N. Meningitidis Carriage Study

Completed

• Conditions: Infections, Meningococcal
• Interventions: Procedure: Posterior pharyngeal swab; Other: Data collection

• Registration Number: NCT01808365
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-07
• Study First Submitted QC: 2013-03-07
• Study First Posted: 2013-03-11
• Study Start: 2013-08-02
• Primary Completion: 2014-03-25
• Study Completion: 2014-03-25
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-08
• Last Update Posted: 2018-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study cohort	Posterior pharyngeal swab	-
Study cohort	Data collection	-

Primary Outcome Measures

Name	Time	Method
Assessing the carriage prevalence of N.meningitidis using posterior pharyngeal swabs	At enrollment (Day 0)

Secondary Outcome Measures

Name	Time	Method
Further characterization of any carried N. meningitidis using Multi Locus Sequence Typing	At enrollment (Day 0)
The serogroup (determined by Polymerase Chain Reaction) of any isolated N. Meningitidis colonies	At enrollment (Day 0)

Trial Locations

Locations (1)

GSK Investigational Site; 🇵🇭 Manila, Philippines