None listed
Conditions
Brief 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.
Interventions
Group A - 2017
Students within schools randomised to group A will receive two doses of 0.5ml of the licensed 4CMenB vaccine administered by intramuscular injection in 2017, with an interval of 1-2 months between doses, as per the Australian Technical Advisory Group on Immunisation recommendations. An oropharyngeal swab will be collected at baseline and at 12 months.
Group B - 2018
Students within schools randomised to group B will receive two doses of 0.5ml of the licensed 4CMenB vaccine admini
Group A - 2017 Students within schools randomised to group A will receive two doses of 0.5ml of the licensed 4CMenB vaccine administered by intramuscular injection in 2017, with an interval of 1-2 months between doses, as per the Australian Technical Advisory Group on Immunisation recommendations. An oropharyngeal swab will be collected at baseline and at 12 months. Group B - 2018 Students within schools randomised to group B will receive two doses of 0.5ml of the licensed 4CMenB vaccine administered by intramuscular injection in 2018, with an interval of 1-2 months between doses. Following completion of baseline and 12 month oropharyngeal swab.
Sponsors
The University of Adelaide
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
14 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
1. South Australian secondary school students in years 10, 11, and 12 in 2017 2. Written parental consent for those under the age of 18 3. Written student consent-assent for those under the age of 18 (or if 18 years old and older consent for themselves) 4. Available at school for at least the first pharyngeal swab
Exclusion criteria
1. Previous recipient of 4CMenB vaccine (Bexsero) 2. Known pregnancy 3. Anaphylaxis following any component of the 4CMenB vaccine
Outcome results
None listed