Safety Profile Following Td Vaccination in Indonesian Pregnant Woman

N/ACompletedNCT03383653

PT Bio Farma200 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Healthy Pregnant

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 39 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Jakarta Provincial Ministry of Health

Jakarta, Jakarta Province, Indonesia

Outcomes

Primary Outcomes

Any serious adverse event occurring from inclusion until 30 minutes after the injection

local and systemic reaction

Time frame: 30 minutes

Secondary Outcomes

Percentage of local and systemic events occurring within 72 hours after each injection

any local and systemics events

Time frame: 72 hours

Percentage of local and systemic events occurring from 72 hours up to 28 days following injection.

any local and systemics events

Time frame: 72 hours - 28 days

Percentage of serious adverse events within 28 days after injection

Any serious adverse events

Time frame: 28 days

Data from ClinicalTrials.gov

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