Healthy Clinical Trial
Official title:
Safety Profile Following Td Vaccination in Indonesian Pregnant Woman
Verified date | March 2018 |
Source | PT Bio Farma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
To assess any serious systemic reaction within 30 minutes after Td immunization in pregnant woman
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 |
Country | Name | City | State |
---|---|---|---|
Indonesia | Jakarta Provincial Ministry of Health | Jakarta | Jakarta Province |
Lead Sponsor | Collaborator |
---|---|
PT Bio Farma | Indonesian Vaccine Safety Advisory Committee |
Indonesia,
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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