Sanofi Pasteur, TIV + H1N1, Pediatric Population
Public ClinicalTrials.gov record NCT00943202. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Effect of Administration of Licensed TIV Vaccine on the Safety and Immunogenicity of an Unadjuvanted Sanofi Pasteur H1N1 Influenza Vaccine in Previously Primed Infants and Toddlers (Greater Than or Equal to 6 - <36 Months), Children (Greater Than or Equal to 36 Months - 9 Years), and Adolescents (10 - 17 Years)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00943202
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 531 participants
Conditions and interventions
Conditions
Interventions
- Inactivated H1N1 Vaccine Biological
- Trivalent Inactivated Influenza Vaccine Biological
Biological
Eligibility (public fields only)
- Age range
- 6 Months to 17 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2009
- Primary completion
- Apr 30, 2010
- Completion
- Apr 30, 2010
- Last update posted
- Apr 21, 2013
2009 – 2010
United States locations
- U.S. sites
- 8
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Emory Children's Center - Pediatric Infectious Diseases | Atlanta | Georgia | 30322 | — |
| Emory University School of Medicine - Emory Children's Center - Pediatric Infectious Diseases | Atlanta | Georgia | 30322 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Saint Louis University Hospital - Internal Medicine - Infectious Diseases, Allergy & Immunology | St Louis | Missouri | 63110 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | — |
| Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center | Nashville | Tennessee | 37232-2573 | — |
| The University of Texas Medical Branch | Galveston | Texas | 77555 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00943202, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 21, 2013 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00943202 live on ClinicalTrials.gov.