Phase 3, open-label, Russian, multicenter, single-arm trial to evaluate the immunogenicity of varicella vaccine (VARIVAX™) in healthy infants, children, and adolescents
| Autor: | Erin M. Paradis, Oleg Tikhonov, Xin Cao, Susanna M. Kharit, Aleksandr Fokin, Heather L. Platt, Frederick Wittke, Veronika Jotterand |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: | |
| Zdroj: | Human Vaccines & Immunotherapeutics, Vol 17, Iss 11, Pp 4183-4189 (2021) |
| Druh dokumentu: | article |
| ISSN: | 2164-5515 2164-554X 21645515 |
| DOI: | 10.1080/21645515.2021.1975451 |
| Popis: | Varicella (chickenpox) is a common, highly contagious disease caused by primary infection with varicella zoster virus (VZV), which can result in bacterial superinfection, central nervous system complications, and hospitalization. Stage 2 of this Phase 3 open-label study (ClinicalTrials.gov identifier: NCT03843632) enrolled 100 healthy infants, children, and adolescents (12 months–6 years, n = 37; 7–12 years, n = 33; 13–17 years, n = 30) without a clinical history of varicella. Participants aged 12 months–12 years were administered 1 dose of VARIVAX™ 0.5 mL (Varicella Virus Vaccine Live [Oka/Merck]) and adolescents aged 13–17 years were administered 2 doses 6 weeks apart. For participants seronegative at baseline (VZV antibody titer |
| Databáze: | Directory of Open Access Journals |
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