Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age

November 18, 2014 updated by: Novartis Vaccines

A Phase III, Observer Blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Chicken Eggs (Fluvirin®), in Healthy Children and Adolescents 4 to 17 Years of Age.

Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents 4 to 17 years of age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2055

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • 100, Novartis Investigational Site
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • 108, Novartis Investigational Site
      • Sherwood, Queensland, Australia, 4075
        • 107, Novartis Investigational Site
    • South Australia
      • North Adelaide, South Australia, Australia, 5006
        • 104, Novartis Investigational Site
    • Victoria
      • Carlton, Victoria, Australia, 3010
        • 103, Novartis Investigational Site
    • Western Australia
      • Subiaco, Western Australia, Australia, 6008
        • 105, Novartis Investigational Site
  • New Zealand
    • Auckland
      • Takapuna, Auckland, New Zealand, 0622
        • 151, Novartis Investigational Site
    • Christchurch
      • Beckenham, Christchurch, New Zealand, 8024
        • 150, Novartis Investigational Site
  • Philippines
    • Alabang
      • Muntinlupa City, Alabang, Philippines, 1781
        • 250, Novartis Investigational Site
      • Muntinlupa City, Alabang, Philippines, 1781
        • 251, Novartis Investigational Site
      • Muntinlupa City, Alabang, Philippines, 1781
        • 254, Novartis Investigational Site
    • Ermita
      • Manila, Ermita, Philippines, 1001
        • 253, Novartis Investigational Site
    • Sampaloc
      • Manila, Sampaloc, Philippines, 1001
        • 252, Novartis Investigation Site
  • Thailand
    • Muang
      • Khon Kaen, Muang, Thailand, 40002
        • 201, Novartis Investigational Site
    • Rajathevi
      • Bangkok, Rajathevi, Thailand, 10400
        • 200, Novartis Investigational Site
    • Siriraj
      • Bangkoknoi, Siriraj, Thailand, 10700
        • 202, Novartis Investigational Site
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • 320, Novartis Investigational Site
    • Florida
      • Ponte Vedra, Florida, United States, 32081
        • 312, Novartis Investigational Site
    • Kansas
      • Augusta, Kansas, United States, 67010
        • 313, Novartis Investigational Site
      • Newton, Kansas, United States, 67114
        • 305, Novartis Investigational Site
      • Wichita, Kansas, United States, 67205
        • 302, Novartis Investigational Site
      • Wichita, Kansas, United States, 67207
        • 301, Novartis Investigational Site
    • Nebraska
      • Fremont, Nebraska, United States, 68025
        • 311, Novartis Investigational Site
    • North Carolina
      • Winston-salem, North Carolina, United States, 27103
        • 308, Novartis Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44121
        • 317, Novartis Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74127
        • 309, Novartis Investigational Site
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • 314, Novartis Investigational Site
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • 319, Novartis Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • 310, Novartis Investigational Site
      • Nashville, Tennessee, United States, 37203
        • 318, Novartis Investigational Site
    • Utah
      • Salt Lake, Utah, United States, 84124
        • 315, Novartis Investigational Site
      • Salt Lake City, Utah, United States, 84109
        • 304, Novartis Investigational Site
      • Salt Lake City, Utah, United States, 84121
        • 306, Novartis Investigational Site
      • South Jordan, Utah, United States, 84095
        • 303, Novartis Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Healthy subjects 4-17 years of age

Exclusion Criteria:

  • Subjects who are not healthy,
  • Subjects who are pregnant or breast feeding,
  • Subjects with a history of severe allergic reaction or allergic to any of the vaccine components.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TIVc
Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
Biological: Mammalian cell based flu vaccine
Active Comparator: TIVf
Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
Biological: Egg based flu vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination.
Time Frame: Day 1 to Day 7 after any vaccination
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events and other indicators of reactogenicity following two doses of either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.
Day 1 to Day 7 after any vaccination
Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.
Time Frame: Day 1 to Day49 for subjects aged ≥4 To ≤8 years not previously vaccinated. Day 1 to Day 38 for subjects aged ≥4 To ≤8 years previously vaccinated and all subjects aged ≥9 To ≤17 years.
Safety was assessed as the number of subjects who reported unsolicited adverse events following vaccination with either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.
Day 1 to Day49 for subjects aged ≥4 To ≤8 years not previously vaccinated. Day 1 to Day 38 for subjects aged ≥4 To ≤8 years previously vaccinated and all subjects aged ≥9 To ≤17 years.
Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination.
Time Frame: Day 1 to Day 183 for previously vaccinated subjects and Day 213 for not-previously vaccinated subjects
Safety was assessed as the number of subjects who reported serious adverse events (SAEs), medically attended AEs and new onset of chronic diseases (NOCD) in subjects aged ≥4 To ≤17 Years.
Day 1 to Day 183 for previously vaccinated subjects and Day 213 for not-previously vaccinated subjects

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Vaccines

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

May 16, 2013

First Submitted That Met QC Criteria

May 17, 2013

First Posted (Estimate)

May 20, 2013

Study Record Updates

Last Update Posted (Estimate)

December 5, 2014

Last Update Submitted That Met QC Criteria

November 18, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V58_31
  • U1111-1139-9440 (Other Identifier: Universal Trial Number (UTN))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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