N. Meningitidis Carriage Study

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Infections, Meningococcal

Treatments: Procedure: Posterior pharyngeal swab; Other: Data collection

Study type: Observational

Funder types: Industry

Identifiers

NCT01808365

114991

Details and patient eligibility

About

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.

Enrollment: 1,000 patients

Sex: All

Ages: 5 to 24 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,000 participants in 1 patient group

Study cohort

Treatment:

Other: Data collection

Procedure: Posterior pharyngeal swab