Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age
NCT ID: NCT01857206
Last Updated: 2014-12-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
2055 participants
INTERVENTIONAL
2013-05-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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TIVc
Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
Mammalian cell based flu vaccine
TIVf
Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
Egg based flu vaccine
Interventions
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Mammalian cell based flu vaccine
Egg based flu vaccine
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subjects who are pregnant or breast feeding,
* Subjects with a history of severe allergic reaction or allergic to any of the vaccine components.
4 Years
17 Years
ALL
Yes
Sponsors
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Novartis Vaccines
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Vaccines and Diagnostics
Role: STUDY_CHAIR
Novartis Vaccines
Locations
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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
150, Novartis Investigational Site
Beckenham, Christchurch, New Zealand
250, Novartis Investigational Site
City of Muntinlupa, Alabang, Philippines
251, Novartis Investigational Site
City of Muntinlupa, Alabang, Philippines
254, Novartis Investigational Site
City of Muntinlupa, Alabang, Philippines
253, Novartis Investigational Site
Manila, Ermita, Philippines
252, Novartis Investigation Site
Manila, Sampaloc, Philippines
201, Novartis Investigational Site
Khon Kaen, Muang, Thailand
200, Novartis Investigational Site
Bangkok, Rajathevi, Thailand
202, Novartis Investigational Site
Bangkoknoi, Siriraj, Thailand
Countries
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References
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Nolan T, Chotpitayasunondh T, Capeding MR, Carson S, Senders SD, Jaehnig P, de Rooij R, Chandra R. Safety and tolerability of a cell culture derived trivalent subunit inactivated influenza vaccine administered to healthy children and adolescents: A Phase III, randomized, multicenter, observer-blind study. Vaccine. 2016 Jan 4;34(2):230-236. doi: 10.1016/j.vaccine.2015.11.040. Epub 2015 Nov 29.
Other Identifiers
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U1111-1139-9440
Identifier Type: OTHER
Identifier Source: secondary_id
V58_31
Identifier Type: -
Identifier Source: org_study_id