A Study to Evaluate the Safety of Two Influenza Vaccines in Children and Adolescents 3 to <18 Years of Age at Risk for Influenza-Related Complications
A Phase III, Observer-Blind, Randomized Multicenter Study to Evaluate the Safety of Trivalent Subunit Influenza Vaccines, Produced Either in Mammalian Cell Culture (TIVc) or in Embryonated Eggs (TIV), in Children and Adolescents 3 to <18 Years of Age at Risk for Influenza-Related Complications
2 other identifiers
interventional
430
2 countries
16
Brief Summary
The study is designed to evaluate the safety of TIVc or TIV vaccine in children 3 to \< 18 years of age who are at risk of complications of influenza disease due to underlying diseases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2013
Shorter than P25 for phase_3
16 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
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 30, 2013
CompletedFirst Posted
Study publicly available on registry
November 29, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedResults Posted
Study results publicly available
April 21, 2017
CompletedApril 21, 2017
April 1, 2017
9 months
October 30, 2013
January 16, 2015
April 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group
Safety was assessed in terms of number of the subjects (3 to \< 18 years of age) who reported solicited local, systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV
Day 1 through Day 7 post injection 1 and Day 29 through Day 35 post injection 2
Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata
Safety was assessed in terms of number of the subjects (3 to \<6 years,(≥ 6 to \< 9 years and 9 to \<18 Years of age) who reported solicited local, systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV
Day 1 through Day 7 after any vaccination
Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata
Safety was assessed in terms of number of subjects who reported any unsolicited AEs (four weeks after 1st vaccination and up to three weeks after 2nd vaccination), serious adverse events (SAEs), new onset of chronic diseases (NOCD), medically attended AEs and AEs leading to vaccine/study withdrawal after receiving one or two doses of either TIVc or TIV by overall age group (3 to \<18 years) and age sub-strata (3 to \<9 years and 9 to \<18 years)
Day 1 -Day 181(one dose group) Day 1 -Day 209(two dose group)
Study Arms (2)
TIVc
EXPERIMENTALflu vaccine
TIV
ACTIVE COMPARATORflu vaccine
Interventions
Madin Darby Canine Kidney (MDCK) cell culture derived subunit influenza vaccine TIVc contained the purified viral envelope glycoproteins, hemagglutinin (HA) and neuraminidase (NA) derived from 3 strains (including HA for each strain \[A/H1N1-like, A/H3N2-like, and B-like\]) intramuscular (IM) injection recommended by the WHO for the 2013-2014 influenza season in the Northern Hemisphere
A conventional egg derived subunit influenza vaccine (TIV) contained the purified viral envelope-glycoproteins, HA and NA derived from 3 strains (including HA for each strain \[A/ H1N1-like, A/H3N2-like, and B-like\]) IM injection recommended by the WHO for the 2013-2014 influenza season in the Northern Hemisphere.
Eligibility Criteria
You may qualify if:
- Individuals 3 to \<18 years of age with underlying medical conditions that indicate an increased risk of complications from influenza infection.
- Further eligibility criteria may be discussed by contacting the site(s)
You may not qualify if:
- Individuals with any fatal prognosis of an underlying medical condition (\<12 month life expectancy).
- Individuals hospitalized at the time of enrolment.
- Individuals with a history of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any of the vaccine components.
- Further eligibility criteria may be discussed by contacting the site(s)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Novartis Investigational Site 022
Florence, 50139, Italy
Novartis Investigational Site 020
Genova, 16132, Italy
Novartis Investigational Site 021
Milan, 20157, Italy
Novartis Investigational Site 023
Roma, 165, Italy
Novartis Investigational Site 031
Badalona, Barcelona, 8916, Spain
Novartis Investigational Site 017
Burriana, Castellon, 12530, Spain
Novartis Investigational Site 016
Castellon, Castellon, 12004, Spain
Novartis Investigational Site 010
Marbella, Malaga, 29603, Spain
Novartis Investigational Site 015
L'Eliana, Valencia, 46183, Spain
Novartis Investigational Site 013
Paiporta, Valencia, 46200, Spain
Novartis Investigational Site 018
Quart de Poblet, Valencia, 46930, Spain
Novartis Investigational Site 030
Madrid, 28050, Spain
Novartis Investigational Site 011
Málaga, 29011, Spain
Novartis Investigational Site 019
Valencia, 46017, Spain
Novartis Investigational Site 014
Valencia, 46020, Spain
Novartis Investigational Site 012
Valencia, 46024, Spain
Related Publications (1)
Diez-Domingo J, de Martino M, Lopez JG, Zuccotti GV, Icardi G, Villani A, Moreno-Perez D, Hernandez MM, Aldean JA, Mateen AA, Enweonye I, de Rooij R, Chandra R. Safety and tolerability of cell culture-derived and egg-derived trivalent influenza vaccines in 3 to <18-year-old children and adolescents at risk of influenza-related complications. Int J Infect Dis. 2016 Aug;49:171-8. doi: 10.1016/j.ijid.2016.06.018. Epub 2016 Jun 23.
PMID: 27343983DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Posting Director
- Organization
- Novartis Vaccines and Diagnostics
Study Officials
- STUDY CHAIR
Novartis Vaccines
Novartis Vaccines
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- 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 30, 2013
First Posted
November 29, 2013
Study Start
October 1, 2013
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
April 21, 2017
Results First Posted
April 21, 2017
Record last verified: 2017-04