NCT02307851

Quadrivalent Influenza VLP Vaccine Dose Ranging Study in Young Adults

A Phase 2 Randomized, Observer-Blind, Dose-Ranging Study to Evaluate the Immunogenicity and SAfety of Quadrivalent Seasonal Virus-Like Particle (VLP) Influenza Vaccine (Recombinant) in Healthy Young (18-49) Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Novavax · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the immune response of three dose levels of the Quadrivalent VLP vaccine in healthy young (18-49) adults. The study is broken down into four treatment groups. Each group will enroll 100 subjects, for a total of 400 subjects. Groups A-C will receive one of three dose levels of the Quadrivalent VLP vaccine, and Group D will receive a commercially available trivalent influenza vaccine (TIV). The study will also evaluate the safety and tolerability of the Quadrivalent VLP vaccine formulations.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent VLP Vaccine
BIOLOGICAL	Comparator TIV

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2014-12-04
• Last updated: 2016-09-23

Locations

5 sites across 1 country: United States