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ACTIVE NOT RECRUITING
NCT06200844
PHASE3

The Efficacy of Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants

Sponsor: Bharat Biotech International Limited

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 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

Interventions

BIOLOGICAL

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.

OTHER

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