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

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ClinicalTrials.gov Identifier: NCT01354730
Recruitment Status : Completed
First Posted : May 17, 2011
Last Update Posted : May 17, 2011
Sponsor:
Information provided by:
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.

Condition or disease
Adverse Drug Reactions

Study Type : Observational
Actual Enrollment : 398 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : June 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.

Responsible Party: Daphne Shen, Adimmune Corporation
ClinicalTrials.gov Identifier: NCT01354730     History of Changes
Other Study ID Numbers: FLU10001
First Posted: May 17, 2011    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: May 2011

Keywords provided by Adimmune Corporation:
incidence
nature
seriousness
ADRs
vaccination

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders