Immunization against influenza in male and female subjects aged 18 to 64 years
Conditions
Interventions
Trade Name: Fluarix
Product Name: Fluarix
Pharmaceutical Form: Suspension for injection
Other descriptive name: Haemagglutinin from A/New Caledonia/20/99 (IVR-116)
Concentration unit: µg/ml microgram(
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To assess the efficacy of Fluarix to prevent all ILI during the influenza season. To compare the severity of culture confirmed influenza between the Fluarix and placebo groups To evaluate the efficacy of Fluarix in the prevention of influenza confirmed by RT- PCR. To evaluate the efficacy of Fluarix in the prevention of culture confirmed influenza by lot of vaccine administered. To compare the incidence of pneumonia related to influenza between the Fluarix and placebo groups. To compare the incidence of any pneumonia occurring during the active surveillance for ILI, between the Fluarix and placebo groups. To determine the immunogenicity of Fluarix approximately 21 days following vaccination, in a subset of subjects. To evaluate the safety and the reactogenicity of Fluarix during 21 days following vaccination, in a subset of subjects. To evaluate the safety of Fluarix in terms of serious adverse events during the entire study period, in all subjects. ;Main Objective: To demonstrate the efficacy of Fluarix compared with placebo (normal saline solution) in the prevention of culture confirmed influenza A and /or B in adults.;Primary end point(s): Incidence of culture confirmed influenza A and/or B | — |
Countries
Czech Republic
Outcome results
None listed