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

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

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 Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: TIVc; Biological: TIV

• Study Type: Interventional
• Enrollment (Actual): 430
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Firenze, Italy, 50139
    • Novartis Investigational Site 022
  • Genova, Italy, 16132
    • Novartis Investigational Site 020
  • Milano, Italy, 20157
    • Novartis Investigational Site 021
  • Roma, Italy, 165
    • Novartis Investigational Site 023
• Spain
  • Madrid, Spain, 28050
    • Novartis Investigational Site 030
  • Malaga, Spain, 29011
    • Novartis Investigational Site 011
  • Valencia, Spain, 46017
    • Novartis Investigational Site 019
  • Valencia, Spain, 46020
    • Novartis Investigational Site 014
  • Valencia, Spain, 46024
    • Novartis Investigational Site 012
  • Barcelona
    • Badalona, Barcelona, Spain, 8916
      • Novartis Investigational Site 031
  • Castellon
    • Burriana, Castellon, Spain, 12530
      • Novartis Investigational Site 017
    • Castellon de la Plana, Castellon, Spain, 12004
      • Novartis Investigational Site 016
  • Malaga
    • Marbella, Malaga, Spain, 29603
      • Novartis Investigational Site 010
  • Valencia
    • L'Eliana, Valencia, Spain, 46183
      • Novartis Investigational Site 015
    • Paiporta, Valencia, Spain, 46200
      • Novartis Investigational Site 013
    • Quart de Poblet, Valencia, Spain, 46930
      • Novartis Investigational Site 018

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TIVc; flu vaccine	Biological: TIVc; 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
Active Comparator: TIV; flu vaccine	Biological: TIV; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Novartis Vaccines

Publications and helpful links

General Publications

• Diez-Domingo J, de Martino M, Lopez JG, Zuccotti GV, Icardi G, Villani A, Moreno-Perez D, Hernandez MM, Aldean JA, Mateen AA, Enweonye I, de Rooij R, Chandra R. Safety and tolerability of cell culture-derived and egg-derived trivalent influenza vaccines in 3 to <18-year-old children and adolescents at risk of influenza-related complications. Int J Infect Dis. 2016 Aug;49:171-8. doi: 10.1016/j.ijid.2016.06.018. Epub 2016 Jun 23.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: October 30, 2013
• First Submitted That Met QC Criteria: November 25, 2013
• First Posted (Estimate): November 29, 2013

Study Record Updates

• Last Update Posted (Actual): April 21, 2017
• Last Update Submitted That Met QC Criteria: April 19, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Adolescents; Children; Influenza; Vaccine; Flu
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: V58P15; 2013-002080-26 (EudraCT Number)