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

This study has been completed.
Sponsor:
Information provided by:
Adimmune Corporation
ClinicalTrials.gov Identifier:
NCT01354730
First received: May 15, 2011
Last updated: May 16, 2011
Last verified: May 2011
  Purpose

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 Phase
Adverse Drug Reactions
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Adimmune Corporation:

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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 398
Study Start Date: June 2010
Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Daphne Shen, Adimmune Corporation
ClinicalTrials.gov Identifier: NCT01354730     History of Changes
Other Study ID Numbers: FLU10001
Study First Received: May 15, 2011
Last Updated: May 16, 2011
Health Authority: Taiwan: Taiwan Food and Drug Administration

Keywords provided by Adimmune Corporation:
incidence
nature
seriousness
ADRs
vaccination

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

ClinicalTrials.gov processed this record on November 20, 2014