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The Efficacy of Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants
Sponsor: Bharat Biotech International Limited
Summary
This is a randomized, double-blind, phase 3 study to evaluate the Efficacy,Safety, and Immunogenicity of ROTAVAC 5D, a live attenuated rotavirus vaccine in healthy infants aged 6-8 weeks. A total of 5800 healthy Chilean infants will be recruited in this study and randomized to receive either vaccine or placebo in 1:1 ratio. Among these participants 300 will be categorized to immunogenicity cohort, 150 from each group, and blood samples will be collected to assess the immune response.
Official title: The Efficacy of Three Doses of Live Attenuated, Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants.
Key Details
Gender
All
Age Range
6 Weeks - 8 Weeks
Study Type
INTERVENTIONAL
Enrollment
5800
Start Date
2023-07-07
Completion Date
2026-07
Last Updated
2025-05-22
Healthy Volunteers
Yes
Conditions
Interventions
ROTAVAC 5D
Rotavirus Vaccine (ROTAVAC 5D), is a monovalent vaccine containing suspension of live attenuated rotavirus 116E prepared in Vero cells, containing NLT 105.0 FFU and administered as a three-dose regimen, 4 weeks apart.
Placebo
Placebo is administered as three doses 4 weeks apart
Locations (16)
Vacunatorio Mediped
Antofagasta, Chile
Vacunatorio Kinewen
Concepción, Chile
CESFAM Dr. Alejandro Gutierrez
Coyhaique, Chile
Hospital de Puerto Montt
Los Lagos, Chile
Hospital Base Osorno ,Av. Guillermo Buhler 1765
Osorno, Chile
CESFAM Puerto Aysen
Puerto Aisén, Chile
Centro de Salud Familiar CESFAM Rosita Renard
Santiago, Chile
Hospital de Carabineros
Santiago, Chile
Consultorio Dr. Alejandro del Rio
Santiago, Chile
Hospital de ninos Roberto del Rio
Santiago, Chile
CESFAM Esmeralda
Santiago, Chile
CESFAM Colina
Santiago, Chile
CESFAM Lo Barnechea
Santiago, Chile
Hospital Exequiel Gónzalez Cortés
Santiago, Chile
CESFAM Jean y Marie Thierry de Valparaíso
Valparaíso, Chile
Hospital Gustavo Fricke
Viña del Mar, Chile