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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03383653
Other study ID # Td0417
Secondary ID
Status Completed
Phase N/A
First received November 1, 2017
Last updated March 4, 2018
Start date August 29, 2017
Est. completion date January 31, 2018

Study information

Verified date March 2018
Source PT Bio Farma
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date January 31, 2018
Est. primary completion date January 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 39 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Indonesia Jakarta Provincial Ministry of Health Jakarta Jakarta Province

Sponsors (2)

Lead Sponsor Collaborator
PT Bio Farma Indonesian Vaccine Safety Advisory Committee

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Any serious adverse event occurring from inclusion until 30 minutes after the injection local and systemic reaction 30 minutes
Secondary Percentage of local and systemic events occurring within 72 hours after each injection any local and systemics events 72 hours
Secondary Percentage of local and systemic events occurring from 72 hours up to 28 days following injection. any local and systemics events 72 hours - 28 days
Secondary Percentage of serious adverse events within 28 days after injection Any serious adverse events 28 days
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