A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine
Phase 3
Withdrawn
- Conditions
- Influenza
- Interventions
- Biological: GSK's candidate influenza vaccine 1562902ABiological: FluarixTMBiological: Placebo
- Registration Number
- NCT00866580
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This observer-blind study is designed to evaluate the immune response and safety of pandemic influenza vaccine in the elderly population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Male or female subjects aged 61 years or above at the time of the first study visit (Day -30).
- Female subjects of non-childbearing potential.
- Healthy subjects or subjects with well controlled chronic medical condition (at the discretion of the investigator).
- Written informed consent obtained from the subject.
- Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device.
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
Exclusion Criteria
- Previous administration of the licensed MF59-containing vaccines, e.g. Fluad™ or Addigrip™ or virosome-based influenza vaccines such as Inflexal V™, InfectoVac Flu™ or Invivac™ .
- Previous administration of the 2009 Southern Hemisphere or 2008-2009 Northern Hemisphere influenza vaccine.
- Previous administration of a pandemic influenza vaccine.
- Administration of licensed vaccines within 4 weeks prior to enrolment in this study.
- Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination with H5N1 vaccine.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first study vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of chronic alcohol consumption and/or drug abuse.
- History of hypersensitivity to vaccines.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Acute disease and/or fever at the time of enrolment.
- Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination..
- Administration of immunoglobulins and/or any blood products within the three months preceding the first study vaccination or during the study.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days prior to the first vaccination, or planned use during the study period.
- Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A GSK's candidate influenza vaccine 1562902A - Group A FluarixTM - Group B GSK's candidate influenza vaccine 1562902A - Group A Placebo - Group B Placebo - Group B FluarixTM -
- Primary Outcome Measures
Name Time Method Serum HI antibody titres Day -30, Day 42
- Secondary Outcome Measures
Name Time Method Serum HI antibody titres Day -30, Day 42, Month 6, Month 12 Serum neutralising antibody titres Day -30, Day 42, Month 6, Month 12 Occurrence, intensity, and relationship to vaccination of solicited local and general signs and symptoms Day 0 - Day 6 after each vaccination Occurrence, intensity and relationship to vaccination of unsolicited adverse events Day 0 - Day 29 after vaccination, Day 0 - Day 20 after investigational vaccination Occurrence and relationship to vaccination of serious adverse events Day 0 - Month 6 Occurrence of adverse events of specific interest Day 0 - Month 12
Trial Locations
- Locations (1)
GSK Investigational Site
🇧🇷Curitiba/Paraná, Paraná, Brazil