Clinical trial NCT01998477: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza
Vaccine
Flu
Children
Adolescents
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-11-29
Enrollment: 430
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group
timeFrame: Day 1 through Day 7 post injection 1 and Day 29 through Day 35 post injection 2
measure: Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata
timeFrame: Day 1 through Day 7 after any vaccination
measure: Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata
timeFrame: Day 1 -Day 181(one dose group) Day 1 -Day 209(two dose group)
Secondary outcomes:
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Novartis Investigational Site 022
city: Genova
country: Italy
facility: Novartis Investigational Site 020
city: Milano
country: Italy
facility: Novartis Investigational Site 021
city: Roma
country: Italy
facility: Novartis Investigational Site 023
city: Badalona
country: Spain
facility: Novartis Investigational Site 031
state: Barcelona
city: Burriana
country: Spain
facility: Novartis Investigational Site 017
state: Castellon
city: Castellon de la Plana
country: Spain
facility: Novartis Investigational Site 016
state: Castellon
city: Marbella
country: Spain
facility: Novartis Investigational Site 010
state: Malaga
city: L'Eliana
country: Spain
facility: Novartis Investigational Site 015
state: Valencia
city: Paiporta
country: Spain
facility: Novartis Investigational Site 013
state: Valencia
city: Quart de Poblet
country: Spain
facility: Novartis Investigational Site 018
state: Valencia
city: Madrid
country: Spain
facility: Novartis Investigational Site 030
city: Malaga
country: Spain
facility: Novartis Investigational Site 011
city: Valencia
country: Spain
facility: Novartis Investigational Site 019
city: Valencia
country: Spain
facility: Novartis Investigational Site 014
city: Valencia
country: Spain
facility: Novartis Investigational Site 012
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: 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.