Non-inferiority Study of GSK Biologicals' Influenza Vaccine GSK576389A Using Different Formulations

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Influenza

Treatments

Biological: Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A)

Biological: Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00633074

111454

Details and patient eligibility

About

The purpose of this study is to show the non-inferiority of different formulations of GlaxoSmithKline Biologicials' influenza vaccine.

Enrollment

720 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female 65 years of age or older at the time of vaccination.
Written informed consent obtained from the subject.
Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.

Exclusion criteria

Suspected (based on clinical symptoms) or confirmed (based on laboratory results) influenza infection within the last 6 months.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Administration of other 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 21 days after vaccination.
Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
Previous vaccination against influenza with any seasonal vaccine since July 2007.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
History of hypersensitivity to a previous dose of influenza vaccine.
History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg and chicken protein.
Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests.
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Any medical conditions in which IM injections are contraindicated