Safety and immunogenicity of Bio Pox™, a live varicella vaccine (Oka strain) in Indian children: A comparative multicentric, randomized phase II/III clinical trial
| Autor: | Anand Prakash Dubey, Mohammad Moonis Akbar Faridi, Monjori Mitra, Iqbal Rajinder Kaur, Aashima Dabas, Jaydeep Choudhury, Mallar Mukherjee, Devendra Mishra |
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| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: | |
| Zdroj: | Human Vaccines & Immunotherapeutics, Vol 13, Iss 9, Pp 2032-2037 (2017) |
| Druh dokumentu: | article |
| ISSN: | 2164-5515 2164-554X 21645515 |
| DOI: | 10.1080/21645515.2017.1318236 |
| Popis: | Varicella or chickenpox is a highly contagious disease with a high secondary attack rate. Almost 30% of Indian adolescents lack protective antibodies against varicella, emphasizing the need of routine varicella immunization. The Oka VZV is a well-established, safe and efficacious vaccine strain that is highly immunogenic and produces lifelong protective immunity. The present multicentric, open label, randomized, controlled Phase II/III study, compared the Bio Pox™ (indigenous investigational vaccine) with a licensed vaccine, Varivax™, for its safety and immunogenicity profile in 252 healthy subjects in the age group of 1–12 y (cohort I: 6–12 years, II:1–6 years) in 3 tertiary medical institutions. Antibodies were measured by VZV Glycoprotein Enzyme Linked Immunoassay (IgG ELISA) kit. Seroconversion percentage in children having pre-vaccination anti VZV IgG titer |
| Databáze: | Directory of Open Access Journals |
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