Safety Profile Following Td Vaccination in Indonesian Pregnant Woman


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

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