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

• Main Authors: Catherine Cohet (Author), Brigitte Cheuvart (Author), Leentje Moerman (Author), Dan Bi (Author), Adrian Caplanusi (Author), Mallesh Kariyappa (Author), Sanjay Lalwani (Author), Monjori Mitra (Author), Amita Sapru (Author), Shruti Saha (Author), P.V. Varughese (Author), Rajeev Zachariah Kompithra (Author), Sanjay Gandhi (Author)
• Format: Book
• Published: Taylor & Francis Group, 2021-11-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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...