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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adverse Drug Reactions Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Adimmune Corporation

Industry

Registry information

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: May 17, 2011
Registry last updated: May 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed