South Australian Meningococcal B Vaccine Herd Immunity Study
NCT03089086 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34489
Last updated 2019-07-02
Summary
To estimate the effect on carriage, all year 10, 11, and 12 students will be offered 4CMenB vaccination in South Australia through schools over the study period with 50% of the students enrolled receiving the vaccine in 2017 and 50% in 2018. In year 10 and 11 students, posterior pharyngeal swabs will be obtained at baseline and 12 months post baseline to estimate the difference in carriage prevalence of all genogroups of N. meningitidis between vaccinated and unvaccinated participants.
Conditions
- Meningococcal Disease
Interventions
- BIOLOGICAL
-
Licensed 4CMenB vaccine
Two doses (0.5 mL each) of Bexsero ® vaccine at least 1 month to \<3 months apart in adolescents.
Sponsors & Collaborators
-
SA Health
collaborator OTHER -
University of Adelaide
lead OTHER
Principal Investigators
-
Helen Marshall · University of Adelaide
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 14 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-04-01
- Primary Completion
- 2018-07-13
- Completion
- 2018-12-31
Countries
- Australia
Study Locations
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