Clinical trial NCT01857206: Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Fever
Keywords: Influenza
children and adolescents
trivalent vaccine
cell culture
embryonated chicken eggs
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-05-20
Enrollment: 2055
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents 4 to 17 years of age.


Eligibility criteria: Inclusion Criteria:

- Healthy subjects 4-17 years of age

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination.
timeFrame: Day 1 to Day 7 after any vaccination
measure: Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.
timeFrame: 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.
measure: Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination.
timeFrame: Day 1 to Day 183 for previously vaccinated subjects and Day 213 for not-previously vaccinated subjects
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: 320, Novartis Investigational Site
state: Alabama
city: Ponte Vedra
country: United States
facility: 312, Novartis Investigational Site
state: Florida
city: Augusta
country: United States
facility: 313, Novartis Investigational Site
state: Kansas
city: Newton
country: United States
facility: 305, Novartis Investigational Site
state: Kansas
city: Wichita
country: United States
facility: 302, Novartis Investigational Site
state: Kansas
city: Wichita
country: United States
facility: 301, Novartis Investigational Site
state: Kansas
city: Fremont
country: United States
facility: 311, Novartis Investigational Site
state: Nebraska
city: Winston-salem
country: United States
facility: 308, Novartis Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: 317, Novartis Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: 309, Novartis Investigational Site
state: Oklahoma
city: Warwick
country: United States
facility: 314, Novartis Investigational Site
state: Rhode Island
city: Mount Pleasant
country: United States
facility: 319, Novartis Investigational Site
state: South Carolina
city: Bristol
country: United States
facility: 310, Novartis Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: 318, Novartis Investigational Site
state: Tennessee
city: Salt Lake City
country: United States
facility: 304, Novartis Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: 306, Novartis Investigational Site
state: Utah
city: Salt Lake
country: United States
facility: 315, Novartis Investigational Site
state: Utah
city: South Jordan
country: United States
facility: 303, Novartis Investigational Site
state: Utah
city: Westmead
country: Australia
facility: 100, Novartis Investigational Site
state: New South Wales
city: Auchenflower
country: Australia
facility: 108, Novartis Investigational Site
state: Queensland
city: Sherwood
country: Australia
facility: 107, Novartis Investigational Site
state: Queensland
city: North Adelaide
country: Australia
facility: 104, Novartis Investigational Site
state: South Australia
city: Carlton
country: Australia
facility: 103, Novartis Investigational Site
state: Victoria
city: Subiaco
country: Australia
facility: 105, Novartis Investigational Site
state: Western Australia
city: Takapuna
country: New Zealand
facility: 151, Novartis Investigational Site
state: Auckland
city: Beckenham
country: New Zealand
facility: 150, Novartis Investigational Site
state: Christchurch
city: Muntinlupa City
country: Philippines
facility: 250, Novartis Investigational Site
state: Alabang
city: Muntinlupa City
country: Philippines
facility: 251, Novartis Investigational Site
state: Alabang
city: Muntinlupa City
country: Philippines
facility: 254, Novartis Investigational Site
state: Alabang
city: Manila
country: Philippines
facility: 253, Novartis Investigational Site
state: Ermita
city: Manila
country: Philippines
facility: 252, Novartis Investigation Site
state: Sampaloc
city: Khon Kaen
country: Thailand
facility: 201, Novartis Investigational Site
state: Muang
city: Bangkok
country: Thailand
facility: 200, Novartis Investigational Site
state: Rajathevi
city: Bangkoknoi
country: Thailand
facility: 202, Novartis Investigational Site
state: Siriraj
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines and Diagnostics
role: STUDY_CHAIR
References:
citation: 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.