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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01857206




Registration number
NCT01857206
Ethics application status
Date submitted
16/05/2013
Date registered
20/05/2013
Date last updated
5/12/2014

Titles & IDs
Public title
Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age
Scientific 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.
Secondary ID [1] 0 0
U1111-1139-9440
Secondary ID [2] 0 0
V58_31
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Fever 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Mammalian cell based flu vaccine
Other interventions - Egg based flu vaccine

Experimental: TIVc - Subjects =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.

Active Comparator: TIVf - Subjects =4 to =17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.


Other interventions: Mammalian cell based flu vaccine


Other interventions: Egg based flu vaccine
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination.
Timepoint [1] 0 0
Day 1 to Day 7 after any vaccination
Primary outcome [2] 0 0
Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.
Timepoint [2] 0 0
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.
Primary outcome [3] 0 0
Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination.
Timepoint [3] 0 0
Day 1 to Day 183 for previously vaccinated subjects and Day 213 for not-previously vaccinated subjects

Eligibility
Key inclusion criteria
- Healthy subjects 4-17 years of age
Minimum age
4 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2014
Sample size
Target
Accrual to date
Final
2055
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
100, Novartis Investigational Site - Westmead
Recruitment hospital [2] 0 0
108, Novartis Investigational Site - Auchenflower
Recruitment hospital [3] 0 0
107, Novartis Investigational Site - Sherwood
Recruitment hospital [4] 0 0
104, Novartis Investigational Site - North Adelaide
Recruitment hospital [5] 0 0
103, Novartis Investigational Site - Carlton
Recruitment hospital [6] 0 0
105, Novartis Investigational Site - Subiaco
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
4075 - Sherwood
Recruitment postcode(s) [4] 0 0
5006 - North Adelaide
Recruitment postcode(s) [5] 0 0
3010 - Carlton
Recruitment postcode(s) [6] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
Nebraska
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Oklahoma
Country [8] 0 0
United States of America
State/province [8] 0 0
Rhode Island
Country [9] 0 0
United States of America
State/province [9] 0 0
South Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Utah
Country [12] 0 0
New Zealand
State/province [12] 0 0
Auckland
Country [13] 0 0
New Zealand
State/province [13] 0 0
Christchurch
Country [14] 0 0
Philippines
State/province [14] 0 0
Alabang
Country [15] 0 0
Philippines
State/province [15] 0 0
Ermita
Country [16] 0 0
Philippines
State/province [16] 0 0
Sampaloc
Country [17] 0 0
Thailand
State/province [17] 0 0
Muang
Country [18] 0 0
Thailand
State/province [18] 0 0
Rajathevi
Country [19] 0 0
Thailand
State/province [19] 0 0
Siriraj

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Vaccines
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents
4 to 17 years of age.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01857206
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Vaccines and Diagnostics
Address 0 0
Novartis Vaccines
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01857206