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N. Meningitidis Carriage Study

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ClinicalTrials.gov Identifier: NCT01808365
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Infections, Meningococcal Procedure: Posterior pharyngeal swab Other: Data collection

Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Neisseria Meningitidis Carriage Study
Actual Study Start Date : August 2, 2013
Actual Primary Completion Date : March 25, 2014
Actual Study Completion Date : March 25, 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Study cohort Procedure: Posterior pharyngeal swab
Posterior pharyngeal swabs will be tested for the presence of N. meningitidis.
Other Name: Throat swab

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




Primary Outcome Measures :
  1. Assessing the carriage prevalence of N.meningitidis using posterior pharyngeal swabs [ Time Frame: At enrollment (Day 0) ]

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

Biospecimen Retention:   Samples With DNA
Throat swab


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Ages Eligible for Study:   5 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy subjects aged between 5 and 24 years attending a school or university in the Philippines.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808365


Locations
Philippines
GSK Investigational Site
Manila, Philippines
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 114991
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 114991
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 114991
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 114991
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 114991
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 114991
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 114991
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01808365     History of Changes
Other Study ID Numbers: 114991
First Posted: March 11, 2013    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: http://

Keywords provided by GlaxoSmithKline:
Neisseria meningitidis
Philippines
carriage
meningococcus

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections