Students who move schools will always remain in the randomisation group of the school they were originally enrolled at. For example a student who is randomised to a group B school and then moves to a group A school, will remain in group B for the duration of the study. The immunisation providers will ensure that the students who move schools either receive/don’t receive the two vaccine doses required, depending on the student’s original enrolment group.
If you have any side effects from the vaccine we recommend that you seek further advice from your doctor, immunisation nurse, or contact the Immunisation Section on 1300 232 272.
Following each vaccine study dose each student is given a leaflet which documents the date and time they received the Bexsero® vaccine and information regarding possible vaccine side effects.
Vaccines are generally safe but like any medication or natural therapy they can have some side effects. These are usually short lasting and do not require special treatment.
Common reactions to the Bexsero® vaccine include: pain, redness, hardness and swelling at the injection site, fever, generally feeling unwell, nausea, dizziness, headache, painful muscles and joints may also occur. If the reaction seems severe or persists and you are concerned, we recommend that you seek further advice from your doctor, immunisation nurse, or contact the Immunisation Section, SA Health on 1300 232 272.
Rare reactions: As with any medication, very rarely an individual may experience a severe allergic reaction to a vaccine. The nurses who deliver the immunisation program are trained to recognise and manage any immediate severe reactions. If a severe allergic reaction is going to occur it will generally be within the first 15 minutes after receiving a vaccine.
Yes, students whose parents/guardians chose to purchase the vaccine privately are encouraged to remain in the study and receive the second swab and complete the questionnaire.
If you have only received one dose of the study vaccine Bexsero® then you are not adequately protected against invasive meningococcal B disease. Two doses are required for protection against meningococcal B disease in adolescents/adults. You will need to contact your immunisation provider to receive the second dose. If you have moved interstate or overseas we recommend that you purchase the Bexsero® vaccine dose 2 privately, so that you have completed the course.
Parent/Guardians of students who miss their immunisation provider vaccine school visit will be sent a letter from their immunisation provider informing the parents that they have missed their vaccine dose. The letter will provide information regarding how/when and where students can access the missed doses.
If parents/guardians are not sure where their children should receive missed vaccine doses they will need to contact their immunisation provider. The student’s school will be able to inform you who your child’s immunisation provider is for the Men B study if you do not know.
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 by letter and SMS text at a later date to inform them where they can access the vaccine doses from immunisation providers in South Australia.
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 also 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 is examining 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 received their first visit from the immunisation nurses between April and June 2017.
Schools across the state were randomised into two groups (group A and B) to assist with the effective and efficient roll out of the study. Group A schools have received visits for a throat swab and two doses of the vaccine in 2017, and will receive a visit for a second throat swab in 2018. Group B schools received one visit for a throat swab in 2017, and will receive visits for two doses of the vaccine and a throat swab in 2018.
The last opportunity to be part of this study was 30 June 2017. So unfortunately it is now too late to enrol in the B Part of It study.
Yes. To be eligible for the study commencement in 2017, students needed to be at school for the first school visit. If students were away from school for further school visits during the study, they were contacted by the school immunisation provider to make arrangements to receive either the vaccine or the swab that they had missed.
The B Part of It study will roll out in stages across South Australia during 2017 and further parts of the study will continue in 2018. Participating students are involved in the study for 12-15 months from the time of participation. Registered schools have been randomly separated into two groups for the study.
Group A schools have received a throat swab two doses of the vaccine in 2017, and will receive a second throat swab in 2018. Group B schools have received one throat swab in 2017, and will receive a second throat swab and 2 doses of the vaccine in 2018. All students in the study will have received 2 doses of the vaccine by the end of the study in 2018.
Registered schools were randomly separated into two groups (A or B). Students from these groups will receive their vaccinations either in 2017 or 2018. On the first school visit date students were informed about when they will be given their vaccinations and were provided with their full meningococcal B vaccination study schedule for 2017 and 2018.
The study process requires two groups (one vaccinated initially and one not) to compare the difference in carriage of the meningococcal bacteria between the two groups over time.
Vaccinations will be rolled out across both 2017 and 2018 to work with the availability of immunisation nurses and to fit in with the wider immunisation program at South Australian schools. This scheduling helps ensure students are not absent on school holidays and can receive two doses of the vaccine within the required period, which is critical for protection.
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.
If your child was enrolled in the study, had received at least one swab, and was away from school for future school visits, you will have been contacted by the school immunisation provider to make arrangements for a catch up visit.
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 very large study, the largest of its kind globally. The throat swabs from the students who were vaccinated in 2017 will be compared with the throat swabs from the students who are being vaccinated in 2018. Also, 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 for the health of the Australian community.
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 is examining 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® and will 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 (Group A) which has received their first dose of the Bexsero vaccine and will receive their second dose of vaccine (and a throat swab) in 2017 between 1 July and 30 September. The other group will receive their 2 doses of vaccine (and a throat swab) between 1 April and 30 September 2018. All students will receive a second throat swab a year after first throat swab.
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 1 April and 30 September 2017 and a second throat swab 12 months later in 2018. Students attending Group B schools will receive a throat swab only between 1 April and 30 September and two doses of vaccine and the second throat swab in 2018. 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 were informed of the date of their immunisation provider school visit and as to which study group (A or B) their school has been allocated. The school study group determines whether the student receives the two doses of meningococcal B vaccine in 2017 or in 2018. All students received a form to take home, following the first immunisation provider visit, which informed them which group were in and when they will be receiving their swabs and vaccines. Parents will receive a message, via the school and/or the immunisation provider, regarding when the immunisation team is visiting the school to administer the swab and (if applicable) the vaccine. An SMS text message is sent out 2 days before the school visit informing you when the immunisation team will be at the school. Year 12 students in group B will be sent a letter from the Study team letting them know when and where and when they may receive their vaccines.
The vaccine is not currently available on Australia’s National Immunisation Program, but can be accessed via the private market. You will need to visit your GP for further information and to discuss receiving of the Bexsero® vaccination.
Children who have already had 1 or 2 doses of the study vaccine (Bexsero®) were not ableto enroll in the study.
Children who have received the MeNZB™ are participating 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.
Yes, international students are participating in the study. Students were able to participate if they were enrolled in a participating SA school in years 10, 11 or 12 for a minimum of a full school year and if they obtained consent from their parents / legal guardian if they were 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.