Safety, Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)

Launched by GLAXOSMITHKLINE · Sep 2, 2009

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.