| Autor: |
Gagandeep Kang, Anand Lakhkar, Chetanraj Bhamare, Abhijeet Dharmadhikari, Jyoti Narwadkar, Arti Kanujia, Dhananjay Kapse, Bhagwat Gunale, Cyrus S. Poonawalla, Prasad S. Kulkarni |
| Jazyk: |
angličtina |
| Rok vydání: |
2023 |
| Předmět: |
|
| Zdroj: |
The Lancet Regional Health - Southeast Asia, Vol 14, Iss , Pp 100207- (2023) |
| Druh dokumentu: |
article |
| ISSN: |
2772-3682 |
| DOI: |
10.1016/j.lansea.2023.100207 |
| Popis: |
Summary: Background: A vero cell-based inactivated Rabies Vaccine (Rabivax-S) and Rabies Human Monoclonal Antibody (Rabishield) have been approved since 2016. A post-marketing surveillance was conducted in India from 2020 to 2021 to gather real world safety data on Rabivax-S and Rabishield. Methods: This was non-interventional active surveillance in patients with category III potential rabies exposure who were administered a post-exposure prophylaxis (PEP) regimen (Rabishield and Rabivax-S) by their healthcare providers (HCPs) as per the dosages and regimens mentioned in the package insert approved by the Indian regulators. The approved schedule for PEP was local infiltration of Rabishield on Day 0 and five doses of Rabivax-S on Day 0, 3, 7, 14, and 28 (Intramuscular route, IM) or four doses of Rabivax-S on Day 0, 3, 7, and 28 (Intradermal route, ID). The primary objective of this surveillance was to generate real-world evidence on the safety and tolerability of Rabishield and Rabivax-S. All patients enrolled in the surveillance were required to report any adverse events (AEs) occurring up to Day 31 after initiation of PEP (administration of Rabishield and the first dose of Rabivax-S) to their HCP. Findings: A total of 1000 patients with category III potential rabies exposure were enrolled across India. 991 patients received the PEP regimen with IM Rabivax-S while 9 received a PEP regimen with the ID regimen. While 32% of the patients were |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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