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 3

Completed

• Conditions: Influenza
• Interventions: Biological: TIVc; Biological: TIV

• Registration Number: NCT01998477
• Lead Sponsor: Novartis Vaccines

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-11-25
• Study First Posted: 2013-11-29
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Results First Submitted: 2015-01-16
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-19
• Last Update Submitted: 2017-04-19
• Results First Posted: 2017-04-21
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 430

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TIVc	TIVc	flu vaccine
TIV	TIV	flu vaccine

Primary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Day 1 through Day 7 post injection 1 and Day 29 through Day 35 post injection 2	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
Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Day 1 -Day 181(one dose group) Day 1 -Day 209(two dose group)	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)
Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Day 1 through Day 7 after any vaccination	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

Trial Locations

Locations (16)

Novartis Investigational Site 020; 🇮🇹 Genova, Italy

Novartis Investigational Site 017; 🇪🇸 Burriana, Castellon, Spain

Novartis Investigational Site 022; 🇮🇹 Firenze, Italy

Novartis Investigational Site 019; 🇪🇸 Valencia, Spain

Novartis Investigational Site 014; 🇪🇸 Valencia, Spain

Novartis Investigational Site 030; 🇪🇸 Madrid, Spain

Novartis Investigational Site 023; 🇮🇹 Roma, Italy

Novartis Investigational Site 010; 🇪🇸 Marbella, Malaga, Spain

Novartis Investigational Site 031; 🇪🇸 Badalona, Barcelona, Spain

Novartis Investigational Site 012; 🇪🇸 Valencia, Spain

Novartis Investigational Site 021; 🇮🇹 Milano, Italy

Novartis Investigational Site 016; 🇪🇸 Castellon de la Plana, Castellon, Spain

Novartis Investigational Site 011; 🇪🇸 Malaga, Spain

Novartis Investigational Site 015; 🇪🇸 L'Eliana, Valencia, Spain

Novartis Investigational Site 013; 🇪🇸 Paiporta, Valencia, Spain

Novartis Investigational Site 018; 🇪🇸 Quart de Poblet, Valencia, Spain