N. Meningitidis Carriage Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-02

Study Completion Date

2014-03-25

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.

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Detailed Description

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Conditions

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Infections, Meningococcal

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Study cohort

Posterior pharyngeal swab

Intervention Type PROCEDURE

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

Data collection

Intervention Type OTHER

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

Interventions

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Posterior pharyngeal swab

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

Intervention Type PROCEDURE

Data collection

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

Intervention Type OTHER

Other Intervention Names

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Throat swab

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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Manila, , Philippines

Site Status

Countries

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Philippines

Study Documents

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