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Immunogenicity and Safety Profile of Primary Dose of bOPV Bio Farma Given Simultaneously With Pentabio And IPV

NCT03310073 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2017-11-08

No results posted yet for this study

Summary

This study is to assess protectivity following four doses of bOPV which given simultaneously with Pentabio® and 1 dose of IPV at the 4th visit

Conditions

  • Healthy

Interventions

BIOLOGICAL

bOPV

Batch Number: 2042015

BIOLOGICAL

Pentabio

Batch number: 5050115 The vaccine shall be given intramuscularly.

BIOLOGICAL

IPV

The vaccine shall be given intramuscularly.

Sponsors & Collaborators

  • PT Bio Farma

    lead INDUSTRY

Principal Investigators

  • Kusnandi Rusmil · Hasan Sadikin General Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-03-31
Completion
2017-03-31

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 NCT03310073 on ClinicalTrials.gov