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

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

Official Title
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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.

Conditions
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Influenza, Fever

Intervention / Treatment
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* Biological: Mammalian cell based flu vaccine
* Biological: Egg based flu vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIVc<br>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. | Biological: Mammalian cell based flu vaccine<br> <br> |
| Active Comparator: TIVf<br>Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status. | Biological: Egg based flu vaccine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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. | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, children and adolescents, trivalent vaccine, cell culture, embryonated chicken eggs