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NCT00439335 · ClinicalTrials.gov registry record · Phase 1
Higher Dose Intradermal H5 Vaccine
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 227
- Enrollment target
NCT00439335: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00439335 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 227 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (278% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00439335, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 227 participants
- Enrollment target
Study Summary
This study will compare the influenza A/H5N1 virus vaccine given by injection in the muscle versus injection in the skin in healthy adults. The study will look at the safety of the injections, how the body reacts, and what the body's immune response does when the vaccine is given in the muscle versus in the skin. The study will look at 226 healthy volunteers, ages 18-49 years old. Study procedures will include getting 2 doses of vaccine 28 days apart, physical exams, follow-up clinic visits to check the places on the body where each vaccine was given, and blood sample collections. Volunteers will complete a memory aid by writing down temperatures and health changes for 7 days after each vaccination. Volunteers will be involved in the study for up to 241 days.
Primary Outcome
Number of participants in each vaccine group achieving a 4-fold or greater increase in serum hemagglutination inhibition (HAI) antibody titers against influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine
Interventions
- DRUG Placebo (IM)
- DRUG Placebo (ID)
- BIOLOGICAL Inactivated Influenza A Vaccine A/H5N1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 227 participants |
| Start Date | 2007-03 |
| Est. Completion | 2008-02 |
| Phase | Phase 1 |
What the finished NCT00439335 record still lists
NCT00439335 is an interventional study that assigns participants to a tested intervention. The registered 227 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 (278% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo (IM) is the first listed.
NCT00439335 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00439335 about?
NCT00439335 is a clinical study titled "Higher Dose Intradermal H5 Vaccine". This study will compare the influenza A/H5N1 virus vaccine given by injection in the muscle versus injection in the skin in healthy adults. The study will look at the safety of the injections, how the body reacts, and what the body's immune response does when the vaccine is given in the muscle versu...
What is the current status of trial NCT00439335?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 227 participants. The study started on 2007-03. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00439335?
The interventions under investigation include: Placebo (IM) (DRUG), Placebo (ID) (DRUG), Inactivated Influenza A Vaccine A/H5N1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00439335?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00439335's enrollment target sits among peer trials
227 221st of 2000 higher than 1,780 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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