Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.
A Phase III, Stratified, Randomized, Observer Blind, Controlled, Multicenter Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to < 72 Months of Age.
2 other identifiers
interventional
10,644
11 countries
167
Brief Summary
Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to \<72 Months of Age. The study was conducted during the 2013/2014 and 2014/2015 northern hemisphere influenza season.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2013
Typical duration for phase_3
167 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2013
CompletedFirst Posted
Study publicly available on registry
October 17, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
March 27, 2023
CompletedMarch 27, 2023
March 1, 2023
1.9 years
October 15, 2013
August 19, 2020
March 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy Endpoint: First-Occurrence Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age
Relative efficacy of aQIV compared to non-adjuvanted comparator (TIV/QIV) was determined by the number of subjects ≥6 to \<72 months of age with RT-PCR confirmed occurrence of influenza A and/or B of any influenza strain that occurred at ≥21 days and ≤180 days after the last vaccination or until the end of the influenza season, whichever was longer. Efficacy was determined on influenza cases caused by any of the influenza strains related to the two A subtypes and the B lineage(s) common to aQIV and TIV (i.e. A/H1N1, A/H3N2 and B/Yamagata during first influenza season), and common to aQIV and QIV (i.e. A/H1N1, A/H3N2 and both B lineages during second season and through the end of the trial).
≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer
Secondary Outcomes (22)
Efficacy Endpoint: First-Occurrence RT-PCR Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age.
≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer
Efficacy Endpoint: First-Occurrence Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months, ≥6 to <24 Months, ≥6 to <36 Months and ≥36 to <72 Months of Age
≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer
Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Subjects at High Risk of Influenza Complications
≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer
Efficacy Endpoint: First-occurrence RT-PCR and Culture Confirmed Influenza A and/or B of Any Influenza Strain in Naive and Non-naive Subjects Separately
≥21 days and ≤180 days after the last vaccination or until the end of the influenza season (Northern Hemisphere: end of June; Southern Hemisphere: end of December; Philippines/Thailand: end of October), whichever was longer
Efficacy Endpoint: First-occurrence RT-PCR-confirmed Influenza A and/or B of Any Influenza Strain in Subjects ≥6 to <72 Months of Age at ≥7 Days and at ≥14 Days After First Vaccination up to the Day of Second Vaccination in Vaccine naïve Subjects Only
≥7 days and at ≥14 days after first vaccination up to day of second vaccination
- +17 more secondary outcomes
Study Arms (2)
aQIV
EXPERIMENTALflu vaccine
non-adjuvanted comparator
ACTIVE COMPARATORflu vaccine
Interventions
1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months
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
You may qualify if:
- Children, males and females, healthy or at high risk of complications from influenza, between ≥6 months to \<72 months of age
- 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.
You may not qualify if:
- Children with history of allergy to vaccine components.
- Additional eligibility criteria may be discussed by contacting the site
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seqiruslead
- Novartis Vaccinescollaborator
Study Sites (167)
222, Novartis Investigational Site
Chandler, Arizona, 85224, United States
267, Novartis Investigational Site
Harrisburg, Arkansas, 72432, United States
259, Novartis Investigational Site
Anaheim, California, 92801, United States
280, Novartis Investigational Site
Anaheim, California, 92804, United States
213, Novartis Investigational Site
Baldwin Park, California, 91706, United States
407, Novartis Investigational Site
Downey, California, 90241, United States
238, Novartis Investigational Site
La Puente, California, 91774, United States
411, Novartis Investigational Site
Ontario, California, 91762, United States
202, Novartis Investigational Site
Paramount, California, 90723, United States
250, Novartis Investigational Site
San Diego, California, 92103, United States
293, Novartis Investigational Site
San Francisco, California, 94102, United States
243, Novartis Investigational Site
Colorado Springs, Colorado, 80902, United States
249, Novartis Investigational Site
Denver, Colorado, 80902, United States
229, Novartis Investigational Site
Boca Raton, Florida, 33432, United States
416, Novartis Investigational Site
Hialeah, Florida, 33013, United States
287, Novartis Investigational Site
Hialeah, Florida, 33106, United States
412, Novartis Investigational Site
Homestead, Florida, 34239, United States
224, Novartis Investigational Site
Melbourne, Florida, 32935, United States
417, Novartis Investigational Site
Miami, Florida, 33015, United States
404, Novartis Investigational Site
Miami, Florida, 33144, United States
285, Novartis Investigational Site
Miami, Florida, 33172, United States
277,Novartis Investigational Site
Miami, Florida, 33412, United States
234, Novartis Investigational Site
Opa-locka, Florida, 33054, United States
297, Novartis Investigational Site
Orlando, Florida, 32801, United States
297, Novartis Investigational vaccine
Orlando, Florida, 32806, United States
410, Novartis Investigational Site
Sarasota, Florida, 34239, United States
401, Novartis iNvestiagtional Site
Atlanta, Georgia, 30322, United States
299, Novartis Investigational Site
DeKalb, Illinois, 60115, United States
268, Novartis Investigational Site
Peoria, Illinois, 61602, United States
209, Novartis Investigational Site
Augusta, Kansas, 67010, United States
210, Novartis Investigational Site
Newton, Kansas, 67114, United States
274 Novartis Investigational Site
Park City, Kansas, 67219, United States
211, Novartis Investigational Site
Wichita, Kansas, 67205, United States
269, Novartis Investigational Site
Bardstown, Kentucky, 40004, United States
226, Novartis Investigational Site
Louisville, Kentucky, 40202, United States
248, Novartis Investigational Site
Louisville, Kentucky, 40217, United States
207, Novartis Investigational Site
Louisville, Kentucky, 40291, United States
290, Novartis Investigational Site
Louisville, Kentucky, 40291, United States
265, Novartis Investigational Site
Haughton, Louisiana, 71037, United States
408, Novartis Investigational Site
Mangham, Louisiana, 71259, United States
225, Novartis Investigational Site
Metairie, Louisiana, 70006, United States
233, Novartis Investigational Site
Metairie, Louisiana, 70006, United States
418, Novartis Investigational SIte
Monroe, Louisiana, 71201, United States
262, Novartis Investigational site
Annapolis, Maryland, 21401, United States
263, Novartis Investigational Site
Frederick, Maryland, 21702, United States
405, Novartis Investigational Site
Silver Spring, Maryland, 20910, United States
278, Novartis Investigational Site
Saint Paul, Minnesota, 55108, United States
221, Novartis Investigational Site
Bellevue, Nebraska, 68005, United States
219, Novartis Investigational Site
Fremont, Nebraska, 68025, United States
402, Novartis Investigational Site
Omaha, Nebraska, 68114, United States
288, Novartis Investigational Site
Omaha, Nebraska, 68131, United States
228, Novartis Investigational Site
Omaha, Nebraska, 68134, United States
244, Novartis Investigational Site
Henderson, Nevada, 89014, United States
286, Novartis Investigational site
Las Vegas, Nevada, 89106, United States
255, Novartis Investigational Site
Binghamton, New York, 13901, United States
414, Novartis Investigational Site
Brooklyn, New York, 11201, United States
264, Novartis Investigational Site
Syracuse, New York, 13057, United States
409, Novartis Investigational Site
Boone, North Carolina, 28607, United States
266, Novartis Investigational Site
Cary, North Carolina, 27518, United States
403, Novartis Investigational Site
Clyde, North Carolina, 28721, United States
240, Novartis Investigational Site
Akron, Ohio, 44311, United States
254, Novartis Investigational Site
Cleveland, Ohio, 44122, United States
245, Novartis Investigational Site
Dayton, Ohio, 45406, United States
281, Novartis Investigational Site
Dayton, Ohio, 45409, United States
281, Novartis Investigational vaccines
Dayton, Ohio, 45409, United States
256, Novartis Investigational Site
Tulsa, Oklahoma, 74127, United States
292, Novartis Investigational Site
Erie, Pennsylvania, 16505, United States
270, Novartis Investigational Site
Scottdale, Pennsylvania, 15683, United States
220, Novartis Investigational Site
Anderson, South Carolina, 29621, United States
406, novartis Investigational Site
Barnwell, South Carolina, 29812, United States
272, Novartis Investigational Site
Charleston, South Carolina, 29407, United States
232, Novartis Investigational Site
Moncks Corner, South Carolina, 29461, United States
291, Novartis Investigational vaccine
Spartanburg, South Carolina, 27262, United States
283, Novartis Investigational Site
Nashville, Tennessee, 37203, United States
208, Novartis Investigational Site
Austin, Texas, 78705, United States
247, Novartis Investigational Site
Fort Worth, Texas, 76107, United States
217, Novartis Investigational Site
Fort Worth, Texas, 76135, United States
214, Novartis Investigational Site
San Angelo, Texas, 76904, United States
400, Novartis investigational Site
San Antonio, Texas, 78229, United States
260, Novartis Investigational Site
Tomball, Texas, 77375, United States
295, Novartis Investigational Site
Layton, Utah, 84041, United States
236, Novartis Investigational Site
Salt Lake City, Utah, 84109, United States
212, Novartis Investigational Site
Salt Lake City, Utah, 84121, United States
246, Novartis Investigational Site
Salt Lake City, Utah, 84124, United States
279, Novartis Investigational Site
Spanish Fork, Utah, 84660, United States
282, Novartis Investigational Site
Syracuse, Utah, 84075, United States
294, Novartis Investigational Site
West Haven, Utah, 84401, United States
201, Novartis Investigational Site
West Jordan, Utah, 84088, United States
271, Novartis Investigational Site
West Jordan, Utah, 84088, United States
251, Novartis Investigational Site
Burke, Virginia, 22015, United States
296, Novartis Investigational Site
Vienna, Virginia, 22180, United States
184, Novartis Investigational Site
Greater Sudbury, Ontario, P3E 1H5, Canada
180, Novartis Investigational Site
Newmarket, Ontario, L3Y 5G8, Canada
182,Novartis Investigational Site
Toronto, Ontario, M9V 4B4, Canada
183, Novartis Investigational Site
Québec, G1E 7G9, Canada
186, Novartis Investigational Site
Québec, Canada
001, Novartis Investigational Site
Espoo, FI-02230, Finland
003, Novartis Investigational Site
Helsinki, FIN-00100, Finland
002, Novartis Investigational Site
Helsinki, FIN-00930, Finland
004, Novartis Investigational Site
Jarvenpaa, FIN-04400, Finland
005, Novartis Investigational Site
Kokkola, FI-67100, Finland
006, Novartis Investigational Site
Oulu, 90220, Finland
007, Novartis Investigational Site
Pori, FI-28100, Finland
008, Novartis Investigational Site
Seinäjoki, FI-60100, Finland
009, Novartis Investigational Site
Tampere, FIN-33100, Finland
010, Novartis Investigational Site
Turku, FIN-20520, Finland
011, Novartis Investigational Site
Vantaa, FIN-01300, Finland
030, Novartis Investigational Site
Florence, 50139, Italy
023, Novartis Investigational Site
Genova, 16132, Italy
020, Novartis Investigational Site
Milan, 20122, Italy
026, Novartis Investigational Site
Milan, 20157, Italy
025, Novartis Investigational Site
Napoli, 80131, Italy
021, Novartis Investigational Site
Novara, 28100, Italy
022, Novartis Investigational Site
Padua, 35128, Italy
024, Novartis Investigational Site
Pisa, 56126, Italy
028, Novartis Investigational Site
Sassari, 07100, Italy
173, Novartis Investigational Site
Morelia, Michoacán, 58070, Mexico
176, Novartis Investigational Site
Durango, 34000, Mexico
170, Novartis Investigational Site
México, 04530, Mexico
177, Novartis Investigational Site
México, 06760, Mexico
178, Novartis Investigational Site
México, 14000, Mexico
175, Novartis Investigational Site
México, 7020, Mexico
300, Novartis Investigational Site
Dasmariñas, Cavite, 4114, Philippines
306, Novartis Investigational Site
Alabang, Muntilupa, 1781, Philippines
303, Novartis Investigational Site
City of Muntinlupa, 1781, Philippines
304, Novartis Investigational Site
City of Muntinlupa, 1781, Philippines
305, Novartis Investigational Site
City of Muntinlupa, 1781, Philippines
302, Novartis Investigational Site
Manila, 1000, Philippines
301, Novartis Investigational Site
Manila, 1001, Philippines
040, Novartis Investigational Site
Dębica, 39-200, Poland
042, Novartis Investigational Site
Katowice, 40-018, Poland
048, Novartis Investigational Site
Lodz, 91347, Poland
049, Novartis Investigational Site
Lubartów, 21-100, Poland
051, Novartis Investigational Site
Oborniki Śląskie, 55-120, Poland
046, Novartis Investigational Site
Osielsko, 86-031, Poland
043, Novartis Investigational Site
Siemianowice Śląskie, 41-103, Poland
047, Novartis Investigational Site
Tarnów, 33-100, Poland
041, Novartis Investigational Site
Warsaw, 01809, Poland
050, Novartis Investigational Site
Warsaw, 04-730, Poland
045, Novartis Investigational Site
Wola, 43-225, Poland
044, Novartis Investigational Site
Wroclaw, 51215, Poland
052, Novartis Investigational Site
Łęczna, 21-010, Poland
257, Novartis Investigational Site
Ponce, 00716, Puerto Rico
415, Novartis Investigational vaccine
San Juan, 00909, Puerto Rico
415, Novartis Investigational Site
San Juan, 00921, Puerto Rico
80, Novartis Investigational Site
Sabadell, Barcelona, 08208, Spain
075, Novartis Investigational Site
Santiago de Compostela, Galicia, 15701, Spain
074, Novartis Investigational Site
Granada, 18009, Spain
076, Novartis Investigational Site
Madrid, 28041, Spain
077, Novartis Investigational Site
Madrid, 28046, Spain
79, Novartis Investigational Site
Málaga, 29011, Spain
078, Novartis Investigational Site
Valencia, 46026, Spain
343, Novartis Investigational Site
Banqiao District, New Taipei City, 220, Taiwan
346, Novartis Investigational Site
Datong, Taipei City, 10341, Taiwan
344, Novartis Investigational Site
Taichung, 40447, Taiwan
345, Novartis Investigational Site
Taichung, 40705, Taiwan
340, Novartis Investigational Site
Taipei, 10041, Taiwan
341, Novartis Investigational Site
Taipei, 10449, Taiwan
342, Novartis Investigational Site
Taoyuan District, 333, Taiwan
321, Novartis Investigational Site
Bangkoknoi, Bangkok, 10700, Thailand
322, Novartis Investigational Site
Bangkoknoi, Bangkok, 10700, Thailand
323, Novartis Investigational Site
Pathum Wan, Bangkok, 10330, Thailand
327, Novartis Investigational Site
Ratchathewi, Bangkok, 10400, Thailand
325, Novartis Investigational Site
Pathum Thani, Changwat Pathum Thani, 12120, Thailand
326, Novartis Investigational Site
Hat Yai, Songkhia, 90110, Thailand
320, Novartis Investigational Site
Bangkok, 10400, Thailand
324, Novartis Investigational Site
Bangkok, 10400, Thailand
Related Publications (2)
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.
PMID: 32404782DERIVEDVesikari 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.
PMID: 29631857DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Study Disclosure Manager
- Organization
- Seqirus
Study Officials
- STUDY DIRECTOR
Clinical Program Director
Seqirus
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2013
First Posted
October 17, 2013
Study Start
November 1, 2013
Primary Completion
October 1, 2015
Study Completion
August 1, 2016
Last Updated
March 27, 2023
Results First Posted
March 27, 2023
Record last verified: 2023-03