Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Neisseria meningitidis carriage study
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Assessing the carriage prevalence of N.meningitidis using posterior pharyngeal swabs
Timeframe: At enrollment (Day 0)
Secondary outcomes:
The serogroup (determined by Polymerase Chain Reaction) of any isolated N. Meningitidis colonies
Timeframe: At enrollment (Day 0)
Further characterization of any carried N. meningitidis using Multi Locus Sequence Typing
Timeframe: At enrollment (Day 0)
Interventions:
Procedure/surgery: Posterior pharyngeal swab
Other: Data collection
Enrollment:
1000
Observational study model:
Case-Only
Primary completion date:
2014-25-03
Time perspective:
Cross-Sectional
Clinical publications:
Gonzales ML et al. (2017) Meningococcal carriage in children and young adults in the Philippines: a single group, cross-sectional study. Epidemiol Infect. 145(1):126–132.
Medical condition
Infections, Meningococcal
Product
GSK2647155A
Collaborators
Not applicable
Study date(s)
August 2013 to March 2014
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
5 - 24 years
Accepts healthy volunteers
Yes
- 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.
- Subjects who have received a meningococcal conjugate vaccine.
- Use of any investigational or non-registered product within one week before the enrollment visit.
Inclusion and exclusion criteria
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 location(s)
Study documents
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2014-25-03
Actual study completion date
2014-25-03
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
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