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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
Date last updated
2/07/2019

Titles & IDs
Public title
South Australian Meningococcal B Vaccine Herd Immunity Study
Scientific title
South Australian Meningococcal B Vaccine Herd Immunity Study
Secondary ID [1] 0 0
ACTRN12617000079347
Secondary ID [2] 0 0
HREC/16/WCHN/140
Universal Trial Number (UTN)
Trial acronym
B Part of It
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Meningococcal Disease 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Prevalence of all disease causing genogroups of N. meningitidis (A, B, C, W, X, Y)
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Prevalence of each N. meningitidis genogroup (A, B, C, W, X, Y)
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Prevalence of all N. meningitidis genogroups
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Acquisition of disease causing N. meningitidis (A, B, C, W, X, Y) genogroups (negative at baseline, positive at 12 month followup)
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Acquisition of all N. meningitidis
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Risk factors associated with carriage prevalence of all N. meningitidis
Timepoint [5] 0 0
Baseline and 12 months
Secondary outcome [6] 0 0
Risk factors associated with carriage prevalence of disease causing N. meningitidis
Timepoint [6] 0 0
Baseline and 12 months

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
Minimum age
14 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Previous anaphylaxis following any component of Bexsero vaccine
2. Previous receipt of meningococcal B vaccine (Bexsero)
3. Known pregnancy

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2018
Sample size
Target
Accrual to date
Final
34489
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Vaccinology & Immunology Research Trials Unit - North Adelaide
Recruitment postcode(s) [1] 0 0
5006 - North Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
SA Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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
https://clinicaltrials.gov/study/NCT03089086
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.
Public notes

Contacts
Principal investigator
Name 0 0
Helen Marshall
Address 0 0
University of Adelaide
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03089086