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Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates

NCT03462108 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-04-03

No results posted yet for this study

Summary

This study is to assess the safety of Rotavirus (Bio Farma) vaccine in adults, children and neonates.

Conditions

  • Safety Issues

Interventions

BIOLOGICAL

Rotavirus (Bio Farma) Vaccine

Rotavirus (Bio Farma) Vaccine

OTHER

Placebo

Placebo contains 30% sucrose in DMEM

Sponsors & Collaborators

  • PT Bio Farma

    lead INDUSTRY

Principal Investigators

  • Jarir At Thobari · Pediatric Research Office (PRO), Departemen Ilmu Kesehatan Anak, Fakultas Kedokteran UGM/RSUP Dr. Sardjito

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-09
Primary Completion
2019-02-18
Completion
2019-03-30

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 NCT03462108 on ClinicalTrials.gov