Clinical trial NCT00866580: A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine
Official title: Immunogenicity and Safety of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine GSK 1562902A.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Influenza
Keywords: Pandemic influenza
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-03-20
Enrollment: 0
Sex: ALL
Minimum age (years): 61
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This observer-blind study is designed to evaluate the immune response and safety of pandemic influenza vaccine in the elderly population.


Eligibility criteria: 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.

Primary outcomes:
measure: Serum HI antibody titres
timeFrame: Day -30, Day 42
Secondary outcomes:
measure: Serum HI antibody titres
timeFrame: Day -30, Day 42, Month 6, Month 12
measure: Serum neutralising antibody titres
timeFrame: Day -30, Day 42, Month 6, Month 12
measure: Occurrence, intensity, and relationship to vaccination of solicited local and general signs and symptoms
timeFrame: Day 0 - Day 6 after each vaccination
measure: Occurrence, intensity and relationship to vaccination of unsolicited adverse events
timeFrame: Day 0 - Day 29 after vaccination, Day 0 - Day 20 after investigational vaccination
measure: Occurrence and relationship to vaccination of serious adverse events
timeFrame: Day 0 - Month 6
measure: Occurrence of adverse events of specific interest
timeFrame: Day 0 - Month 12
Other outcomes:
Locations:
city: Curitiba/Paraná
country: Brazil
facility: GSK Investigational Site
state: Paraná
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: