N. Meningitidis Carriage Study

Infections, Meningococcal Clinical Trial

Official title:

Neisseria Meningitidis Carriage Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01808365
• Other study ID #: 114991
• Status: Completed
• Phase: N/A
• First received: March 7, 2013
• Last updated: March 8, 2018
• Start date: August 2, 2013
• Est. completion date: March 25, 2014

Study information

• Verified date: March 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: March 25, 2014
• Est. primary completion date: March 25, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infections, Meningococcal
• Meningococcal Infections

Intervention

Procedure:
• Posterior pharyngeal swab
Posterior pharyngeal swabs will be tested for the presence of N. meningitidis.

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

Locations

Country	Name	City	State
Philippines	GSK Investigational Site	Manila

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing the carriage prevalence of N.meningitidis using posterior pharyngeal swabs		At enrollment (Day 0)
Secondary	The serogroup (determined by Polymerase Chain Reaction) of any isolated N. Meningitidis colonies		At enrollment (Day 0)
Secondary	Further characterization of any carried N. meningitidis using Multi Locus Sequence Typing		At enrollment (Day 0)

External Links

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