drugset / Trial / NCT01561768

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

NCT01561768 ↗

RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2012-03
Primary completion
2013-01
Completion
2013-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Novavax Quadrivalent vaccine Vaccine — Intramuscular
Subject Novavax Trivalent vaccine Vaccine — Intramuscular
Subject cTIV Vaccine — Intramuscular

Indications