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The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of several formulations of an investigational Staphylococcal vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
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| Group B | Experimental |
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| Group C | Experimental |
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| Group D | Experimental |
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| Group E | Placebo Comparator |
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| Group F | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Staphylococcal investigational vaccine GSK2392103A | Biological | intramuscular vaccination according to protocol schedule |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 | |
| Occurrence of any Serious Adverse events (SAE) in all subjects, in all vaccine groups. | From first vaccination (Day 0) to study conclusion (Day 540) | |
| 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) | |
| Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. | Prior to each vaccine dose | |
| Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. | 1 day after each vaccine dose | |
| Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. | 7 days after each vaccine dose | |
| Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. | 29/30 days after each vaccine dose | |
| Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | |
| Colonisation with Staphylococcus aureus in all subjects, in all vaccine groups. |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | La Louvière | 7100 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25715157 | Derived | Levy J, Licini L, Haelterman E, Moris P, Lestrate P, Damaso S, Van Belle P, Boutriau D. Safety and immunogenicity of an investigational 4-component Staphylococcus aureus vaccine with or without AS03B adjuvant: Results of a randomized phase I trial. Hum Vaccin Immunother. 2015;11(3):620-31. doi: 10.1080/21645515.2015.1011021. |
| Label | URL |
|---|---|
| Results for study 113949 can be found on the GSK Clinical Study Register | View source |
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| Staphylococcal investigational vaccine GSK2392105A | Biological | intramuscular vaccination according to protocol schedule |
|
| Staphylococcal investigational vaccine GSK2392106A | Biological | intramuscular vaccination according to protocol schedule |
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| Staphylococcal investigational vaccine GSK2392019A | Biological | intramuscular vaccination according to protocol schedule |
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| Saline placebo | Drug | intramuscular vaccination according to protocol schedule |
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| 6 months after the last vaccine dose |
| Occurrence of haematological, biochemical or urinary laboratory abnormalities in all subjects, in all vaccine groups. | 12 months after the last vaccine dose |
| At Screening (pre-Day 0) and at Days 0, 30, 60, 180, 210 and 540. |
| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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