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NCT00943631 · ClinicalTrials.gov registry record · Phase 2
Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels in Adult and Elderly Populations
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 406
- Enrollment target
NCT00943631 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 406 participants.
The verdict
NCT00943631, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 406 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and the body's immune response (body's defense against disease) to an experimental H1N1 influenza vaccine in healthy adult and elderly populations. The study will enroll up to 450 healthy adults ages 18 and older with no history of H1N1 infection or vaccination. Two hundred individuals will be 18-64 years old, and the other 200 will be greater than or equal to 65 years of age. Participants will be randomly assigned to 1 of 2 possible vaccine groups: group 1 will receive 15 mcg of H1N1 vaccine; group 2 will receive 30 mcg of H1N1 vaccine. Both groups will receive vaccine injections on days 0 and 21 in the arm muscle. Study procedures include: medical history, physical exam, maintaining a memory aid, and blood sample collection. Participants will be involved in study related procedures for approximately 7 months.
Interventions
- BIOLOGICAL Inactivated H1N1 Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 406 participants |
| Start Date | 2009-08 |
| Est. Completion | 2010-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00943631
The ClinicalTrials.gov registry entry for NCT00943631 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 406 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 1 intervention - of which Inactivated H1N1 Vaccine is the first listed.
NCT00943631 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00943631 about?
NCT00943631 is a clinical study titled "Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels in Adult and Elderly Populations". The purpose of this study is to assess the safety and the body's immune response (body's defense against disease) to an experimental H1N1 influenza vaccine in healthy adult and elderly populations. The study will enroll up to 450 healthy adults ages 18 and older with no history of H1N1 infection or ...
What is the current status of trial NCT00943631?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 406 participants. The study started on 2009-08. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00943631?
The interventions under investigation include: Inactivated H1N1 Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00943631?
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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