of this study is to evaluate, in a stepwise fashion, dose levels for an investigational quadrivalent influenza vaccine containing 2 influenza A strains and 2 influenza B strains. This is a multi-center, randomized, double-blind, placebo-controlled, dose escalating study in which up to 200 healthy adults age 65-75 years will be administered a single dose of either placebo or an investigational influenza vaccine (VAX2012Q, Quadrivalent Recombinant Hemagglutinin Seasonal Influenza Vaccine) at one of up to 3 dose levels. Fifty or up to 75 subjects will be enrolled in each dose level. Data for safety and immunogenicity will be collected for all dose levels. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02247362
Study type Interventional
Source VaxInnate Corporation
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date November 2014
Completion date March 2016
View Details
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