Meningococcal DiseasePhase 4B Part of ItNCT03089086
South Australian Meningococcal B Vaccine Herd Immunity Study
A Phase 4 study testing Licensed 4CMenB vaccine in people with Meningococcal Disease, run by University of Adelaide at 1 site in Australia.
Trial summary
To estimate the effect on carriage, all year 10, 11, and 12 students will be offered 4CMenB vaccination in South Australia through schools over the study period with 50% of the students enrolled receiving the vaccine in 2017 and 50% in 2018. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Disease
- What is being tested?
- Licensed 4CMenB vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34,489 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Apr 2017to 31 Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- South Australian secondary school students in years 10, 11, and 12 in 2017
- Written parental consent for those under the age of 18
- Written student consent assent for those under the age of 18 (or if 18 years old and older consent for themselves)
- Available at school for at least the first pharyngeal swab and willing to comply with study procedures
Who cannot join
- Previous anaphylaxis following any component of Bexsero vaccine
- Previous receipt of meningococcal B vaccine (Bexsero)
- Known pregnancy
Trial locations and contacts
1 site in 1 country.
Australia1 site
Vaccinology & Immunology Research Trials Unit
North Adelaide, South Australia, 5006
About this study
To estimate the effect on carriage, all year 10, 11, and 12 students will be offered 4CMenB vaccination in South Australia through schools over the study period with 50% of the students enrolled receiving the vaccine in 2017 and 50% in 2018. In year 10 and 11 students, posterior pharyngeal swabs will be obtained at baseline and 12 months post baseline to estimate the difference in carriage prevalence of all genogroups of N. meningitidis between vaccinated and unvaccinated participants.
Read the detailed description
This cluster randomised controlled study will be conducted in the context of funded 4CMenB vaccine offered to all students in years 10, 11, and 12.
Year 10 and 11 students will undergo baseline and 12 months posterior pharyngeal swabs. Year 12 students will undergo baseline posterior pharyngeal swabs only.
Randomisation will take place at the school level and will be stratified by school size ((<60, 60 to 119, and ≥120 students per year level) and school socio-economic status (SES), as measured by the Index of Community Socio-Educational Advantage (ICSEA); (ICSEA <970, 970 to 1020, >1020) For the purposes of the study a school is defined as an educational institution at which students in years 10, 11, 12 physically attend school during the week. All 260 schools in metropolitan and rural SA will be approached to participate in the study. All schools agreeing to participate will be randomised to 4CMenB vaccine in 2017 or 2018. Students at schools randomised to receive the vaccine at baseline will receive the 4CMenB vaccine in 2017. Students at schools randomised to receive the vaccine at the 12 month posterior pharyngeal swab will receive the 4CMenB vaccine in 2018.
Primary Objectives
- Estimate the difference in carriage prevalence of disease causing genogroup of N. meningitidis (A, B, C, W, X, Y) following the 12 month pharyngeal swab in year 10 and 11 students who received two doses of Bexsero®, compared to unvaccinated students.
Secondary objectives
- Estimate the difference in carriage prevalence of each disease causing genogroup of N. meningitidis (A, B, C, W, X, Y) following the 12 month pharyngeal swab in year 10 and 11 students who received two doses of Bexsero®, compared to unvaccinated students.
- Estimate the difference in carriage prevalence of all genogroups of N. meningitidis following the 12 month pharyngeal swab in year 10 and 11 students who received two doses of Bexsero ®, compared to unvaccinated students.
- Estimate the difference in acquisition (negative at baseline, positive at 12 month followup) of carriage of disease causing genogroups of N. meningitidis (A, B, C, W, X, Y) over a 12 month period in students who received two doses of Bexsero ®, compared to unvaccinated students.
- Estimate the difference in acquisition (negative at baseline, positive at 12 month followup) of carriage of all genogroups of N. meningitidis over a 12 month period in students who received two doses of Bexsero ®, compared to unvaccinated students
- Identify characteristics associated with carriage prevalence of all genogroups N. meningitidis in South Australian school students at baseline and 12 months.
- Identify characteristics associated with carriage prevalence of disease causing genogroups of N. meningitidis (A, B, C, W, X, Y) in South Australian school students at baseline and 12 months.
Exploratory objectives
- Describe changes in invasive meningococcal rates (attack rates) across all age groups pre and post 4CMenB vaccine intervention in South Australia.
- Describe N. meningitidis carriage density in year 10, 11, and 12 students using qPCR at baseline and 12 months in both vaccinated and unvaccinated students.
- Describe genome sequencing of N. meningitidis disease causing (A, B, C, W, X, Y) sequence types in year 10, 11, and 12 students at baseline and at 12 months.
- In schools randomized to Group A, describe the association of carriage prevalence of disease causing genogroups and vaccine uptake at school level following implementation.
- In schools randomized to Group A, describe the association of carriage prevalence of all N. meningitidis and vaccine uptake at school level following implementation.
- Conditions
- Meningococcal Disease
- Being tested
- Licensed 4CMenB vaccine
- Keywords
- meningococcal B vaccine, herd immunity, adolescents, young adults, south australia
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Licensed 4CMenB vaccineBiological
Also called Bexsero®
Two doses (0.5 mL each) of Bexsero ® vaccine at least 1 month to <3 months apart in adolescents.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Students within schools randomised to group A will receive two doses of licensed 4CMenB vaccine after baseline oropharyngeal swab with an interval of 1 to 2 months between doses, with the first dose given at the baseline visit in 2017. Receives: Biological: Licensed 4CMenB vaccine |
| Group B | No intervention | Students within schools randomised to group B will receive the licensed 4CMenB vaccine following completion of baseline and 12 month oropharyngeal swab in 2018. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of all disease causing genogroups of N. meningitidis (A, B, C, W, X, Y)
As measured by PCR at 12 months in vaccinated and unvaccinated year 10 and 11 school students
Measured: 12 months
Secondary outcomes (6)
Prevalence of each N. meningitidis genogroup (A, B, C, W, X, Y)
As measured by PCR at the 12 month pharyngeal swab in vaccinated and unvaccinated year 10 and 11 school students
Measured: 12 months
Prevalence of all N. meningitidis genogroups
As measured by PCR at the 12 month pharyngeal swab in vaccinated and unvaccinated year 10 and 11 school students
Measured: 12 months
Acquisition of disease causing N. meningitidis (A, B, C, W, X, Y) genogroups (negative at baseline, positive at 12 month followup)
As measured by PCR in vaccinated and unvaccinated year 10 and 11 school students
Measured: 12 months
Acquisition of all N. meningitidis
As measured by PCR in vaccinated and unvaccinated year 10 and 11 school students
Measured: 12 months
Risk factors associated with carriage prevalence of all N. meningitidis
As measured by PCR at baseline and 12 months
Measured: Baseline and 12 months
Risk factors associated with carriage prevalence of disease causing N. meningitidis
As measured by PCR at baseline and 12 months
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start1 Apr 2017
- Primary completion13 Jul 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Meningococcal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A cluster randomised controlled trial to assess the impact of meningococcal B vaccine 4CMenB on nasopharyngeal carriage of N. Meningitidis
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34,489 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Adelaide
- Sponsor type
- University, hospital or other
- Collaborators
- SA Health
- Responsible party
- Principal investigator, Helen Marshall, University of Adelaide
- Investigators
- Helen Marshall, Principal investigator, University of Adelaide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089086
- Sponsor's protocol ID
- HREC/16/WCHN/140
- Other IDs
- ACTRN12617000079347
- Acronym
- B Part of It
- Status last verified
- Jun 2019
- First submitted
- 17 Mar 2017
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified, individual participant data underlying published results will be available.
Publications
Marshall HS, McMillan M, Koehler A, Lawrence A, MacLennan JM, Maiden MCJ, Ramsay M, Ladhani SN, Trotter C, Borrow R, Finn A, Sullivan T, Richmond P, Kahler CM, Whelan J, Vadivelu K. B Part of It protocol: a cluster randomised controlled trial to assess the impact of 4CMenB vaccine on pharyngeal carriage of Neisseria meningitidis in adolescents. BMJ Open. 2018 Jul 10;8(7):e020988. doi: 10.1136/bmjopen-2017-020988.
PubMed 29991629Milazzo A, McMillan M, Giles L, Page K, Flood L, Marshall H. Geographical distribution of invasive meningococcal disease and carriage: A spatial analysis. Epidemiol Infect. 2024 Jan 18;152:e22. doi: 10.1017/S0950268824000116.
PubMed 38234190McMillan M, Wang B, Koehler AP, Sullivan TR, Marshall HS. Impact of Meningococcal B Vaccine on Invasive Meningococcal Disease in Adolescents. Clin Infect Dis. 2021 Jul 1;73(1):e233-e237. doi: 10.1093/cid/ciaa1636.
PubMed 33587122Marshall HS, Koehler AP, Wang B, A'Houre M, Gold M, Quinn H, Crawford N, Pratt N, Sullivan TR, Macartney K. Safety of meningococcal B vaccine (4CMenB) in adolescents in Australia. Vaccine. 2020 Aug 18;38(37):5914-5922. doi: 10.1016/j.vaccine.2020.07.009. Epub 2020 Jul 22.
PubMed 32712083McMillan M, Walters L, Sullivan T, Leong LEX, Turra M, Lawrence A, Koehler AP, Finn A, Andrews RM, Marshall HS. Impact of Meningococcal B (4CMenB) Vaccine on Pharyngeal Neisseria meningitidis Carriage Density and Persistence in Adolescents. Clin Infect Dis. 2021 Jul 1;73(1):e99-e106. doi: 10.1093/cid/ciaa610.
PubMed 32447370Marshall HS, McMillan M, Koehler AP, Lawrence A, Sullivan TR, MacLennan JM, Maiden MCJ, Ladhani SN, Ramsay ME, Trotter C, Borrow R, Finn A, Kahler CM, Whelan J, Vadivelu K, Richmond P. Meningococcal B Vaccine and Meningococcal Carriage in Adolescents in Australia. N Engl J Med. 2020 Jan 23;382(4):318-327. doi: 10.1056/NEJMoa1900236.
PubMed 31971677
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- South Australian Meningococcal B Vaccine Herd Immunity Study
- ClinicalTrials.gov ID
- NCT03089086
- Acronym / sponsor ID
- B Part of It / HREC/16/WCHN/140
- Conditions
- Meningococcal Disease
- Keywords
- meningococcal B vaccine, herd immunity, adolescents, young adults, south australia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34,489 participants (actual)
- Lead sponsor
- University of AdelaideUniversity, hospital or other
- Collaborators
- SA Health
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 13 Jul 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To estimate the effect on carriage, all year 10, 11, and 12 students will be offered 4CMenB vaccination in South Australia through schools over the study period with 50% of the students enrolled receiving the vaccine in 2017 and 50% in 2018. In year 10 and 11 students, posterior pharyngeal swabs will be obtained at baseline and 12 months post baseline to estimate the difference in carriage prevalence of all genogroups of N. meningitidis between vaccinated and unvaccinated participants.
Detailed description
This cluster randomised controlled study will be conducted in the context of funded 4CMenB vaccine offered to all students in years 10, 11, and 12.
Year 10 and 11 students will undergo baseline and 12 months posterior pharyngeal swabs. Year 12 students will undergo baseline posterior pharyngeal swabs only.
Randomisation will take place at the school level and will be stratified by school size ((<60, 60 to 119, and ≥120 students per year level) and school socio-economic status (SES), as measured by the Index of Community Socio-Educational Advantage (ICSEA); (ICSEA <970, 970 to 1020, >1020) For the purposes of the study a school is defined as an educational institution at which students in years 10, 11, 12 physically attend school during the week. All 260 schools in metropolitan and rural SA will be approached to participate in the study. All schools agreeing to participate will be randomised to 4CMenB vaccine in 2017 or 2018. Students at schools randomised to receive the vaccine at baseline will receive the 4CMenB vaccine in 2017. Students at schools randomised to receive the vaccine at the 12 month posterior pharyngeal swab will receive the 4CMenB vaccine in 2018.
Primary Objectives
- Estimate the difference in carriage prevalence of disease causing genogroup of N. meningitidis (A, B, C, W, X, Y) following the 12 month pharyngeal swab in year 10 and 11 students who received two doses of Bexsero®, compared to unvaccinated students.
Secondary objectives
- Estimate the difference in carriage prevalence of each disease causing genogroup of N. meningitidis (A, B, C, W, X, Y) following the 12 month pharyngeal swab in year 10 and 11 students who received two doses of Bexsero®, compared to unvaccinated students.
- Estimate the difference in carriage prevalence of all genogroups of N. meningitidis following the 12 month pharyngeal swab in year 10 and 11 students who received two doses of Bexsero ®, compared to unvaccinated students.
- Estimate the difference in acquisition (negative at baseline, positive at 12 month followup) of carriage of disease causing genogroups of N. meningitidis (A, B, C, W, X, Y) over a 12 month period in students who received two doses of Bexsero ®, compared to unvaccinated students.
- Estimate the difference in acquisition (negative at baseline, positive at 12 month followup) of carriage of all genogroups of N. meningitidis over a 12 month period in students who received two doses of Bexsero ®, compared to unvaccinated students
- Identify characteristics associated with carriage prevalence of all genogroups N. meningitidis in South Australian school students at baseline and 12 months.
- Identify characteristics associated with carriage prevalence of disease causing genogroups of N. meningitidis (A, B, C, W, X, Y) in South Australian school students at baseline and 12 months.
Exploratory objectives
- Describe changes in invasive meningococcal rates (attack rates) across all age groups pre and post 4CMenB vaccine intervention in South Australia.
- Describe N. meningitidis carriage density in year 10, 11, and 12 students using qPCR at baseline and 12 months in both vaccinated and unvaccinated students.
- Describe genome sequencing of N. meningitidis disease causing (A, B, C, W, X, Y) sequence types in year 10, 11, and 12 students at baseline and at 12 months.
- In schools randomized to Group A, describe the association of carriage prevalence of disease causing genogroups and vaccine uptake at school level following implementation.
- In schools randomized to Group A, describe the association of carriage prevalence of all N. meningitidis and vaccine uptake at school level following implementation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A cluster randomised controlled trial to assess the impact of meningococcal B vaccine 4CMenB on nasopharyngeal carriage of N. Meningitidis
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Biological: Licensed 4CMenB vaccineStudents within schools randomised to group A will receive two doses of licensed 4CMenB vaccine after baseline oropharyngeal swab with an interval of 1 to 2 months between doses, with the first dose given at the baseline visit in 2017. |
| Group B | No intervention | –Students within schools randomised to group B will receive the licensed 4CMenB vaccine following completion of baseline and 12 month oropharyngeal swab in 2018. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- South Australian secondary school students in years 10, 11, and 12 in 2017
- Written parental consent for those under the age of 18
- Written student consent assent for those under the age of 18 (or if 18 years old and older consent for themselves)
- Available at school for at least the first pharyngeal swab and willing to comply with study procedures
Key exclusion criteria (3 listed)
- Previous anaphylaxis following any component of Bexsero vaccine
- Previous receipt of meningococcal B vaccine (Bexsero)
- Known pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Licensed 4CMenB vaccineAlso: Bexsero®Two doses (0.5 mL each) of Bexsero ® vaccine at least 1 month to <3 months apart in adolescents. | Biological | Group A |
Primary outcome
Prevalence of all disease causing genogroups of N. meningitidis (A, B, C, W, X, Y)
Time frame: 12 months
As measured by PCR at 12 months in vaccinated and unvaccinated year 10 and 11 school students
6 secondary outcomes
Prevalence of each N. meningitidis genogroup (A, B, C, W, X, Y)
Time frame: 12 months
Prevalence of all N. meningitidis genogroups
Time frame: 12 months
Acquisition of disease causing N. meningitidis (A, B, C, W, X, Y) genogroups (negative at baseline, positive at 12 month followup)
Time frame: 12 months
Acquisition of all N. meningitidis
Time frame: 12 months
Risk factors associated with carriage prevalence of all N. meningitidis
Time frame: Baseline and 12 months
Risk factors associated with carriage prevalence of disease causing N. meningitidis
Time frame: Baseline and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Background: PubMed 29991629Marshall HS, McMillan M, Koehler A, Lawrence A, MacLennan JM, Maiden MCJ, Ramsay M, Ladhani SN, Trotter C, Borrow R, Finn A, Sullivan T, Richmond P, Kahler CM, Whelan J, Vadivelu K. B Part of It protocol: a cluster randomised controlled trial to assess the impact of 4CMenB vaccine on pharyngeal carriage of Neisseria meningitidis in adolescents. BMJ Open. 2018 Jul 10;8(7):e020988. doi: 10.1136/bmjopen-2017-020988.
- Derived from this study: PubMed 38234190Milazzo A, McMillan M, Giles L, Page K, Flood L, Marshall H. Geographical distribution of invasive meningococcal disease and carriage: A spatial analysis. Epidemiol Infect. 2024 Jan 18;152:e22. doi: 10.1017/S0950268824000116.
- Derived from this study: PubMed 33587122McMillan M, Wang B, Koehler AP, Sullivan TR, Marshall HS. Impact of Meningococcal B Vaccine on Invasive Meningococcal Disease in Adolescents. Clin Infect Dis. 2021 Jul 1;73(1):e233-e237. doi: 10.1093/cid/ciaa1636.
- Derived from this study: PubMed 32712083Marshall HS, Koehler AP, Wang B, A'Houre M, Gold M, Quinn H, Crawford N, Pratt N, Sullivan TR, Macartney K. Safety of meningococcal B vaccine (4CMenB) in adolescents in Australia. Vaccine. 2020 Aug 18;38(37):5914-5922. doi: 10.1016/j.vaccine.2020.07.009. Epub 2020 Jul 22.
- Derived from this study: PubMed 32447370McMillan M, Walters L, Sullivan T, Leong LEX, Turra M, Lawrence A, Koehler AP, Finn A, Andrews RM, Marshall HS. Impact of Meningococcal B (4CMenB) Vaccine on Pharyngeal Neisseria meningitidis Carriage Density and Persistence in Adolescents. Clin Infect Dis. 2021 Jul 1;73(1):e99-e106. doi: 10.1093/cid/ciaa610.
- Derived from this study: PubMed 31971677Marshall HS, McMillan M, Koehler AP, Lawrence A, Sullivan TR, MacLennan JM, Maiden MCJ, Ladhani SN, Ramsay ME, Trotter C, Borrow R, Finn A, Kahler CM, Whelan J, Vadivelu K, Richmond P. Meningococcal B Vaccine and Meningococcal Carriage in Adolescents in Australia. N Engl J Med. 2020 Jan 23;382(4):318-327. doi: 10.1056/NEJMoa1900236.
- Individual participant dataSharing planned: Yes. De-identified, individual participant data underlying published results will be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Marshall principal investigator
University of Adelaide
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Licensed 4CMenB vaccine in people with Meningococcal Disease, run by University of Adelaide at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of all disease causing genogroups of N. meningitidis (A, B, C, W, X, Y) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03089086, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.