Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in Children
1 other identifier
interventional
3,317
5 countries
69
Brief Summary
The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline Biologicals' seasonal influenza vaccine, Fluarix, compared to Fluzone (a US-licensed vaccine) in children, 6 to 35 months of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2008
Shorter than P25 for phase_3
69 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
October 1, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedFirst Posted
Study publicly available on registry
October 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
July 27, 2010
CompletedJuly 31, 2018
October 1, 2016
5 months
October 1, 2008
February 25, 2010
July 2, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains
GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine. Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
Day 0 (PRE), Day 28 or Day 56 (POST)
Number of Subjects Who Seroconverted
Seroconversion is defined as the number of subjects with either a pre-vaccination anti-HA 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. Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
Day 28 or Day 56
Secondary Outcomes (7)
Number of Seroprotected Subjects
Day 0 (PRE), Day 28 or Day 56 (POST)
Seroconversion Factor
Day 28 or Day 56
Number of Subjects Reporting Solicited Local Symptoms
During a 4-day follow-up period after vaccination
Number of Subjects Reporting Solicited General Symptoms
During a 4-day follow-up period after vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AE)
During a 28-day follow-up period after vaccination
- +2 more secondary outcomes
Study Arms (3)
Fluarix Dose A Group
EXPERIMENTALSubjects were administered 1 or 2 doses\* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age). \* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
Fluarix Dose B Group
EXPERIMENTALSubjects were administered 1 or 2 doses\*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age). \* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
Fluzone Group
ACTIVE COMPARATORSubjects were administered 1 or 2 doses\* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children \>12 months of age) or in the anterolateral thigh (children \<12 months of age). \* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
Interventions
Eligibility Criteria
You may qualify if:
- A male or female child aged 6 to 35 months at the time of the first 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.
- Written informed consent obtained from the subject's parent/guardian.
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 enrolment.
- History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
- Receipt of an influenza vaccine outside of this study, during current (2008-09) flu season.
- Administration of immunoglobulins and/or blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (69)
GSK Investigational Site
Birmingham, Alabama, 35205, United States
GSK Investigational Site
Birmingham, Alabama, 35244, United States
GSK Investigational Site
Dothan, Alabama, 36305, United States
GSK Investigational Site
Benton, Arkansas, 72019, United States
GSK Investigational Site
Conway, Arkansas, 72034, United States
GSK Investigational Site
Fayetteville, Arkansas, 72703, United States
GSK Investigational Site
Jonesboro, Arkansas, 72401, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Long Beach, California, 90806, United States
GSK Investigational Site
Paramount, California, 90723, United States
GSK Investigational Site
Sacramento, California, 95816, United States
GSK Investigational Site
San Francisco, California, 94102, United States
GSK Investigational Site
West Covina, California, 91790, United States
GSK Investigational Site
Longmont, Colorado, 80501, United States
GSK Investigational Site
Norwich, Connecticut, 06360, United States
GSK Investigational Site
Nampa, Idaho, 83686, United States
GSK Investigational Site
DeKalb, Illinois, 60115, United States
GSK Investigational Site
New Albany, Indiana, 47150, United States
GSK Investigational Site
Arkansas City, Kansas, 67005, United States
GSK Investigational Site
Newton, Kansas, 67114, United States
GSK Investigational Site
Wichita, Kansas, 67207, United States
GSK Investigational Site
Bardstown, Kentucky, 40004, United States
GSK Investigational Site
Louisville, Kentucky, 40207, United States
GSK Investigational Site
Bossier City, Louisiana, 71111, United States
GSK Investigational Site
Metairie, Louisiana, 70006, United States
GSK Investigational Site
Stevensville, Michigan, 49127, United States
GSK Investigational Site
Saint Paul, Minnesota, 55108, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Omaha, Nebraska, 68134, United States
GSK Investigational Site
Henderson, Nevada, 89015, United States
GSK Investigational Site
Cortland, New York, 13045, United States
GSK Investigational Site
Boone, North Carolina, 28607, United States
GSK Investigational Site
Cary, North Carolina, 27518, United States
GSK Investigational Site
Raleigh, North Carolina, 27609, United States
GSK Investigational Site
Fargo, North Dakota, 58103, United States
GSK Investigational Site
Austintown, Ohio, 44515, United States
GSK Investigational Site
Cincinnati, Ohio, 45245, United States
GSK Investigational Site
Cleveland, Ohio, 44121, United States
GSK Investigational Site
Dayton, Ohio, 45406, United States
GSK Investigational Site
Gresham, Oregon, 97030, United States
GSK Investigational Site
Erie, Pennsylvania, 16505, United States
GSK Investigational Site
Greenville, Pennsylvania, 16125, United States
GSK Investigational Site
Latrobe, Pennsylvania, 15650, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15236, United States
GSK Investigational Site
Uniontown, Pennsylvania, 15401, United States
GSK Investigational Site
Wexford, Pennsylvania, 15090, United States
GSK Investigational Site
Charleston, South Carolina, 29406, United States
GSK Investigational Site
Clarksville, Tennessee, 37043, United States
GSK Investigational Site
Jackson, Tennessee, 38305, United States
GSK Investigational Site
Kingsport, Tennessee, 37660, United States
GSK Investigational Site
Austin, Texas, 78705, United States
GSK Investigational Site
Fort Worth, Texas, 76135, United States
GSK Investigational Site
Houston, Texas, 77055, United States
GSK Investigational Site
San Angelo, Texas, 76904, United States
GSK Investigational Site
Bountiful, Utah, 84010, United States
GSK Investigational Site
Layton, Utah, 84041, United States
GSK Investigational Site
Murray, Utah, 84107, United States
GSK Investigational Site
Provo, Utah, 84604, United States
GSK Investigational Site
Roy, Utah, 84067, United States
GSK Investigational Site
South Jordan, Utah, 84095, United States
GSK Investigational Site
Burke, Virginia, 22015, United States
GSK Investigational Site
Pokfulam, Hong Kong
GSK Investigational Site
Shatin, Hong Kong
GSK Investigational Site
Mexico City, 04530, Mexico
GSK Investigational Site
México, 6720, Mexico
GSK Investigational Site
Taipei, 104, Taiwan
GSK Investigational Site
Taipei, Taiwan
GSK Investigational Site
Bangkok, 10400, Thailand
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: 29465480DERIVEDPavia-Ruz N, Angel Rodriguez Weber M, Lau YL, Nelson EA, Kerdpanich A, Huang LM, Silas P, Qaqundah P, Blatter M, Jeanfreau R, Lei P, Jain V, El Idrissi M, Feng Y, Innis B, Peeters M, Devaster JM. A randomized controlled study to evaluate the immunogenicity of a trivalent inactivated seasonal influenza vaccine at two dosages in children 6 to 35 months of age. Hum Vaccin Immunother. 2013 Sep;9(9):1978-88. doi: 10.4161/hv.25363. Epub 2013 Jun 19.
PMID: 23782962DERIVED
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
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2008
First Posted
October 2, 2008
Study Start
October 1, 2008
Primary Completion
March 5, 2009
Study Completion
June 1, 2009
Last Updated
July 31, 2018
Results First Posted
July 27, 2010
Record last verified: 2016-10
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.