Safety Profile Following Td Vaccination in Indonesian Pregnant Woman

Completed

• Conditions: Pregnant; Healthy

• Registration Number: NCT03383653
• Lead Sponsor: PT Bio Farma

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)

Study Timeline

• Study Start: 2017-08-29
• Study First Submitted: 2017-11-01
• Study First Submitted QC: 2017-12-19
• Study First Posted: 2017-12-26
• Primary Completion: 2018-01-15
• Study Completion: 2018-01-31
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-04
• Last Update Posted: 2018-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Any serious adverse event occurring from inclusion until 30 minutes after the injection	30 minutes	local and systemic reaction

Secondary Outcome Measures

Name	Time	Method
Percentage of serious adverse events within 28 days after injection	28 days	Any serious adverse 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 local and systemic events occurring within 72 hours after each injection	72 hours	any local and systemics events

Trial Locations

Locations (1)

Jakarta Provincial Ministry of Health; 🇮🇩 Jakarta, Jakarta Province, Indonesia