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Trial registered on ANZCTR


Registration number
ACTRN12617000079347
Ethics application status
Approved
Date submitted
8/01/2017
Date registered
16/01/2017
Date last updated
13/08/2019
Date data sharing statement initially provided
3/07/2019
Date results information initially provided
3/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
South Australian Meningococcal B Vaccine Herd Immunity Study in Adolescents
Scientific title
A cluster randomised controlled trial to assess the impact of meningococcal B vaccine 4CMenB on nasopharyngeal carriage of N. Meningitidis in adolescents in South Australia
Secondary ID [1] 291747 0
ClinicalTrials.gov Identifier: NCT03089086
Universal Trial Number (UTN)
Trial acronym
B Part of It
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Invasive Meningococcal disease 301180 0
Neisseria meningitides nasopharyngeal carriage 301561 0
Condition category
Condition code
Infection 300935 300935 0 0
Studies of infection and infectious agents
Public Health 301274 301274 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 296535 0
Prevention
Comparator / control treatment
Group B - 2018
Students within schools randomised to group B will receive the licensed 4CMenB vaccine following completion of baseline and 12 month oropharyngeal swab in 2018.
Control group
Active

Outcomes
Primary outcome [1] 300356 0
Prevalence of all disease causing genogroups of N. meningitidis (A, B, C, W, X, Y) as measured by PCR at 12 months in vaccinated and unvaccinated year 10 and 11 school students.
Timepoint [1] 300356 0
One year after baseline visit
Secondary outcome [1] 329772 0
Prevalence of each N. meningitidis genogroup (A, B, C, W, X, Y) as measured by PCR at the 12 month pharyngeal swab in vaccinated and unvaccinated year 10 and 11 high school students.
Timepoint [1] 329772 0
One year after baseline visit
Secondary outcome [2] 330602 0
Prevalence of all N. meningitidis genogroups as measured by PCR at the 12 month pharyngeal swabs in vaccinated and unvaccinated year 10 and 11 school students
Timepoint [2] 330602 0
One year after baseline visit
Secondary outcome [3] 330603 0
Acquisition of disease causing N. meningitidis (A, B, C, W, X, Y) genogroups (negative at baseline, positive at 12 month followup) as measured by PCR in vaccinated and unvaccinated year 10 and 11 school students.
Timepoint [3] 330603 0
One year after baseline visit
Secondary outcome [4] 372216 0
Acquisition of all N. meningitidis as measured by PCR in vaccinated and unvaccinated year 10 and 11 school students.
Timepoint [4] 372216 0
12 months
Secondary outcome [5] 372217 0
Risk factors associated with carriage prevalence of disease causing N. meningitidis at baseline and 12 months. Risk factors were collected using a study-specific questionnaire.
Timepoint [5] 372217 0
Baseline and 12 months
Secondary outcome [6] 372218 0
Risk factors associated with carriage prevalence of all N. meningitidis at baseline and 12 months. Risk factors were collected using a study-specific questionnaire.
Timepoint [6] 372218 0
baseline and 12 months

Eligibility
Key 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
Minimum age
14 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Previous recipient of 4CMenB vaccine (Bexsero)
2. Known pregnancy
3. Anaphylaxis following any component of the 4CMenB vaccine

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment by central randomisation by computer (Adelaide Health Technology Assessment)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation at two stages using computer software. Stratified allocation (school size, education sector and SES) following school agreement to participate.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Randomisation occurs at the school level.. Randomisation will occur in two stages; stage 1 randomisation of schools that agree to participate and are schools associated with large councils (to facilitate program delivery), stage 2 randomisation of remaining schools once consent forms have been returned. 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.
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All analyses will be undertaken according to a pre-specified statistical analysis plan. Students with available outcome data will be analysed according to the randomised group of their school (intention to treat principle). A sensitivity per-protocol analysis of the primary outcome will also be conducted in vaccine group students that followed a 2 dose schedule of 4CMenB and control group students that did not receive 4CMenB before the 12 month follow-up.

The primary outcome of carriage of N. meningitidis at 12 months (yes/no) will be compared between groups using logistic regression, with generalized estimating equations used to account for clustering at the school level. The difference in carriage between groups will be expressed as an odds ratio with 95% confidence interval. Adjustment will be made for baseline carriage, randomisation strata (school size, ICSEA) and other baseline variables pre-specified for adjustment.

Missing data on the primary outcome will be addressed using multiple imputation. All secondary outcomes will be compared between groups using logistic regression models, with generalized estimating equations used to account for clustering due to school. In planned sub-group analyses of the primary and secondary outcomes, the effect of the 4CMenB vaccine will also be examined separately for metropolitan and rural schools, and year 10 and year 11 students. Effect modification by these factors will be assessed separately by including an interaction term involving randomised group within each statistical model.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 15822 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 295085 0
Commercial sector/Industry
Name [1] 295085 0
GlaxoSmithKline Biologicals S.A.
Address [1] 295085 0
Rue d I'Institut 89, 1330 Rixensart
Country [1] 295085 0
Belgium
Primary sponsor type
University
Name
The University of Adelaide
Address
Robinson Research Institute and Adelaide Medical School
Discipline of Paediatrics
Women's & Children's Hospital
Level 2 Clarence Reiger Building
72 King William Road
North Adelaide SA 5006
Country
Australia
Secondary sponsor category [1] 293905 0
None
Name [1] 293905 0
None
Address [1] 293905 0
None
Country [1] 293905 0
Other collaborator category [1] 279334 0
Government body
Name [1] 279334 0
SA Health
Address [1] 279334 0
Citi Centre
11 Hindmarsh Square
Adelaide SA 5000
Country [1] 279334 0
Australia
Other collaborator category [2] 279385 0
Hospital
Name [2] 279385 0
Women's and Children's Health Network
Address [2] 279385 0
Women's and Children's Hospital
72 king William Rd
North Adelaide
SA 5006
Country [2] 279385 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296438 0
Women's and Children's Health Network (WCHN) Human Research Ethics Committee's (HREC) Women's and Children's Health Network (WCHN) Human Research Ethics Committee's (HREC) 
Ethics committee address [1] 296438 0
Research Secretariat
Women's and Children's Health Network
72 King William Road
North Adelaide SA 5006
Ethics committee country [1] 296438 0
Australia
Date submitted for ethics approval [1] 296438 0
Approval date [1] 296438 0
02/11/2016
Ethics approval number [1] 296438 0
HREC/16/WCHN/140

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.
Trial website
www.bpartofit.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70850 0
Prof Helen Marshall
Address 70850 0
Vaccinology & Immunology Research Trials Unit
Women's and Children's Hospital
Level 2 Clarence Reiger Building
72 King William Road
North Adelaide SA 5006
Country 70850 0
Australia
Phone 70850 0
+ 61 (0)8 8161 8115
Fax 70850 0
+ 61 (0)8 81617031
Email 70850 0
helen.marshall@adelaide.edu.au
Contact person for public queries
Name 70851 0
Ms Kathryn Riley
Address 70851 0
Vaccinology & Immunology Research Trials Unit
Women's and Children's Hospital
Level 2 Clarence Reiger Building
72 King William Road
North Adelaide SA 5006
Country 70851 0
Australia
Phone 70851 0
+61 8 8161 6328
Fax 70851 0
+61 (0)8 8161 7031
Email 70851 0
kathryn.riley@adelaide.edu.au
Contact person for scientific queries
Name 70852 0
Prof Helen Marshall
Address 70852 0
Vaccinology & Immunology Research Trials Unit
Women's and Children's Hospital
Level 2 Clarence Reiger Building
72 King William Road
North Adelaide SA 5006
Country 70852 0
Australia
Phone 70852 0
+61 (0)8 8161 8115
Fax 70852 0
+61 (0)8 8161 7031
Email 70852 0
helen.marshall@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified; individual participant data underlying published results only.
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.
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.
Available for what types of analyses?
Achieve the aims in the approved proposal.
How or where can data be obtained?
helen.marshall@adelaide.edu.au
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
How or where can supporting documents be obtained?
Type [1] 2472 0
Study protocol
Citation [1] 2472 0
Link [1] 2472 0
Email [1] 2472 0
helen.marshall@adelaide.edu.au
Other [1] 2472 0
Attachment [1] 2472 0
Type [2] 2473 0
Statistical analysis plan
Citation [2] 2473 0
Link [2] 2473 0
Email [2] 2473 0
helen.marshall@adelaide.edu.au
Other [2] 2473 0
Attachment [2] 2473 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary