Peds Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels
Public ClinicalTrials.gov record NCT00944073. 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
A Phase II Study in Infants (Greater Than or Equal to 6 - Less Than 36 Months), Children (Greater Than or Equal to 36 Months - 9 Years) and Adolescents (10 - 17 Years) to Assess the Safety and Immunogenicity of an Unadjuvanted Sanofi Pasteur H1N1 Influenza Vaccine Administered at Two Dose Levels
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to assess the safety and the body's immune response (body's defense against disease) to an experimental H1N1 influenza vaccine. Up to 650 healthy volunteers from three age groups (greater than or equal to 6 months to less than 36 months, greater than or equal to 36 months to 9 years, and 10 - 17 years) with no history of influenza H1N1 2009 influenza infection or influenza H1N1 2009 vaccination will participate. Participants will be randomly (by chance) assigned to 1 of 2 possible H1N1 vaccine groups. Group 1 will receive 15 mcg of vaccine; Group 2 will receive 30 mcg of vaccine. Participants will receive vaccine injections on Days 0 and 21 in the arm or thigh muscle. Study procedures include: medical history, physical exam, maintaining a memory aid, and blood sample collection. Participants will be involved in study related procedures for approximately 7 months.
Study identification
- NCT ID
- NCT00944073
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 583 participants
Conditions and interventions
Conditions
Interventions
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
- Mar 31, 2010
- Completion
- Mar 31, 2010
- Last update posted
- Feb 17, 2015
2009 – 2010
United States locations
- U.S. sites
- 9
- U.S. states
- 7
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Maryland School of Medicine - Center for Vaccine Development - Baltimore | Baltimore | Maryland | 21201 | — |
| Children's Mercy Hospital and Clinics - Infectious Diseases | Kansas City | Missouri | 64108 | — |
| Saint Louis University - Center for Vaccine Development | St Louis | Missouri | 63104-1015 | — |
| Duke Translational Medicine Institute - Clinical Vaccine Unit | Durham | North Carolina | 27704 | — |
| Cincinnati Children's Hospital Medical Center - Infectious Diseases | Cincinnati | Ohio | 45231 | — |
| Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center | Nashville | Tennessee | 37232-2573 | — |
| University of Texas Medical Branch - Pediatrics - Infectious Diseases and Immunology - Galveston | Galveston | Texas | 77555-5302 | — |
| Baylor College of Medicine - Molecular Virology and Microbiology | Houston | Texas | 77030-3411 | — |
| Seattle Children's Hospital - Infectious Diseases | Seattle | Washington | 98105 | — |
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 NCT00944073, 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 Feb 17, 2015 · Synced Sep 24, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00944073 live on ClinicalTrials.gov.