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In this study, two experimental malaria vaccines (with adjuvants) are tested to evaluate and characterise how the vaccine exactly works on the immune system by comparing it to a control (without adjuvant). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Experimental |
| |
| Group C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK Malaria vaccine 257049 | Biological | Three-dose vaccination by slow intramuscular injection. Three different formulations of this vaccine are tested (without adjuvant, with adjuvant AS01B, with adjuvant AS02A). |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-CS antibody titers. | One month post Dose 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence, intensity and relationship to vaccination of solicited local and general symptoms. | During the 7-day follow-up period following vaccination after each vaccine dose. | |
| Occurrence, intensity and relationship to vaccination of unsolicited symptoms. |
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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 | Ghent | 9000 | Belgium |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 107731 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| During the 30-day follow-up period following vaccination after each vaccine dose. |
| Occurrence of serious adverse events. | Up until 1 month post dose 3. |
| Antibody responses to the P. falciparum circumsporozoite (CS) antigen. | At Day 0, prior to dose 2, prior to dose 3 and 1 month post-dose 3. |
| Antibody responses to HBs antigen. | At Day 0, prior to dose 2, prior to dose 3 and 1 month post-dose 3 |
| Frequency of CS and Hepatitis B surface agent (HBs)-specific CD4+ and CD8+ T cells expressing Th1 specific activation markers and cytokines. | At Day 0, prior to dose 2, prior to dose 3 and 1 month post-dose 3 |
For additional information about this study please refer to the GSK Clinical Study Register |
| 107731 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107731 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107731 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107731 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107731 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D000079426 |
| Vector Borne Diseases |