Status:
COMPLETED
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Staphylococcal Investigational Vaccine in Healthy Adults
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Staphylococcal
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of several formulations of an investigational Staphylococcal vaccine.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 19 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2012
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT01160172
Start Date
July 19 2010
End Date
August 23 2012
Last Update
May 30 2017
Active Locations (1)
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1
GSK Investigational Site
La Louvière, Belgium, 7100