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Completed Phase 2Phase 3 Interventional Accepts healthy volunteers Results available

Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)

ClinicalTrials.gov ID: NCT00972816

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.

ClinicalTrials.gov public records Last synced Oct 31, 2026, 9:39 PM EDT

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children.

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

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
Sep 2009 (Type not available)
Primary completion
Nov 2009 (Actual)
Completion
Oct 2010 (Actual)
Last update posted
Apr 14, 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 14, 2016 · Synced Oct 31, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00972816 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →