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NCT00296634 · ClinicalTrials.gov registry record · Phase 1
H5 Vaccine Alone or With Adjuvant in Healthy Adults
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 600
- Enrollment target
NCT00296634 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 600 participants.
The verdict
NCT00296634, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 600 participants
- Enrollment target
Study Summary
This randomized, controlled, double-blinded, dose-ranging, Phase I-II study in 600 healthy adults, 18 to 49 years old, is designed to investigate the safety, reactogenicity, and dose-related immunogenicity of an investigational inactivated influenza A/H5N1 virus vaccine when given alone or combined with aluminum hydroxide. A secondary goal is to guide selection of vaccine dosage levels for expanded Phase II trials based on reactogenicity and immunogenicity profiles. This dose optimization will be applied to both younger and older subject populations in subsequent studies. Subjects who meet the entry criteria for the study will be enrolled at one of 4 study sites and will be randomized into one of 8 groups to receive 2 doses of influenza A/H5N1 vaccine containing 3.75, 7.5, 15, or 45 mcg of HA with or without aluminum hydroxide adjuvant by intramuscular injection. Participants may be involved in study related procedures for up to 8 months.
Interventions
- DRUG Aluminum hydroxide
- BIOLOGICAL Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur pre-adsorbed)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2006-03 |
| Est. Completion | 2006-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00296634
The ClinicalTrials.gov registry entry for NCT00296634 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 600 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 2 interventions - of which Aluminum hydroxide is the first listed.
NCT00296634 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00296634 about?
NCT00296634 is a clinical study titled "H5 Vaccine Alone or With Adjuvant in Healthy Adults". This randomized, controlled, double-blinded, dose-ranging, Phase I-II study in 600 healthy adults, 18 to 49 years old, is designed to investigate the safety, reactogenicity, and dose-related immunogenicity of an investigational inactivated influenza A/H5N1 virus vaccine when given alone or combined ...
What is the current status of trial NCT00296634?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 600 participants. The study started on 2006-03. Estimated completion is 2006-12.
What interventions are being tested in trial NCT00296634?
The interventions under investigation include: Aluminum hydroxide (DRUG), Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur pre-adsorbed) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00296634?
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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