N. Meningitidis Carriage Study

NCT01808365 | Completed

• 1 other identifier: 114991
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Infections, Meningococcal

Keywords

Neisseria meningitidis; Philippines; carriage; meningococcus

Outcome Measures

Primary Outcomes (1)

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

  At enrollment (Day 0)

Secondary Outcomes (2)

• 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)

Study Arms (1)

Study cohort

Procedure: Posterior pharyngeal swab; Other: Data collection

Interventions

Posterior pharyngeal swab PROCEDURE

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

Also known as: Throat swab

Study cohort

Data collection OTHER

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

Study cohort

Eligibility Criteria

• Age: 5 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects aged between 5 and 24 years attending a school or university in the Philippines.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Manila, Philippines

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Biospecimen

Retention: SAMPLES WITH DNA

Throat swab

MeSH Terms

Conditions

Meningococcal Infections

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2013
• First Posted: March 11, 2013
• Study Start: August 2, 2013
• Primary Completion: March 25, 2014
• Study Completion: March 25, 2014
• Last Updated: March 9, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share

Locations

PH (1)