A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Staphylococcal Investigational Vaccine in Healthy Adults
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01160172
First received: July 1, 2010
Last updated: August 30, 2012
Last verified: August 2012
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Purpose
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of several formulations of an investigational Staphylococcal vaccine.
| Condition | Intervention | Phase |
|---|---|---|
|
Diseases Caused by Staphylococcus Aureus |
Biological: Staphylococcal investigational vaccine GSK2392103A Biological: Staphylococcal investigational vaccine GSK2392105A Biological: Staphylococcal investigational vaccine GSK2392106A Biological: Staphylococcal investigational vaccine GSK2392019A Drug: Saline placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention |
| 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 |
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Occurrence of solicited local and general adverse events (AEs) in all subjects, in all vaccine groups. [ Time Frame: During a 7-day (day 0-6) follow up period after each vaccine dose ] [ Designated as safety issue: No ]
- Occurrence of unsolicited adverse events (AEs) in all subjects, in all vaccine groups. [ Time Frame: During a 30-day (day 0-29) follow up period after each vaccine dose ] [ Designated as safety issue: No ]
- Occurrence of any Serious Adverse events (SAE) in all subjects, in all vaccine groups. [ Time Frame: From first vaccination (Day 0) to study conclusion (Day 540) ] [ Designated as safety issue: No ]
- Occurrence of any adverse event (AE) of specific interest in all subjects, in all vaccine groups. [ Time Frame: From first vaccination (Day 0) to study conclusion (Day 540) ] [ Designated as safety issue: No ]
- Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. [ Time Frame: Prior to each vaccine dose ] [ Designated as safety issue: No ]
- Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. [ Time Frame: 1 day after each vaccine dose ] [ Designated as safety issue: No ]
- Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. [ Time Frame: 7 days after each vaccine dose ] [ Designated as safety issue: No ]
- Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. [ Time Frame: 29/30 days after each vaccine dose ] [ Designated as safety issue: No ]
- Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. [ Time Frame: 6 months after the last vaccine dose ] [ Designated as safety issue: No ]
- Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. [ Time Frame: 12 months after the last vaccine dose ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Immune response to components of the Staphylococcal vaccine formulations in all subjects, in all vaccine groups. [ Time Frame: 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. ] [ Designated as safety issue: No ]
- Colonisation with Staphylococcus aureus in all subjects, in all vaccine groups. [ Time Frame: At Screening (pre-Day 0) and at Days 0, 30, 60, 180, 210 and 540. ] [ Designated as safety issue: No ]
| Enrollment: | 88 |
| Study Start Date: | July 2010 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group A
Not Applicable
|
Biological: Staphylococcal investigational vaccine GSK2392103A
intramuscular vaccination according to protocol schedule
|
|
Experimental: Group B
Not Applicable
|
Biological: Staphylococcal investigational vaccine GSK2392105A
intramuscular vaccination according to protocol schedule
|
|
Experimental: Group C
Not Applicable
|
Biological: Staphylococcal investigational vaccine GSK2392106A
intramuscular vaccination according to protocol schedule
|
|
Experimental: Group D
Not Applicable
|
Biological: Staphylococcal investigational vaccine GSK2392019A
intramuscular vaccination according to protocol schedule
|
|
Placebo Comparator: Group E
Not Applicable
|
Drug: Saline placebo
intramuscular vaccination according to protocol schedule
|
|
Placebo Comparator: Group F
Not Applicable
|
Drug: Saline placebo
intramuscular vaccination according to protocol schedule
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01160172 History of Changes |
| Other Study ID Numbers: | 113949 |
| Study First Received: | July 1, 2010 |
| Last Updated: | August 30, 2012 |
| Health Authority: | Belgium: Agence Fédérale des Médicaments et des Produits de la Santé |
Keywords provided by GlaxoSmithKline:
|
vaccine young adults Staphylococcus aureus |
Additional relevant MeSH terms:
|
Staphylococcal Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 23, 2013