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NCT00952419 · ClinicalTrials.gov registry record · Phase 2
A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Children Aged 6 Months to 9 Years
A Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 474
- Enrollment target
NCT00952419: Completed Phase 2 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT00952419 is a Phase 2 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 474 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (256% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00952419, a Phase 2 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 474 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in toddlers and children. 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- and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Interventions
- BIOLOGICAL Monovalent Subvirion A/H1N1 Influenza vaccine
- BIOLOGICAL Normal saline solution (placebo)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 474 participants |
| Start Date | 2009-08 |
| Est. Completion | 2010-06 |
| Phase | Phase 2 |
What the finished NCT00952419 record still lists
NCT00952419 is an interventional study that assigns participants to a tested intervention. The registered 474 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 (256% higher).
The record links to 0 conditions, and to 2 interventions - of which Monovalent Subvirion A/H1N1 Influenza vaccine is the first listed.
NCT00952419 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00952419 about?
NCT00952419 is a clinical study titled "A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Children Aged 6 Months to 9 Years". The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in toddlers and children. 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 NCT00952419?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 474 participants. The study started on 2009-08. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00952419?
The interventions under investigation include: Monovalent Subvirion A/H1N1 Influenza vaccine (BIOLOGICAL), Normal saline solution (placebo) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00952419?
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 NCT00952419's enrollment target sits among peer trials
474 77th of 2000 higher than 1,923 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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