Study of the Immunogenicity and Safety of a Quadrivalent Influenza Vaccine (VAX2012Q) in Adults 18-64 Years
NCT02434276 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 450
Last updated 2015-06-26
Summary
This is a multi-center, randomized, double-blind, active comparator controlled study in which up to 450 healthy adults age 18-64 years will be administered either one of two dose levels of VAX2012Q or a licensed quadrivalent influenza vaccine. The subjects will be randomized at a 1:1:1 ratio.
Conditions
Interventions
- BIOLOGICAL
-
VAX2012Q
Recombinant influenza hemagglutinin (HA) vaccine consisting of two influenza A subtypes and two influenza B lineages
- BIOLOGICAL
-
Fluzone Quadrivalent
Fluzone Quadrivalent (Influenza Vaccine)
Sponsors & Collaborators
-
Accelovance
collaborator INDUSTRY -
Department of Health and Human Services
collaborator FED -
VaxInnate Corporation
lead INDUSTRY
Principal Investigators
-
Stephen J. Haworth, MD · VaxInnate Corporation
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-05-31
- Primary Completion
- 2015-08-31
- Completion
- 2016-06-30
Countries
- United States
Study Locations
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