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NCT00944073 · ClinicalTrials.gov registry record · Phase 2
Peds Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 583
- Enrollment target
NCT00944073 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 583 participants.
The verdict
NCT00944073, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 583 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. Up to 650 healthy volunteers from three age groups (greater than or equal to 6 months to less than 36 months, greater than or equal to 36 months to 9 years, and 10 - 17 years) with no history of influenza H1N1 2009 influenza infection or influenza H1N1 2009 vaccination will participate. Participants will be randomly (by chance) assigned to 1 of 2 possible H1N1 vaccine groups. Group 1 will receive 15 mcg of vaccine; Group 2 will receive 30 mcg of vaccine. Participants will receive vaccine injections on Days 0 and 21 in the arm or thigh 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 Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 583 participants |
| Start Date | 2009-08 |
| Est. Completion | 2010-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00944073
The ClinicalTrials.gov registry entry for NCT00944073 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 583 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 Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179A is the first listed.
NCT00944073 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00944073 about?
NCT00944073 is a clinical study titled "Peds Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels". 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. Up to 650 healthy volunteers from three age groups (greater than or equal to 6 months to less than 36 months, greater than or equal to 36 month...
What is the current status of trial NCT00944073?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 583 participants. The study started on 2009-08. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00944073?
The interventions under investigation include: Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179A (BIOLOGICAL).
Who is sponsoring clinical trial NCT00944073?
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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