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

Completed · Phase 2/Phase 3

Conditions studied: Influenza

In brief

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

Key facts

Study ID

NCT00972816

Run by

Novartis Vaccines

People needed

1357

Starts

2009-09-01

Expected to finish

2010-10-01

Last updated by the study team

2016-04-14

Who can join

Age: 3 and older, up to 8. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Children 3 to < 9 years of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.

You may not qualify if…

• History of serious disease.
• History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
• Known or suspected impairment/alteration of immune function.
• Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.
• For additional entry criteria, please refer to protocol.

Where it is running

• Premier Health Research Center, LLC — Downey, California, United States
• Madera Family Medical Group — Madera, California, United States
• Center for Clincal Trials, LLC — Paramount, California, United States
• Center for Clinical Trials, LLC — Paramount, California, United States
• Center for Clinical Trials of San Gabriel — West Covina, California, United States
• 1st International Research Centers — Thornton, Colorado, United States
• Pediatrics and Adolescent Medicine — Marietta, Georgia, United States
• Pediatrics and Adolescent Medicine — Woodstock, Georgia, United States
• Northern Illinois Research Associates — DeKalb, Illinois, United States
• Bluegrass Clinical Research, Inc. — New Albany, Indiana, United States
• Heartland Research Associates LLC — Arkansas City, Kansas, United States
• Heartland Research Associates LLC — Newton, Kansas, United States
• Bluegrass Clinical Research, Inc (Brownsboro for drug shipment) — Louisville, Kentucky, United States
• Meridien Clinical Research — Omaha, Nebraska, United States
• Clinical Research Center of Nevada — Henderson, Nevada, United States
• Capital Pediatrics and Adolescent Ctr. — Raleigh, North Carolina, United States
• Dr. Senders and Associates, Pediatrics — Cleveland, Ohio, United States
• Prestige Clinical Research — Franklin, Ohio, United States
• IPS Research — Oklahoma City, Oklahoma, United States
• The Portland Clinic LLP — Beaverton, Oregon, United States
• Children's Health Care -West — Erie, Pennsylvania, United States
• UPMC/Community Medicine (pediatrics) — Greenville, Pennsylvania, United States
• Pediatric Physicians Research, Inc. — Jefferson Hills, Pennsylvania, United States
• Pediatric Alliance - Greentree Division (pediatrics) — Pittsburgh, Pennsylvania, United States
• Omega Clinical Research — Warwick, Rhode Island, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.