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A Pharmacovigilance Study for...

A Pharmacovigilance Study for AdimFlu-S (A/H1N1) Influenza Vaccine in Pregnant Women

Last Updated: 2011-05-17

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

398 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-05-31

Brief Summary

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This was a retrospective cohort study of pregnant women who had received the AdimFlu-S (A/H1N1) influenza vaccine during gestation period. Eligibility into the study was confirmed by chart review. If subject meets the eligibility criteria during the study period, data from the medical chart were extracted retrospectively from the date of vaccination and the infant (s) health status were followed until 8 weeks after the delivery.The unexposed cohort included pregnant women who did not receive any influenza vaccine during pregnancy. Within each participated study center, women who were gestation after April 2009 were randomly selected according to maternal age matching. The pregnancy outcome, including the status of delivery, abortion and gestational age, were extracted retrospectively by chart review.

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Detailed Description

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Conditions

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Adverse Drug Reactions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Exposed cohort

The woman received AdimFlu-S (A/H1N1) vaccination between 2009/10 and 2010/02. The woman was pregnant at the time of vaccination.

No interventions assigned to this group

Unexposed cohort

The woman was gestation after April 2009.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Exposed Cohort:

* The woman received AdimFlu-S (A/H1N1) vaccination between 2009/10 and 2010/02.l
* The woman was pregnant at the time of vaccination.

Unexposed Cohort:

* The woman was gestation after April 2009.

Exclusion Criteria

Exposed Cohort:

* Received any other H1N1 vaccination, e.g., Focetria.

Unexposed Cohort:

* The woman received any influenza vaccine during gestation period.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes