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

NCT04185545 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1400

Last updated 2023-11-29

No results posted yet for this study

Summary

This phase III trial aims to assess the efficacy, safety and immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in neonates, lot-to-lot consistency, and antigen interference with co-administered EPI vaccines

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

Sponsors & Collaborators

  • PT Bio Farma

    lead INDUSTRY

Principal Investigators

  • Titis Widowati · Center for Child Health Universitas Gadjah Mada (CCH-PRO UGM

  • Hari Wahyu N. · Pediatric Research Center Universitas Sebelas Maret (PRC UNS)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
5 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-30
Primary Completion
2022-04-30
Completion
2023-05-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04185545 on ClinicalTrials.gov