Please see some FAQs below. Full FAQs can be downloaded as part of the toolkit.
South Australia currently has the highest rate of meningococcal disease in Australia, with more cases occurring in adolescents than infants. Meningococcal bacteria can be carried without causing harm in the nose and throat of around 10 per cent of the population, however this increases in adolescents and may be as high as up to 25 per cent in adolescents and young adults.
The Meningococcal B vaccine is recommended for adolescents aged 15-19 years of age and babies and young children, particularly those aged under two years. It is particularly recommended for adolescents and young adults living in close quarters, such as students living in residential accommodation.
This study will examine if the licensed and recommended Meningococcal B vaccine reduces the spread of meningococcal bacteria in teenagers.
All schools registered with the B Part of It study will have their first visit from immunisation nurses between April and June 2017.
Schools across the state have been randomised into two groups to assist with the effective and efficient roll out of the study. One school group will receive a throat swab and two doses of the vaccine in 2017, and a second throat swab in 2018, while the other will receive one throat swab in 2017, then two doses of the vaccine and a throat swab in 2018.
While consent forms were due to be returned by early March, students who still wish to be involved can return their signed consent forms up to and on the day the immunisation nurses first visit their school for the B Part of It study.
Yes, to receive the vaccines (either in 2017 or 2018) the student must be at school on the days of vaccination and for the first visit in 2017. They must also participate in the throat swab on the first day. If the student is not present on one of the days the immunisation nurses are visiting the school, he/she will not be able to participate in the study.
The B Part of It study will roll out in stages across South Australia during 2017 and 2018. Participating students will be involved in the study for 12-15 months from the time of participation. Registered schools will be randomly split into two groups for the study.
One school group will receive a throat swab and two doses of the vaccine in 2017 (this will take approximately 6 months for swabs and vaccination doses), and a second throat swab in 2018, while the other will receive one throat swab in 2017, then two doses of the vaccine and a throat swab in 2018.
Registered schools will be randomly divided into two groups and students from these groups will then receive their vaccinations either in 2017 or 2018. Schools and students will not be aware of which group they are in until the first school visit. At this time, they will be informed about when they will be given their first vaccination and will be provided with their full planned Meningococcal B vaccination schedule.
Although all students who consent are provided with the MenB vaccine during the study, the study process requires two groups (one vaccinated and one unvaccinated) to know whether the licensed MenB vaccine has a herd immunity effect as well as providing individual protection against meningococcal disease.
Additionally, providing 2 doses of the MenB vaccine and taking throat swabs from to up to 60,000 students means we need to roll out the program over 12-15 months so enough immunisation nurses are available and there is not impact on the wider immunisation program at South Australian schools. The vaccination scheduling from April to September (2 doses) in 2017 and 2018 will ensure students are not absent due to school holidays and to avoid exam periods.
If the student has a high fever (more than 38 degrees Celsius) then they should not receive the vaccine until they are well. Students with minor coughs and colds, without a fever, and students receiving antibiotics and recovering from an illness, can receive the vaccine if the immunisation nurses assess them as being well enough on the day. There is no contraindication to the throat swab being taken.
If your child is unable to access the Bexsero® vaccine through the study, it can be purchased privately through your pharmacy and/or doctor (the cost is approximately $300 per adolescent/adult). See your GP for further information and medical advice.
Yes, students must have throat swabs to participate in the study. The throat swab is the key component of the study. The swab collects bacteria sitting at the back of the student’s throat. The bacteria are identified and counted in the laboratory and compared across time to assess any changes in the meningococcal bacteria carriage.
This is a very large study, the largest of its kind globally. Vaccinations need to be rolled out across both 2017 and 2018 to work with the numbers and availability of immunisation nurses and to fit in with the existing immunisation program within South Australian schools.
South Australia has had the highest rate of meningococcal disease in Australia since 2012, with more cases in adolescents than infants. It is vital we learn more about the disease and the benefits of vaccinating against Meningococcal B. At this point in time, the licensed and recommended vaccine to immunise against Meningococcal B is not available for free through the National Immunisation Program, as more information is required to demonstrate it has a herd immunity effect (that immunisation prevents transmission to others) in addition to the individual protection it offers. This study will examine if the licensed and recommended Meningococcal B vaccine reduces the spread of meningococcal bacteria in teenagers. Participating students will be involved in the study for 12-15 months and will receive two doses of Bexsero®, as well as have two throat swabs taken.
All students will receive the two doses of free vaccine during 2017-2018. There are two groups in the study: one group will receive their 2 doses of vaccine (and a throat swab) in 2017 between 1st April and September 30. The other group will receive their 2 doses of vaccine (and a throat swab) between April 1st and September 30th 2018. Students receive a second throat swab a year after first throat swab.
Year 12 students whose school is in group B will still be eligible to receive the 2 free doses of Meningococcal B vaccine after they have left school. They will be contacted by the study team at a later date to inform them where they can go to receive the vaccine doses from immunisation providers in South Australia.
All participating schools have been randomized by a computer into two groups A and B. All students in both school groups will receive the two free doses of vaccine between 2017 and 2018. Students attending Group A schools will receive two vaccine doses and a throat swab between April 1st and September 30th 2017 and a second throat swab 12 months later in 2018. Students attending Group B schools will receive a throat swab only between April 1st and September 30th and two doses of vaccine and the second throat swab in 2018. All year 12 students will only receive one throat swab. Year 12 students who attend group B schools will still be able to receive the two free doses of vaccine: they will be contacted to inform them where they can attend clinics to receive the vaccine in 2018.
Students and parents will be informed on the day of their immunisation provider school visit as to which study group they are in. The school study group will determine whether the student will receive the two doses of Meningococcal B vaccine this year or next. This information is being kept confidential until the day of the provider visit for the study integrity. All students will receive a form to take home following the immunisation provider visit which informs them which group they are in and when they will be receiving their swabs and vaccines.
There continues to be an increase in demand globally for Bexsero®, which is reflected in Australia as well. The vaccine is not currently available on Australia’s National Immunisation Program, but can be accessed via the private market with supplies to Australia increasing within 2017.
The supplier, GSK, has confirmed that a robust supply of Bexsero® is planned for the Australian private market for 2017, with five times the volume of vaccine expected to be delivered into the country this year compared to 2016.
Vaccine demand remains high therefore as deliveries of Bexsero® are released into the market, it is possible that supply may be depleted quickly to fill back orders and waiting lists.
If your child has already had 1 or 2 doses of the study vaccine (Bexsero®) then they may not participate in the study.
If your child has had the MeNZB™ they are able to participate in the Study. Between 2004 and 2006 the MeNZB™ vaccine was offered in New Zealand to anyone under 20 years old and routine immunisation for babies and preschoolers continued until June 2008. The vaccine was a short-term measure to reduce risk during an epidemic of meningococcal B in New Zealand and was not expected to provide life-long protection.
Yes, international students may participate in the study if the student is enrolled in a participating SA school in years 10, 11 or 12 for a minimum of a full school year and if they can obtain consent from their parents / legal guardian if they are less than 18 years old.
Yes if your child/ren move schools they can remain in the study. A text message will be sent to parents (if they provided a mobile phone number on the consent form) prior to each school visit and prior to the start of the 2018 school year. The text message will ask parents to respond if their child has moved schools and this will enable the study team to inform the relevant school immunisation providers. If you do not have a mobile phone number, parents should advise the school immunisation provider of their school change and which group they were in at the previous school.