Meningococcal serogroup B carriage, Prevalence rates, Adolescents, Young adults, Neisseria meningitidis
Conditions
Interventions
During study enrolment (after giving informed consent), all subjects from all groups will undergo two procedures. The subjects will be interviewed by a research nurse to complete the questionnaire on
Sponsors
Linnaeus Institute.
Eligibility
Inclusion criteria
Inclusion criteria: Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study. Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study: 1. Adolescents and young adults aged 13-22 years; 2. Students in second, third an last two years of high school or first or second year of tertiary school (MBO/HBO/university); 3. For subjects aged 16 years and over willing and able to comprehend and give written informed consent. For subjects aged 15 years, the parents/guardian willing and able to comply with study requirements and give consent, and the child is able to comply with study requirements and willing to give assent, as appropriate to age; 4. Subjects who are willing and able to comply with scheduled visit(s), and other study procedures; 5. Available for entire study period (only for group 1). For the longitudinal study: 1. With the intention to go to MBO/HBO/university in the next academic year in the Netherlands.
Exclusion criteria
Exclusion criteria: 1. Any severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry in this study; 2. Antibiotic use during last month before study start; 3. Previously immunized at any point with any meningococcal serogroup B vaccine; 4. Participation in a clinical trial with an investigational drug in the 4 weeks prior to study entry and/or concomitantly with this study; 5. Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate meningococcal group B (MnB) oropharyngeal carriage prevalence rates at each time point among adolescents and young adults, as determined by PCR testing of cultured isolates (“isolate PCR”). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To estimate MnB oropharyngeal carriage prevalence rates at each time point among adolescents and young adults, as determined by PCR testing of the sample transport medium in which the swab was suspended (“direct swab PCR”); 2. To estimate the proportion of subjects with changes in MnB carriage status (as determined by isolate PCR and/or by direct swab PCR) in adolescents during the transition from high (secondary) school to tertiary school (MBO/HBO/university), i.e. prevalence rates in the last year of high school and in first year (approximately 3 and 8 months following study enrolment) of tertiary school will be estimated within the same cohort (group 1); 3. To estimate the prevalence of overall meningococcal carriage that is not group B (non-MnB) at each time point among adolescents and young adults, as determined by isolate PCR; 4. To describe the factor H binding protein (fHBP) variants present in the MnB isolates detected. | — |
Contacts
Public ContactM. Ravenhorst, van
Linnaeus Institute Spaarne Hospital PO box 770
Outcome results
None listed