Oropharyngeal meningococcal carriage. Meningococci have the potential to cause invasive meningococcal disease. This study investigates the ability of Meningococcal B vaccines to reduce the carriage of meningococci. MedDRA version: 20.0 Level: PT Classification code 10027249 Term: Meningitis meningococcal System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0
Conditions
Sponsors
Clinical Trials and Research Governance (CTRG), University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or Female, aged 16-18 years attending year 12 (or equivalent) at one of the participating schools. • Participant is willing and able to give informed consent for participation • In the Investigator’s opinion, is able and willing to comply with all trial requirements. • Willing to have bacterial isolates from throat swabs stored for future research in ethically approved studies • Willing to allow his or her General Practitioner, to be contacted to confirm vaccination status if necessary. . Are the trial subjects under 18? yes Number of subjects for this age range: 24000 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: The participant may not enter the trial if ANY of the following apply: • Evidence of a course of either 4CMenB or MenB-fHBP in the past (documentation or self-report) • History of anaphylaxis to any component of 4CMenB or MenB-fHBP • Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participants ability to participate. • Participant is known to be pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if immunisation with 4CMenB (Bexsero) or MenB-fHBP (Trumenba) influences the carriage of pathogenic meningococci.;Secondary Objective: To determine the broader impact of immunisation with either 4CMenB (Bexsero) or MenB-fHBP (Trumenba) on meningococcal species.;Primary end point(s): Rates of carriage prevalence of any of meningococci genogroup B, C, W , X and Y before and after immunisation in both immunisation cohorts, compared with unimmunised controls;Timepoint(s) of evaluation of this end point: This will be evaluated at baseline, and again at 12 months post baseline for each participant. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Rates of carriage prevalence of particular Neisseria before and after immunisation in both immunisation cohorts, compared with controls, specifically: a. Serogroup B meningococci b. Hyper-invasive meningococcal strains c. All meningococcal strains d. Other Neisseria species e. Meningococci of other non B serogroups and capsule null meningococci f. Meningococci expressing antigens contained in 4CMenB and rLP2086 The difference in acquisition of carriage of all N. meningitidis over a 12 month period in both immunised cohorts compared to unvaccinated students ;Timepoint(s) of evaluation of this end point: This will be evaluated at baseline, and again at 12 months post baseline for each participant. | — |
Countries
United Kingdom
Contacts
Public ContactDr Matthew Snape
University of Oxford
Outcome results
None listed