N. Meningitidis Carriage Study

Study Overview
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Brief Summary
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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.

Official Title
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Neisseria Meningitidis Carriage Study

Conditions
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Infections, Meningococcal

Intervention / Treatment
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* Procedure: Posterior pharyngeal swab
* Other: Data collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who the investigator believes can and will comply with the requirements of the protocol or subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol. Written informed consent obtained from the subject/from the parent(s)/LAR of the subject. Asymptomatic subjects attending a school or university. A male or female between, and including 5 and 24 years of age at the time of enrollment. Exclusion Criteria: Subjects who have received a meningococcal conjugate vaccine. Use of any investigational or non-registered product within one week before the enrollment visit. Acute respiratory tract infection within 14 days of sample collection. Immune deficiencies, haematological disorders and oncological disease. Use of steroids or immunosuppressant drugs within 14 days of sample collection. Administration of antibiotics within the 2 weeks preceding the collection of sample. Cranio-facial malformations prohibiting the collection of posterior pharyngeal swabs. Child in care.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study cohort<br> | Procedure: Posterior pharyngeal swab<br>* Posterior pharyngeal swabs will be tested for the presence of N. meningitidis.<br>* Other names: Throat swab;Other: Data collection<br>* Collection of socio-demographic data and recording of serious adverse events by interview of subjects or subjects' parents/legally acceptable representatives.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing the carriage prevalence of N.meningitidis using posterior pharyngeal swabs |  | At enrollment (Day 0) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neisseria meningitidis, Philippines, carriage, meningococcus