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

May 16, 2011 updated by: Adimmune Corporation
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

398

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The target population was derived from medical centers in Taiwan: National Taiwan University Hospital, Chang Gung Memorial Hospital - LinKou and China Medical University Hospital.

The sample size for this study was planned to include 500 cases in exposed cohort and 500 cases in unexposed cohort. Actual recruitment depended on the volume of pregnancy women received AdimFlu-S (A/H1N1) at each hospital. The size of unexposed cohort was be equal to the exposed cohort.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.
Unexposed cohort
The woman was gestation after April 2009.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks after the delivery or abortion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adimmune Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

May 15, 2011

First Submitted That Met QC Criteria

May 16, 2011

First Posted (Estimate)

May 17, 2011

Study Record Updates

Last Update Posted (Estimate)

May 17, 2011

Last Update Submitted That Met QC Criteria

May 16, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLU10001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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