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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)
Scientific title
Immunisation for Adolescents Against Serious Communicable Diseases
Secondary ID [1] 0 0
Menzies HREC/2019-3507-V1.7
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gonorrhea 0 0
Meningococcal Disease 0 0
Condition category
Condition code
Infection 0 0 0 0
Sexually transmitted infections
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
1. 4CMenB vaccination status in the population with gonorrhoea compared to randomly selected Chlamydia controls (Case-control)
Timepoint [1] 0 0
3 years
Primary outcome [2] 0 0
Effect of 4CMenB vaccine on carriage of all N.meningitidis
Timepoint [2] 0 0
12 months
Secondary outcome [1] 0 0
4CMenB vaccination status in the population with gonorrhoea compared to randomly selected controls from the Australian Immunisation Register (Case-control)
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
4CMenB vaccination status in the population with gonorrhoea compared to the general population (Screening method)
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
All laboratory confirmed notifications of gonorrhoea in the six years preceding 4CMenB vaccination compared to three years post vaccination (Interrupted time series analysis)
Timepoint [3] 0 0
7 years
Secondary outcome [4] 0 0
All laboratory confirmed notifications of gonorrhoea in 15-19 year olds in the vaccinated population compared to the unvaccinated population
Timepoint [4] 0 0
3 years
Secondary outcome [5] 0 0
All laboratory confirmed notifications of gonorrhoea in the vaccinated population compared to the unvaccinated population stratified by gender
Timepoint [5] 0 0
3 years
Secondary outcome [6] 0 0
All laboratory confirmed notifications of gonorrhoea in the vaccinated population compared to the unvaccinated population stratified by geographical location (regional/remote/very remote)
Timepoint [6] 0 0
3 years
Secondary outcome [7] 0 0
Effect of 4CMenB vaccine on carriage of all disease causing N.meningitidis
Timepoint [7] 0 0
12 months
Secondary outcome [8] 0 0
Effect of 4CMenB vaccine on carriage of each disease causing N.meningitidis
Timepoint [8] 0 0
12 months
Secondary outcome [9] 0 0
Effect of 4CMenB vaccine on carriage of all non-groupable N.meningitidis
Timepoint [9] 0 0
12 months
Secondary outcome [10] 0 0
Effect of 4CMenB vaccine on acquisition of all N. meningitidis
Timepoint [10] 0 0
12 months
Secondary outcome [11] 0 0
Effect of 4CMenB impact on Group B IMD (Interrupted time series)
Timepoint [11] 0 0
3 years
Secondary outcome [12] 0 0
Effect of 4CMenB effectiveness on Group B IMD (screening method)
Timepoint [12] 0 0
3 years
Secondary outcome [13] 0 0
Effect of 4CMenB effectiveness on Group B IMD (case-control method)
Timepoint [13] 0 0
3 years
Secondary outcome [14] 0 0
Risk factors for gonorrhoea
Timepoint [14] 0 0
12 months
Secondary outcome [15] 0 0
Risk factors for carriage of all N.meningitidis
Timepoint [15] 0 0
12 months
Secondary outcome [16] 0 0
Risk for carriage of disease causing genogroups of N.meningitidis
Timepoint [16] 0 0
12 months
Secondary outcome [17] 0 0
Cost effectiveness of the 4CMenB vaccine
Timepoint [17] 0 0
3 years

Eligibility
Key inclusion criteria
All consenting 14-19 year olds residing in the Northern Territory in 2020-2021
Minimum age
14 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
7100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Northern Territory - Central Australia
Recruitment postcode(s) [1] 0 0
- Central Australia

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of New South Wales
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Menzies School of Health Research
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Sydney
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
The University of Western Australia
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Government body
Name [5] 0 0
Northern Territory Government of Australia
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
SA Health
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
The University of Queensland
Address [7] 0 0
Country [7] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Helen Marshall, MBBS,MD,MPH
Address 0 0
Country 0 0
Phone 0 0
+61 8 8161 8115
Fax 0 0
Email 0 0
helen.marshall@adelaide.edu.au
Contact person for scientific queries

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 will be available

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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
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
Available for what types of analyses?
How or where can data be obtained?


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