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The study has been stopped for logistic reasons not related to the safety or efficacy of the vaccine.
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The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK2231395A candidate vaccine in adults and elderly adults with chronic obstructive pulmonary disease. Subjects will be vaccinated 3 times with an interval of respectively 2 and 10 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2231395A | Biological | 3 doses intramuscular injections |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence, intensity and relationship of adverse events after each vaccine dose. | Defined period in function of the measured parameter | |
| Occurrence of any vaccine-related serious adverse events | Throughout the study | |
| Occurrence of any adverse event of specific interest | Throughout the study |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the disease progression of subjects receiving the candidate vaccine versus subjects receiving the comparator vaccine. | Defined time points in function of the measured parameter | |
| Evaluation of antibody responses against candidate vaccine antigens. |
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Inclusion Criteria:
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 | Halifax | Nova Scotia | B3K 6R8 | Canada |
| ID | Term |
|---|---|
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| TwinrixTM |
| Biological |
3 doses intramuscular injections |
|
| Defined time points in function of the measured parameter |
| Evaluation of the clinical outcomes of subjects receiving the candidate vaccine versus subjects receiving the comparator vaccine. | Defined time points in function of the measured parameter |
| D007239 | Infections |