Status:
COMPLETED
Safety, Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
6-35 years
Phase:
PHASE2
Brief Summary
This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 6 and 35 months. This protoco...
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
- Children, male or female, aged between 6 and 35 months at the time of first study vaccination.
- Written informed consent obtained from the parent(s) or LAR(s) of the subject.
- Healthy children, as established by medical history and clinical examination when entering the study.
- Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
Exclusion
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
- Clinically or virologically confirmed influenza infection within six months preceding the study start.
- Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
- Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
- History of hypersensitivity to vaccines.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines
- History of any neurological disorders or seizures.
- Acute disease and/or fever at the time of enrolment
- Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
- Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
- Child in Care.
Key Trial Info
Start Date :
September 10 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2010
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT00971321
Start Date
September 10 2009
End Date
November 24 2010
Last Update
February 25 2019
Active Locations (5)
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1
GSK Investigational Site
Bilbao, Spain, 48013
2
GSK Investigational Site
Burgos, Spain, 09005
3
GSK Investigational Site
Madrid, Spain, 28046
4
GSK Investigational Site
Móstoles/Madrid, Spain, 28935