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

Completed

• Conditions: Adverse Drug Reactions

• Registration Number: NCT01354730
• Lead Sponsor: Adimmune Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2011-04
• Status Verified: 2011-05
• Study Completion: 2011-05
• Study First Submitted: 2011-05-15
• Study First Submitted QC: 2011-05-16
• Last Update Submitted: 2011-05-16
• Study First Posted: 2011-05-17
• Last Update Posted: 2011-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 398

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The purpose of this study was to evaluate the incidence, nature and seriousness of adverse drug reactions (ADRs) occurring after vaccination.	8 weeks after the delivery or abortion	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.