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South Australian Meningococcal B Vaccine Herd Immunity Study (B Part of It)

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ClinicalTrials.gov Identifier: NCT03089086
Recruitment Status : Completed
First Posted : March 24, 2017
Last Update Posted : July 2, 2019
Sponsor:
Collaborator:
SA Health
Information provided by (Responsible Party):
Helen Marshall, University of Adelaide

Tracking Information
First Submitted Date  ICMJE March 17, 2017
First Posted Date  ICMJE March 24, 2017
Last Update Posted Date July 2, 2019
Actual Study Start Date  ICMJE April 1, 2017
Actual Primary Completion Date July 13, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
Prevalence of all disease causing genogroups of N. meningitidis (A, B, C, W, X, Y) [ Time Frame: 12 months ]
As measured by PCR at 12 months in vaccinated and unvaccinated year 10 and 11 school students
Original Primary Outcome Measures  ICMJE
 (submitted: March 17, 2017)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
  • Prevalence of each N. meningitidis genogroup (A, B, C, W, X, Y) [ Time Frame: 12 months ]
    As measured by PCR at the 12 month pharyngeal swab in vaccinated and unvaccinated year 10 and 11 school students
  • Prevalence of all N. meningitidis genogroups [ Time Frame: 12 months ]
    As measured by PCR at the 12 month pharyngeal swab in vaccinated and unvaccinated year 10 and 11 school students
  • Acquisition of disease causing N. meningitidis (A, B, C, W, X, Y) genogroups (negative at baseline, positive at 12 month followup) [ Time Frame: 12 months ]
    As measured by PCR in vaccinated and unvaccinated year 10 and 11 school students
  • Acquisition of all N. meningitidis [ Time Frame: 12 months ]
    As measured by PCR in vaccinated and unvaccinated year 10 and 11 school students
  • Risk factors associated with carriage prevalence of all N. meningitidis [ Time Frame: Baseline and 12 months ]
    As measured by PCR at baseline and 12 months
  • Risk factors associated with carriage prevalence of disease causing N. meningitidis [ Time Frame: Baseline and 12 months ]
    As measured by PCR at baseline and 12 months
Original Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2017)
  • 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
Current Other Pre-specified Outcome Measures
 (submitted: June 28, 2019)
  • Age specific IMD attack rates [ Time Frame: Prior to and following implementation of the intervention ]
    Age specific IMD attack rates (per 100,000 population) in all age groups in South Australia
  • Carriage density of N. meningitidis (all genogroups) [ Time Frame: Baseline and 12 months ]
    as measured by qPCR in year 10, 11 and 12 school students at baseline and 12 months
  • Description of whole genome sequences of carriage isolates [ Time Frame: Baseline and 12 months ]
    Description of whole genome sequences of isolates known to cause disease (serogroup B, W, Y, C)
  • Whole genogroup sequencing of all carriage isolates [ Time Frame: Baseline and 12 months ]
    Description of whole genome sequences of isolates
  • Vaccine uptake and carriage prevalence of all N. meningitidis. [ Time Frame: 12 months ]
    Carriage prevalence as measured by PCR
  • Vaccine uptake and carriage prevalence of disease causing N. meningitidis. [ Time Frame: 12 months ]
    Carriage prevalence as measured by PCR
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE South Australian Meningococcal B Vaccine Herd Immunity Study
Official Title  ICMJE South Australian Meningococcal B Vaccine Herd Immunity Study
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.
Detailed Description

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 carriage prevalence of disease causing genogroup of N. meningitidis (A, B, C, W, X, Y) 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 carriage prevalence of each disease causing genogroup of N. meningitidis (A, B, C, W, X, Y) following the 12 month pharyngeal swab in year 10 and 11 students who received two doses of Bexsero®, compared to unvaccinated students.
  • Estimate the difference in carriage prevalence of all genogroups of N. meningitidis following the 12 month pharyngeal swab in year 10 and 11 students who received two doses of Bexsero ®, compared to unvaccinated students.
  • Estimate the difference in acquisition (negative at baseline, positive at 12 month followup) of carriage of disease causing genogroups of N. meningitidis (A, B, C, W, X, Y) over a 12 month period in students who received two doses of Bexsero ®, compared to unvaccinated students.
  • Estimate the difference in acquisition (negative at baseline, positive at 12 month followup) of carriage of all genogroups of N. meningitidis over a 12 month period in students who received two doses of Bexsero ®, compared to unvaccinated students
  • Identify characteristics associated with carriage prevalence of all genogroups N. meningitidis in South Australian school students at baseline and 12 months.
  • Identify characteristics associated with carriage prevalence of disease causing genogroups of N. meningitidis (A, B, C, W, X, Y) in South Australian school students at baseline and 12 months.

Exploratory objectives

  • Describe changes in invasive meningococcal rates (attack rates) across all age groups pre and post 4CMenB vaccine intervention in South Australia.
  • Describe N. meningitidis carriage density in year 10, 11, and 12 students using qPCR at baseline and 12 months in both vaccinated and unvaccinated students.
  • Describe genome sequencing of N. meningitidis disease causing (A, B, C, W, X, Y) sequence types in year 10, 11, and 12 students at baseline and at 12 months.
  • In schools randomized to Group A, describe the association of carriage prevalence of disease causing genogroups and vaccine uptake at school level following implementation.
  • In schools randomized to Group A, describe the association of carriage prevalence of all N. meningitidis and vaccine uptake at school level following implementation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A cluster randomised controlled trial to assess the impact of meningococcal B vaccine 4CMenB on nasopharyngeal carriage of N. Meningitidis
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Meningococcal Disease
Intervention  ICMJE Biological: Licensed 4CMenB vaccine
Two doses (0.5 mL each) of Bexsero ® vaccine at least 1 month to <3 months apart in adolescents.
Other Name: Bexsero®
Study Arms  ICMJE
  • Active Comparator: Group A
    Students within schools randomised to group A will receive two doses of licensed 4CMenB vaccine after baseline oropharyngeal swab with an interval of 1 to 2 months between doses, with the first dose given at the baseline visit in 2017.
    Intervention: Biological: Licensed 4CMenB vaccine
  • No Intervention: Group B
    Students within schools randomised to group B will receive the licensed 4CMenB vaccine following completion of baseline and 12 month oropharyngeal swab in 2018.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2019)
34489
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2017)
44000
Actual Study Completion Date  ICMJE December 31, 2018
Actual Primary Completion Date July 13, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • South Australian secondary school students in years 10, 11, and 12 in 2017
  • Written parental consent for those under the age of 18
  • Written student consent assent for those under the age of 18 (or if 18 years old and older consent for themselves)
  • Available at school for at least the first pharyngeal swab and willing to comply with study procedures

Exclusion Criteria:

  1. Previous anaphylaxis following any component of Bexsero vaccine
  2. Previous receipt of meningococcal B vaccine (Bexsero)
  3. Known pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03089086
Other Study ID Numbers  ICMJE HREC/16/WCHN/140
ACTRN12617000079347 ( Registry Identifier: Australian New Zealand Clinical Trials Registry )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified, individual participant data underlying published results will be available.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: We estimate the data will be available from the start of 2021 for approximately 12 months.
Access Criteria: IPD will be made available on a case-by-case basis at the discretion of the International Scientific Advisory Committee and WCHN HREC. IPD data will only be available to achieve the aims in the approved proposal.
Responsible Party Helen Marshall, University of Adelaide
Study Sponsor  ICMJE University of Adelaide
Collaborators  ICMJE SA Health
Investigators  ICMJE
Principal Investigator: Helen Marshall University of Adelaide
PRS Account University of Adelaide
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP