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COMPLETED
NCT05958771
PHASE3

The Efficacy of Three Doses of Live Attenuated, Oral Rotavirus Vaccine 116E

Sponsor: University of Chile

View on ClinicalTrials.gov

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

Interventions

DRUG

ROTAVAC 5D

monovalent vaccine containing suspension of live attenuated rotavirus 116E prepared in Vero cells. Each dose contains NLT 10 e 5.0 FFU

DRUG

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