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NCT01573312 · ClinicalTrials.gov registry record · Phase 1
H5N1 Vaccination With and Without AS03: Systems Biology Analysis
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01573312 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 20 participants.
The verdict
NCT01573312, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This is a single center, randomized, double-blinded, controlled, Phase I, small targeted prospective study in healthy male and non-pregnant female subjects, 18 to 49 years old, inclusive, designed to determine the safety, reactogenicity, and immunogenicity of an intramuscular subvirion inactivated monovalent influenza A/H5N1 (HA of A/Indonesia/05/2005) virus vaccine manufactured by Sanofi Pasteur administered at 3.75 mcg per dose given with or without AS03 adjuvant manufactured by GSK. In the study, each subject will receive two doses administered 28 days apart. This study will use a systems biology approach to assess the human early gene and protein signatures expressed at Days 1, 3, 7, and 28 after the first vaccination. The systems data will be integrated with immunogenicity and reactogenicity data to develop a systems model of the human immune response to A/H5N1 vaccine with or without AS03 adjuvant.
Interventions
- BIOLOGICAL Influenza A/H5N1 Vaccine
- DRUG ASO3 Adjuvant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2012-05-24 |
| Est. Completion | 2014-01-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01573312
The ClinicalTrials.gov registry entry for NCT01573312 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 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 Influenza A/H5N1 Vaccine is the first listed.
NCT01573312 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01573312 about?
NCT01573312 is a clinical study titled "H5N1 Vaccination With and Without AS03: Systems Biology Analysis". This is a single center, randomized, double-blinded, controlled, Phase I, small targeted prospective study in healthy male and non-pregnant female subjects, 18 to 49 years old, inclusive, designed to determine the safety, reactogenicity, and immunogenicity of an intramuscular subvirion inactivated m...
What is the current status of trial NCT01573312?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2012-05-24. Estimated completion is 2014-01-02.
What interventions are being tested in trial NCT01573312?
The interventions under investigation include: Influenza A/H5N1 Vaccine (BIOLOGICAL), ASO3 Adjuvant (DRUG).
Who is sponsoring clinical trial NCT01573312?
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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