A randomized, double-blind, placebo-controlled, post-marketing phase III Study to evaluate the efficacy of GSK Biologicals’ influenza vaccine (Fluarix™) administered intramuscularly in adults - FluarixUS-004

Conditions: Immunization against influenza in male and female subjects aged 18 to 64 years

Registration Number: EUCTR2005-002044-26-CZ

Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 6213

Inclusion Criteria

? Subjects whom the investigator believes can and will comply with the requirements of the protocol (e.g., return for follow-up visit and completion of the diary cards) should be enrolled in the study.

? A male or female age between, and including, 18 and 64 years of age at the time of the vaccination.

? Written informed consent obtained from the subject.

? Availability to follow up by phone during the study period.

? Female subjects must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal. If subject is of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g. intrauterine contraceptive device; oral contraceptives or other equivalent hormonal contraception, e.g. progestogen-only implantable, cutaneous hormonal patch or injectable contraceptives, diaphragm or condom in combination with contraceptive jelly, cream or foam) for 30 days prior to vaccination. She must also have a negative pregnancy test at study entry and must agree to continue such precautions for two months after vaccination.

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
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

? History of hypersensitivity to a previous dose of influenza vaccine.

? History of allergy or reactions likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, thimerosal, gentamicin sulfate or sodium deoxycholate.

? Acute disease at the time of enrollment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C).

? Pregnancy

? Chronic disorders of the pulmonary or cardiovascular system, including asthma

? History of requiring regular medical follow-up or hospitalization during the preceding year because of chronic metabolic diseases (including diabetes mellitus), renal dysfunction, hemoglobinopathies, or immunosuppression (including immunosuppression caused by medications or by human immunodeficiency virus.