drugset / Trial / NCT01594320

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

NCT01594320 ↗

RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2012-04
Primary completion
2012-07
Completion
2013-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Monovalent Avian Influenza VLP (H5N1) Vaccine — Intramuscular

Indications