Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children
NCT ID: NCT00383123
Last Updated: 2018-06-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3327 participants
INTERVENTIONAL
2006-11-02
2007-10-19
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
SINGLE
Study Groups
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Fluarix Group
Subjects 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
Fluarix™
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.
Fluzone Group
Subjects 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
Fluzone
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.
Interventions
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Fluarix™
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.
Fluzone
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
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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 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.
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 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.
6 Months
17 Years
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
Antioch, California, United States
GSK Investigational Site
Fairfield, California, United States
GSK Investigational Site
Fresno, California, United States
GSK Investigational Site
Pleasanton, California, United States
GSK Investigational Site
Redwood City, California, United States
GSK Investigational Site
Richmond, California, United States
GSK Investigational Site
Rolling Hills Estates, California, United States
GSK Investigational Site
Sacramento, California, United States
GSK Investigational Site
San Francisco, California, United States
GSK Investigational Site
San Francisco, California, United States
GSK Investigational Site
Santa Clara, California, United States
GSK Investigational Site
Santa Rosa, California, United States
GSK Investigational Site
Vacaville, California, United States
GSK Investigational Site
Vallejo, California, United States
GSK Investigational Site
Walnut Creek, California, United States
GSK Investigational Site
Englewood, Colorado, United States
GSK Investigational Site
Lakewood, Colorado, United States
GSK Investigational Site
Tifton, Georgia, United States
GSK Investigational Site
Bardstown, Kentucky, United States
GSK Investigational Site
Lexington, Kentucky, United States
GSK Investigational Site
Metairie, Louisiana, United States
GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
Whitehouse Station, New Jersey, United States
GSK Investigational Site
Fishkill, New York, United States
GSK Investigational Site
Hopewell Junction, New York, United States
GSK Investigational Site
Poughkeepsie, New York, United States
GSK Investigational Site
Rochester, New York, United States
GSK Investigational Site
Rochester, New York, United States
GSK Investigational Site
Cary, North Carolina, United States
GSK Investigational Site
Sylva, North Carolina, United States
GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, United States
GSK Investigational Site
Uniontown, Pennsylvania, United States
GSK Investigational Site
Austin, Texas, United States
GSK Investigational Site
Fort Worth, Texas, United States
GSK Investigational Site
San Angelo, Texas, United States
GSK Investigational Site
Layton, Utah, United States
GSK Investigational Site
Salt Lake City, Utah, United States
GSK Investigational Site
South Jordan, Utah, United States
GSK Investigational Site
West Jordan, Utah, United States
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.
Baxter 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.
Study Documents
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Document Type: Informed Consent 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: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
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: Study Protocol
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 DocumentRelated Links
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Other Identifiers
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104858
Identifier Type: -
Identifier Source: org_study_id
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