Who is sponsoring NCT01561768?

NCT01561768 is sponsored by Novavax.

What drugs are being tested in NCT01561768?

Interventions: Novavax Quadrivalent vaccine, Novavax Quadrivalent vaccine, Novavax Quadrivalent vaccine, Novavax Trivalent vaccine, cTIV.

What is the status of NCT01561768?

NCT01561768 is currently COMPLETED.

Last reviewed 2013-07-16 · How we verify

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

NCT01561768 Phase 2 COMPLETED

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.

Details

Lead sponsor	Novavax
Phase	Phase 2
Status	COMPLETED
Enrolment	500
Start date	2012-03
Completion	2013-01

Conditions

Influenza

Interventions

Novavax Quadrivalent vaccine
Novavax Quadrivalent vaccine
Novavax Quadrivalent vaccine
Novavax Trivalent vaccine
cTIV

Primary outcomes

Immunogenicity of 3 dose levels of the Novavax Quadrivalent vaccine based on HAI responses — Day 21
Number of Solicited and Unsolicited Adverse Events for the Novavax Quadrivalent vaccine — 6 months

Countries

Australia