N. Meningitidis Carriage Study

March 8, 2018 updated by: GlaxoSmithKline

Neisseria Meningitidis Carriage Study

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 Overview

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Manila, Philippines
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study cohort
Posterior pharyngeal swabs will be tested for the presence of N. meningitidis.
Other Names:
  • Throat swab
Collection of socio-demographic data and recording of serious adverse events by interview of subjects or subjects' parents/legally acceptable representatives.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2013

Primary Completion (Actual)

March 25, 2014

Study Completion (Actual)

March 25, 2014

Study Registration Dates

First Submitted

March 7, 2013

First Submitted That Met QC Criteria

March 7, 2013

First Posted (Estimate)

March 11, 2013

Study Record Updates

Last Update Posted (Actual)

March 9, 2018

Last Update Submitted That Met QC Criteria

March 8, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Statistical Analysis Plan
    Information identifier: 114991
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Study Protocol
    Information identifier: 114991
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Dataset Specification
    Information identifier: 114991
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Annotated Case Report Form
    Information identifier: 114991
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Clinical Study Report
    Information identifier: 114991
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Individual Participant Data Set
    Information identifier: 114991
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Informed Consent Form
    Information identifier: 114991
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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