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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Influenza

Intervention / Treatment
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* Biological: TIVc
* Biological: TIV


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 3 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIVc<br>flu vaccine | Biological: TIVc<br>* Madin Darby Canine Kidney (MDCK) cell culture derived subunit influenza vaccine TIVc contained the purified viral envelope glycoproteins, hemagglutinin (HA) and neuraminidase (NA) derived from 3 strains (including HA for each strain [A/H1N1-like, A/H3N2-like, and B-like]) intramuscular (IM) injection recommended by the WHO for the 2013-2014 influenza season in the Northern Hemisphere<br>|
| Active Comparator: TIV<br>flu vaccine | Biological: TIV<br>* A conventional egg derived subunit influenza vaccine (TIV) contained the purified viral envelope-glycoproteins, HA and NA derived from 3 strains (including HA for each strain [A/ H1N1-like, A/H3N2-like, and B-like]) IM injection recommended by the WHO for the 2013-2014 influenza season in the Northern Hemisphere.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group | Safety was assessed in terms of number of the subjects (3 to < 18 years of age) who reported solicited local, systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV | Day 1 through Day 7 post injection 1 and Day 29 through Day 35 post injection 2 | 
| Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata | Safety was assessed in terms of number of the subjects (3 to <6 years,(≥ 6 to < 9 years and 9 to <18 Years of age) who reported solicited local, systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV | Day 1 through Day 7 after any vaccination | 
| Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata | Safety was assessed in terms of number of subjects who reported any unsolicited AEs (four weeks after 1st vaccination and up to three weeks after 2nd vaccination), serious adverse events (SAEs), new onset of chronic diseases (NOCD), medically attended AEs and AEs leading to vaccine/study withdrawal after receiving one or two doses of either TIVc or TIV by overall age group (3 to <18 years) and age sub-strata (3 to <9 years and 9 to <18 years) | Day 1 -Day 181(one dose group) Day 1 -Day 209(two dose group) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flu, Influenza, Vaccine, Children, Adolescents