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

Phase 3CompletedNCT01998477

Novartis Vaccines430 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

430

Conditions

Influenza

Interventions

TIVcBIOLOGICAL

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

TIVBIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (16)

Novartis Investigational Site 022

Florence, Italy

Novartis Investigational Site 020

Genova, Italy

Novartis Investigational Site 021

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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)

Time frame: Day 1 -Day 181(one dose group) Day 1 -Day 209(two dose group)

Data from ClinicalTrials.gov

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