Safety Profile Following Td Vaccination in Indonesian Pregnant Woman

NCT ID: NCT03383653

Last Updated: 2018-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-29

Study Completion Date

2018-01-31

Brief Summary

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

Detailed Description

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

Conditions

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Healthy Pregnant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Indonesian Vaccine Safety Advisory Committee

UNKNOWN

Sponsor Role collaborator

PT Bio Farma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julitasari Sundoro, MD

Role: PRINCIPAL_INVESTIGATOR

Indonesian Vaccine Safety Advisory Commitee

Locations

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Jakarta Provincial Ministry of Health

Jakarta, Jakarta Province, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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Td0417

Identifier Type: -

Identifier Source: org_study_id

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