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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04398849
Registration number
NCT04398849
Ethics application status
Date submitted
18/05/2020
Date registered
21/05/2020
Titles & IDs
Public title
Immunisation for Adolescents Against Serious Communicable Diseases (B Part of it NT)
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Scientific title
Immunisation for Adolescents Against Serious Communicable Diseases
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Secondary ID [1]
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Menzies HREC/2019-3507-V1.7
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gonorrhea
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0
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Meningococcal Disease
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0
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Condition category
Condition code
Infection
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0
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0
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Sexually transmitted infections
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Reproductive Health and Childbirth
0
0
0
0
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Other reproductive health and childbirth disorders
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Infection
0
0
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0
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Other infectious diseases
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Infection
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0
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0
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Other - Licenced 4CMenB Vaccine
14-19 year olds residing in the Northern Territory - All consenting 14-19 year olds residing in the Northern Territory in 2020-2021
Treatment: Other: Licenced 4CMenB Vaccine
Two doses (0.5 mL each) of Bexsero ® vaccine at least 2 months apart to be given to consenting 14-19 year olds
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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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1. 4CMenB vaccination status in the population with gonorrhoea compared to randomly selected Chlamydia controls (Case-control)
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Assessment method [1]
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Vaccination status among 15-19 year olds diagnosed with gonorrhoea compared to vaccination status of 15 - 19 year olds diagnosed with Chlamydia
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Timepoint [1]
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3 years
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Primary outcome [2]
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Effect of 4CMenB vaccine on carriage of all N.meningitidis
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Assessment method [2]
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Prevalence of all N. meningitidis in the pharynx among 14-19 year olds as measured by PCR at baseline compared to 12 months
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Timepoint [2]
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12 months
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Secondary outcome [1]
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4CMenB vaccination status in the population with gonorrhoea compared to randomly selected controls from the Australian Immunisation Register (Case-control)
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Assessment method [1]
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4CMenB vaccination status among 15-19 year olds diagnosed with gonorrhoea compared to controls from the Australian Immunisation register
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Timepoint [1]
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3 years
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Secondary outcome [2]
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4CMenB vaccination status in the population with gonorrhoea compared to the general population (Screening method)
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Assessment method [2]
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4CMenB vaccination status among 15-19 year olds diagnosed with gonorrhoea compared to the general population
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Timepoint [2]
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3 years
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Secondary outcome [3]
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All laboratory confirmed notifications of gonorrhoea in the six years preceding 4CMenB vaccination compared to three years post vaccination (Interrupted time series analysis)
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Assessment method [3]
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Laboratory confirmed notifications of gonorrhoea in years preceding 4CMenB vaccination compared to post vaccination
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Timepoint [3]
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7 years
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Secondary outcome [4]
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All laboratory confirmed notifications of gonorrhoea in 15-19 year olds in the vaccinated population compared to the unvaccinated population
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Assessment method [4]
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Gonorrhoea notifications in vaccinated vs unvaccinated
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Timepoint [4]
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3 years
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Secondary outcome [5]
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All laboratory confirmed notifications of gonorrhoea in the vaccinated population compared to the unvaccinated population stratified by gender
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Assessment method [5]
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Gonorrhoea notifications in vaccinated vs unvaccinated (stratified by gender)
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Timepoint [5]
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3 years
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Secondary outcome [6]
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All laboratory confirmed notifications of gonorrhoea in the vaccinated population compared to the unvaccinated population stratified by geographical location (regional/remote/very remote)
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Assessment method [6]
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Gonorrhoea notifications in vaccinated vs unvaccinated stratified by location
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Timepoint [6]
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3 years
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Secondary outcome [7]
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Effect of 4CMenB vaccine on carriage of all disease causing N.meningitidis
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Assessment method [7]
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Prevalence of all disease-causing genogroup of N. meningitidis (A, B, C, E, X, W, Y) by PCR at baseline and at 12 months
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Timepoint [7]
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12 months
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Secondary outcome [8]
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Effect of 4CMenB vaccine on carriage of each disease causing N.meningitidis
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Assessment method [8]
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Prevalence of each disease-causing genogroup of N. meningitidis (A, B, C, E, X, W, Y) by PCR at baseline and at 12 months
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Timepoint [8]
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12 months
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Secondary outcome [9]
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Effect of 4CMenB vaccine on carriage of all non-groupable N.meningitidis
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Assessment method [9]
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Prevalence of all non groupable N. meningitidis at baseline and at 12 months
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Timepoint [9]
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12 months
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Secondary outcome [10]
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Effect of 4CMenB vaccine on acquisition of all N. meningitidis
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Assessment method [10]
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Acquisition of all N. meningitidis (negative at baseline, positive at 12-month follow-up) as measured by PCR
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Timepoint [10]
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12 months
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Secondary outcome [11]
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Effect of 4CMenB impact on Group B IMD (Interrupted time series)
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Assessment method [11]
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Notifications of group B IMD (invasive meningococcal disease) in the 4CMenB vaccinated population compared to the unvaccinated population and in years preceding 4CMenB vaccination compared to post vaccination (Interrupted time series analysis).
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Timepoint [11]
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3 years
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Secondary outcome [12]
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Effect of 4CMenB effectiveness on Group B IMD (screening method)
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Assessment method [12]
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4CMenB vaccination status in the population with IMD, compared to the general population (Screening method) and compared to randomly selected controls (Case-control method).
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Timepoint [12]
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3 years
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Secondary outcome [13]
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Effect of 4CMenB effectiveness on Group B IMD (case-control method)
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Assessment method [13]
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4CMenB vaccination status in the population with IMD, compared to the general population (Screening method) and compared to randomly selected controls (Case-control method).
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Timepoint [13]
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3 years
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Secondary outcome [14]
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Risk factors for gonorrhoea
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Assessment method [14]
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Risk factors associated with gonorrhoea in 15-19 year olds
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Timepoint [14]
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12 months
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Secondary outcome [15]
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Risk factors for carriage of all N.meningitidis
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Assessment method [15]
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Risk factors associated with carriage of all genogroups of N. meningitidis in 14 -19 year olds at baseline and 12 months
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Timepoint [15]
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12 months
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Secondary outcome [16]
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Risk for carriage of disease causing genogroups of N.meningitidis
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Assessment method [16]
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Risk factors associated with carriage of disease-causing genogroups of N. meningitidis (A, B, C, E, W, X, Y) in 14 -19 year olds at baseline and 12 months
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Timepoint [16]
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12 months
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Secondary outcome [17]
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Cost effectiveness of the 4CMenB vaccine
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Assessment method [17]
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Cost of meningococcal disease (acute care and management of sequelae up to one year) and cost of treatment of gonorrhoea compared to cost of 4CMenB vaccine
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Timepoint [17]
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3 years
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Eligibility
Key inclusion criteria
All consenting 14-19 year olds residing in the Northern Territory in 2020-2021
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Minimum age
14
Years
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Maximum age
19
Years
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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
* Anaphylaxis following any component of Bexsero® vaccine
* Previous receipt of MenB vaccine (Bexsero® (Previous receipt of MenNZBTM is allowed).
* Known pregnancy
* Clinical conditions representing a contraindication to intramuscular vaccination and venipuncture
* Any clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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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
4/03/2021
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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
31/12/2024
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Actual
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Sample size
Target
7100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Northern Territory - Central Australia
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Recruitment postcode(s) [1]
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- Central Australia
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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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The University of New South Wales
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Menzies School of Health Research
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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University of Sydney
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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The University of Western Australia
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Address [4]
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Country [4]
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Other collaborator category [5]
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Government body
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Name [5]
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Northern Territory Government of Australia
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Address [5]
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Country [5]
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Other collaborator category [6]
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Other
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Name [6]
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SA Health
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Address [6]
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Country [6]
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Other collaborator category [7]
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Other
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Name [7]
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The University of Queensland
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Address [7]
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Country [7]
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Ethics approval
Ethics application status
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Summary
Brief summary
This study aims to implement a targeted 4CMenB immunisation program in young people aged 14-19 years in the Northern Territory (NT). As part of the NT program consenting 14-19 year olds will receive 2 doses of the licensed 4CMenB vaccine. An oropharyngeal swab will be collected on the same day as the first dose of the vaccine and 12 months later to assess carriage of Neisseria meningitidis. The first swab will assess baseline carriage prevalence among 14-19 year olds in the NT. The swab taken 12 months later will provide data on the change in carriage that may occur after implementation of the immunisation program. Emerging evidence suggests that the 4CMenB vaccine may be protective against gonorrhea. Therefore, vaccine effect (impact and effectiveness) against both invasive meningococcal disease (IMD) and gonorrhea in the NT will be assessed using data from the above study comparing notifications between vaccinated and unvaccinated as well as comparing pre and post implementation periods.
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Trial website
https://clinicaltrials.gov/study/NCT04398849
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Trial related presentations / publications
Marshall HS, Andraweera PH, Ward J, Kaldor J, Andrews R, Macartney K, Richmond P, Krause V, Koehler A, Whiley D, Giles L, Webby R, D'Antoine H, Karnon J, Baird R, Lawrence A, Petousis-Harris H, De Wals P, Greenwood-Smith B, Binks M, Whop L. An Observational Study to Assess the Effectiveness of 4CMenB against Meningococcal Disease and Carriage and Gonorrhea in Adolescents in the Northern Territory, Australia-Study Protocol. Vaccines (Basel). 2022 Feb 16;10(2):309. doi: 10.3390/vaccines10020309.
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Public notes
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Contacts
Principal investigator
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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Email
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Contact person for public queries
Name
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Helen Marshall, MBBS,MD,MPH
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Address
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Country
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Phone
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+61 8 8161 8115
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Fax
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Email
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[email protected]
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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 2025 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 The NT Department of Health and Menzies School of Health Research and the Central Australian 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/NCT04398849