Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children
A Phase III, Single-blind, Randomized Study to Evaluate the Immunogenicity and Safety of Fluarix® (GSK Biologicals') Compared With Fluzone® (Aventis Pasteur/Sanofi) Administered Intramuscularly in Children (6 Months and Older)
1 other identifier
interventional
3,327
1 country
40
Brief Summary
The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2006
Shorter than P25 for phase_3
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2006
CompletedFirst Posted
Study publicly available on registry
October 2, 2006
CompletedStudy Start
First participant enrolled
November 2, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 19, 2007
CompletedResults Posted
Study results publicly available
December 4, 2008
CompletedJune 8, 2018
November 1, 2016
11 months
September 29, 2006
October 15, 2008
May 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies
GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.
21 or 28 days after last vaccine dose
Number of Seroconverted Subjects
Seroconverted subjects are defined as subjects with either a pre-vaccination HI titer \<1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer. Data are presented for all 3 viral strains comprised in the vaccine.
21 or 28 days after last vaccine dose
Number of Subjects Reporting Rare Serious Events
Rare serious event is defined as any untoward medical event with an occurrence rate of ≥1/300 that: * resulted in death, * was life-threatening, * required hospitalization or prolongation of existing hospitalization, * resulted in disability/incapacity, or * was a congenital anomaly/birth defect in the offspring of a study subject.
Up to 6 months after vaccination
Secondary Outcomes (5)
Number of Seroprotected Subjects
Before (PRE) and 21 or 28 days after (POST) the last vaccine dose
Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer
21 or 28 days after last vaccine dose
Number of Subjects Reporting Solicited Local and General Symptoms
During a 4-day follow-up period after each vaccination
Number of Subjects Reporting Unsolicited Adverse Events
Within 28 days following vaccination
Number of Subjects Reporting New Onset Chronic Illnesses and/or Serious Adverse Events (SAE)
Up to 6 months after vaccination
Study Arms (2)
Fluarix Group
EXPERIMENTALSubjects in this group received Fluarix™ and will be further stratified by 3 age groups * 1:1 in 6 months to \< 36 months * 1:1 in 3 to \< 5 years * 3:1 in 5 to \< 18 years
Fluzone Group
ACTIVE COMPARATORSubjects in this group received Fluzone and will be further stratified by 3 age groups * 1:1 in 6 months to \< 36 months * 1:1 in 3 to \< 5 years * 3:1 in 5 to \< 18 years
Interventions
Subjects were administered 1 or 2 doses\* intramuscularly, into the non-dominant upper arm for children \> 12 months of age, in the anterolateral thigh for children \< 12 months. \*Only those subjects between the age of 6 months and \< 9 years, who had no history of prior influenza vaccination, received 2 doses at months 0 \& 1.
Subjects were administered 1 or 2 doses\* intramuscularly, into the non-dominant upper arm for children \> 12 months of age, in the anterolateral thigh for children \< 12 months. \*Only those subjects between the age of 6 months and \< 9 years, who had no history of prior influenza vaccination, received 2 doses at months 0 \& 1.
Eligibility Criteria
You may qualify if:
- A male or female child age 6 months to \< 18 years at the time of the vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
- Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- Written informed consent obtained from the subject's parent/guardian; assent obtained in subjects \> 10 years.
- Female subjects of childbearing potential must agree to take a pregnancy test.
You may not qualify if:
- History of hypersensitivity to any vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine.
- Acute disease at the time of enrollment.
- History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
- Pregnant or lactating female.
- Receipt of an influenza vaccine outside of this study, during current (2006-07) flu season.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (40)
GSK Investigational Site
Antioch, California, 94509, United States
GSK Investigational Site
Fairfield, California, 94533, United States
GSK Investigational Site
Fresno, California, 93710, United States
GSK Investigational Site
Pleasanton, California, 94588, United States
GSK Investigational Site
Redwood City, California, 94063, United States
GSK Investigational Site
Richmond, California, 94801, United States
GSK Investigational Site
Rolling Hills Estates, California, 90274, United States
GSK Investigational Site
Sacramento, California, 95815, United States
GSK Investigational Site
San Francisco, California, 94102, United States
GSK Investigational Site
San Francisco, California, 94115, United States
GSK Investigational Site
Santa Clara, California, 95051, United States
GSK Investigational Site
Santa Rosa, California, 95403, United States
GSK Investigational Site
Vacaville, California, 95688, United States
GSK Investigational Site
Vallejo, California, 94589, United States
GSK Investigational Site
Walnut Creek, California, 94596, United States
GSK Investigational Site
Englewood, Colorado, 80112, United States
GSK Investigational Site
Lakewood, Colorado, 80401, United States
GSK Investigational Site
Tifton, Georgia, 31794, United States
GSK Investigational Site
Bardstown, Kentucky, 40004, United States
GSK Investigational Site
Lexington, Kentucky, 40509, United States
GSK Investigational Site
Metairie, Louisiana, 70006, United States
GSK Investigational Site
Omaha, Nebraska, 68134, United States
GSK Investigational Site
Whitehouse Station, New Jersey, 08889, United States
GSK Investigational Site
Fishkill, New York, 12524, United States
GSK Investigational Site
Hopewell Junction, New York, 12533, United States
GSK Investigational Site
Poughkeepsie, New York, 12603, United States
GSK Investigational Site
Rochester, New York, 14609, United States
GSK Investigational Site
Rochester, New York, 14620, United States
GSK Investigational Site
Cary, North Carolina, 27518, United States
GSK Investigational Site
Sylva, North Carolina, 28779, United States
GSK Investigational Site
Cleveland, Ohio, 44118, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site
Uniontown, Pennsylvania, 15401, United States
GSK Investigational Site
Austin, Texas, 78728, United States
GSK Investigational Site
Fort Worth, Texas, 76135, United States
GSK Investigational Site
San Angelo, Texas, 76904, United States
GSK Investigational Site
Layton, Utah, 84041, United States
GSK Investigational Site
Salt Lake City, Utah, 84121, United States
GSK Investigational Site
South Jordan, Utah, 84095, United States
GSK Investigational Site
West Jordan, Utah, 84084, United States
Related Publications (2)
Li-Kim-Moy J, Wood N, Jones C, Macartney K, Booy R. Impact of Fever and Antipyretic Use on Influenza Vaccine Immune Reponses in Children. Pediatr Infect Dis J. 2018 Oct;37(10):971-975. doi: 10.1097/INF.0000000000001949.
PMID: 29465480DERIVEDBaxter R, Jeanfreau R, Block SL, Blatter M, Pichichero M, Jain VK, Dewe W, Innis BL. A Phase III evaluation of immunogenicity and safety of two trivalent inactivated seasonal influenza vaccines in US children. Pediatr Infect Dis J. 2010 Oct;29(10):924-30. doi: 10.1097/INF.0b013e3181e075be.
PMID: 20431425DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2006
First Posted
October 2, 2006
Study Start
November 2, 2006
Primary Completion
October 1, 2007
Study Completion
October 19, 2007
Last Updated
June 8, 2018
Results First Posted
December 4, 2008
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.