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Completed

NCT Number: NCT01808365

N. 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.

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Key information

Conditions

Infections, Meningococcal Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Meningococcal Infections Neisseriaceae Infections

Age range

5 year–24 year

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Manila, Philippines

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Posterior pharyngeal swab

Procedure

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

Other names: Throat swab

Data Collection

Other

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

Primary outcomes

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

    Time frame: At enrollment (Day 0)

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Neisseria Meningitidis Carriage Study

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 11, 2013
Registry last updated
Mar 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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