A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine (NCT00866580) | Clinical Trial Compass
WithdrawnPhase 3
A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine
Stopped: Study was cancelled before enrolment for reasons not related to vaccine safety or efficacy.
Brazil0Started 2010-05
Plain-language summary
This observer-blind study is designed to evaluate the immune response and safety of pandemic influenza vaccine in the elderly population.
Who can participate
Age range61 Years
SexALL
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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, bas…