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NCT00972816 · ClinicalTrials.gov registry record · Phase 2
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)
A Phase 2 study of Influenza, sponsored by Novartis Vaccines.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,357
- Enrollment target
- 20
- Study locations
NCT00972816: Completed Phase 2 study of Influenza, sponsored by Novartis Vaccines.
NCT00972816 is a Phase 2 study of Influenza that has completed, run by Novartis Vaccines. The registered enrollment target is 1,357 participants, below the 36,795-participant average among 156 other Influenza trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00972816, a Phase 2 study of Influenza, has completed, sponsored by Novartis Vaccines.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,357 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children.
Primary Outcome
HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Center for Biologics Evaluation and Research (CBER) guidance for \<65 years of age: The lower bound of the two-sided 95% Confidence Interval (CI) for the percentages of subjects achieving seroconversion for HI antibody should be ≥ 40% and the lower bound of the two-sided 95% CI for the percentages of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%. Both criteria (seroconversion a
Conditions Studied
Interventions
- BIOLOGICAL MF59-eH1N1
Study Locations (20)
California
- Premier Health Research Center, LLC - Downey
- Madera Family Medical Group - Madera
- Center for Clincal Trials, LLC - Paramount
- Center for Clinical Trials, LLC - Paramount
- Center for Clinical Trials of San Gabriel - West Covina
Georgia
- Pediatrics and Adolescent Medicine - Marietta
- Pediatrics and Adolescent Medicine - Woodstock
Kansas
- Heartland Research Associates LLC - Arkansas City
- Heartland Research Associates LLC - Newton
Ohio
- Dr. Senders and Associates, Pediatrics - Cleveland
- Prestige Clinical Research - Franklin
Colorado
- 1st International Research Centers - Thornton
Illinois
- Northern Illinois Research Associates - DeKalb
Indiana
- Bluegrass Clinical Research, Inc. - New Albany
Kentucky
- Bluegrass Clinical Research, Inc (Brownsboro for drug shipment) - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,357 participants |
| Start Date | 2009-09 |
| Est. Completion | 2010-10 |
| Phase | Phase 2 |
What the finished NCT00972816 record still lists
NCT00972816 is an interventional study that assigns participants to a tested intervention. Its 1,357 participants enrollment target places it among the larger protocols in the corpus, below the 36,795-participant average among 156 other Influenza trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 1 intervention - of which MF59-eH1N1 is the first listed.
NCT00972816 names 20 study sites across 13 states, led by California, Georgia, Kansas.
Frequently Asked Questions
What is clinical trial NCT00972816 about?
NCT00972816 is a clinical study titled "Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)". This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children.
What is the current status of trial NCT00972816?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,357 participants. The study started on 2009-09. Estimated completion is 2010-10.
What conditions does trial NCT00972816 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT00972816?
The interventions under investigation include: MF59-eH1N1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00972816?
This trial is sponsored by Novartis Vaccines, which has 32 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00972816 being conducted?
This trial has 20 study locations across California, Colorado, Georgia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00972816's enrollment target sits among peer trials
1,357 30th of 156 higher than 127 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza 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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