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NCT00963157 · ClinicalTrials.gov registry record · Phase 2
Sanofi H1N1 Influenza Vaccine Administered at Different Dose Levels With and Without AS03 Adjuvant in Healthy 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
- 789
- Enrollment target
NCT00963157 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 789 participants.
The verdict
NCT00963157, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 789 participants
- Enrollment target
Study Summary
The purpose of this study is to see how the body reacts to different strengths of the H1N1 flu shot when it is given with or without an "adjuvant." An adjuvant is a substance that may cause the body to produce more antibodies when it is given with a vaccine. This study will also compare how age affects the body's response to the H1N1 flu shot. In this study, 3 strengths of the H1N1 flu shot will be tested combined with an adjuvant. In addition, 2 strengths of the H1N1 flu shot will be tested without adjuvant. Two H1N1 flu shots of the same strength, with or without adjuvant, will be given about 3 weeks apart. Participants will include up to 800 healthy adults, approximately 500 individuals ages 18-64 and 250 individuals greater than or equal to age 65. Study procedures include: physical exam, blood samples, completing a memory aid to record vaccine side effects, medications and daily oral temperature. Participants will be involved in study related procedures for up to 13 months.
Interventions
- DRUG AS03
- BIOLOGICAL Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 789 participants |
| Start Date | 2009-09 |
| Est. Completion | 2010-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00963157
The ClinicalTrials.gov registry entry for NCT00963157 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 789 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 AS03 is the first listed.
NCT00963157 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00963157 about?
NCT00963157 is a clinical study titled "Sanofi H1N1 Influenza Vaccine Administered at Different Dose Levels With and Without AS03 Adjuvant in Healthy Adult and Elderly Populations". The purpose of this study is to see how the body reacts to different strengths of the H1N1 flu shot when it is given with or without an "adjuvant." An adjuvant is a substance that may cause the body to produce more antibodies when it is given with a vaccine. This study will also compare how age affe...
What is the current status of trial NCT00963157?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 789 participants. The study started on 2009-09. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00963157?
The interventions under investigation include: AS03 (DRUG), Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179A (BIOLOGICAL).
Who is sponsoring clinical trial NCT00963157?
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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