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This carriage study aims to evaluate the presence of meningococcus in Asian populations (and potential for disease) and explore the extent and serogroup distribution of meningococci circulating in the population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posterior pharyngeal swab | Procedure | Posterior pharyngeal swabs will be tested for the presence of N. meningitidis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessing the carriage prevalence of N.meningitidis using posterior pharyngeal swabs | At enrollment (Day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| The serogroup (determined by Polymerase Chain Reaction) of any isolated N. Meningitidis colonies | At enrollment (Day 0) | |
| Further characterization of any carried N. meningitidis using Multi Locus Sequence Typing | At enrollment (Day 0) |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy subjects aged between 5 and 24 years attending a school or university in the Philippines.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Manila | Philippines |
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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 |
|---|---|---|---|
| 114991 | 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 |
|---|---|
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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Throat swab
| Data collection | Other | Collection of socio-demographic data and recording of serious adverse events by interview of subjects or subjects' parents/legally acceptable representatives. |
|
For additional information about this study please refer to the GSK Clinical Study Register |
| 114991 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114991 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114991 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114991 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114991 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114991 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D007239 | Infections |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |