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Meningococcal B Vaccine Study called 'B part of It NT'

Dear Parent/Legal Guardian/Student,

Meningococcal B Vaccine Study called ‘B part of It NT’

The University of Adelaide and the Northern Territory (NT) Government are conducting a large study of the Meningococcal B vaccine in young people who are 14 – 19 year old. We will look at whether this vaccine can protect against Meningococcal B and also gonorrhoea, which is caused by a closely related bacteria.

Health Promoting School Nurses (HPSNs) will visit schools across Northern Territory in 2021 to oﬀer free Meningococcal B vaccination to participating students in years 10, 11 and 12. The vaccine will also be available for 14-19 year olds through participating government clinics and Aboriginal Health Services.

* ONLY STUDENTS/YOUNG PEOPLE WITH A COMPLETED AND SIGNED CONSENT FORM CAN PARTICIPATE IN THE STUDY *

This information is for you to keep

Meningococcal disease and gonorrhoea are infections that can affect young people in the Northern Territory (NT). The licensed Meningococcal B vaccine (Bexsero®), which protects against meningococcal B disease, may protect against related bugs that cause gonorrhoea. The Meningococcal B vaccine is not usually free for adolescents and young adults. This Meningococcal B vaccine is different to the meningococcal ACWY vaccine that young people usually get for free.

This research study aims to see how effective the Meningococcal B vaccine is against meningococcal disease, the carriage of meningococcal bacteria in the throat, and gonorrhoea in the NT.

This study is for all young people aged 14 – 19 years in the NT.

Over 12 months each participant will:
• Receive 2 free doses of the recommended Meningococcal B vaccine (visits 1 and 2)
• Fill out a one-page questionnaire (visits 1 and 3)
• Have 2 throat swabs taken to test for meningococcal bacteria in their throat (visits 1 and 3)
• Get a $40 voucher after the first visit and $20 at visits two and three.

What do I need to do to join in?
If you received this form from your school, then your parent/carer or guardian must sign the consent form. If you are going to a clinic and are 16 years of age or older you may sign the consent form for yourself. If you are going to a clinic and are 14-15 years old your parent/carer or guardian must sign the consent form.

What is meningococcal disease?
Meningococcal disease is a very serious illness caused by meningococcal bacteria. In Australia, most cases are due to the meningococcal B strain, which this vaccine protects against. The meningococcus bacteria can be found in the nose and throat of up to 20% of young people.

What is gonorrhoea and how is it spread?
Gonorrhoea is a sexually transmitted infection that can infect both men and women. It is common, especially among young people aged 15-24 years. Women can become infertile (unable to have a baby) after having gonorrhoea.

Prevention/Immunisation
Meningococcal B vaccine (Bexsero®) is a licensed vaccine recommended in Australia for infants and young people. It is the same vaccine funded for Aboriginal and Torres Strait Islander babies in the Northern Territory.

What does the study involve?
Participants will be part of the study for 12 months. During the 12 months, all young people in the study will be immunised with the licensed Meningococcal B vaccine Bexsero® (2 doses given 2 months apart) at no cost, and 2 throat swabs will be collected. Participants will also be asked to fill out a one-page questionnaire when they have their throat swabs taken. The throat swab specimens will be stored and may be used for research in the future for this project and other research about the types of bugs that live at the back of the throat. A $40.00 voucher will be given to all participants for their first visit, and $20 vouchers will be given for the 2nd and 3rd visits, to reimburse you for your time.

The NT government routinely counts the number of cases of meningococcal disease and gonorrhoea in the NT. We will look at the number of cases after the study and see whether the meningococcal B vaccine leads to fewer infections.

How is the throat swab taken?
A cotton-tipped swab is rubbed gently on the back of the throat for 1-2 seconds.

Common risks of Meningococcal (Bexsero®) vaccine
The Meningococcal B vaccine is safe and is well tolerated, with over 17 million doses already given worldwide. There is the chance of common side effects that are mild and may include a mild fever, soreness at the injection site, headache, and generally feeling unwell for 1-2 days. Severe allergic reactions are very rare.

What are the alternatives to participation?
You do not have to join the study if you do not want to; it will not affect your Centrelink family benefits. You can buy the Meningococcal B vaccine privately through your GP instead if you prefer. If you have already had the Meningococcal B vaccine, you do not need to receive the study vaccine.

What happens to personal information?
No names will be placed on the questionnaires, and the answers will be confidential. Study results will not contain any personal information, as they will be removed to ensure privacy.

Ethics Committee Clearance
This project has been approved by the Human Research Ethics Committee of the NT Department of Health and Menzies School of Health Research, the Central Australian Human Research Ethics Committee, and the Western Australian Aboriginal Health Ethics Committee. The NT Government and AMSANT are working with us on this project.

Concerns and Complaints
If you have any concerns or complaints about the study, you are invited to contact:
Dr Rosalind Webby: rosalind.webby@nt.gov.au or
Dr Belinda Greenwood-Smith: Belinda.greenwoodsmith@nt.gov.au
For concerns regarding the ethical conduct of the study, contact the following institutions:
Top End: Human Research Ethics Committee of the NT Department of Health and Menzies School of Health Research on 08 8946 8600 or email ethics@menzies.edu.au
Central Australia: Central Australian Human Research Ethics Committee on 08 8951 4700 or email cahrec@flinders.edu.au
Western Australia: Western Australian Aboriginal Health Ethics Committee (WAAHEC) on
08 9227 1631 or email ethics@ahcwa.org

For further request for information or queries regarding the study should be directed to the NT Immunisation Register (NTIR) 08 8922 8315 or the study website: www.bpartofitnt.com.au

Study contacts: Central Australia: 08 9851 7549, Top End: 08 8922 8315

Information Sheet version 8.0 18 Oct 2021

Student/Participant First Name:

* must provide value

Student/Participant Last Name:

* must provide value

Other Legal Names (if applicable):

Date of Birth:

* must provide value

D-M-Y

Gender:

* must provide value

Male

Female

Other

Home address:

* must provide value

School:

* must provide value

School (other), please enter:

* must provide value

School year:

* must provide value

Class:

Medicare Number:

Mobile Phone Number:

* must provide value

Non Indigenous

Aboriginal

Torres Strait Islander

Aboriginal and Torres Strait Islander

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Any serious reactions to previous vaccines:

* must provide value

Yes

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If yes, please list:

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Consent for Immunisation, throat swabs and questionnaires for Parent/Guardian to complete

I have read and understood the B Part of It NT study Participant Information Sheet and I consent for my child to receive the Meningococcal B (Bexsero) vaccine, two throat swabs and complete two questionnaires.

* must provide value

Yes

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Parent / Guardian Name:

* must provide value

Daytime Phone Number:

E-mail:

Address:

Parent / Guardian Signature:

* must provide value

Add signature

Date:

* must provide value

D-M-Y

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