Safety and Immune Response Study of GSK Biologicals' Influenza Virus Vaccine 1388442A Compared With Fluarix

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Influenza

Treatments: Biological: Fluarix; Biological: Trivalent influenza vaccine GSK 138842A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00693706

110127

Details and patient eligibility

About

The purpose of the study is to compare the safety of & immune response to a single dose of GSK Biologicals' cell-culture based influenza vaccine 138842A with that of a US licensed, egg-based trivalent influenza vaccine [Fluarix] in healthy adults.

Enrollment: 200 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who the investigator believes can and will comply with the requirements of the protocol
• A male or non-pregnant, non-lactating female between 18 and 49 years of age at the time of vaccination
• Access to a telephone for scheduled follow-up telephone contacts
• Ability to provide written informed consent
• Healthy subjects as established by medical history and physical examination before entering into the study
• If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination and continue such precautions for 2 months after receipt of the study vaccine. All women will have a pregnancy test on the day of vaccination.

Exclusion criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period
• Receipt of systemic glucocorticoids within 30 days of study enrollment
• Administration of immunosuppressant, cytotoxic, or other immune-modifying drugs (other than glucocorticoids) or irradiation within 6 months prior to study enrollment or planned administration during the study period
• Administration of immunoglobulins and/or blood products within 3 months prior to study enrollment or planned administration during the study period
• Previous vaccination against influenza (2007-2008 influenza season)
• History of anaphylactic or other allergic reaction to influenza vaccine, any other vaccine, or any vaccine component or excipient
• History of Guillain-Barre Syndrome (GBS)
• Acute disease, febrile illness, or upper respiratory infection at screening.
• History of splenectomy
• Any confirmed or suspected, acquired, congenital, or hereditary immunodeficiency or immunosuppressive condition (including human immunodeficiency virus [HIV]) based on medical history and physical examination
• Acquired or congenital coagulation disorders or known thrombocytopenia
• Current treatment with warfarin or heparin derivatives
• Known use of an analgesic or antipyretic medication within 12 hours prior to treatment for the purposes of prophylaxis of adverse events
• Any medical condition for which the US Advisory Committee on Immunization Practices recommends vaccination against influenza

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

GSK 1388442A Group

Experimental group

Description:

Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Treatment:

Biological: Trivalent influenza vaccine GSK 138842A

Fluarix Group

Active Comparator group

Description:

Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Treatment:

Biological: Fluarix