A phase III randomized, open-label, non-inferiority clinical trial comparing liquid and lyophilized formulations of oral live attenuated human rotavirus vaccine (HRV) in Indian infants

A phase III randomized, open-label, non-inferiority clinical trial comparing liquid and lyophilized formulations of oral live attenuated human rotavirus vaccine (HRV) in Indian infants

The human rotavirus vaccine (HRV; Rotarix, GSK) is available as liquid (Liq) and lyophilized (Lyo) formulations, but only Lyo HRV is licensed in India. In this phase III, randomized, open-label trial (NCT02141204), healthy Indian infants aged 6–10 weeks received 2 doses (1 month apart) of either Liq...

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Bibliographic Details
Main Authors: Catherine Cohet, Brigitte Cheuvart, Leentje Moerman, Dan Bi, Adrian Caplanusi, Mallesh Kariyappa, Sanjay Lalwani, Monjori Mitra, Amita Sapru, Shruti Saha, P.V. Varughese, Rajeev Zachariah Kompithra, Sanjay Gandhi
Format: Article
Language:English
Published: Taylor & Francis Group 2021-11-01
Series:Human Vaccines & Immunotherapeutics
Subjects:
rotavirus vaccine
rotarix
liquid
lyophilized
india
immunogenicity
non-inferiority
Online Access:http://dx.doi.org/10.1080/21645515.2021.1960136

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