Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age

Influenza Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01857206
• Other study ID #: V58_31
• Secondary ID: U1111-1139-9440
• Status: Completed
• Phase: Phase 3
• First received: May 16, 2013
• Last updated: November 18, 2014
• Start date: May 2013
• Est. completion date: June 2014

Study information

• Verified date: November 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationThailand: Food and Drug AdministrationPhilippines : Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationNew Zealand: Medsafe
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2055
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fever
• Influenza
• Influenza, Human

Intervention

Biological:
• Mammalian cell based flu vaccine

• Egg based flu vaccine

Locations

Country	Name	City	State
Australia	108, Novartis Investigational Site	Auchenflower	Queensland
Australia	103, Novartis Investigational Site	Carlton	Victoria
Australia	104, Novartis Investigational Site	North Adelaide	South Australia
Australia	107, Novartis Investigational Site	Sherwood	Queensland
Australia	105, Novartis Investigational Site	Subiaco	Western Australia
Australia	100, Novartis Investigational Site	Westmead	New South Wales
New Zealand	150, Novartis Investigational Site	Beckenham	Christchurch
New Zealand	151, Novartis Investigational Site	Takapuna	Auckland
Philippines	252, Novartis Investigation Site	Manila	Sampaloc
Philippines	253, Novartis Investigational Site	Manila	Ermita
Philippines	250, Novartis Investigational Site	Muntinlupa City	Alabang
Philippines	251, Novartis Investigational Site	Muntinlupa City	Alabang
Philippines	254, Novartis Investigational Site	Muntinlupa City	Alabang
Thailand	200, Novartis Investigational Site	Bangkok	Rajathevi
Thailand	202, Novartis Investigational Site	Bangkoknoi	Siriraj
Thailand	201, Novartis Investigational Site	Khon Kaen	Muang
United States	313, Novartis Investigational Site	Augusta	Kansas
United States	310, Novartis Investigational Site	Bristol	Tennessee
United States	317, Novartis Investigational Site	Cleveland	Ohio
United States	311, Novartis Investigational Site	Fremont	Nebraska
United States	320, Novartis Investigational Site	Mobile	Alabama
United States	319, Novartis Investigational Site	Mount Pleasant	South Carolina
United States	318, Novartis Investigational Site	Nashville	Tennessee
United States	305, Novartis Investigational Site	Newton	Kansas
United States	312, Novartis Investigational Site	Ponte Vedra	Florida
United States	315, Novartis Investigational Site	Salt Lake	Utah
United States	304, Novartis Investigational Site	Salt Lake City	Utah
United States	306, Novartis Investigational Site	Salt Lake City	Utah
United States	303, Novartis Investigational Site	South Jordan	Utah
United States	309, Novartis Investigational Site	Tulsa	Oklahoma
United States	314, Novartis Investigational Site	Warwick	Rhode Island
United States	301, Novartis Investigational Site	Wichita	Kansas
United States	302, Novartis Investigational Site	Wichita	Kansas
United States	308, Novartis Investigational Site	Winston-salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Countries where clinical trial is conducted

United States,  Australia,  New Zealand,  Philippines,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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.	No
Primary	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	No