Safety Profile Following Td Vaccination in Indonesian Pregnant Woman

PT Bio Farma

Status: Completed

Conditions: Healthy; Pregnant

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03383653

Td0417

Details and patient eligibility

About

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

Full description

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

Enrollment: 200 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

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