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NCT00280033 · ClinicalTrials.gov registry record · Phase 1

H5 Adult - Chiron Study of Bird Flu Vaccine

A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
394
Enrollment target

NCT00280033: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00280033 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 394 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (557% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00280033, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
394 participants
Enrollment target

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.

Interventions

  • DRUG Placebo
  • BIOLOGICAL Aluminum hydroxide
  • BIOLOGICAL MF-59
  • BIOLOGICAL Inactivated Influenza A/H5N1 Vaccine (Chiron)

Trial Details

FieldValue
Enrollment Target 394 participants
Start Date 2006-02
Est. Completion 2006-11
Phase Phase 1

What the finished NCT00280033 record still lists

NCT00280033 is an interventional study that assigns participants to a tested intervention. The registered 394 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (557% higher).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT00280033 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00280033 about?

NCT00280033 is a clinical study titled "H5 Adult - Chiron Study of Bird Flu Vaccine". 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 mon...

What is the current status of trial NCT00280033?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 394 participants. The study started on 2006-02. Estimated completion is 2006-11.

What interventions are being tested in trial NCT00280033?

The interventions under investigation include: Placebo (DRUG), Aluminum hydroxide (BIOLOGICAL), MF-59 (BIOLOGICAL), Inactivated Influenza A/H5N1 Vaccine (Chiron) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00280033?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00280033's enrollment target sits among peer trials

394 77th of 2000 higher than 1,924 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00280033, the US trial registry maintained by the National Library of Medicine. NCT00280033 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.