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H5 Adult - Chiron Study of Bird Flu Vaccine

NCT00280033 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 394

Last updated 2013-09-13

No results posted yet for this study

Summary

This study is will gather critical information on the safety, tolerability, and the immunogenicity (capability of causing an immune response) of A/H5N1 (Bird flu) virus vaccine in healthy adults. Up to 400 healthy adults, aged 18 to 64, will participate. Each subject will participate for about 7 months and will be randomly placed in one of several different study groups receiving a different dose of vaccine or placebo. All subjects will receive two injections of their assigned study product, about 28 days apart, in the muscle. Subjects will keep a journal of their temperature and any adverse effects between study visits. A small amount of blood will also be drawn before the first injection, 7 days after each injection, 1 month after the first injection, and 1 and 6 months after the second injection.

Conditions

Interventions

BIOLOGICAL

Aluminum hydroxide

Provided in vials that contain 0.8 mL volume per vial.

BIOLOGICAL

Inactivated Influenza A/H5N1 Vaccine (Chiron)

Monovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in unit-dose vials containing 60 mcg/mL A/H5N1 HA as determined by single radial immunodiffusion. It may be formulated with MF59 or aluminum hydroxide. Dosages: 7.5 mcg, 15 mcg, 30 mcg, or 45 mcg.

BIOLOGICAL

MF-59

Proprietary experimental adjuvant. Provided in vials that contain 0.7 mL volume per vial.

DRUG

Placebo

Saline placebo.

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
2006-02-28
Primary Completion
2006-11-30
Completion
2006-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT00280033 on ClinicalTrials.gov