Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age
A Phase III, Observer Blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Chicken Eggs (Fluvirin®), in Healthy Children and Adolescents 4 to 17 Years of Age.
2 other identifiers
interventional
2,055
5 countries
34
Brief Summary
Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents 4 to 17 years of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2013
Shorter than P25 for phase_3
34 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
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 16, 2013
CompletedFirst Posted
Study publicly available on registry
May 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
November 3, 2014
CompletedDecember 5, 2014
November 1, 2014
1.1 years
May 16, 2013
September 18, 2014
November 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination.
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events and other indicators of reactogenicity following two doses of either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.
Day 1 to Day 7 after any vaccination
Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.
Safety was assessed as the number of subjects who reported unsolicited adverse events following vaccination with either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.
Day 1 to Day49 for subjects aged ≥4 To ≤8 years not previously vaccinated. Day 1 to Day 38 for subjects aged ≥4 To ≤8 years previously vaccinated and all subjects aged ≥9 To ≤17 years.
Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination.
Safety was assessed as the number of subjects who reported serious adverse events (SAEs), medically attended AEs and new onset of chronic diseases (NOCD) in subjects aged ≥4 To ≤17 Years.
Day 1 to Day 183 for previously vaccinated subjects and Day 213 for not-previously vaccinated subjects
Study Arms (2)
TIVc
EXPERIMENTALSubjects ≥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.
TIVf
ACTIVE COMPARATORSubjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
320, Novartis Investigational Site
Mobile, Alabama, 36608, United States
312, Novartis Investigational Site
Ponte Vedra, Florida, 32081, United States
313, Novartis Investigational Site
Augusta, Kansas, 67010, United States
305, Novartis Investigational Site
Newton, Kansas, 67114, United States
302, Novartis Investigational Site
Wichita, Kansas, 67205, United States
301, Novartis Investigational Site
Wichita, Kansas, 67207, United States
311, Novartis Investigational Site
Fremont, Nebraska, 68025, United States
308, Novartis Investigational Site
Winston-Salem, North Carolina, 27103, United States
317, Novartis Investigational Site
Cleveland, Ohio, 44121, United States
309, Novartis Investigational Site
Tulsa, Oklahoma, 74127, United States
314, Novartis Investigational Site
Warwick, Rhode Island, 02886, United States
319, Novartis Investigational Site
Mt. Pleasant, South Carolina, 29464, United States
310, Novartis Investigational Site
Bristol, Tennessee, 37620, United States
318, Novartis Investigational Site
Nashville, Tennessee, 37203, United States
304, Novartis Investigational Site
Salt Lake City, Utah, 84109, United States
306, Novartis Investigational Site
Salt Lake City, Utah, 84121, United States
315, Novartis Investigational Site
Salt Lake City, Utah, 84124, United States
303, Novartis Investigational Site
South Jordan, Utah, 84095, United States
100, Novartis Investigational Site
Westmead, New South Wales, 2145, Australia
108, Novartis Investigational Site
Auchenflower, Queensland, 4066, Australia
107, Novartis Investigational Site
Sherwood, Queensland, 4075, Australia
104, Novartis Investigational Site
North Adelaide, South Australia, 5006, Australia
103, Novartis Investigational Site
Carlton, Victoria, 3010, Australia
105, Novartis Investigational Site
Subiaco, Western Australia, 6008, Australia
151, Novartis Investigational Site
Takapuna, Auckland, 0622, New Zealand
150, Novartis Investigational Site
Beckenham, Christchurch, 8024, New Zealand
250, Novartis Investigational Site
City of Muntinlupa, Alabang, 1781, Philippines
251, Novartis Investigational Site
City of Muntinlupa, Alabang, 1781, Philippines
254, Novartis Investigational Site
City of Muntinlupa, Alabang, 1781, Philippines
253, Novartis Investigational Site
Manila, Ermita, 1001, Philippines
252, Novartis Investigation Site
Manila, Sampaloc, 1001, Philippines
201, Novartis Investigational Site
Khon Kaen, Muang, 40002, Thailand
200, Novartis Investigational Site
Bangkok, Rajathevi, 10400, Thailand
202, Novartis Investigational Site
Bangkoknoi, Siriraj, 10700, Thailand
Related Publications (1)
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.
PMID: 26643931DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Posting Director
- Organization
- Novartis Vaccines and Diagnostics
Study Officials
- STUDY CHAIR
Novartis Vaccines and Diagnostics
Novartis Vaccines
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2013
First Posted
May 20, 2013
Study Start
May 1, 2013
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
December 5, 2014
Results First Posted
November 3, 2014
Record last verified: 2014-11