NCT03089086

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34,489

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

July 2, 2019

Status Verified

June 1, 2019

Enrollment Period

1.3 years

First QC Date

March 17, 2017

Last Update Submit

June 28, 2019

Conditions

Meningococcal Disease

Keywords

meningococcal B vaccineherd immunityadolescentsyoung adultssouth australia

Outcome Measures

Primary Outcomes (1)

  • 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

    12 months

Secondary Outcomes (6)

  • Prevalence of each N. meningitidis genogroup (A, B, C, W, X, Y)

    12 months

  • Prevalence of all N. meningitidis genogroups

    12 months

  • Acquisition of disease causing N. meningitidis (A, B, C, W, X, Y) genogroups (negative at baseline, positive at 12 month followup)

    12 months

  • Acquisition of all N. meningitidis

    12 months

  • Risk factors associated with carriage prevalence of all N. meningitidis

    Baseline and 12 months

  • +1 more secondary outcomes

Other Outcomes (6)

  • Age specific IMD attack rates

    Prior to and following implementation of the intervention

  • Carriage density of N. meningitidis (all genogroups)

    Baseline and 12 months

  • Description of whole genome sequences of carriage isolates

    Baseline and 12 months

  • +3 more other outcomes

Study Arms (2)

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.

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.

Interventions

Licensed 4CMenB vaccineBIOLOGICAL

Two doses (0.5 mL each) of Bexsero ® vaccine at least 1 month to \<3 months apart in adolescents.

Also known as: Bexsero®
Group A

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Previous anaphylaxis following any component of Bexsero vaccine
  • Previous receipt of meningococcal B vaccine (Bexsero)
  • Known pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vaccinology & Immunology Research Trials Unit

North Adelaide, South Australia, 5006, Australia

Location

Related Publications (5)

  • 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.

    PMID: 29991629BACKGROUND

  • McMillan 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.

    PMID: 33587122DERIVED

  • Marshall 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.

    PMID: 32712083DERIVED

  • McMillan 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.

    PMID: 32447370DERIVED

  • Marshall 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.

    PMID: 31971677DERIVED

MeSH Terms

Conditions

Meningococcal Infections

Interventions

4CMenB vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Helen Marshall

    University of Adelaide

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A cluster randomised controlled trial to assess the impact of meningococcal B vaccine 4CMenB on nasopharyngeal carriage of N. Meningitidis
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Vaccinology and Immunology Research Trials Unit

Study Record Dates

First Submitted

March 17, 2017

First Posted

March 24, 2017

Study Start

April 1, 2017

Primary Completion

July 13, 2018

Study Completion

December 31, 2018

Last Updated

July 2, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will share

De-identified, individual participant data underlying published results will be available.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
We estimate the data will be available from the start of 2021 for approximately 12 months.
Access Criteria
IPD will be made available on a case-by-case basis at the discretion of the International Scientific Advisory Committee and WCHN HREC. IPD data will only be available to achieve the aims in the approved proposal.

Locations

AU(1)