Safety Profile Following Pentabio Vaccination in Indonesian Infants

November 1, 2017 updated by: PT Bio Farma

Phase IV, Study of Safety Profile Following Pentabio Vaccination in Indonesian Infants

To assess any serious systemic reaction within 30 minutes after Pentabio immunization

Study Overview

Status

Completed

Conditions

Detailed Description

Any local and systemic reaction after Pentabio immunization

Study Type

Observational

Enrollment (Actual)

4000

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
      • Bali, Indonesia
        • Bali Provincial Ministry of Health
      • Yogyakarta, Indonesia
        • Yogyakarta Provincial Ministry of Health
    • West Java
      • Bandung, West Java, Indonesia
        • West Java Provincial Ministry of Health
    • West Nusa Tenggara
      • Mataram, West Nusa Tenggara, Indonesia
        • West Nusa Tenggara Provincial Ministry of Health

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

2 months to 11 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

4000 infants, 2-11 months old From 4 provincial health primary center

Description

Inclusion Criteria:

  • Immunization with Pentabio vaccine
  • Parents already understood the consequences to be involved in this study and having signed the informed consent form
  • Parents agree and willing to fill in the Diary Card, to record all the reactions after immunization

Exclusion Criteria:

  • Given simultaneously with other vaccines or with the interval less than 1 month with other vaccination except OPV/IPV.

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

Cohorts and Interventions

Group / Cohort
Pentabio Vaccine
1 dose of Pentabio vaccine, 0.5 ml Will be given intramuscularly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Any serious adverse event occurring from inclusion until 30 minutes after the injection
Time Frame: 30 minutes
local and systemic reaction
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of local and systemic events occurring within 72 hours after each injection
Time Frame: 72 hours
any local and systemics events
72 hours
Percentage of serious adverse events within 28 days after injection
Time Frame: 28 days
Any serious adverse events
28 days
Percentage of local and systemic events occurring from 72 hours up to 28 days following injection.
Time Frame: 25 days
any local and systemic events
25 days

Collaborators and Investigators

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

Sponsor

PT Bio Farma

Investigators

  • Principal Investigator: Julitasari Sundoro, MD, AEFI National Committee

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, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

December 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 (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 1, 2017

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PMS Penta 0414

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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