A phase II, open, randomized study in adults aged between 18 and 60 years designed to evaluate the reactogenicity and immunogenicity of a 1- and 2-dose prime-boost concept of pandemic monovalent (H5N1) influenza vaccine (split virus formulation) adjuvanted with AS03, administered according to different vaccination schedules. - H5N1-012

GlaxoSmithKline Biologicals0 sites504 target enrollmentDecember 4, 2006

Overview

Phase: N/A
Intervention: Not specified
Conditions: Immunization against influenza disease during pandemic in subjects aged 18 to 60 years.
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 504
Status: Active, Not Recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

December 4, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow\-up visits) should be enrolled in the study.
•A male or female between, and including, 18 and 60 years of age at the time of the first vaccination.
•Written informed consent obtained from the subject.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•If the subject is female, she must be of non\-childbearing potential, i.e., either surgically sterilized or one year post\-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (i.e., intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam) for 30 days prior to first vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no

•Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
•History of vaccination with investigational influenza pandemic vaccine.
•History of administration of an experimental/licensed vaccine containing squalene and/or tocopherol (Vitamin E)
•Planned administration of a vaccine not foreseen by the study protocol during the following periods: from Day 0 up to Day 51; from 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Month 6 and Month 12; from Month 6 up to Month 6 \+ 30 days; from Month 12 up to Month 12 \+ 30 days.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune\-modifying drugs within six months prior to the first administration of the candidate vaccines. (For corticosteroids, this will mean prednisone, or equivalent, \>\= 0\.5 mg/kg/day. Inhaled and topical steroids are allowed.)
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•History of hypersensitivity to vaccines.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
•History of chronic alcohol consumption and/or drug abuse.
•Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.