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The Efficacy of Three Doses of Live Attenuated, Oral Rotavirus Vaccine 116E
Sponsor: University of Chile
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. 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
60 Days - 89 Days
Study Type
INTERVENTIONAL
Enrollment
4270
Start Date
2023-07-06
Completion Date
2026-02-27
Last Updated
2026-06-30
Healthy Volunteers
Yes
Conditions
Interventions
ROTAVAC 5D
monovalent vaccine containing suspension of live attenuated rotavirus 116E prepared in Vero cells. Each dose contains NLT 10 e 5.0 FFU
Placebo
Placebo contains all the excipients of ROTAVAC 5D but without the suspension of live attenuated rotavirus
Locations (16)
Vacunatorio Mediped
Antofagasta, Antofagasta, Chile
CESFAM Dr. Alejandro Gutierrez, Coyahique
Coyhaique, Aysén, Chile
CESFAM Puerto Aysen
Puerto Aisén, Aysén, Chile
Vacunatorio Kinewen, Concepción
Concepción, Biobio, Chile
Hospital Base de Osorno
Osorno, Los Lagos Region, Chile
Hospital de Puerto Montt
Port Montt, Los Lagos Region, Chile
CESFAM Colina
Santiago, Metropolitan Region, Chile
CESFAM Dr. Alejandro del Rio, Puente Alto
Santiago, Metropolitan Region, Chile
CESFAM Esmeralda
Santiago, Metropolitan Region, Chile
CESFAM Lo Barnechea
Santiago, Metropolitan Region, Chile
Clínica Dávila
Santiago, Metropolitan Region, Chile
Hospital de Carabineros
Santiago, Metropolitan Region, Chile
Hospital Dr. Exequiel González Cortés
Santiago, Metropolitan Region, Chile
Hospital Roberto del Rio
Santiago, Metropolitan Region, Chile
CESFAM Jean y Marie Thierry de Valparaíso
Valparaíso, Valparaiso, Chile
Hospital Dr. Gustavo Fricke
Viña del Mar, Chile