A phase II, randomised, open study to evaluate the immunogenicity and safety of a single or double-dose of the pandemic influenza candidate vaccine (split virus formulation adjuvanted with AS03) given following a two-administration schedule (21 days apart) in adults over 60 years of age. - H5N1-010, H5N1-021 EXT 010 D180, H5N1-010 EXT:MTH12, H5N1-010 EXT:MTH24

GlaxoSmithKline Biologicals0 sites480 target enrollmentOctober 24, 2006

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Immunization against influenza disease during pandemic in subjects over 60 years of age.
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 480
Status: Active, not recruiting
Last Updated: 11 years ago

No summary available.

Registry

who.int

Start Date

October 24, 2006

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow\-up visits) should be enrolled in the study.
•A male or female aged 61 years or above at the time of the first vaccination.
•Written informed consent obtained from the subject.
•Healthy subjects or subjects with well controlled underlying disease.
•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) yes
•F.1\.3\.1 Number of subjects for this age range

•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.
•Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) 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 administration of the study vaccine.
•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 allergic disease or reactions likely to be exacerbated by any component of the vaccine (including egg and thiomersal allergy).
•Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
•Acute disease at the time of enrolment.