Status:
COMPLETED
A Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine in Children
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
3-8 years
Phase:
PHASE3
Brief Summary
This study is designed to test the efficacy of an investigational influenza vaccine, in children compared to Havrix®, a licensed Hepatitis A virus vaccine. This study will also evaluate the immunogen...
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that they and/or their parent(s) or legally acceptable representative(s) can and will comply with the requirements of the protocol.
- A male or female child aged between 3 and 8 years inclusive at the time of the first vaccination; children are eligible regardless of history of administration of influenza vaccine in a previous season. However, subjects who have received any seasonal or pandemic influenza vaccine within 6 months preceding the first dose of study vaccine will not be enrolled.
- Written informed consent obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.
- Written assent obtained from the subject if/as required by local regulations.
- Subjects in stable health as determined by investigator's clinical examination and assessment of subjects' medical history.
- Access to a consistent means of telephone contact
Exclusion
- Child in care.
- Use of an investigational or non-registered product other than the study vaccines within 30 days before study vaccination or planned use during study period. Routine registered childhood vaccinations are permitted.
- Prior receipt of any seasonal or pandemic influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use of such vaccines during the study period. Prior receipt of more than one dose of a licensed hepatitis A vaccine, with the first dose administered at \>=12 months of age.
- Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
- History of Guillain-Barre syndrome within 6 weeks of receipt of prior influenza virus vaccine.
- Any known or suspected allergy to any constituent of influenza vaccines ; a history of anaphylactic-type reaction to constituent of vaccine; or a history of severe adverse reaction to a previous influenza vaccine.
- Fever at the time of enrolment.
- Acute disease at the time of enrolment.
- Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Ongoing aspirin therapy.
- Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
Key Trial Info
Start Date :
December 9 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2012
Estimated Enrollment :
5220 Patients enrolled
Trial Details
Trial ID
NCT01218308
Start Date
December 9 2010
End Date
January 9 2012
Last Update
August 1 2018
Active Locations (12)
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1
GSK Investigational Site
Dhaka, Bangladesh, 1000
2
GSK Investigational Site
Santo Domingo, Dominican Republic
3
GSK Investigational Site
Tegucigalpa, Honduras
4
GSK Investigational Site
Beirut, Lebanon, 1107-2020