Status:
COMPLETED
Clinical Study in Children, 6 Months to 3 Years of Age, to Assess Two Dose Levels of an Experimental Flu Vaccine, Using a Licensed Influenza Virus Vaccine, Vaxigrip® as the Control
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
6-36 years
Phase:
PHASE2
Brief Summary
Children younger than 5 years of age are at high risk for severe influenza disease (flu) and hospitalization due to flu. Scientists are in the process of re-evaluating the dosing initially based on wh...
Detailed Description
This is a study of two different dose levels of a new formulation of flu vaccine for the 2008/2009 flu season using the World Health Organization recommended virus strains. Subjects will be randomly p...
Eligibility Criteria
Inclusion
- A male or female child 6 months to \< 3 years of age at the time of the vaccination, regardless of previous administration of influenza vaccine in a previous season;
- Subjects must be in good health established by medical history and physical examination before entering into the study;
- 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.
- Parents/guardian access to a consistent means of telephone contact, land line or mobile
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 to or reactions likely to be exacerbated by, any component of the vaccine including egg, chicken protein, formaldehyde, or sodium deoxycholate;
- History of any congenital, acquired, or iatrogenic immunodeficiency state (current or potential) including HIV infection, disorders of the lymphoid system or bone marrow, or chronic administration (defined as more than 14 consecutive days) of immunosuppressant or other immune-modifying drugs within 3 months prior to the administration of the study vaccine.
- Acute disease at the time of enrolment.
- History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine;
- Any significant disorder of blood coagulation or treatment with vitamin K antagonists; or any known disorder of hemostasis;
- Receipt of any immunoglobulins and/or any blood products within three months of study enrollment or planned administration of any of these products during the study period.
- Receipt of a non-study related influenza vaccine outside of this study and during the current (2008-09) influenza immunization campaign.
- Any use of analgesics/antipyretics 12 hours before receipt of vaccine.
Key Trial Info
Start Date :
November 10 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2009
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT00778895
Start Date
November 10 2008
End Date
August 19 2009
Last Update
August 17 2018
Active Locations (18)
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1
GSK Investigational Site
Calgary, Alberta, Canada, T3B 6A8
2
GSK Investigational Site
Langley, British Columbia, Canada, V3A 4H9
3
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3E 3P4
4
GSK Investigational Site
Mount Pearl, Newfoundland and Labrador, Canada, A1N 5B6