Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)
Public ClinicalTrials.gov record NCT00972816. 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 Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Pediatric Subjects 3 to < 9 Years of Age
Study identification
- NCT ID
- NCT00972816
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Lead sponsor
- Novartis Vaccines
- Industry
- Enrollment
- 1,357 participants
Conditions and interventions
Conditions
Interventions
- MF59-eH1N1 Biological
Biological
Eligibility (public fields only)
- Age range
- 3 Years to 8 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
- Aug 31, 2009
- Primary completion
- Oct 31, 2009
- Completion
- Sep 30, 2010
- Last update posted
- Apr 13, 2016
2009 – 2010
United States locations
- U.S. sites
- 34
- U.S. states
- 20
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Premier Health Research Center, LLC | Downey | California | 90241-4982 | — |
| Madera Family Medical Group | Madera | California | 93637 | — |
| Center for Clincal Trials, LLC | Paramount | California | 90723 | — |
| Center for Clinical Trials, LLC | Paramount | California | 90723 | — |
| Center for Clinical Trials of San Gabriel | West Covina | California | 91790 | — |
| 1st International Research Centers | Thornton | Colorado | 80233 | — |
| Pediatrics and Adolescent Medicine | Marietta | Georgia | 30062 | — |
| Pediatrics and Adolescent Medicine | Woodstock | Georgia | 30189 | — |
| Northern Illinois Research Associates | DeKalb | Illinois | 60115 | — |
| Bluegrass Clinical Research, Inc. | New Albany | Indiana | 47150 | — |
| Heartland Research Associates LLC | Arkansas City | Kansas | 67005 | — |
| Heartland Research Associates LLC | Newton | Kansas | 67114 | — |
| Bluegrass Clinical Research, Inc (Brownsboro for drug shipment) | Louisville | Kentucky | 40291 | — |
| Meridien Clinical Research | Omaha | Nebraska | 68134 | — |
| Clinical Research Center of Nevada | Henderson | Nevada | 89015 | — |
| Capital Pediatrics and Adolescent Ctr. | Raleigh | North Carolina | 27609 | — |
| Dr. Senders and Associates, Pediatrics | Cleveland | Ohio | 44121 | — |
| Prestige Clinical Research | Franklin | Ohio | 45005 | — |
| IPS Research | Oklahoma City | Oklahoma | 73103 | — |
| The Portland Clinic LLP | Beaverton | Oregon | 97006 | — |
| Children's Health Care -West | Erie | Pennsylvania | 16506 | — |
| UPMC/Community Medicine (pediatrics) | Greenville | Pennsylvania | 16125 | — |
| Pediatric Physicians Research, Inc. | Jefferson Hills | Pennsylvania | 15025 | — |
| Pediatric Alliance - Greentree Division (pediatrics) | Pittsburgh | Pennsylvania | 15220 | — |
| Omega Clinical Research | Warwick | Rhode Island | 02886 | — |
| Holston Medical Group | Kingsport | Tennessee | 37660 | — |
| Research Across America | Dallas | Texas | 75234 | — |
| West Houston Clinical Research Service | Houston | Texas | 77055 | — |
| Pediatric Healthcare of NW Houston | Tomball | Texas | 77375 | — |
| J.Lewis Research, Inc./Foothill Family Clinic | Salt Lake City | Utah | 84109 | — |
| J. Lewis Research, Inc./Foothill Family Clinic South | Salt Lake City | Utah | 84121 | — |
| PI-Coor Clinical Research | Burke | Virginia | 22015 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23219 | — |
| Rockwood Research Center | Spokane | Washington | 99202 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00972816, 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 13, 2016 · Synced May 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00972816 live on ClinicalTrials.gov.