N. Meningitidis Carriage Study

GlaxoSmithKline1,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Infections, Meningococcal

Interventions

Posterior pharyngeal swabPROCEDURE

Posterior pharyngeal swabs will be tested for the presence of N. meningitidis.

Data collectionOTHER

Collection of socio-demographic data and recording of serious adverse events by interview of subjects or subjects' parents/legally acceptable representatives.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 24 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

GSK Investigational Site

Manila, Philippines

Outcomes

Primary Outcomes

Assessing the carriage prevalence of N.meningitidis using posterior pharyngeal swabs

Time frame: At enrollment (Day 0)

Secondary Outcomes

The serogroup (determined by Polymerase Chain Reaction) of any isolated N. Meningitidis colonies

Time frame: At enrollment (Day 0)

Further characterization of any carried N. meningitidis using Multi Locus Sequence Typing

Time frame: At enrollment (Day 0)

Data from ClinicalTrials.gov

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