Status:
COMPLETED
N. Meningitidis Carriage Study
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Meningococcal
Eligibility:
All Genders
5-24 years
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 2 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 25 2014
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT01808365
Start Date
August 2 2013
End Date
March 25 2014
Last Update
March 9 2018
Active Locations (1)
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1
GSK Investigational Site
Manila, Philippines