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NCT01776554 · ClinicalTrials.gov registry record · Phase 2
Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Children
A Phase 2 study of Pandemic H5N1 Influenza, sponsored by Novartis Vaccines.
- Completed
- Registry status
- Phase 2
- Development phase
- 662
- Enrollment target
- 12
- Study locations
NCT01776554: Completed Phase 2 study of Pandemic H5N1 Influenza, sponsored by Novartis Vaccines.
NCT01776554 is a Phase 2 study of Pandemic H5N1 Influenza that has completed, run by Novartis Vaccines. The registered enrollment target is 662 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (398% higher). The trial reports 12 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01776554, a Phase 2 study of Pandemic H5N1 Influenza, has completed, sponsored by Novartis Vaccines.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 662 participants
- Enrollment target
- 12
- Study locations
Study Summary
Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived influenza vaccine in children.
Primary Outcome
The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects aged 6 to \<36 months, achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion. As there is no CBER criteria defined for children, immunogenicity was evaluated using CBER criterion applicable for adults (18-64 years). CBER criterion is me
Conditions Studied
Interventions
- BIOLOGICAL Adjuvanted H5N1 pandemic influenza vaccine
Study Locations (12)
Kansas
- 7 Heartland Research Associates - Newton
- 5 Heartland Research Associates - Wichita
- 9 Heartland Research Associates - Wichita
Utah
- 8 Foothill Family Clinic - Salt Lake City
- 4 Foothill Family Clinic - South Cottonwood Heights
Other
- 75 Phramongkutklao Hospital - Bangkok
- 76 Faculty of Tropical Medicine Mahidol University - Bangkok
Florida
- 3 Meridian Clinical Research - Miami
Missouri
- 1 Saint Louis University - St Louis
Nebraska
- 6 Meridian Clinical Research - Omaha
Texas
- 10 Tekton Research - Georgetown
Washington
- 2 Rockwood Clinic P S - Spokane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 662 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-06 |
| Phase | Phase 2 |
What the finished NCT01776554 record still lists
NCT01776554 is an interventional study that assigns participants to a tested intervention. The registered 662 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 (398% higher).
The record links to 1 condition, with Pandemic H5N1 Influenza appearing as the primary indexed condition, and to 1 intervention - of which Adjuvanted H5N1 pandemic influenza vaccine is the first listed.
NCT01776554 lists 12 locations in 8 states (Kansas, Utah, Other).
Frequently Asked Questions
What is clinical trial NCT01776554 about?
NCT01776554 is a clinical study titled "Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Children". Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived influenza vaccine in children.
What is the current status of trial NCT01776554?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 662 participants. The study started on 2013-01. Estimated completion is 2014-06.
What conditions does trial NCT01776554 study?
This clinical trial studies the following conditions: Pandemic H5N1 Influenza.
What interventions are being tested in trial NCT01776554?
The interventions under investigation include: Adjuvanted H5N1 pandemic influenza vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01776554?
This trial is sponsored by Novartis Vaccines, which has 32 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01776554 being conducted?
This trial has 12 study locations across Florida, Kansas, Missouri, Nebraska, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01776554's enrollment target sits among peer trials
662 49th of 2000 higher than 1,952 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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