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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03089086
Registration number
NCT03089086
Ethics application status
Date submitted
17/03/2017
Date registered
24/03/2017
Titles & IDs
Public title
South Australian Meningococcal B Vaccine Herd Immunity Study
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Scientific title
South Australian Meningococcal B Vaccine Herd Immunity Study
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Secondary ID [1]
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ACTRN12617000079347
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Secondary ID [2]
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HREC/16/WCHN/140
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Universal Trial Number (UTN)
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Trial acronym
B Part of It
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Meningococcal Disease
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Condition category
Condition code
Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Licensed 4CMenB vaccine
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.
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.
Treatment: Other: Licensed 4CMenB vaccine
Two doses (0.5 mL each) of Bexsero ® vaccine at least 1 month to \<3 months apart in adolescents.
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Prevalence of all disease causing genogroups of N. meningitidis (A, B, C, W, X, Y)
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Assessment method [1]
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As measured by PCR at 12 months in vaccinated and unvaccinated year 10 and 11 school students
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Timepoint [1]
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12 months
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Secondary outcome [1]
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Prevalence of each N. meningitidis genogroup (A, B, C, W, X, Y)
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Assessment method [1]
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As measured by PCR at the 12 month pharyngeal swab in vaccinated and unvaccinated year 10 and 11 school students
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Timepoint [1]
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12 months
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Secondary outcome [2]
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Prevalence of all N. meningitidis genogroups
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Assessment method [2]
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As measured by PCR at the 12 month pharyngeal swab in vaccinated and unvaccinated year 10 and 11 school students
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Timepoint [2]
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12 months
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Secondary outcome [3]
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Acquisition of disease causing N. meningitidis (A, B, C, W, X, Y) genogroups (negative at baseline, positive at 12 month followup)
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Assessment method [3]
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As measured by PCR in vaccinated and unvaccinated year 10 and 11 school students
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Timepoint [3]
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12 months
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Secondary outcome [4]
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Acquisition of all N. meningitidis
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Assessment method [4]
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As measured by PCR in vaccinated and unvaccinated year 10 and 11 school students
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Timepoint [4]
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12 months
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Secondary outcome [5]
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Risk factors associated with carriage prevalence of all N. meningitidis
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Assessment method [5]
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As measured by PCR at baseline and 12 months
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Timepoint [5]
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Baseline and 12 months
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Secondary outcome [6]
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Risk factors associated with carriage prevalence of disease causing N. meningitidis
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Assessment method [6]
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As measured by PCR at baseline and 12 months
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Timepoint [6]
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Baseline and 12 months
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Eligibility
Key inclusion criteria
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
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Minimum age
14
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Previous anaphylaxis following any component of Bexsero vaccine
2. Previous receipt of meningococcal B vaccine (Bexsero)
3. Known pregnancy
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/12/2018
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Sample size
Target
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Accrual to date
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Final
34489
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Vaccinology & Immunology Research Trials Unit - North Adelaide
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Recruitment postcode(s) [1]
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5006 - North Adelaide
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Adelaide
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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SA Health
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT03089086
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Trial related presentations / publications
Marshall HS, McMillan M, Koehler A, Lawrence A, MacLennan JM, Maiden MCJ, Ramsay M, Ladhani SN, Trotter C, Borrow R, Finn A, Sullivan T, Richmond P, Kahler CM, Whelan J, Vadivelu K. B Part of It protocol: a cluster randomised controlled trial to assess the impact of 4CMenB vaccine on pharyngeal carriage of Neisseria meningitidis in adolescents. BMJ Open. 2018 Jul 10;8(7):e020988. doi: 10.1136/bmjopen-2017-020988. McMillan M, Wang B, Koehler AP, Sullivan TR, Marshall HS. Impact of Meningococcal B Vaccine on Invasive Meningococcal Disease in Adolescents. Clin Infect Dis. 2021 Jul 1;73(1):e233-e237. doi: 10.1093/cid/ciaa1636. Marshall HS, Koehler AP, Wang B, A'Houre M, Gold M, Quinn H, Crawford N, Pratt N, Sullivan TR, Macartney K. Safety of meningococcal B vaccine (4CMenB) in adolescents in Australia. Vaccine. 2020 Aug 18;38(37):5914-5922. doi: 10.1016/j.vaccine.2020.07.009. Epub 2020 Jul 22. McMillan M, Walters L, Sullivan T, Leong LEX, Turra M, Lawrence A, Koehler AP, Finn A, Andrews RM, Marshall HS. Impact of Meningococcal B (4CMenB) Vaccine on Pharyngeal Neisseria meningitidis Carriage Density and Persistence in Adolescents. Clin Infect Dis. 2021 Jul 1;73(1):e99-e106. doi: 10.1093/cid/ciaa610. Marshall HS, McMillan M, Koehler AP, Lawrence A, Sullivan TR, MacLennan JM, Maiden MCJ, Ladhani SN, Ramsay ME, Trotter C, Borrow R, Finn A, Kahler CM, Whelan J, Vadivelu K, Richmond P. Meningococcal B Vaccine and Meningococcal Carriage in Adolescents in Australia. N Engl J Med. 2020 Jan 23;382(4):318-327. doi: 10.1056/NEJMoa1900236.
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Public notes
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Contacts
Principal investigator
Name
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Helen Marshall
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Address
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University of Adelaide
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified, individual participant data underlying published results will be available.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
We estimate the data will be available from the start of 2021 for approximately 12 months.
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Available to whom?
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.
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03089086