Safety Profile Following Td Vaccination in Indonesian Pregnant Woman

Healthy Clinical Trial

Official title:

Safety Profile Following Td Vaccination in Indonesian Pregnant Woman

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03383653
• Other study ID #: Td0417
• Status: Completed
• Phase: N/A
• First received: November 1, 2017
• Last updated: March 4, 2018
• Start date: August 29, 2017
• Est. completion date: January 31, 2018

Study information

• Verified date: March 2018
• Source: PT Bio Farma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 31, 2018
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Pregnant

Locations

Country	Name	City	State
Indonesia	Jakarta Provincial Ministry of Health	Jakarta	Jakarta Province

Sponsors (2)

Lead Sponsor	Collaborator
PT Bio Farma	Indonesian Vaccine Safety Advisory Committee

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any serious adverse event occurring from inclusion until 30 minutes after the injection	local and systemic reaction	30 minutes
Secondary	Percentage of local and systemic events occurring within 72 hours after each injection	any local and systemics events	72 hours
Secondary	Percentage of local and systemic events occurring from 72 hours up to 28 days following injection.	any local and systemics events	72 hours - 28 days
Secondary	Percentage of serious adverse events within 28 days after injection	Any serious adverse events	28 days