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Immunisation for Adolescents Against Serious Communicable Diseases (B Part of it NT)

NCT04398849 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 7100

Last updated 2023-03-09

No results posted yet for this study

Summary

This study aims to implement a targeted 4CMenB immunisation program in young people aged 14-19 years in the Northern Territory (NT). As part of the NT program consenting 14-19 year olds will receive 2 doses of the licensed 4CMenB vaccine. An oropharyngeal swab will be collected on the same day as the first dose of the vaccine and 12 months later to assess carriage of Neisseria meningitidis. The first swab will assess baseline carriage prevalence among 14-19 year olds in the NT. The swab taken 12 months later will provide data on the change in carriage that may occur after implementation of the immunisation program. Emerging evidence suggests that the 4CMenB vaccine may be protective against gonorrhea. Therefore, vaccine effect (impact and effectiveness) against both invasive meningococcal disease (IMD) and gonorrhea in the NT will be assessed using data from the above study comparing notifications between vaccinated and unvaccinated as well as comparing pre and post implementation periods.

Conditions

  • Gonorrhea
  • Meningococcal Disease

Interventions

BIOLOGICAL

Licenced 4CMenB Vaccine

Two doses (0.5 mL each) of Bexsero ® vaccine at least 2 months apart to be given to consenting 14-19 year olds

Sponsors & Collaborators

  • The University of New South Wales

    collaborator OTHER

  • Menzies School of Health Research

    collaborator OTHER

  • University of Sydney

    collaborator OTHER

  • The University of Western Australia

    collaborator OTHER

  • Northern Territory Government of Australia

    collaborator OTHER_GOV

  • SA Health

    collaborator OTHER

  • The University of Queensland

    collaborator OTHER

  • University of Adelaide

    lead OTHER

Eligibility

Min Age
14 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-04
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Australia

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04398849 on ClinicalTrials.gov