دورية أكاديمية
Safety and immunogenicity of a 15-valent pneumococcal conjugate vaccine in Japanese healthy infants: A Phase I study (V114-028)
| العنوان: | Safety and immunogenicity of a 15-valent pneumococcal conjugate vaccine in Japanese healthy infants: A Phase I study (V114-028) |
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| المؤلفون: | Yasunori Ishihara, Haruo Kuroki, Hidenobu Hidaka, Kazuyuki Iwai, Keiko Wan, Masayoshi Shirakawa, Miyuki Sawata |
| المصدر: | Human Vaccines & Immunotherapeutics, Vol 19, Iss 1 (2023) |
| بيانات النشر: | Taylor & Francis Group, 2023. |
| سنة النشر: | 2023 |
| المجموعة: | LCC:Immunologic diseases. Allergy LCC:Therapeutics. Pharmacology |
| مصطلحات موضوعية: | clinical trial, pcv15, pcv13, dtap–ipv, pneumococcal infections, pneumococcal vaccines, japan, child, infant, Immunologic diseases. Allergy, RC581-607, Therapeutics. Pharmacology, RM1-950 |
| الوصف: | This Phase I study evaluated the safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine (PCV), via subcutaneous (SC) or intramuscular (IM) administration, in healthy Japanese infants 3 months of age. A total of 133 participants were randomized to receive four doses (3 + 1 regimen) of V114-SC (n = 44), V114-IM (n = 45), or 13-valent PCV (PCV13)-SC (n = 44) at 3, 4, 5, and 12–15 months of age. Diphtheria, tetanus, and pertussis–inactivated poliovirus (DTaP–IPV) vaccine was administered concomitantly at all vaccination visits. The primary objective was to assess the safety and tolerability of V114-SC and V114-IM. Secondary objectives were to assess the immunogenicity of PCV and DTaP–IPV at 1-month post-dose 3 (PD3). On days 1–14 following each vaccination, the proportions of participants with systemic adverse events (AEs) were comparable across interventions, whereas injection-site AEs were higher with V114-SC (100.0%) and PCV13-SC (100.0%) than with V114-IM (88.9%). Most AEs were mild or moderate in severity and no vaccine-related serious AEs or deaths were reported. Serotype-specific immunoglobulin G (IgG) response rates at 1-month PD3 were comparable across groups for most shared serotypes between V114 and PCV13. For additional V114 serotypes 22F and 33F, IgG response rates were higher with V114-SC and V114-IM than with PCV13-SC. DTaP–IPV antibody response rates at 1-month PD3 for V114-SC and V114-IM were comparable with PCV13-SC. Findings suggest that vaccination with V114-SC or V114-IM in healthy Japanese infants is generally well tolerated and immunogenic. |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 2164-5515 2164-554X 21645515 |
| Relation: | https://doaj.org/toc/2164-5515; https://doaj.org/toc/2164-554X |
| DOI: | 10.1080/21645515.2023.2180973 |
| URL الوصول: | https://doaj.org/article/bd2f6571c8134d74b33d486dc8c24bf6 |
| رقم الأكسشن: | edsdoj.bd2f6571c8134d74b33d486dc8c24bf6 |
| قاعدة البيانات: | Directory of Open Access Journals |
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Full Text Finder | تدمد: | 21645515 2164554X |
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| DOI: | 10.1080/21645515.2023.2180973 |