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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: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (493% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more.
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 |
What the finished NCT00963157 record still lists
NCT00963157 is an interventional study that assigns participants to a tested intervention. The registered 789 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (493% higher).
The record links to 0 conditions, and to 2 interventions - of which AS03 is the first listed.
NCT00963157 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00963157's enrollment target sits among peer trials
789 40th of 2000 higher than 1,961 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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