Healthy, Pregnant
Conditions
Keywords
Td Vaccine, Safety, Pregnant, Pregnant Women
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)
Interventions
None listed
Sponsors
Indonesian Vaccine Safety Advisory Committee
PT Bio Farma
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Any serious adverse event occurring from inclusion until 30 minutes after the injection | 30 minutes | local and systemic reaction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of local and systemic events occurring within 72 hours after each injection | 72 hours | any local and systemics events |
| Percentage of local and systemic events occurring from 72 hours up to 28 days following injection. | 72 hours - 28 days | any local and systemics events |
| Percentage of serious adverse events within 28 days after injection | 28 days | Any serious adverse events |
Countries
Indonesia
Outcome results
None listed