Safety Profile Following Td Vaccination in Indonesian Pregnant Woman

Overview

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

Study Type

• Study Type: Observational [Patient Registry]
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: January 15, 2018

Detailed Description

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

Clinical Trial Outcome Measures

Primary Measures

• Any serious adverse event occurring from inclusion until 30 minutes after the injection
  • Time Frame: 30 minutes
  • local and systemic reaction

Secondary Measures

• Percentage of local and systemic events occurring within 72 hours after each injection
  • Time Frame: 72 hours
  • any local and systemics events
• Percentage of local and systemic events occurring from 72 hours up to 28 days following injection.
  • Time Frame: 72 hours – 28 days
  • any local and systemics events
• Percentage of serious adverse events within 28 days after injection
  • Time Frame: 28 days
  • Any serious adverse events

Participating in This Clinical Trial

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

Gender Eligibility: Female

Pregnant Woman

Minimum Age: 18 Years

Maximum Age: 39 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • PT Bio Farma
• Collaborator
  • Indonesian Vaccine Safety Advisory Committee
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Julitasari Sundoro, MD, Principal Investigator, Indonesian Vaccine Safety Advisory Commitee