Safety Profile Following Td Vaccination in Indonesian Pregnant Woman

March 4, 2018 updated by: PT Bio Farma
To assess any serious systemic reaction within 30 minutes after Td immunization in pregnant woman

Study Overview

Status

Completed

Conditions

Detailed Description

Any local and systemic reaction after Td immunization in pregnant woman (as a routine immunization program)

Study Type

Observational

Enrollment (Actual)

200

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
    • Jakarta Province
      • Jakarta, Jakarta Province, Indonesia
        • Jakarta 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

18 years to 39 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

200 pregnant woman, 18-39 years old From provincial health primary center

Description

Inclusion Criteria:

  • Healthy Pregnant Woman aged 18-39 years old
  • 27-36 weeks of pregnancy
  • Subject have been informed properly regarding the study and signed the informed consent form
  • Subject will commit to comply with the instructions of the investigator and the schedule of the trial

Exclusion Criteria:

  • Given simultaneously with other vaccines or with the interval less than 1 month with other vaccination

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

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

Collaborators and Investigators

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

Sponsor

PT Bio Farma

Collaborators

Indonesian Vaccine Safety Advisory 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 (ACTUAL)

August 29, 2017

Primary Completion (ACTUAL)

January 15, 2018

Study Completion (ACTUAL)

January 31, 2018

Study Registration Dates

First Submitted

November 1, 2017

First Submitted That Met QC Criteria

December 19, 2017

First Posted (ACTUAL)

December 26, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 6, 2018

Last Update Submitted That Met QC Criteria

March 4, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Td0417

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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