NCT01594320

A/H5N1 Virus-Like Particle Antigen Dose Ranging Study With Adjuvant 1

A Phase 1 Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Monovalent A/Indonesia/05/05 (H5N1) Virus-Like Particle (VLP) Avian Influenza Antigen (Recombinant) in Healthy Young Adults With and Without Adjuvant 1.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 333 (actual)
• Sponsor: Novavax · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the immunogenicity and safety profile of the Avian flu vaccine with and without adjuvant 1 in healthy, young adults. The study is divided down into Parts A1, A2 and B. Groups within each Part will receive two doses of the assigned test article on Study Days 0 and 21. There will be a Safety Monitoring Committee assessment following Day 7 for each part, prior to allowing vaccination of subjects in subsequent Parts of the study.

Conditions

• Influenza (Pandemic)

Interventions

Type	Name	Description
BIOLOGICAL	Monovalent Avian Influenza VLP (H5N1)	Dose A without Adjuvant 1; intramuscular, deltoid, Day 0 \& Day 21
BIOLOGICAL	Monovalent Avian Influenza VLP (H5N1)	Dose B without Adjuvant 1; intramuscular, deltoid, Day 0 \& Day 21
BIOLOGICAL	Monovalent Avian Influenza VLP (H5N1); Adjuvant	Dose B with Adjuvant 1; intramuscular, deltoid, Day 0 \& Day 21
BIOLOGICAL	Monovalent Avian Influenza VLP (H5N1); Adjuvant	Dose C with Adjuvant 1; intramuscular, deltoid, Day 0 \& Day 21
BIOLOGICAL	Monovalent Avian Influenza VLP (H5N1); Adjuvant	Dose D with Adjuvant 1; intramuscular, deltoid, Day 0 \& Day 21
BIOLOGICAL	Saline placebo	Placebo; Intramuscular, deltoid, Day 0 \& Day 21

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-07-01
• Completion: 2013-08-01
• First posted: 2012-05-09
• Last updated: 2014-02-06

Locations

5 sites across 1 country: United States