Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.
NCT ID: NCT01964989
Last Updated: 2023-03-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
10644 participants
INTERVENTIONAL
2013-11-30
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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aQIV
flu vaccine
Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months
non-adjuvanted comparator
flu vaccine
Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV)
1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months
Interventions
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Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months
Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV)
1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months
Eligibility Criteria
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Inclusion Criteria
* Documented consent provided by the subject's parent(s)/legal guardian(s)
* Subjects and/or subject's parent(s)/legal guardian(s) able to comply with all study procedures.
Exclusion Criteria
* Additional eligibility criteria may be discussed by contacting the site
6 Months
71 Months
ALL
Yes
Sponsors
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Novartis Vaccines
INDUSTRY
Seqirus
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Program Director
Role: STUDY_DIRECTOR
Seqirus
Locations
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222, Novartis Investigational Site
Chandler, Arizona, United States
267, Novartis Investigational Site
Harrisburg, Arkansas, United States
259, Novartis Investigational Site
Anaheim, California, United States
280, Novartis Investigational Site
Anaheim, California, United States
213, Novartis Investigational Site
Baldwin Park, California, United States
407, Novartis Investigational Site
Downey, California, United States
238, Novartis Investigational Site
La Puente, California, United States
411, Novartis Investigational Site
Ontario, California, United States
202, Novartis Investigational Site
Paramount, California, United States
250, Novartis Investigational Site
San Diego, California, United States
293, Novartis Investigational Site
San Francisco, California, United States
243, Novartis Investigational Site
Colorado Springs, Colorado, United States
249, Novartis Investigational Site
Denver, Colorado, United States
229, Novartis Investigational Site
Boca Raton, Florida, United States
416, Novartis Investigational Site
Hialeah, Florida, United States
287, Novartis Investigational Site
Hialeah, Florida, United States
412, Novartis Investigational Site
Homestead, Florida, United States
224, Novartis Investigational Site
Melbourne, Florida, United States
417, Novartis Investigational Site
Miami, Florida, United States
404, Novartis Investigational Site
Miami, Florida, United States
285, Novartis Investigational Site
Miami, Florida, United States
277,Novartis Investigational Site
Miami, Florida, United States
234, Novartis Investigational Site
Opa-locka, Florida, United States
297, Novartis Investigational Site
Orlando, Florida, United States
297, Novartis Investigational vaccine
Orlando, Florida, United States
410, Novartis Investigational Site
Sarasota, Florida, United States
401, Novartis iNvestiagtional Site
Atlanta, Georgia, United States
299, Novartis Investigational Site
DeKalb, Illinois, United States
268, Novartis Investigational Site
Peoria, Illinois, United States
209, Novartis Investigational Site
Augusta, Kansas, United States
210, Novartis Investigational Site
Newton, Kansas, United States
274 Novartis Investigational Site
Park City, Kansas, United States
211, Novartis Investigational Site
Wichita, Kansas, United States
269, Novartis Investigational Site
Bardstown, Kentucky, United States
226, Novartis Investigational Site
Louisville, Kentucky, United States
248, Novartis Investigational Site
Louisville, Kentucky, United States
207, Novartis Investigational Site
Louisville, Kentucky, United States
290, Novartis Investigational Site
Louisville, Kentucky, United States
265, Novartis Investigational Site
Haughton, Louisiana, United States
408, Novartis Investigational Site
Mangham, Louisiana, United States
225, Novartis Investigational Site
Metairie, Louisiana, United States
233, Novartis Investigational Site
Metairie, Louisiana, United States
418, Novartis Investigational SIte
Monroe, Louisiana, United States
262, Novartis Investigational site
Annapolis, Maryland, United States
263, Novartis Investigational Site
Frederick, Maryland, United States
405, Novartis Investigational Site
Silver Spring, Maryland, United States
278, Novartis Investigational Site
Saint Paul, Minnesota, United States
221, Novartis Investigational Site
Bellevue, Nebraska, United States
219, Novartis Investigational Site
Fremont, Nebraska, United States
402, Novartis Investigational Site
Omaha, Nebraska, United States
288, Novartis Investigational Site
Omaha, Nebraska, United States
228, Novartis Investigational Site
Omaha, Nebraska, United States
244, Novartis Investigational Site
Henderson, Nevada, United States
286, Novartis Investigational site
Las Vegas, Nevada, United States
255, Novartis Investigational Site
Binghamton, New York, United States
414, Novartis Investigational Site
Brooklyn, New York, United States
264, Novartis Investigational Site
Syracuse, New York, United States
409, Novartis Investigational Site
Boone, North Carolina, United States
266, Novartis Investigational Site
Cary, North Carolina, United States
403, Novartis Investigational Site
Clyde, North Carolina, United States
240, Novartis Investigational Site
Akron, Ohio, United States
254, Novartis Investigational Site
Cleveland, Ohio, United States
245, Novartis Investigational Site
Dayton, Ohio, United States
281, Novartis Investigational Site
Dayton, Ohio, United States
281, Novartis Investigational vaccines
Dayton, Ohio, United States
256, Novartis Investigational Site
Tulsa, Oklahoma, United States
292, Novartis Investigational Site
Erie, Pennsylvania, United States
270, Novartis Investigational Site
Scottdale, Pennsylvania, United States
220, Novartis Investigational Site
Anderson, South Carolina, United States
406, novartis Investigational Site
Barnwell, South Carolina, United States
272, Novartis Investigational Site
Charleston, South Carolina, United States
232, Novartis Investigational Site
Moncks Corner, South Carolina, United States
291, Novartis Investigational vaccine
Spartanburg, South Carolina, United States
283, Novartis Investigational Site
Nashville, Tennessee, United States
208, Novartis Investigational Site
Austin, Texas, United States
247, Novartis Investigational Site
Fort Worth, Texas, United States
217, Novartis Investigational Site
Fort Worth, Texas, United States
214, Novartis Investigational Site
San Angelo, Texas, United States
400, Novartis investigational Site
San Antonio, Texas, United States
260, Novartis Investigational Site
Tomball, Texas, United States
295, Novartis Investigational Site
Layton, Utah, United States
236, Novartis Investigational Site
Salt Lake City, Utah, United States
212, Novartis Investigational Site
Salt Lake City, Utah, United States
246, Novartis Investigational Site
Salt Lake City, Utah, United States
279, Novartis Investigational Site
Spanish Fork, Utah, United States
282, Novartis Investigational Site
Syracuse, Utah, United States
294, Novartis Investigational Site
West Haven, Utah, United States
201, Novartis Investigational Site
West Jordan, Utah, United States
271, Novartis Investigational Site
West Jordan, Utah, United States
251, Novartis Investigational Site
Burke, Virginia, United States
296, Novartis Investigational Site
Vienna, Virginia, United States
184, Novartis Investigational Site
Greater Sudbury, Ontario, Canada
180, Novartis Investigational Site
Newmarket, Ontario, Canada
182,Novartis Investigational Site
Toronto, Ontario, Canada
183, Novartis Investigational Site
Québec, , Canada
186, Novartis Investigational Site
Québec, , Canada
001, Novartis Investigational Site
Espoo, , Finland
003, Novartis Investigational Site
Helsinki, , Finland
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Helsinki, , Finland
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Järvenpää, , Finland
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Kokkola, , Finland
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Oulu, , Finland
007, Novartis Investigational Site
Pori, , Finland
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Seinäjoki, , Finland
009, Novartis Investigational Site
Tampere, , Finland
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Turku, , Finland
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Vantaa, , Finland
030, Novartis Investigational Site
Florence, , Italy
023, Novartis Investigational Site
Genova, , Italy
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Milan, , Italy
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Milan, , Italy
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Napoli, , Italy
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Novara, , Italy
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Padua, , Italy
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Pisa, , Italy
028, Novartis Investigational Site
Sassari, , Italy
173, Novartis Investigational Site
Morelia, Michoacán, Mexico
176, Novartis Investigational Site
Durango, , Mexico
170, Novartis Investigational Site
México, , Mexico
177, Novartis Investigational Site
México, , Mexico
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México, , Mexico
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México, , Mexico
300, Novartis Investigational Site
Dasmariñas, Cavite, Philippines
306, Novartis Investigational Site
Alabang, Muntilupa, Philippines
303, Novartis Investigational Site
City of Muntinlupa, , Philippines
304, Novartis Investigational Site
City of Muntinlupa, , Philippines
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City of Muntinlupa, , Philippines
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Manila, , Philippines
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Manila, , Philippines
040, Novartis Investigational Site
Dębica, , Poland
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Katowice, , Poland
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Lodz, , Poland
049, Novartis Investigational Site
Lubartów, , Poland
051, Novartis Investigational Site
Oborniki Śląskie, , Poland
046, Novartis Investigational Site
Osielsko, , Poland
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Siemianowice Śląskie, , Poland
047, Novartis Investigational Site
Tarnów, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wola, , Poland
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Wroclaw, , Poland
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Łęczna, , Poland
257, Novartis Investigational Site
Ponce, , Puerto Rico
415, Novartis Investigational vaccine
San Juan, , Puerto Rico
415, Novartis Investigational Site
San Juan, , Puerto Rico
80, Novartis Investigational Site
Sabadell, Barcelona, Spain
075, Novartis Investigational Site
Santiago de Compostela, Galicia, Spain
074, Novartis Investigational Site
Granada, , Spain
076, Novartis Investigational Site
Madrid, , Spain
077, Novartis Investigational Site
Madrid, , Spain
79, Novartis Investigational Site
Málaga, , Spain
078, Novartis Investigational Site
Valencia, , Spain
343, Novartis Investigational Site
Banqiao District, New Taipei City, Taiwan
346, Novartis Investigational Site
Datong, Taipei City, Taiwan
344, Novartis Investigational Site
Taichung, , Taiwan
345, Novartis Investigational Site
Taichung, , Taiwan
340, Novartis Investigational Site
Taipei, , Taiwan
341, Novartis Investigational Site
Taipei, , Taiwan
342, Novartis Investigational Site
Taoyuan District, , Taiwan
321, Novartis Investigational Site
Bangkoknoi, Bangkok, Thailand
322, Novartis Investigational Site
Bangkoknoi, Bangkok, Thailand
323, Novartis Investigational Site
Pathum Wan, Bangkok, Thailand
327, Novartis Investigational Site
Ratchathewi, Bangkok, Thailand
325, Novartis Investigational Site
Pathum Thani, Changwat Pathum Thani, Thailand
326, Novartis Investigational Site
Hat Yai, Songkhia, Thailand
320, Novartis Investigational Site
Bangkok, , Thailand
324, Novartis Investigational Site
Bangkok, , Thailand
Countries
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References
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Esposito S, Fling J, Chokephaibulkit K, de Bruijn M, Oberye J, Zhang B, Vossen J, Heijnen E, Smolenov I. Immunogenicity and Safety of an MF59-adjuvanted Quadrivalent Seasonal Influenza Vaccine in Young Children at High Risk of Influenza-associated Complications: A Phase III, Randomized, Observer-blind, Multicenter Clinical Trial. Pediatr Infect Dis J. 2020 Aug;39(8):e185-e191. doi: 10.1097/INF.0000000000002727.
Vesikari T, Kirstein J, Devota Go G, Leav B, Ruzycky ME, Isakov L, de Bruijn M, Oberye J, Heijnen E. Efficacy, immunogenicity, and safety evaluation of an MF59-adjuvanted quadrivalent influenza virus vaccine compared with non-adjuvanted influenza vaccine in children: a multicentre, randomised controlled, observer-blinded, phase 3 trial. Lancet Respir Med. 2018 May;6(5):345-356. doi: 10.1016/S2213-2600(18)30108-5. Epub 2018 Apr 6.
Other Identifiers
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2012-000218-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V118_05
Identifier Type: -
Identifier Source: org_study_id
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