drugset / Trial / NCT00617331

H9 Priming Study in Healthy Adults

NCT00617331 ↗

RandomizedParallel-groupTriple-blindPrevention

Summary

The purpose of this research study is to determine whether prior exposure to A/H2N2 viruses is associated with better antibody (part of the immune system that fights infection) responses after vaccination with an A/H9N2 flu vaccine. The study will evaluate how much antibody is made to the influenza virus after H9N2 flu vaccination and how the body reacts to different strengths of the H9N2 flu vaccine. This information may guide vaccine development for this virus as well as other bird flu viruses that have infected humans. Study participants will include 120 healthy subjects, age 18-38 or 44-59 years. Two different dosages of vaccine will be given in the muscle of the upper arm about 1 month apart. The assignment of vaccines to participants is governed by chance. Study procedures may include medical history, physical exam, and blood samples. Study participation duration is about 7 months.

Timeline

Start
2008-02
Primary completion
2008-08
Completion
2009-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Subvirion inactivated influenza A/H9N2 (G9 variant) vaccine Vaccine 7.5 ug Intramuscular
Subject Subvirion inactivated influenza A/H9N2 (G9 variant) vaccine Vaccine 30 ug Intramuscular

Indications