- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03419533
Study to Assess Oropharyngeal Carriage of N. Meningitidis in South Australian School Leavers (B Part Of It)
An Observational Cross-sectional Study to Assess Oropharyngeal Carriage of N. Meningitidis in South Australian School Leavers
Aperçu de l'étude
Statut
Les conditions
Description détaillée
This carriage study of a cohort of school leavers in South Australia (SA) will provide an opportunity to assess carriage rates in the young adult population (school leavers) following introduction of a 4CMenB vaccination program in senior school students from 2017-2018.This will allow a comparison of carriage prevalence in the two years (2018 and 2019) following implementation of the school program to assess impact on carriage at a population level and compare carriage prevalence in vaccinated versus non-vaccinated groups. Assessment of any association between risk factors and prevalence of nasopharyngeal carriage in school leavers will be made and compared between vaccinated and unvaccinated students.
School leavers are defined as students who were enrolled in year 12 at school in the preceding year of recruitment and have been chosen as they are likely to have the highest carriage rates. A high proportion (approximately two thirds) of students will be immunised by the time of throat swab collection in years 2018 and 2019. Assessing carriage in both vaccinated and unvaccinated cohorts will further inform the effect of 4CMenB vaccine on carriage at a population level. This will help determine any herd immunity impact of 4CMenB vaccine and persistence of any effect.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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South Australia
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Adelaide, South Australia, Australie, 5006
- Women's and Children's Hosptial
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- No exclusion criteria
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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2018 school leavers
South Australian school leavers in 2018 (year 12 in 2017)
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2019 school leavers
South Australian school leavers in 2019 (year 12 in 2018)
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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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
Délai: 2018 to 2019
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As measured by PCR in school leavers in 2018 and 2019
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2018 to 2019
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
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)
Délai: 2018 to 2019
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As measured by PCR in school leavers in 2018 and 2019
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2018 to 2019
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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)
Délai: 2018 to 2019
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As measured by PCR in school leavers in 2018 and 2019
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2018 to 2019
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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
Délai: 2018 to 2019
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As measured by PCR in vaccinated and unvaccinated school leavers
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2018 to 2019
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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.
Délai: 2018 to 2019
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As measured by PCR in vaccinated and unvaccinated school leavers in 2018 and 2019
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2018 to 2019
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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
Délai: 2018 to 2019
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As measured by PCR in vaccinated and unvaccinated school leavers
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2018 to 2019
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Identify Characteristics Associated With Carriage Prevalence of All N. Meningitidis Genogroups in South Australian School Leavers in 2018/2019
Délai: 2018 to 2019
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As measured by PCR in school leavers
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2018 to 2019
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Identify Characteristics Associated With Carriage Prevalence of N. Meningitidis Genogroups Causing Disease (A, B, C, W, X, Y) in South Australian School Leavers in 2018 /2019
Délai: 2018 to 2019
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As measured by PCR in school leavers
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2018 to 2019
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
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Describe Carriage Density of N. Meningitidis Genogroups as Measured by qPCR in School Leavers
Délai: 2018 to 2019
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Density of N. meningitides by qPCR
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2018 to 2019
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Describe Genome Sequencing of Pathogenic N. Meningitidis (A, B, C, W, X, Y) in Carriage Among School Leavers.
Délai: 2018 to 2019
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Whole genome sequencing of N. meningitidis
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2018 to 2019
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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.
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- HREC/16/WCHN/140_3
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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Essais cliniques sur Neisseria Meningitidis
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University of OxfordComplétéInfections méningococciques | Neisseria Meningitidis | Vaccins contre le méningocoque | Protéine de liaison au facteur H, Neisseria MeningitidiRoyaume-Uni