NCT01561768

A Study to Evaluate the Immune Response and Safety of a Seasonal Virus-Like Particle Influenza Vaccine in Healthy 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 (18-64) Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Novavax · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the immune response of three dose levels of the Novavax Quadrivalent vaccine in healthy young adults (18-64). The study is broken down into 5 treatment groups. Each group will enroll 100 subjects, for a total of 500 subjects. Group 1-3 will receive one of three dose levels of the Novavax Quadrivalent vaccine, Group 4 will receive a dose of the Novavax Trivalent vaccine, and Group 5 will receive a commercially available trivalent influenza vaccine (TIV). The study will also evaluate the safety and tolerability of the Novavax Quadrivalent vaccine.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Novavax Quadrivalent vaccine	Quadrivalent VLP vaccine: low dose; intramuscular injection, deltoid
BIOLOGICAL	Novavax Quadrivalent vaccine	Quadrivalent VLP vaccine: medium dose; intramuscular injection, deltoid
BIOLOGICAL	Novavax Quadrivalent vaccine	Quadrivalent VLP vaccine: high dose; intramuscular injection, deltoid
BIOLOGICAL	Novavax Trivalent vaccine	Trivalent Dose; intramuscular injection, deltoid
BIOLOGICAL	cTIV	Preconfigured dose; intramuscular injection, deltoid

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2012-03-23
• Last updated: 2013-07-18

Locations

4 sites across 1 country: Australia