Influenza
Conditions
Keywords
Pandemic influenza
Brief summary
This observer-blind study is designed to evaluate the immune response and safety of pandemic influenza vaccine in the elderly population.
Interventions
BIOLOGICALGSK's candidate influenza vaccine 1562902A
Intramuscular dose on Day 0 and Day 21
BIOLOGICALFluarixTM
Intramuscular dose on Day 42 or on Day -30, according to the vaccination schedule
BIOLOGICALPlacebo
Intramuscular dose on Day 42 or on Day -30, according to the vaccination schedule
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
61 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum HI antibody titres | Day -30, Day 42 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Serum HI antibody titres | Day -30, Day 42, Month 6, Month 12 |
| Occurrence and relationship to vaccination of serious adverse events | Day 0 - Month 6 |
| Occurrence of adverse events of specific interest | Day 0 - Month 12 |
| Occurrence, intensity and relationship to vaccination of unsolicited adverse events | Day 0 - Day 29 after vaccination, Day 0 - Day 20 after investigational vaccination |
Countries
Brazil
Outcome results
None listed