Efficacy, Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates

PHASE3CompletedINTERVENTIONAL
Enrollment

1,400

Participants

Timeline

Start Date

October 30, 2020

Primary Completion Date

April 30, 2022

Study Completion Date

May 30, 2023

Conditions
Rotavirus Gastroenteritis
Interventions
BIOLOGICAL

Rotavirus RV3 Vaccine (Bio Farma)

Each 1 mL dose of the final product of oral liquid rotavirus vaccine contains \> 5x10\^6 fcfu/mL rotavirus vaccine strain RV3

OTHER

Placebo

Each 1 mL dose of placebo contains 30% of sucrose in DMEM

Trial Locations (21)

Unknown

Dr. Moewardi District Hospital, Surakarta

Gajahan Primary Health Center, Surakarta

Gambirsari Primary Health Center, Surakarta

Pajang Primary Health Center, Surakarta

Sangkrah Primary Health Center, Surakarta

Sibela Primary Health Center, Surakarta

Bayat Primary Health Center, Yogyakarta

dr. Soeradji Tirtonegoro General Hospital, Yogyakarta

Gantiwarno Primary Health Center, Yogyakarta

Jogonalan 1 Primary Health Center, Yogyakarta

Jogonalan 2 Primary Health Center, Yogyakarta

Karanganom Primary Health Center, Yogyakarta

Kebonarum Primary Health Center, Yogyakarta

Kebondalem Lor Primary Health Center, Yogyakarta

Klaten Selatan Primary Health Center, Yogyakarta

Ngawen Primary Health Center, Yogyakarta

Pedan Primary Health Center, Yogyakarta

Prambanan Primary Health Center, Yogyakarta

Trucuk 1 Primary Health Center, Yogyakarta

Trucuk 2 Primary Health Center, Yogyakarta

Wedi Primary Health Center, Yogyakarta

Sponsors

Lead Sponsor

All Listed Sponsors
lead

PT Bio Farma

INDUSTRY