|- candidate number||14179|
|- NTR Number||NTR3785|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-jan-2013|
|- Secondary IDs||LI-2012 Linnaeus Institute|
|- Public Title||Cross sectional cohort study to investigate meningococcal serogroup B carriage prevalence rates and aquisition rate among adolescents and young adults in the Netherlands.|
|- Scientific Title||Cross sectional cohort study to investigate meningococcal serogroup B carriage prevalence rates and aquisition rate among adolescents and young adults in the Netherlands.|
|- hypothesis||Carriage rates increase in late adolescence and early adulthood.|
|- Healt Condition(s) or Problem(s) studied||Adolescents, Prevalence, Young adults, Neisseria meningitidis, Meningococcal serogroup B carriage|
|- 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||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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||7-jan-2013|
|- planned closingdate||1-nov-2013|
|- Target number of participants||1700|
|- 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 environmental/life style factors and two (twinned) oropharyngeal swabs will be taken for group 1-4, and one oropharyngeal swab will be taken for group 5-8.
Group 1 will also be followed longitudinally at 3 and 8 months after study enrolment. More specifically, these subjects will have their first two visits during the last year of high school, and their last visit (approximately 8 months) during the autumn term of the next academic year, i.e., their first year in tertiary school. This sampling schedule will allow for covering of the transition from high school to MBO/HBO/university within the same subjects. The same procedures as during study enrolment will take place at the other two time points.
|- Primary outcome||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 outcome||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.
|- Timepoints||The estimated study duration will be approximately 10 months for group 1-4 (First Subject In in February – Last Subject Out in November 2013).|
1. The point prevalence study comprising subjects in Group 1-4 will be performed during February-March 2013;
2. The longitudinal study comprises Group 1 subjects only and the scheme will be as follows:
A. First swab at enrolment (February-March 2013);
B. Second swab 3 months later (May-June 2013);
C. Third swab 8 months later (October-November 2013).
The estimated study duration will be approximately 3 months for group 5-8 (First subject in January 2014 – Last subject in March 2014).
|- Trial web site||www.wetenschapsbureau.nl/studies|
|- CONTACT FOR PUBLIC QUERIES||Dr. M. Ravenhorst, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Veerle Struben|
|- Sponsor/Initiator ||Linnaeus Institute|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale: |
Neisseria meningitidis causes life-threatening meningitis and septicemia. Since implementation of vaccination against serogroup C meningococcal disease in the Dutch National Immunization Program for toddlers in 2002 the incidence of meningococcal disease has dropped from 11.8 to 2.2 per 100,000 in children up to the age of 19. However, this vaccine does not provide protection against non-serogroup C meningococci. At present, approximately 130 cases per year of meningococcus serotype B disease are observed in The Netherlands. However, due to the cyclical nature of the epidemiology this rate is likely to increase again in the coming decade. Currently, no vaccine against serogroup B meningococci is available on the market, but candidate vaccines are under development. If such a vaccine was demonstrated to have an impact on oropharyngeal carriage of group B meningococci, the vaccine would have the potential to induce herd immunity. This could broaden the protection it could provide to the population and improve its cost effectiveness. In order to demonstrate such an effect, it is crucial to conduct an intervention study in an age group in whom acquisition of oropharyngeal carriage is occurring. It is known that carriage rates increase in late adolescence and early adulthood but current rates in the Netherlands are not known. The aim of this study is therefore to investigate the oropharyngeal meningococcal carriage, in particular serogroup B, in adolescents and young adults aged 15-22 years. In addition, we will assess the rate of acquisition of serogroup B meningococci in adolescents during transition from high school to tertiary school (MBO/HBO/university).
To investigate meningococcal serogroup B carriage prevalence rates and acquisition rate among adolescents and young adults in the Netherlands.
Cross sectional observational cohort study in four subject cohorts of which one cohort is also followed longitudinally.
Adolescents and young adults in the last two years of high school and the first two years of tertiary school (MBO/HBO/university) in the Netherlands. It is targeted to enrol 900 subjects, distributed over 4 subject cohorts, approximately as follows:
Group 1: 300 students who are in their last year of high school and who plan to attend a tertiary school during the subsequent academic year.
Group 2: 200 students, who are in the year before the last year of high school.
Group 3: 200 students who are in their first year of tertiary school (MBO/HBO/university).
Group 4: 200 students who are in the second year of tertiary school (MBO/HBO/university).
Group 5: 200 student who are in their second year of high school; 100 havo and 100 vwo.
Group 6: 200 students who are in their third year of high school; 100 havo and 100 vwo.
Group 7: 200 students who are in their fourth year of high school; 100 havo and 100 vwo.
Group 8: 200 students who are in their fifth year of high school; 100 havo and 100 vwo.
Group 1 (n=300) will also be followed longitudinally approximately 3 and 8 months after study enrolment.
Main study parameters/endpoints:
Meningococcal serogroup B carriage in adolescents and young adults and acquisition of serogroup B meningococci in adolescents during transition from high school to tertiary school (MBO/HBO/university) in the Netherlands.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
|- Main changes (audit trail)|
|- RECORD||7-jan-2013 - 2-feb-2014|