Status:
COMPLETED
Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in Children
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
6-35 years
Phase:
PHASE3
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,...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion criterion.
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
3317 Patients enrolled
Trial Details
Trial ID
NCT00764790
Start Date
October 1 2008
End Date
June 1 2009
Last Update
July 31 2018
Active Locations (69)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35205
2
GSK Investigational Site
Birmingham, Alabama, United States, 35244
3
GSK Investigational Site
Dothan, Alabama, United States, 36305
4
GSK Investigational Site
Benton, Arkansas, United States, 72019