MedTrace Logo

Evaluation on Immunogenicity and Safety Profile of Trivalent OPV (tOPV Bio Farma)

NCT02093273 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2014-03-20

No results posted yet for this study

Summary

The objective of this study is to compare the antibody response 30 days after two doses of t OPV

Conditions

  • Healthy

Interventions

BIOLOGICAL

tOPV pilot batch

the tOPV vaccine is given orally

BIOLOGICAL

tOPV commercial batch

tOPV vaccine is given orally

Sponsors & Collaborators

  • PT Bio Farma

    lead INDUSTRY

Principal Investigators

  • Eddy Fadlyana, MD · Department of Child Health of Medicine Padjadjaran University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
1 Day
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-01-31
Completion
2014-02-28

Countries

  • Indonesia

Study Locations

More Related Trials

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 NCT02093273 on ClinicalTrials.gov