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Safety Profile Following Td Vaccination in Indonesian Pregnant Woman

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ClinicalTrials.gov Identifier: NCT03383653
Recruitment Status : Completed
First Posted : December 26, 2017
Last Update Posted : March 6, 2018
Sponsor:
Collaborator:
Indonesian Vaccine Safety Advisory Committee
Information provided by (Responsible Party):
PT Bio Farma

Brief Summary:
To assess any serious systemic reaction within 30 minutes after Td immunization in pregnant woman

Condition or disease
Healthy Pregnant

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

Study Type : Observational [Patient Registry]
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Safety Profile Following Td Vaccination in Indonesian Pregnant Woman
Actual Study Start Date : August 29, 2017
Actual Primary Completion Date : January 15, 2018
Actual Study Completion Date : January 31, 2018



Primary Outcome Measures :
  1. Any serious adverse event occurring from inclusion until 30 minutes after the injection [ Time Frame: 30 minutes ]
    local and systemic reaction


Secondary Outcome Measures :
  1. Percentage of local and systemic events occurring within 72 hours after each injection [ Time Frame: 72 hours ]
    any local and systemics events

  2. 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

  3. Percentage of serious adverse events within 28 days after injection [ Time Frame: 28 days ]
    Any serious adverse events



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant Woman
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
200 pregnant woman, 18-39 years old From provincial health primary center
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383653


Locations
Indonesia
Jakarta Provincial Ministry of Health
Jakarta, Jakarta Province, Indonesia
Sponsors and Collaborators
PT Bio Farma
Indonesian Vaccine Safety Advisory Committee
Investigators
Principal Investigator: Julitasari Sundoro, MD Indonesian Vaccine Safety Advisory Commitee

Responsible Party: PT Bio Farma
ClinicalTrials.gov Identifier: NCT03383653     History of Changes
Other Study ID Numbers: Td0417
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by PT Bio Farma:
Td Vaccine
Safety
Pregnant
Pregnant Women