1. Results from a large post-marketing safety surveillance study in the Republic of Korea with a quadrivalent meningococcal CRM-conjugate vaccine in individuals aged 2 months–55 years
- Author
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Chiranjiwi Bhusal, Dong Ki Han, Byung-Wook Yoo, Yoon Seob Byeon, Yan Miao, Michele Pellegrini, Hye Lim Jung, Nak Yeong Jeong, Luca Moraschini, Carlo Curina, and Sung Jin Kim
- Subjects
MenACWY-CRM ,030231 tropical medicine ,Immunology ,Meningococcal Vaccines ,Neisseria meningitidis ,03 medical and health sciences ,0302 clinical medicine ,children ,Conjugate vaccine ,Environmental health ,Republic of Korea ,adults ,Humans ,Immunology and Allergy ,Medicine ,adolescents ,030212 general & internal medicine ,Safety surveillance ,Marketing ,Pharmacology ,Vaccines, Conjugate ,business.industry ,Meningococcal Infections ,Observational study ,Meningococcal conjugate vaccine ,business ,Research Article ,Research Paper - Abstract
The quadrivalent meningococcal conjugate vaccine MenACWY-CRM is approved in the Republic of Korea for use in individuals from 2 months of age. This single-arm, open-label, observational, multicenter, post-marketing study (NCT01766206) assessed the safety of MenACWY-CRM vaccine administered according to local clinical practice. A total of 3939 individuals aged 2 months–55 years provided safety data post-vaccination; the analysis was conducted on the per-protocol set (3920 participants). Solicited and unsolicited adverse events (AEs) were collected over 7 days post-vaccination and medically-attended AEs (MAAEs) and serious AEs (SAEs) over 29 days post-vaccination. Among recorded solicited AEs, injection site AEs were reported by 21.38% of participants, with tenderness/pain being most frequent across age groups; systemic AEs were reported in 13.95% of participants, with irritability (in ˂6-year-olds), headache and myalgia (in ≥6 year-olds) being the most frequently reported. Most solicited AEs were mild or moderate in nature. The percentage of participants reporting unsolicited AEs varied in the study population, i.e. 12.56% in participants aged 2–23 months and 3.18% in those ≥2 years of age. Overall, less than 22% of unsolicited AEs were considered as related to vaccination. MAAEs (10.89% of participants) were mostly mild; 2.82% were considered as related to vaccination. Three (0.46%) and 5 (0.15%) SAEs (none vaccination-related) occurred in participants aged 2–23 months and 2–55 years, respectively. No deaths were reported. The safety profile for MenACWY-CRM in this post-marketing surveillance was consistent with observations from studies conducted during the vaccine’s clinical development, with no new safety concerns.
- Published
- 2019
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