Infections, Staphylococcal Clinical Trial
Official title:
A Partially Blind Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Staphylococcal 4-component Investigational Vaccine (GSK2392102A) in Healthy Adults
| Verified date | May 2017 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of several formulations of an investigational Staphylococcal vaccine.
| Status | Completed |
| Enrollment | 88 |
| Est. completion date | August 23, 2012 |
| Est. primary completion date | August 23, 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 40 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | GSK Investigational Site | La Louvière |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Occurrence of solicited local and general adverse events (AEs) in all subjects, in all vaccine groups. | During a 7-day (day 0-6) follow up period after each vaccine dose | ||
| Primary | Occurrence of unsolicited adverse events (AEs) in all subjects, in all vaccine groups. | During a 30-day (day 0-29) follow up period after each vaccine dose | ||
| Primary | Occurrence of any Serious Adverse events (SAE) in all subjects, in all vaccine groups. | From first vaccination (Day 0) to study conclusion (Day 540) | ||
| Primary | Occurrence of any adverse event (AE) of specific interest in all subjects, in all vaccine groups. | From first vaccination (Day 0) to study conclusion (Day 540) | ||
| Primary | Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. | Prior to each vaccine dose | ||
| Primary | Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. | 1 day after each vaccine dose | ||
| Primary | Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. | 7 days after each vaccine dose | ||
| Primary | Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. | 29/30 days after each vaccine dose | ||
| Primary | Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. | 6 months after the last vaccine dose | ||
| Primary | Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. | 12 months after the last vaccine dose | ||
| Secondary | Immune response to components of the Staphylococcal vaccine formulations in all subjects, in all vaccine groups. | Prior to each vaccine dose, 1, 7 and 29/30 days after each vaccine dose, and 6 and 12 months after the last vaccine dose. | ||
| Secondary | Colonisation with Staphylococcus aureus in all subjects, in all vaccine groups. | At Screening (pre-Day 0) and at Days 0, 30, 60, 180, 210 and 540. |