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A/H5N1in Adult - Aventis

NCT00115986 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 452

Last updated 2013-08-23

No results posted yet for this study

Summary

The purpose of this research study is to compare how the body reacts to different strengths of the new H5N1 flu vaccine. The study will also look at how antibodies are made after a subject receives the H5N1 flu vaccine. The vaccine will be given as a shot in the arm. Participants will be randomly assigned to receive 1 of 4 different dosages of the vaccine or a placebo (dummy) dose of the vaccine. Study procedures will include a physical exam, a urine pregnancy test for women, and blood samples. Participants will be asked to complete a diary to record temperatures, medications taken, and side effects from the vaccine. Volunteers will be involved with study procedures for approximately 7 months. The study will enroll about 450-470 healthy participants, ages 18-64.

Conditions

Interventions

BIOLOGICAL

Influenza A/H5N1 Vaccine

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-03-31
Completion
2006-02-28

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 NCT00115986 on ClinicalTrials.gov