A Pharmacovigilance Study for AdimFlu-S (A/H1N1) Influenza Vaccine in Pregnant Women
|ClinicalTrials.gov Identifier: NCT01354730|
Recruitment Status : Completed
First Posted : May 17, 2011
Last Update Posted : May 17, 2011
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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.
|Condition or disease||Phase|
|Adverse Drug Reactions||Phase 4|
|Study Type :||Observational|
|Actual Enrollment :||398 participants|
|Study Start Date :||June 2010|
|Primary Completion Date :||April 2011|
|Study Completion Date :||May 2011|
The woman received AdimFlu-S (A/H1N1) vaccination between 2009/10 and 2010/02. The woman was pregnant at the time of vaccination.
The woman was gestation after April 2009.
Primary Outcome Measures :
- The purpose of this study was to evaluate the incidence, nature and seriousness of adverse drug reactions (ADRs) occurring after vaccination. [ Time Frame: 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.
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