Post-marketing surveillance study of the safety of the HPV-16/18 vaccine in Korea (2017–2021)
Human papillomavirus (HPV) infection is associated with the risk of developing certain cancers, including cancers of the cervix, vulva, vagina, penis, anus, rectum, and oropharynx. In 2016, the bivalent HPV-16/18 vaccine was included in the Korea National Immunization Program. This vaccine protects...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2023-01-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | http://dx.doi.org/10.1080/21645515.2023.2184756 |
| _version_ | 1827806332773728256 |
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| author | Byung-Wook Eun Enas Bahar Stebin Xavier Hyungwoo Kim Dorota Borys |
| author_facet | Byung-Wook Eun Enas Bahar Stebin Xavier Hyungwoo Kim Dorota Borys |
| author_sort | Byung-Wook Eun |
| collection | DOAJ |
| description | Human papillomavirus (HPV) infection is associated with the risk of developing certain cancers, including cancers of the cervix, vulva, vagina, penis, anus, rectum, and oropharynx. In 2016, the bivalent HPV-16/18 vaccine was included in the Korea National Immunization Program. This vaccine protects against HPV types 16 and 18 and other oncogenic HPV types predominant in cervical and anal cancers. This post-marketing surveillance (PMS) study assessed the safety of the HPV-16/18 vaccine in Korea. The study was conducted in males and females aged between 9 and 25 years, from 2017 to 2021. Safety was measured in terms of frequency and intensity of adverse events (AEs), adverse drug reactions (ADRs), and serious adverse events (SAEs) after each vaccine dose. The safety analysis included all participants who were vaccinated as per prescribing information and who completed a 30-day follow-up after at least one dose. Data were collected using individual case report forms. The total safety cohort included 662 participants. A total of 220 AEs were reported in 144 subjects (21.75%), and there were 158 ADRs in 111 subjects (16.77%), with the most common being injection site pain in all cases. No SAEs or serious ADRs were reported. Most AEs were reported after the first dose and were injection site reactions with mild intensity that recovered. No individuals required hospitalization or an emergency department visit. Safety results showed that the HPV-16/18 vaccine was generally well tolerated in the Korean population, and no safety concerns were identified. ClinicalTrials.gov Identifier: NCT03671369. |
| first_indexed | 2024-03-11T21:39:43Z |
| format | Article |
| id | doaj.art-5a25eb9d14604677b32720e83ddb91cf |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T21:39:43Z |
| publishDate | 2023-01-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-5a25eb9d14604677b32720e83ddb91cf2023-09-26T13:25:48ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2023-01-0119110.1080/21645515.2023.21847562184756Post-marketing surveillance study of the safety of the HPV-16/18 vaccine in Korea (2017–2021)Byung-Wook Eun0Enas Bahar1Stebin Xavier2Hyungwoo Kim3Dorota Borys4Nowon Eulji University HospitalGSKGSKGSKGSKHuman papillomavirus (HPV) infection is associated with the risk of developing certain cancers, including cancers of the cervix, vulva, vagina, penis, anus, rectum, and oropharynx. In 2016, the bivalent HPV-16/18 vaccine was included in the Korea National Immunization Program. This vaccine protects against HPV types 16 and 18 and other oncogenic HPV types predominant in cervical and anal cancers. This post-marketing surveillance (PMS) study assessed the safety of the HPV-16/18 vaccine in Korea. The study was conducted in males and females aged between 9 and 25 years, from 2017 to 2021. Safety was measured in terms of frequency and intensity of adverse events (AEs), adverse drug reactions (ADRs), and serious adverse events (SAEs) after each vaccine dose. The safety analysis included all participants who were vaccinated as per prescribing information and who completed a 30-day follow-up after at least one dose. Data were collected using individual case report forms. The total safety cohort included 662 participants. A total of 220 AEs were reported in 144 subjects (21.75%), and there were 158 ADRs in 111 subjects (16.77%), with the most common being injection site pain in all cases. No SAEs or serious ADRs were reported. Most AEs were reported after the first dose and were injection site reactions with mild intensity that recovered. No individuals required hospitalization or an emergency department visit. Safety results showed that the HPV-16/18 vaccine was generally well tolerated in the Korean population, and no safety concerns were identified. ClinicalTrials.gov Identifier: NCT03671369.http://dx.doi.org/10.1080/21645515.2023.2184756hpvbivalent vaccineas04-adjuvanted hpv-16/18 vaccinehpv-16/18safetypost-marketing surveillancekorea |
| spellingShingle | Byung-Wook Eun Enas Bahar Stebin Xavier Hyungwoo Kim Dorota Borys Post-marketing surveillance study of the safety of the HPV-16/18 vaccine in Korea (2017–2021) Human Vaccines & Immunotherapeutics hpv bivalent vaccine as04-adjuvanted hpv-16/18 vaccine hpv-16/18 safety post-marketing surveillance korea |
| title | Post-marketing surveillance study of the safety of the HPV-16/18 vaccine in Korea (2017–2021) |
| title_full | Post-marketing surveillance study of the safety of the HPV-16/18 vaccine in Korea (2017–2021) |
| title_fullStr | Post-marketing surveillance study of the safety of the HPV-16/18 vaccine in Korea (2017–2021) |
| title_full_unstemmed | Post-marketing surveillance study of the safety of the HPV-16/18 vaccine in Korea (2017–2021) |
| title_short | Post-marketing surveillance study of the safety of the HPV-16/18 vaccine in Korea (2017–2021) |
| title_sort | post marketing surveillance study of the safety of the hpv 16 18 vaccine in korea 2017 2021 |
| topic | hpv bivalent vaccine as04-adjuvanted hpv-16/18 vaccine hpv-16/18 safety post-marketing surveillance korea |
| url | http://dx.doi.org/10.1080/21645515.2023.2184756 |
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