Safety of meningococcal B vaccine (4CMenB) in adolescents in Australia.

Adolescent Australia / epidemiology Female Humans Infant Meningococcal Infections / epidemiology Meningococcal Vaccines / adverse effects Odds Ratio South Australia / epidemiology
4CMenB Adolescents Adverse events Meningococcal B disease Vaccine safety

Journal

Vaccine
ISSN: 1873-2518
Titre abrégé: Vaccine
Pays: Netherlands
ID NLM: 8406899

Informations de publication

Date de publication:
18 08 2020
Historique:
received: 21 04 2020
revised: 04 07 2020
accepted: 07 07 2020
pubmed: 28 7 2020
medline: 28 4 2021
entrez: 27 7 2020
Statut: ppublish

Résumé

Four-component meningococcal B (4CMenB) vaccine is licensed in many countries but has had limited use in adolescents despite this age group being at increased risk of meningococcal disease. To assess the safety profile of two doses of 4CMenB in adolescents. Cluster randomised controlled trial of senior school students in South Australia (SA) with participating schools randomised to intervention (4CMenB) or control. Vaccine safety was monitored using the South Australian Vaccine Safety Surveillance System (SAVSS), a spontaneous reporting system for adverse events following immunisation (AEFI) with enhanced follow-up of AEFI. 58,637 doses of 4CMenB vaccine were administered to 30,522 students (median age 16 years) during 2017-2018. Of 18,348 and 12,174 students vaccinated in 2017 and 2018, 97.3% and 84.3%, respectively, received both scheduled doses (N = 28,115). 193 AEFI in 187 students were reported with a reporting rate of 0.32% (95%CI: 0.28-0.39%). Seventy individuals sought medical review, including nine serious adverse events. 98% (166/169) of those who were contactable for AEFI follow-up (87.6% 169/193) reported resolution of the event. Most common AEFI were injection site reaction (126/193), headache (99/193) and nausea (61/193). AEFI were more frequently reported in females (aOR = 1.409 (95%CI: 1.002, 1.980)), schools with high level of educational advantage (adjusted Odds Ratio (aOR) = 1.515 (95%CI: 1.005, 2.284)), following first dose (aOR = 1.619 (95%CI: 1.168, 2.244)), and in 2017 (aOR = 1.437 (95%CI: 1.001, 2.064)). Reported AEFI declined with increasing age (aOR = 0.771 (95%CI: 0.673, 0.883)). In this largest post-licensure use of 4CMenB in adolescents, the low AEFI reporting rate provides real-world evidence of 4CMenB safety in this age group. (ClinicalTrials.gov number: NCT03089086).

Sections du résumé

BACKGROUND
Four-component meningococcal B (4CMenB) vaccine is licensed in many countries but has had limited use in adolescents despite this age group being at increased risk of meningococcal disease.
OBJECTIVES
To assess the safety profile of two doses of 4CMenB in adolescents.
METHODS
Cluster randomised controlled trial of senior school students in South Australia (SA) with participating schools randomised to intervention (4CMenB) or control. Vaccine safety was monitored using the South Australian Vaccine Safety Surveillance System (SAVSS), a spontaneous reporting system for adverse events following immunisation (AEFI) with enhanced follow-up of AEFI.
RESULTS
58,637 doses of 4CMenB vaccine were administered to 30,522 students (median age 16 years) during 2017-2018. Of 18,348 and 12,174 students vaccinated in 2017 and 2018, 97.3% and 84.3%, respectively, received both scheduled doses (N = 28,115). 193 AEFI in 187 students were reported with a reporting rate of 0.32% (95%CI: 0.28-0.39%). Seventy individuals sought medical review, including nine serious adverse events. 98% (166/169) of those who were contactable for AEFI follow-up (87.6% 169/193) reported resolution of the event. Most common AEFI were injection site reaction (126/193), headache (99/193) and nausea (61/193). AEFI were more frequently reported in females (aOR = 1.409 (95%CI: 1.002, 1.980)), schools with high level of educational advantage (adjusted Odds Ratio (aOR) = 1.515 (95%CI: 1.005, 2.284)), following first dose (aOR = 1.619 (95%CI: 1.168, 2.244)), and in 2017 (aOR = 1.437 (95%CI: 1.001, 2.064)). Reported AEFI declined with increasing age (aOR = 0.771 (95%CI: 0.673, 0.883)).
CONCLUSION
In this largest post-licensure use of 4CMenB in adolescents, the low AEFI reporting rate provides real-world evidence of 4CMenB safety in this age group. (ClinicalTrials.gov number: NCT03089086).

Identifiants

DOI: 10.1016/j.vaccine.2020.07.009 PMID: 32712083
pubmed: 32712083
pii: S0264-410X(20)30909-9
doi: 10.1016/j.vaccine.2020.07.009
pii:
doi:

Substances chimiques

Meningococcal Vaccines 0

Banques de données

ClinicalTrials.gov
['NCT03089086']

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

5914-5922

Informations de copyright

Copyright © 2020 Elsevier Ltd. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: “HM is an investigator on clinical trials of investigational vaccines sponsored by Industry. Her institution receives funding from Industry (GSK, Pfizer, Sanofi-Pasteur) for Investigator led research and for sponsored studies (Novavax). She does not receive any personal payments from Industry. Other authors report no conflict”.

Auteurs

H S Marshall (HS)

Robinson Research Institute and Adelaide Medical School, The University of Adelaide, Australia; Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network, Adelaide, Australia. Electronic address: helen.marshall@adelaide.edu.au.

A P Koehler (AP)

Communicable Disease Control Branch, SA Health, Government of South Australia, Adelaide, Australia.

B Wang (B)

Robinson Research Institute and Adelaide Medical School, The University of Adelaide, Australia; Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network, Adelaide, Australia.

M A'Houre (M)

Communicable Disease Control Branch, SA Health, Government of South Australia, Adelaide, Australia.

M Gold (M)

Robinson Research Institute and Adelaide Medical School, The University of Adelaide, Australia.

H Quinn (H)

National Centre for Immunisation Research and Surveillance (NCIRS), Westmead, Sydney, Australia; Discipline of Child and Adolescent Health, University of Sydney, Sydney, Australia.

N Crawford (N)

Murdoch Children's Research Institute (MCRI), Royal Children's Hospital & Department of Paediatrics, The University of Melbourne, Parkville, Australia.

N Pratt (N)

School of Pharmacy and Medical Services, University of South Australia, Adelaide, Australia.

T R Sullivan (TR)

SAHMRI Women & Kids, South Australian Health & Medical Research Institute, Adelaide, Australia; School of Public Health, The University of Adelaide, Australia.

K Macartney (K)

National Centre for Immunisation Research and Surveillance (NCIRS), Westmead, Sydney, Australia; Discipline of Child and Adolescent Health, University of Sydney, Sydney, Australia.

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Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Adolescent › Safety of meningococcal B vaccine (4CMenB) in...
questionsmedicales.fr › Régions géographiques › Océanie › Australasie › Australie › Safety of meningococcal B vaccine (4CMenB) in...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Safety of meningococcal B vaccine (4CMenB) in...
questionsmedicales.fr › Personnes › Tranches d'âge › Nourrisson › Safety of meningococcal B vaccine (4CMenB) in...
questionsmedicales.fr › Infection › Infections bactériennes et mycoses › Infections bactériennes › Infections bactériennes à Gram négatif › Infections à Neisseriaceae › Infections à méningocoques › Safety of meningococcal B vaccine (4CMenB) in...
questionsmedicales.fr › Mélanges complexes › Produits biologiques › Vaccins › Vaccins antibactériens › Vaccins antiméningococciques › Safety of meningococcal B vaccine (4CMenB) in...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Statistiques comme sujet › Probabilité › Odds ratio › Safety of meningococcal B vaccine (4CMenB) in...
questionsmedicales.fr › Régions géographiques › Océanie › Australasie › Australie › Australie-Méridionale › Safety of meningococcal B vaccine (4CMenB) in...