Safety and immunogenicity of GSK Biologicals’ (pre-) pandemic influenza vaccine in children aged 6 to 35 months.

Active, not recruiting

• Conditions: Immunisation of healthy children aged 6 to 35 months against H5N1 influenza.; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-004734-33-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-12
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: Active
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

•Subjects who the investigator believes that parents/Legally Acceptable Representatives (LARs) can and will comply with the requirements of the protocol.
•Children, male or female between, and including, 6 and 35 months of age at the time of first study vaccination.
•Written informed consent obtained from the parent(s)/LAR(s) of the subject.
•Healthy children as established by medical history and clinical examination before entering the study.
•Parent/LAR access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
•Subjects who are likely to reside in the vicinity of the study centre for the duration of the study. In studies using the home-based model for vaccination and follow-up, subjects who are likely to remain in the vicinity of the area where they were recruited.

Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
•Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
•Planned administration of any vaccine 30 days prior and 21 days after any study vaccine administration.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines such as egg protein or thiomersal.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
•History of any neurological disorders or seizures.
•Acute disease at the time of enrolment.
•Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
•Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned administration during the study period.
•Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
•Child in care.
•Previous vaccination at any time with an H5N1 vaccine.
•Medical history of physician-confirmed infection with a H5N1 virus.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified