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H9 Priming Study in Healthy Adults

NCT00617331 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2011-07-22

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Subvirion inactivated influenza A/H9N2 (G9 variant) vaccine

Inactivated subvirion influenza A/chicken/Hong Kong/G9/97 (H9N2) vaccine administered via intramuscular (IM) injection, dose 7.5 or 30 micrograms.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-08-31
Completion
2009-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00617331 on ClinicalTrials.gov