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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00439335
The ClinicalTrials.gov registry entry for NCT00439335 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 227 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo (IM) is the first listed.
NCT00439335 reports 0 study locations.
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.
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