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
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...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2020-06-01
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| Series: | Human Vaccines & Immunotherapeutics |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/21645515.2019.1670125 |
| _version_ | 1797677371054096384 |
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| author | Byung Wook Yoo Hye Lim Jung Yoon Seob Byeon Dong Ki Han Nak Yeong Jeong Carlo Curina Luca Moraschini Sung Jin Kim Chiranjiwi Bhusal Michele Pellegrini Yan Miao |
| author_facet | Byung Wook Yoo Hye Lim Jung Yoon Seob Byeon Dong Ki Han Nak Yeong Jeong Carlo Curina Luca Moraschini Sung Jin Kim Chiranjiwi Bhusal Michele Pellegrini Yan Miao |
| author_sort | Byung Wook Yoo |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T22:44:06Z |
| format | Article |
| id | doaj.art-c47b928758774878bd4e7be26580e4f6 |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T22:44:06Z |
| publishDate | 2020-06-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-c47b928758774878bd4e7be26580e4f62023-09-22T08:45:33ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2020-06-011661260126710.1080/21645515.2019.16701251670125Results 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 yearsByung Wook Yoo0Hye Lim Jung1Yoon Seob Byeon2Dong Ki Han3Nak Yeong Jeong4Carlo Curina5Luca Moraschini6Sung Jin Kim7Chiranjiwi Bhusal8Michele Pellegrini9Yan Miao10Soonchunhyang University Seoul HospitalSungkyunkwan University, Kangbuk Samsung HospitalMoran Women’s HospitalPediatrics ClinicYonsei Koum Internal Medicine ClinicGSKGSKGSKGSKGSKGSKThe 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.http://dx.doi.org/10.1080/21645515.2019.1670125safety surveillancemenacwy-crmchildrenadolescentsadultsrepublic of korea |
| spellingShingle | Byung Wook Yoo Hye Lim Jung Yoon Seob Byeon Dong Ki Han Nak Yeong Jeong Carlo Curina Luca Moraschini Sung Jin Kim Chiranjiwi Bhusal Michele Pellegrini Yan Miao 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 Human Vaccines & Immunotherapeutics safety surveillance menacwy-crm children adolescents adults republic of korea |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | safety surveillance menacwy-crm children adolescents adults republic of korea |
| url | http://dx.doi.org/10.1080/21645515.2019.1670125 |
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