NCT06200844View on ClinicalTrials.gov

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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

5,800

Participants

Timeline

Start Date

July 7, 2023

Primary Completion Date

January 4, 2025

Study Completion Date

July 31, 2026

Conditions
Rotavirus Infection of Children
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

Trial Locations (16)

1240000

Vacunatorio Mediped, Antofagasta

2340319

CESFAM Jean y Marie Thierry de Valparaíso, Valparaíso

2520000

Hospital Gustavo Fricke, Viña del Mar

4070118

Vacunatorio Kinewen, Concepción

5290000

Hospital Base Osorno ,Av. Guillermo Buhler 1765, Osorno

5480000

Hospital de Puerto Montt, Los Lagos

5950000

CESFAM Dr. Alejandro Gutierrez, Coyhaique

6000594

CESFAM Puerto Aysen, Puerto Aisén

7500539

Centro de Salud Familiar CESFAM Rosita Renard, Santiago

7770201

Hospital de Carabineros, Santiago

8210269

Consultorio Dr. Alejandro del Rio, Santiago

8380418

Hospital de ninos Roberto del Rio, Santiago

9340000

CESFAM Esmeralda, Santiago

9350079

CESFAM Colina, Santiago

Unknown

CESFAM Lo Barnechea, Santiago

Hospital Exequiel Gónzalez Cortés, Santiago

All Listed Sponsors
lead

Bharat Biotech International Limited

INDUSTRY