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

Novartis

Status and phase

Completed

Phase 3

Conditions

Influenza

Treatments

Biological: TIV

Biological: TIVc

Study type

Interventional

Funder types

Industry

Identifiers

NCT01998477

2013-002080-26 (EudraCT Number)

V58P15

Details and patient eligibility

About

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.

Enrollment

430 patients

Sex

All

Ages

3 to 17 years old

Volunteers

Accepts Healthy Volunteers

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)