Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in Children
NCT ID: NCT00764790
Last Updated: 2018-07-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3317 participants
INTERVENTIONAL
2008-10-01
2009-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Fluarix Dose A Group
Subjects 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
One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested.
Fluarix Dose B Group
Subjects 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.
Fluarix
One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested.
Fluzone Group
Subjects 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.
Fluzone
One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection.
Interventions
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Fluarix
One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested.
Fluzone
One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
6 Months
35 Months
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Dothan, Alabama, United States
GSK Investigational Site
Benton, Arkansas, United States
GSK Investigational Site
Conway, Arkansas, United States
GSK Investigational Site
Fayetteville, Arkansas, United States
GSK Investigational Site
Jonesboro, Arkansas, United States
GSK Investigational Site
Little Rock, Arkansas, United States
GSK Investigational Site
Huntington Beach, California, United States
GSK Investigational Site
Long Beach, California, United States
GSK Investigational Site
Paramount, California, United States
GSK Investigational Site
Sacramento, California, United States
GSK Investigational Site
San Francisco, California, United States
GSK Investigational Site
West Covina, California, United States
GSK Investigational Site
Longmont, Colorado, United States
GSK Investigational Site
Norwich, Connecticut, United States
GSK Investigational Site
Nampa, Idaho, United States
GSK Investigational Site
DeKalb, Illinois, United States
GSK Investigational Site
New Albany, Indiana, United States
GSK Investigational Site
Arkansas City, Kansas, United States
GSK Investigational Site
Newton, Kansas, United States
GSK Investigational Site
Wichita, Kansas, United States
GSK Investigational Site
Bardstown, Kentucky, United States
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Bossier City, Louisiana, United States
GSK Investigational Site
Metairie, Louisiana, United States
GSK Investigational Site
Stevensville, Michigan, United States
GSK Investigational Site
Saint Paul, Minnesota, United States
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
Henderson, Nevada, United States
GSK Investigational Site
Cortland, New York, United States
GSK Investigational Site
Boone, North Carolina, United States
GSK Investigational Site
Cary, North Carolina, United States
GSK Investigational Site
Raleigh, North Carolina, United States
GSK Investigational Site
Fargo, North Dakota, United States
GSK Investigational Site
Austintown, Ohio, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
Dayton, Ohio, United States
GSK Investigational Site
Gresham, Oregon, United States
GSK Investigational Site
Erie, Pennsylvania, United States
GSK Investigational Site
Greenville, Pennsylvania, United States
GSK Investigational Site
Latrobe, Pennsylvania, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, United States
GSK Investigational Site
Uniontown, Pennsylvania, United States
GSK Investigational Site
Wexford, Pennsylvania, United States
GSK Investigational Site
Charleston, South Carolina, United States
GSK Investigational Site
Clarksville, Tennessee, United States
GSK Investigational Site
Jackson, Tennessee, United States
GSK Investigational Site
Kingsport, Tennessee, United States
GSK Investigational Site
Austin, Texas, United States
GSK Investigational Site
Fort Worth, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
San Angelo, Texas, United States
GSK Investigational Site
Bountiful, Utah, United States
GSK Investigational Site
Layton, Utah, United States
GSK Investigational Site
Murray, Utah, United States
GSK Investigational Site
Provo, Utah, United States
GSK Investigational Site
Roy, Utah, United States
GSK Investigational Site
South Jordan, Utah, United States
GSK Investigational Site
Burke, Virginia, United States
GSK Investigational Site
Pokfulam, , Hong Kong
GSK Investigational Site
Shatin, , Hong Kong
GSK Investigational Site
Mexico City, , Mexico
GSK Investigational Site
México, , Mexico
GSK Investigational Site
Taipei, , Taiwan
GSK Investigational Site
Taipei, , Taiwan
GSK Investigational Site
Bangkok, , Thailand
Countries
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References
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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.
Pavia-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.
Study Documents
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Document Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Annotated Case Report Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Other Identifiers
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111751
Identifier Type: -
Identifier Source: org_study_id
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