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A Trial to Evaluate the Safety and Immunogenicity of a Trivalent Seasonal Influenza Virus-Like Particle (VLP) Vaccine (Recombinant) in Older Adults

2014-08-27 03:17:56 | BioPortfolio

Summary

- To assess the tolerability and safety of a single injection of Influenza VLP Vaccine when administered intramuscularly (IM) at 15 µg and 60 µg HA per each strain.

- To assess the immunogenicity of Influenza VLP Vaccine administered at 15 µg and 60 µg HA per strain as measured by hemagglutination inhibition (HAI) antibody titers to each of the component viral strains [A/Brisbane/59/2007 (H1N1); A/Brisbane/10/2007 (H3N2) and B/Brisbane/60/2008].

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Influenza

Intervention

Investigational Influenza VLP Vaccine 15ug/strain, Investigational Influenza VLP Vaccine 60ug/strain, TIV

Location

Universtity Clinical Research
Pembroke Pines
Florida
United States
33024

Status

Active, not recruiting

Source

Novavax

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:56-0400

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