NCT03419533

Brief Summary

This is an observational cross sectional study to evaluate the impact of a 4CMenB vaccination program on oropharyngeal N. meningitidis carriage in vaccinated and unvaccinated school leavers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6,802

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

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

January 17, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
10 months until next milestone

Results Posted

Study results publicly available

November 5, 2021

Completed
Last Updated

November 5, 2021

Status Verified

October 1, 2021

Enrollment Period

2.9 years

First QC Date

January 17, 2018

Results QC Date

January 28, 2021

Last Update Submit

October 10, 2021

Conditions

Neisseria Meningitidis

Outcome Measures

Primary Outcomes (1)

  • Estimate the Difference in Carriage Prevalence of Disease Associated Genogroups of N. Meningitidis (A, B, C, W, X, Y) Between School Leavers in 2018 (Year 12 in 2017) and 2019 (Year 12 in 2018), Following a 4CMenB School Immunisation Program

    As measured by PCR in school leavers in 2018 and 2019

    2018 to 2019

Secondary Outcomes (7)

  • Estimate the Difference in Carriage Prevalence of All N. Meningitidis Genogroups Between South Australian School Leavers in 2018 (Year 12 in 2017) and 2019 (Year 12 in 2018)

    2018 to 2019

  • Estimate the Difference in Carriage Prevalence of Each N. Meningitidis Genogroup (A, B, C, W, X, Y) Between South Australian School Leavers in 2018 (Year 12 in 2017) and 2019 (Year 12 in 2018)

    2018 to 2019

  • Across Years, Estimate the Difference in Carriage Prevalence of N. Meningitidis Genogroups Causing Disease (A, B, C, W, X, Y) Between South Australian School Leavers Who Received 4CMenB Vaccine and Unvaccinated Students

    2018 to 2019

  • Across Years, Estimate the Difference in Carriage Prevalence of All N. Meningitidis Genogroups Between South Australian School Leavers Who Have Received 4CMenB and Unvaccinated Students.

    2018 to 2019

  • Across Years, Estimate the Difference in Each N. Meningitidis Genogroup (A, B, C, W, X, Y) Carriage Prevalence Between South Australian School Leavers Who Received 4CMenB Vaccine and Unvaccinated Students

    2018 to 2019

  • +2 more secondary outcomes

Other Outcomes (2)

  • Describe Carriage Density of N. Meningitidis Genogroups as Measured by qPCR in School Leavers

    2018 to 2019

  • Describe Genome Sequencing of Pathogenic N. Meningitidis (A, B, C, W, X, Y) in Carriage Among School Leavers.

    2018 to 2019

Study Arms (2)

2018 school leavers

South Australian school leavers in 2018 (year 12 in 2017)

2019 school leavers

South Australian school leavers in 2019 (year 12 in 2018)

Eligibility Criteria

Age17 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

School leavers recruited through tertiary education sites and mail out through schools.

You may qualify if:

  • South Australian school leavers between 17 to 25 years of age (enrolled in year 12 in the previous year ie year 2018, students are eligible if they were enrolled in year 12 in 2017, year 2019, students are eligible if they were enrolled in year 12 in 2018).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's and Children's Hosptial

Adelaide, South Australia, 5006, Australia

Location

Related Publications (3)

  • Marshall HS, McMillan M, Koehler A, Lawrence A, MacLennan J, Maiden M, Ramsay M, Ladhani SN, Trotter C, Borrow R, Finn A, Sullivan T, Richmond P, Kahler C, Whelan J, Vadivelu K. B Part of It School Leaver protocol: an observational repeat cross-sectional study to assess the impact of a meningococcal serogroup B (4CMenB) vaccine programme on carriage of Neisseria meningitidis. BMJ Open. 2019 May 6;9(5):e027233. doi: 10.1136/bmjopen-2018-027233.

    PMID: 31064808BACKGROUND

  • McMillan M, Bednarz J, Leong LEX, Lawrence A, Marshall HS. Impact of COVID-19 Containment Strategies and Meningococcal Conjugate ACWY Vaccination on Meningococcal Carriage in Adolescents. Pediatr Infect Dis J. 2022 Nov 1;41(11):e468-e474. doi: 10.1097/INF.0000000000003660. Epub 2022 Jul 27.

    PMID: 35895880DERIVED

  • McMillan M, Koehler AP, Lawrence A, Sullivan TR, Bednarz J, MacLennan JM, Maiden MCJ, Ladhani SN, Ramsay ME, Trotter C, Borrow R, Finn A, Kahler CM, Whelan J, Vadivelu K, Richmond PC, Marshall HS. B Part of It School Leaver Study: A Repeat Cross-Sectional Study to Assess the Impact of Increasing Coverage With Meningococcal B (4CMenB) Vaccine on Carriage of Neisseria meningitidis. J Infect Dis. 2022 Feb 15;225(4):637-649. doi: 10.1093/infdis/jiab444.

    PMID: 34487174DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Oropharyngeal throat swabs

Results Point of Contact

Title
Prof. Helen Marshall
Organization
The University of Adelaide
helen.marshall@adelaide.edu.au
8161 8115

Study Officials

  • Helen Marshall

    University of Adelaide

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 17, 2018

First Posted

February 5, 2018

Study Start

February 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

November 5, 2021

Results First Posted

November 5, 2021

Record last verified: 2021-10

Locations

AU(1)