Status:
COMPLETED
Safety Profile Following Td Vaccination in Indonesian Pregnant Woman
Lead Sponsor:
PT Bio Farma
Collaborating Sponsors:
Indonesian Vaccine Safety Advisory Committee
Conditions:
Healthy
Pregnant
Eligibility:
FEMALE
18-39 years
Brief Summary
To assess any serious systemic reaction within 30 minutes after Td immunization in pregnant woman
Detailed Description
Any local and systemic reaction after Td immunization in pregnant woman (as a routine immunization program)
Eligibility Criteria
Inclusion
- 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
- Given simultaneously with other vaccines or with the interval less than 1 month with other vaccination
Key Trial Info
Start Date :
August 29 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2018
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03383653
Start Date
August 29 2017
End Date
January 31 2018
Last Update
March 6 2018
Active Locations (1)
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1
Jakarta Provincial Ministry of Health
Jakarta, Jakarta Province, Indonesia