A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Staphylococcal Investigational Vaccine in Healthy Adults

• Status: Completed
• Trial end date: 2012-08-23
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of several formulations of an investigational Staphylococcal vaccine.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Vaccines

Criteria

Inclusion Criteria:

• Subjects who the investigator believes can and will comply with the requirements of the protocol.

• A male or female between 18 and 40 years of age, inclusive, at the time of first vaccination.

• Written informed consent obtained from the subject.

• Healthy subjects as established by medical history, clinical examination and laboratory assessment before entering into the study.

• Female subjects of non-childbearing potential may be enrolled in the study.

• Female subjects of childbearing potential may be enrolled in the study, if the subject:

• has practiced adequate contraception for 30 days prior to vaccination, and

• has a negative pregnancy test at Screening, and

• has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series

Exclusion Criteria:

• Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.

• Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.

• Any clinically significant acute or chronic, local or systemic infection, proven or suspected to be caused by Staphylococcus aureus and requiring antibiotic treatment, within the 6 months preceding the first vaccination.

• Previous administration of any investigational Staphylococcus aureus vaccine/antibodies.

• History of; or current bleeding or coagulation disorder.

• Known or suspected reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.

• History of; or current autoimmune or other immune-mediated disease.

• Administration or planned administration, of any vaccine not foreseen by the study protocol within 30 days of the first dose of vaccines up to 1 month after the last vaccine dose.

• Administration of immunoglobulins and/or any blood products within the last 3 months preceding the first dose of study vaccine or planned administration during the study period.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.

• Any clinically relevant abnormal haematological or biochemical or urine laboratory values at screening.

• Any acute or chronic, clinically significant disease, as determined by physical examination or laboratory screening tests.

• Acute disease and/or fever at study entry.

• Pregnant or lactating female.

• Female planning to become pregnant or planning to discontinue contraceptive precautions.

• History of; or current alcoholism and/or drug abuse.

• Any other condition that the principal investigator judges may interfere with study findings.