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

Primary Purpose

Influenza, Fever

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Mammalian cell based flu vaccine
Egg based flu vaccine
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, children and adolescents, trivalent vaccine, cell culture, embryonated chicken eggs

Eligibility Criteria

4 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • 320, Novartis Investigational Site
  • 312, Novartis Investigational Site
  • 313, Novartis Investigational Site
  • 305, Novartis Investigational Site
  • 302, Novartis Investigational Site
  • 301, Novartis Investigational Site
  • 311, Novartis Investigational Site
  • 308, Novartis Investigational Site
  • 317, Novartis Investigational Site
  • 309, Novartis Investigational Site
  • 314, Novartis Investigational Site
  • 319, Novartis Investigational Site
  • 310, Novartis Investigational Site
  • 318, Novartis Investigational Site
  • 304, Novartis Investigational Site
  • 306, Novartis Investigational Site
  • 315, Novartis Investigational Site
  • 303, Novartis Investigational Site
  • 100, Novartis Investigational Site
  • 108, Novartis Investigational Site
  • 107, Novartis Investigational Site
  • 104, Novartis Investigational Site
  • 103, Novartis Investigational Site
  • 105, Novartis Investigational Site
  • 151, Novartis Investigational Site
  • 150, Novartis Investigational Site
  • 250, Novartis Investigational Site
  • 251, Novartis Investigational Site
  • 254, Novartis Investigational Site
  • 253, Novartis Investigational Site
  • 252, Novartis Investigation Site
  • 201, Novartis Investigational Site
  • 200, Novartis Investigational Site
  • 202, Novartis Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TIVc

TIVf

Arm Description

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.

Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.

Outcomes

Primary Outcome Measures

Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity 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.
Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.
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.
Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination.
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.

Secondary Outcome Measures

Full Information

First Posted
May 16, 2013
Last Updated
November 18, 2014
Sponsor
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT01857206
Brief Title
Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 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
Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents 4 to 17 years of age.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Fever
Keywords
Influenza, children and adolescents, trivalent vaccine, cell culture, embryonated chicken eggs

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2055 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TIVc
Arm Type
Experimental
Arm Description
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.
Arm Title
TIVf
Arm Type
Active Comparator
Arm Description
Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
Intervention Type
Biological
Intervention Name(s)
Mammalian cell based flu vaccine
Intervention Type
Biological
Intervention Name(s)
Egg based flu vaccine
Primary Outcome Measure Information:
Title
Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination.
Description
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.
Time Frame
Day 1 to Day 7 after any vaccination
Title
Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.
Description
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.
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.
Title
Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination.
Description
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.
Time Frame
Day 1 to Day 183 for previously vaccinated subjects and Day 213 for not-previously vaccinated subjects

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines and Diagnostics
Organizational Affiliation
Novartis Vaccines
Official's Role
Study Chair
Facility Information:
Facility Name
320, Novartis Investigational Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
312, Novartis Investigational Site
City
Ponte Vedra
State/Province
Florida
ZIP/Postal Code
32081
Country
United States
Facility Name
313, Novartis Investigational Site
City
Augusta
State/Province
Kansas
ZIP/Postal Code
67010
Country
United States
Facility Name
305, Novartis Investigational Site
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
302, Novartis Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
301, Novartis Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
311, Novartis Investigational Site
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
Country
United States
Facility Name
308, Novartis Investigational Site
City
Winston-salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
317, Novartis Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
Facility Name
309, Novartis Investigational Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74127
Country
United States
Facility Name
314, Novartis Investigational Site
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
319, Novartis Investigational Site
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
310, Novartis Investigational Site
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
318, Novartis Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
304, Novartis Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
306, Novartis Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
315, Novartis Investigational Site
City
Salt Lake
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
303, Novartis Investigational Site
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
100, Novartis Investigational Site
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
108, Novartis Investigational Site
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
107, Novartis Investigational Site
City
Sherwood
State/Province
Queensland
ZIP/Postal Code
4075
Country
Australia
Facility Name
104, Novartis Investigational Site
City
North Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Facility Name
103, Novartis Investigational Site
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3010
Country
Australia
Facility Name
105, Novartis Investigational Site
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
151, Novartis Investigational Site
City
Takapuna
State/Province
Auckland
ZIP/Postal Code
0622
Country
New Zealand
Facility Name
150, Novartis Investigational Site
City
Beckenham
State/Province
Christchurch
ZIP/Postal Code
8024
Country
New Zealand
Facility Name
250, Novartis Investigational Site
City
Muntinlupa City
State/Province
Alabang
ZIP/Postal Code
1781
Country
Philippines
Facility Name
251, Novartis Investigational Site
City
Muntinlupa City
State/Province
Alabang
ZIP/Postal Code
1781
Country
Philippines
Facility Name
254, Novartis Investigational Site
City
Muntinlupa City
State/Province
Alabang
ZIP/Postal Code
1781
Country
Philippines
Facility Name
253, Novartis Investigational Site
City
Manila
State/Province
Ermita
ZIP/Postal Code
1001
Country
Philippines
Facility Name
252, Novartis Investigation Site
City
Manila
State/Province
Sampaloc
ZIP/Postal Code
1001
Country
Philippines
Facility Name
201, Novartis Investigational Site
City
Khon Kaen
State/Province
Muang
ZIP/Postal Code
40002
Country
Thailand
Facility Name
200, Novartis Investigational Site
City
Bangkok
State/Province
Rajathevi
ZIP/Postal Code
10400
Country
Thailand
Facility Name
202, Novartis Investigational Site
City
Bangkoknoi
State/Province
Siriraj
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
26643931
Citation
Nolan T, Chotpitayasunondh T, Capeding MR, Carson S, Senders SD, Jaehnig P, de Rooij R, Chandra R. Safety and tolerability of a cell culture derived trivalent subunit inactivated influenza vaccine administered to healthy children and adolescents: A Phase III, randomized, multicenter, observer-blind study. Vaccine. 2016 Jan 4;34(2):230-236. doi: 10.1016/j.vaccine.2015.11.040. Epub 2015 Nov 29.
Results Reference
derived

Learn more about this trial

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

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