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

March 19, 2014 updated by: PT Bio Farma

Phase II, Randomized, Double Blind, Prospective Intervention Study to Evaluate the Immunogenicity and Safety Profile of tOPV (Bio Farma) With Different Batch Numbers in Indonesian Infants

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The trial design is phase II, randomized, double blind, prospective intervention study. The subject study are 240 healthy, full term, newborn infants.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • West Java
      • Bandung, West Java, Indonesia
        • Ibrahim Adjie Primary Health Centre
      • Bandung, West Java, Indonesia
        • Garuda Primary Health Center
      • Bandung, West Java, Indonesia
        • Puter Primary Health Centre
      • Bandung, West Java, Indonesia
        • Padasuka Primary Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 1 day (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy, full term, newborns infants
  • newborn residing within a relatively short and easily accessible distance A(<30km) from the study clinic(s) and not planning to travel away during the entire study period
  • Infant born after 37 weeks of pregnancy
  • Infant weighing 2.5kg or more at birth (birth weight >= 2.5kg)
  • Healthy newborns, with no history of asphyxia or meconium aspiration
  • Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
  • Parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial
  • Mother at least elementary school graduate

Exclusion Criteria:

  • Child concomitantly enrolled or scheduled to be enrolled in another trial
  • Known history of congenital or acquired immunodeficiency (including HIV infection)
  • Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature >=37.5oC
  • Newborns requiring hospitalization at birth
  • Infant immunized with non-scheduled OPV or IPV during trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: tOPV commercial batch (Bio Farma)
tOPV (Bio Farma) one dose correspond to 2 drops (0.1ml)
Biological: tOPV commercial batch
tOPV vaccine is given orally
Other Names:
  • tOPV (Bio Farma)
Experimental: tOPV pilot batch
tOPV (Bio Farma), one dose correspond to 2 drops (0.1ml)
Biological: tOPV pilot batch
the tOPV vaccine is given orally
Other Names:
  • tOPV (Bio Farma)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the antibody response 30 days after two doses of tOPV
Time Frame: 30 days
antibody titer to Polio
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To asses and compare the safety of tOPV
Time Frame: 30 days
Data collection of local and systemic reaction after immunization
30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To describe the antibody response after two doses of tOPV
Time Frame: 30 days
Measurement of titer antibody
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PT Bio Farma

Investigators

  • Principal Investigator: Eddy Fadlyana, MD, Department of Child Health of Medicine Padjadjaran University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

March 19, 2014

First Submitted That Met QC Criteria

March 19, 2014

First Posted (Estimate)

March 20, 2014

Study Record Updates

Last Update Posted (Estimate)

March 20, 2014

Last Update Submitted That Met QC Criteria

March 19, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OPV 0213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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