Infections, Meningococcal
Conditions
Keywords
Neisseria meningitidis, Philippines, carriage, meningococcus
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.
Interventions
PROCEDUREPosterior pharyngeal swab
Posterior pharyngeal swabs will be tested for the presence of N. meningitidis.
OTHERData collection
Collection of socio-demographic data and recording of serious adverse events by interview of subjects or subjects' parents/legally acceptable representatives.
Sponsors
GlaxoSmithKline
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
5 Years to 24 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessing the carriage prevalence of N.meningitidis using posterior pharyngeal swabs | At enrollment (Day 0) |
Secondary
| Measure | Time frame |
|---|---|
| The serogroup (determined by Polymerase Chain Reaction) of any isolated N. Meningitidis colonies | At enrollment (Day 0) |
| Further characterization of any carried N. meningitidis using Multi Locus Sequence Typing | At enrollment (Day 0) |
Countries
Philippines
Outcome results
None listed