Clinical Trial: South Australian Meningococcal B Vaccine Herd Immunity Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: South Australian Meningococcal B Vaccine Herd Immunity Study

Brief Summary: To estimate the effect on carriage, approximately 60,000 year 10, 11, and 12 students will be offered 4CMenB vaccination in South Australia through schools over the study period with 50% 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 serogroups of N. meningitidis and serogroup B between vaccinated and unvaccinated participants.

Detailed Summary:

This cluster randomised controlled study will be conducted in the context of funded 4CMenB vaccine offered to all students in years 10, 11, and 12.

Year 10 and 11 students will undergo baseline and 12 months posterior pharyngeal swabs. Year 12 students will undergo baseline posterior pharyngeal swabs only.

Randomisation will take place at the school level and will be stratified by school size ((<60, 60 to 119, and ≥120 students per year level) and school socio-economic status (SES), as measured by the Index of Community Socio-Educational Advantage (ICSEA); (ICSEA <970, 970 to 1020, >1020) For the purposes of the study a school is defined as an educational institution at which students in years 10, 11, 12 physically attend school during the week. All 260 schools in metropolitan and rural SA will be approached to participate in the study. All schools agreeing to participate will be randomised to 4CMenB vaccine in 2017 or 2018. Students at schools randomised to receive the vaccine at baseline will receive the 4CMenB vaccine in 2017. Students at schools randomised to receive the vaccine at the 12 month posterior pharyngeal swab will receive the 4CMenB vaccine in 2018.

Primary Objectives

• Estimate the difference in all serogroups of N. meningitidis carriage prevalence following the 12 month pharyngeal swab in year 10 and 11 students who received two doses of Bexsero®, compared to unvaccinated students.

Secondary objectives

• Estimate the difference in each N. meningitidis serogroup (A, B, C, W, Y) carriage prevalence following the 12 month pharyngeal swab in year 10 and 11 st
  Sponsor: University of Adelaide
  

  Current Primary Outcome: Prevalence of all serogroups of N. meningitidis [ Time Frame: 12 months ]

  As measured by PCR in vaccinated and unvaccinated year 10 and 11 school students
  
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:

  • Prevalence of each N. meningitidis serogroup (A, B, C, W, Y) [ Time Frame: 12 months ]
    As measured by PCR in vaccinated and unvaccinated year 10 and 11 school students
  • Prevalence of all N. meningitidis serogroups over a 12 month period (baseline vs 12 month swabs) [ Time Frame: Baseline and 12 months ]
    As measured by PCR in vaccinated and unvaccinated year 10 and 11 school students
  • Prevalence of each N. meningitidis serogroup (A, B, C, W, Y) over a 12 month period (baseline vs 12 month swabs) [ Time Frame: Baseline and 12 months ]
    As measured by PCR in vaccinated and unvaccinated year 10 and 11 school students
  • Density of N. meningitidis (all serogroups) [ Time Frame: Baseline and 12 months ]
    Quantitative PCR (qPCR) in vaccinated and unvaccinated year 10 and 11 school students
  • Prevalence of each N. meningitidis serogroup at baseline [ Time Frame: Baseline ]
    As measured by PCR in year 10, 11, and 12 school students
  
  
  

  Original Secondary Outcome: Same as current
  
  Information By: University of Adelaide
  

  Dates:
  Date Received: March 17, 2017
  Date Started: April 1, 2017
  Date Completion: July 31, 2020
  Last Updated: March 17, 2017
  Last Verified: March 2017