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South Australian Meningococcal B Vaccine Herd Immunity Study (B Part of It)

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ClinicalTrials.gov Identifier: NCT03089086
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
SA Health, South Australia, Australia
Information provided by (Responsible Party):
Helen Marshall, University of Adelaide

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.

Condition or disease Intervention/treatment Phase
Meningococcal Disease Biological: Licensed 4CMenB vaccine Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A cluster randomised controlled trial to assess the impact of meningococcal B vaccine 4CMenB on nasopharyngeal carriage of N. Meningitidis
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: South Australian Meningococcal B Vaccine Herd Immunity Study
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : July 13, 2018
Estimated Study Completion Date : June 30, 2020


Arm Intervention/treatment
Active Comparator: Group A
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
Two doses (0.5 mL each) of Bexsero ® vaccine at least 1 month to <3 months apart in adolescents.
Other Name: Bexsero®

No Intervention: Group B
Students within schools randomised to group B will receive the licensed 4CMenB vaccine following completion of baseline and 12 month oropharyngeal swab in 2018.



Primary Outcome Measures :
  1. Prevalence of all disease causing genogroups of N. meningitidis (A, B, C, W, X, Y) [ Time Frame: 12 months ]
    As measured by PCR in vaccinated and unvaccinated year 10 and 11 school students


Secondary Outcome Measures :
  1. Prevalence of each N. meningitidis genogroup (A, B, C, W, X, Y) [ Time Frame: 12 months ]
    As measured by PCR in vaccinated and unvaccinated year 10 and 11 school students

  2. Prevalence of all N. meningitidis genogroups [ Time Frame: 12 months ]
    As measured by PCR in vaccinated and unvaccinated year 10 and 11 school students

  3. Acquisition of disease causing N. meningitidis (A, B, C, W, X, Y) genogroups (negative at baseline, positive at 12 month followup) [ Time Frame: Baseline and 12 months ]
    As measured by PCR in vaccinated and unvaccinated year 10 and 11 school students

  4. Acquisition of all N. meningitidis [ Time Frame: 12 months ]
    As measured by PCR in vaccinated and unvaccinated year 10 and 11 school students

  5. Risk factors associated with carriage prevalence of all N. meningitidis [ Time Frame: 12 months ]
    As measured by PCR in vaccinated and unvaccinated year 10 and 11 school students and questionnaire.

  6. Risk factors associated with carriage prevalence of disease causing N. meningitidis [ Time Frame: 12 months ]
    As measured by PCR in vaccinated and unvaccinated year 10 and 11 school students and questionnaire.


Other Outcome Measures:
  1. Age specific IMD attack rates [ Time Frame: Following implementation of the intervention ]
    Age specific IMD attack rates (per 100,000 population) in all age groups in South Australia

  2. Carriage density of N. meningitidis (all genogroups) [ Time Frame: 12 months ]
    as measured by qPCR in year 10, 11 and 12 school students

  3. Description of whole genome sequences of carriage isolates [ Time Frame: 12 months ]
    Description of whole genome sequences of isolates known to cause disease (serogroup B, W, Y, C)

  4. Whole genogroup sequencing of all carriage isolates [ Time Frame: 12 months ]
    Description of whole genome sequences of isolates

  5. Vaccine uptake and carriage prevalence of all N. meningitidis. [ Time Frame: 12 months ]
    Carriage prevalence as measured by PCR

  6. Vaccine updake and carriage prevalence of disease causing N. meningitidis. [ Time Frame: 12 months ]
    Carriage prevalence as measured by PCR



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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • 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

Exclusion Criteria:

  1. Previous anaphylaxis following any component of Bexsero vaccine
  2. Previous receipt of meningococcal B vaccine (Bexsero)
  3. Known pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03089086


Contacts
Contact: Helen Marshall 61 08 8161 8117 helen.marshall@adelaide.edu.au
Contact: Su-San Lee 61 08 8161 8117 su-san.lee@adelaide.edu.au

Locations
Australia, South Australia
Vaccinology & Immunology Research Trials Unit Recruiting
North Adelaide, South Australia, Australia, 5006
Contact: Su-San Lee    61 08 8161 8117    su-san.lee@adelaide.edu.au   
Sponsors and Collaborators
University of Adelaide
SA Health, South Australia, Australia
Investigators
Principal Investigator: Helen Marshall University of Adelaide

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Helen Marshall, Director, Vaccinology and Immunology Research Trials Unit, University of Adelaide
ClinicalTrials.gov Identifier: NCT03089086     History of Changes
Other Study ID Numbers: HREC/16/WCHN/140
ACTRN12617000079347 ( Registry Identifier: Australian New Zealand Clinical Trials Registry )
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Helen Marshall, University of Adelaide:
meningococcal B vaccine
herd immunity
adolescents
young adults
south australia

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs