Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age

Completed · Phase 3

Conditions studied: Influenza, Fever

In brief

Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents 4 to 17 years of age.

Key facts

Study ID

NCT01857206

Run by

Novartis Vaccines

People needed

2055

Starts

2013-05-01

Expected to finish

2014-06-01

Last updated by the study team

2014-12-05

Who can join

Age: 4 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy subjects 4-17 years of age

You may not qualify if…

• Subjects who are not healthy,
• Subjects who are pregnant or breast feeding,
• Subjects with a history of severe allergic reaction or allergic to any of the vaccine components.

Where it is running

• 320, Novartis Investigational Site — Mobile, Alabama, United States
• 312, Novartis Investigational Site — Ponte Vedra, Florida, United States
• 313, Novartis Investigational Site — Augusta, Kansas, United States
• 305, Novartis Investigational Site — Newton, Kansas, United States
• 302, Novartis Investigational Site — Wichita, Kansas, United States
• 301, Novartis Investigational Site — Wichita, Kansas, United States
• 311, Novartis Investigational Site — Fremont, Nebraska, United States
• 308, Novartis Investigational Site — Winston-Salem, North Carolina, United States
• 317, Novartis Investigational Site — Cleveland, Ohio, United States
• 309, Novartis Investigational Site — Tulsa, Oklahoma, United States
• 314, Novartis Investigational Site — Warwick, Rhode Island, United States
• 319, Novartis Investigational Site — Mt. Pleasant, South Carolina, United States
• 310, Novartis Investigational Site — Bristol, Tennessee, United States
• 318, Novartis Investigational Site — Nashville, Tennessee, United States
• 304, Novartis Investigational Site — Salt Lake City, Utah, United States
• 306, Novartis Investigational Site — Salt Lake City, Utah, United States
• 315, Novartis Investigational Site — Salt Lake City, Utah, United States
• 303, Novartis Investigational Site — South Jordan, Utah, United States
• 100, Novartis Investigational Site — Westmead, New South Wales, Australia
• 108, Novartis Investigational Site — Auchenflower, Queensland, Australia
• 107, Novartis Investigational Site — Sherwood, Queensland, Australia
• 104, Novartis Investigational Site — North Adelaide, South Australia, Australia
• 103, Novartis Investigational Site — Carlton, Victoria, Australia
• 105, Novartis Investigational Site — Subiaco, Western Australia, Australia
• 151, Novartis Investigational Site — Takapuna, Auckland, New Zealand

Full record on ClinicalTrials.gov

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