Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months

Completed · Phase 2/Phase 3

Conditions studied: Influenza

In brief

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children

Key facts

Study ID

NCT00996307

Run by

Novartis Vaccines

People needed

654

Starts

2009-10-01

Expected to finish

2010-12-01

Last updated by the study team

2017-05-30

Who can join

Age: 1 and older, up to 3. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Children 6 to 35 months 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

• Study site — Bentonville, Arkansas, United States
• Study site — Fort Smith, Arkansas, United States
• Study site — Canoga Park, California, United States
• Study site — Dinuba, California, United States
• Study site — Fresno, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Madera, California, United States
• Study site — Torrance, California, United States
• Study site — New Albany, Indiana, United States
• Study site — Newton, Kansas, United States
• Study site — Wichita, Kansas, United States
• Study site — Bardstown, Kentucky, United States
• Study site — Woburn, Massachusetts, United States
• Study site — Fargo, North Dakota, United States
• Study site — Dayton, Ohio, United States
• Study site — Huber Heights, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Charleston, South Carolina, United States
• Study site — Spartanburg, South Carolina, United States
• Study site — Lebanon, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Provo, Utah, United States
• Study site — South Jordan, Utah, United States

Full record on ClinicalTrials.gov

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