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NCT00943202 · ClinicalTrials.gov registry record · Phase 2
Sanofi Pasteur, TIV + H1N1, Pediatric Population
A Phase 2 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 531
- Enrollment target
- 8
- Study locations
NCT00943202 is a Phase 2 study of Influenza that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 531 participants, below the 36,801-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The trial reports 8 study locations across 6 states.
The verdict
NCT00943202, a Phase 2 study of Influenza, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 531 participants
- Enrollment target
- 8
- Study locations
Study Summary
The purpose of this study is to assess the safety and immune response (body's defense against disease) to an experimental H1N1 influenza vaccine against the 2009 H1N1 virus. This study will help determine how and when the H1N1 flu shot should be given with the seasonal flu shot to make it most effective. The 650 participants will be divided into the following age groups: infants from 6 months-36 months old, children 36 months-9 years old, and adolescents 10-17 years old. Each age group will have 200 children. There are 4 treatment groups in each age level. Study procedures include: medical history, targeted physical exam based on history, maintaining a memory aid, and blood sample collection. Participants will be involved in the study for about 8 months.
Conditions Studied
Interventions
- BIOLOGICAL Trivalent Inactivated Influenza Vaccine
- BIOLOGICAL Inactivated H1N1 Vaccine
Study Locations (8)
Georgia
- Emory Children's Center - Pediatric Infectious Diseases - Atlanta
- Emory University School of Medicine - Emory Children's Center - Pediatric Infectious Diseases - Atlanta
Texas
- The University of Texas Medical Branch - Galveston
- Baylor College of Medicine - Houston
Iowa
- University of Iowa - Iowa City
Missouri
- Saint Louis University Hospital - Internal Medicine - Infectious Diseases, Allergy & Immunology - St Louis
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Tennessee
- Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 531 participants |
| Start Date | 2009-08 |
| Est. Completion | 2010-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00943202
The ClinicalTrials.gov registry entry for NCT00943202 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 531 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,801-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Trivalent Inactivated Influenza Vaccine is the first listed.
NCT00943202 reports 8 study locations spanning 6 distinct geographic areas - top geographies include Georgia, Texas, Iowa.
Frequently Asked Questions
What is clinical trial NCT00943202 about?
NCT00943202 is a clinical study titled "Sanofi Pasteur, TIV + H1N1, Pediatric Population". The purpose of this study is to assess the safety and immune response (body's defense against disease) to an experimental H1N1 influenza vaccine against the 2009 H1N1 virus. This study will help determine how and when the H1N1 flu shot should be given with the seasonal flu shot to make it most effec...
What is the current status of trial NCT00943202?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 531 participants. The study started on 2009-08. Estimated completion is 2010-05.
What conditions does trial NCT00943202 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT00943202?
The interventions under investigation include: Trivalent Inactivated Influenza Vaccine (BIOLOGICAL), Inactivated H1N1 Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00943202?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00943202 being conducted?
This trial has 8 study locations across Georgia, Iowa, Missouri, Ohio, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.