Immunogenicity, safety, and reactogenicity of combined reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine administered as a booster vaccine dose in healthy Russian participants: a phase III, open-label study
Rattachement africain : be, ru. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
As vaccine-induced immunity and protection following natural pertussis infection wane over time, adults and adolescents may develop pertussis and become transmitters to unprotected infants. In Russia, diphtheria and tetanus but not pertussis-containing vaccines are registered for older children, adolescents, or adults. The reduced-antigen-content diphtheria toxoid, tetanus toxoid, and acellular pertussis (dTpa) vaccine (Boostrix, GSK) was developed for booster vaccination of children ≥4 years of age, adolescents, and adults. A phase III, open-label, non-randomized study was performed in eight centers in Russia between January and July 2018. The objective of this study was to assess immunogenicity, reactogenicity and safety of a single dose of dTpa vaccine in healthy Russian participants ≥4 years of age (age categories 4–9 years, 10–17 years, 18–64 years, and ≥65 years). At 1 month post-booster vaccination, across all age groups, >99.0% of participants were seroprotected against diphtheria and tetanus and >96.0% of participants were seropositive for anti-pertussis antibodies. For all antibodies across all age groups, antibody GMCs increased from pre- to 1 month post-booster vaccination and booster responses to diphtheria (in 71.5% of participants), tetanus (85.3%), and pertussis antigens (≥85.6%) were observed. One serious adverse event that was not causally related to the study vaccine was reported. No fatal cases were reported throughout the study period. In conclusion, administration of the dTpa vaccine as a booster dose in healthy Russian participants induced a robust immune response to all vaccine antigens and was generally well tolerated across all age groups.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Immunogenicity, safety, and reactogenicity of combined reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine administered as a booster vaccine dose in healthy Russian participants: a phase III, open-label study
- Date Crossref
- 26/08/2020
- Éditeur
- Informa UK Limited
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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GlaxoSmithKline (Belgium) pays non établi dans la noticeEntreprise
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Children's City Clinical Hospital №11 pays non établi dans la noticeÉtablissement de santé
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Saint Petersburg State Pediatric Medical University pays non établi dans la noticeUniversité ou école supérieure
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Pirogov Russian National Research Medical University pays non établi dans la noticeUniversité ou école supérieure
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Institute of Immunology and Physiology pays non établi dans la noticeStructure de recherche
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Hospital Stomamedservice pays non établi dans la noticeÉtablissement de santé
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GSK pays non établi dans la noticeInstitution
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Children’s City Hospital No11 pays non établi dans la noticeÉtablissement de santé
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Ooo “Asko-med-plus” pays non établi dans la noticeInstitution
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Ooo "Asko-med-plus" pays non établi dans la noticeInstitution
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St. Petersburg State Pediatric Medical University of the Ministry of Healthcare of the Russian Federation Federal State Budgetary Educational Institution of Higher Education pays non établi dans la noticeUniversité ou école supérieure
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Medical Technologies Ltd pays non établi dans la noticeEntreprise
GlaxoSmithKline (Belgium), Children's City Clinical Hospital №11 et Saint Petersburg State Pediatric Medical University, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.