NCT02247362

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: VaxInnate Corporation · Industry
• Sex: All
• Age: 65 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	VAX2012Q	Recombinant influenza HA vaccine consisting of two Influenza A subtypes and two Influenza B lineages and delivered IM
OTHER	Placebo	Vaccine Diluent

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-04-01
• Completion: 2016-03-01
• First posted: 2014-09-25
• Last updated: 2015-04-17

Locations

3 sites across 1 country: Australia