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NCT00391391 · ClinicalTrials.gov registry record · Phase 2
Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children
A Phase 2 study of Influenza and Orthomyxoviridae Infection, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 520
- Enrollment target
- 19
- Study locations
NCT00391391: Completed Phase 2 study of Influenza and Orthomyxoviridae Infection, sponsored by Sanofi.
NCT00391391 is a Phase 2 study of Influenza and Orthomyxoviridae Infection that has completed, run by Sanofi. The registered enrollment target is 520 participants, below the 36,801-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The trial reports 19 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00391391, a Phase 2 study of Influenza and Orthomyxoviridae Infection, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 520 participants
- Enrollment target
- 19
- Study locations
Study Summary
Primary Objective: To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years. Secondary Objectives: * To describe the immunogenicity of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years. * To describe the safety of of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.
Primary Outcome
Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.
Conditions Studied
Interventions
- BIOLOGICAL Split, Inactivated, Trivalent Influenza Vaccine
- BIOLOGICAL Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)
Study Locations (19)
California
- - Bellflower
- - Downey
- - Fountain Valley
- - Paramount
Pennsylvania
- - Erie
- - Pittsburgh
- - Uniontown
- - Wexford
Arkansas
- - Harrisburg
- - Little Rock
- - Trumann
Louisiana
- - Bossier City
- - Shreveport
Utah
- - Salt Lake City
- - Salt Lake City
Kentucky
- - Owensboro
Minnesota
- - Brainerd
Ohio
- - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 520 participants |
| Start Date | 2006-10 |
| Est. Completion | 2007-10 |
| Phase | Phase 2 |
What the finished NCT00391391 record still lists
NCT00391391 is an interventional study that assigns participants to a tested intervention. The registered 520 participants enrollment target is mid-sized for trials with a published cap, below the 36,801-participant average among 156 other Influenza trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Split, Inactivated, Trivalent Influenza Vaccine is the first listed.
NCT00391391 lists 19 locations in 9 states (California, Pennsylvania, Arkansas).
Frequently Asked Questions
What is clinical trial NCT00391391 about?
NCT00391391 is a clinical study titled "Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children". Primary Objective: To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years. Secondary Objectives: * To describe the immunogenicity of of Investigational Fluzone vaccine to...
What is the current status of trial NCT00391391?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 520 participants. The study started on 2006-10. Estimated completion is 2007-10.
What conditions does trial NCT00391391 study?
This clinical trial studies the following conditions: Influenza, Orthomyxoviridae Infection, Myxovirus Infection.
What interventions are being tested in trial NCT00391391?
The interventions under investigation include: Split, Inactivated, Trivalent Influenza Vaccine (BIOLOGICAL), Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00391391?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00391391 being conducted?
This trial has 19 study locations across Arkansas, California, Kentucky, Louisiana, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT00391391's enrollment target sits among peer trials
520 49th of 156 higher than 108 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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