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NCT00996307 · ClinicalTrials.gov registry record · Phase 2
Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months
A Phase 2 study, sponsored by Novartis Vaccines.
- Completed
- Registry status
- Phase 2
- Development phase
- 654
- Enrollment target
NCT00996307: Completed Phase 2 study, sponsored by Novartis Vaccines.
NCT00996307 is a Phase 2 study that has completed, run by Novartis Vaccines. The registered enrollment target is 654 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (392% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00996307, a Phase 2 study, has completed, sponsored by Novartis Vaccines.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 654 participants
- Enrollment target
Study Summary
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children
Primary Outcome
CBER guidance (\<65 years of age): The lower bound of the two-sided 95% CI for the percent of subjects achieving seroconversion for HI antibody should be ≥ 40% AND the lower bound of the two sided 95% CI for the percent of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%.
Interventions
- BIOLOGICAL MF59-eH1N1_f
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 654 participants |
| Start Date | 2009-10 |
| Est. Completion | 2010-12 |
| Phase | Phase 2 |
What the finished NCT00996307 record still lists
NCT00996307 is an interventional study that assigns participants to a tested intervention. The registered 654 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 (392% higher).
The record links to 0 conditions, and to 1 intervention - of which MF59-eH1N1_f is the first listed.
NCT00996307 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00996307 about?
NCT00996307 is a clinical study titled "Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months". This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children
What is the current status of trial NCT00996307?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 654 participants. The study started on 2009-10. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00996307?
The interventions under investigation include: MF59-eH1N1_f (BIOLOGICAL).
Who is sponsoring clinical trial NCT00996307?
This trial is sponsored by Novartis Vaccines, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00996307's enrollment target sits among peer trials
654 50th of 2000 higher than 1,951 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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