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NCT00953524 · ClinicalTrials.gov registry record · Phase 2
A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly
A Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 849
- Enrollment target
NCT00953524: Completed Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT00953524 is a Phase 2 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 849 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (538% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00953524, a Phase 2 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 849 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine. Primary Objectives: * To describe the immunogenicity of the candidate vaccines after each injection. * To describe the safety of the candidate vaccines after each injection.
Primary Outcome
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Interventions
- BIOLOGICAL Normal saline solution (placebo)
- BIOLOGICAL Monovalent Subvirion A/H1N1 Influenza vaccine (7.5 µg of HA)
- BIOLOGICAL Monovalent Subvirion A/H1N1 Influenza vaccine (15 µg of HA)
- BIOLOGICAL Monovalent Subvirion A/H1N1 Influenza vaccine (30 µg of HA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 849 participants |
| Start Date | 2009-08 |
| Est. Completion | 2010-12 |
| Phase | Phase 2 |
What the finished NCT00953524 record still lists
NCT00953524 is an interventional study that assigns participants to a tested intervention. The registered 849 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 (538% higher).
The record links to 0 conditions, and to 4 interventions - of which Normal saline solution (placebo) is the first listed.
NCT00953524 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00953524 about?
NCT00953524 is a clinical study titled "A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly". The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine. Primary Objectives: * To describe the immunogenicity of the candidate vaccines after each injection. * To describe the safety of the candidate vaccines after each injection.
What is the current status of trial NCT00953524?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 849 participants. The study started on 2009-08. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00953524?
The interventions under investigation include: Normal saline solution (placebo) (BIOLOGICAL), Monovalent Subvirion A/H1N1 Influenza vaccine (7.5 µg of HA) (BIOLOGICAL), Monovalent Subvirion A/H1N1 Influenza vaccine (15 µg of HA) (BIOLOGICAL), Monovalent Subvirion A/H1N1 Influenza vaccine (30 µg of HA) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00953524?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00953524's enrollment target sits among peer trials
849 36th of 2000 higher than 1,965 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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