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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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TIVc
TIV
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Vaccine, Flu, Children, Adolescents

Eligibility Criteria

3 Years - 17 Years (Child)All SexesAccepts 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)

Sites / Locations

  • Novartis Investigational Site 022
  • Novartis Investigational Site 020
  • Novartis Investigational Site 021
  • Novartis Investigational Site 023
  • Novartis Investigational Site 031
  • Novartis Investigational Site 017
  • Novartis Investigational Site 016
  • Novartis Investigational Site 010
  • Novartis Investigational Site 015
  • Novartis Investigational Site 013
  • Novartis Investigational Site 018
  • Novartis Investigational Site 030
  • Novartis Investigational Site 011
  • Novartis Investigational Site 019
  • Novartis Investigational Site 014
  • Novartis Investigational Site 012

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TIVc

TIV

Arm Description

flu vaccine

flu vaccine

Outcomes

Primary Outcome Measures

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
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
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)

Secondary Outcome Measures

Full Information

First Posted
October 30, 2013
Last Updated
April 19, 2017
Sponsor
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT01998477
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Vaccine, Flu, Children, Adolescents

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
430 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TIVc
Arm Type
Experimental
Arm Description
flu vaccine
Arm Title
TIV
Arm Type
Active Comparator
Arm Description
flu vaccine
Intervention Type
Biological
Intervention Name(s)
TIVc
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
TIV
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group
Description
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
Title
Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata
Description
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
Title
Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis Vaccines
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Investigational Site 022
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Novartis Investigational Site 020
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Novartis Investigational Site 021
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Novartis Investigational Site 023
City
Roma
ZIP/Postal Code
165
Country
Italy
Facility Name
Novartis Investigational Site 031
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
8916
Country
Spain
Facility Name
Novartis Investigational Site 017
City
Burriana
State/Province
Castellon
ZIP/Postal Code
12530
Country
Spain
Facility Name
Novartis Investigational Site 016
City
Castellon de la Plana
State/Province
Castellon
ZIP/Postal Code
12004
Country
Spain
Facility Name
Novartis Investigational Site 010
City
Marbella
State/Province
Malaga
ZIP/Postal Code
29603
Country
Spain
Facility Name
Novartis Investigational Site 015
City
L'Eliana
State/Province
Valencia
ZIP/Postal Code
46183
Country
Spain
Facility Name
Novartis Investigational Site 013
City
Paiporta
State/Province
Valencia
ZIP/Postal Code
46200
Country
Spain
Facility Name
Novartis Investigational Site 018
City
Quart de Poblet
State/Province
Valencia
ZIP/Postal Code
46930
Country
Spain
Facility Name
Novartis Investigational Site 030
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Novartis Investigational Site 011
City
Malaga
ZIP/Postal Code
29011
Country
Spain
Facility Name
Novartis Investigational Site 019
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Novartis Investigational Site 014
City
Valencia
ZIP/Postal Code
46020
Country
Spain
Facility Name
Novartis Investigational Site 012
City
Valencia
ZIP/Postal Code
46024
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
27343983
Citation
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.
Results Reference
derived

Learn more about this trial

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

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