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

NCT01354730 | Completed

• 1 other identifier: FLU10001
• Study Type: observational
• Target: 398
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Adverse Drug Reactions

Keywords

incidence; nature; seriousness; ADRs; vaccination

Outcome Measures

Primary Outcomes (1)

• The purpose of this study was to evaluate the incidence, nature and seriousness of adverse drug reactions (ADRs) occurring after vaccination.

  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

Study Arms (2)

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 Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Exposed Cohort:
• Received any other H1N1 vaccination, e.g., Focetria.
• Unexposed Cohort:
• The woman received any influenza vaccine during gestation period.

Sponsors & Collaborators

• Adimmune Corporation: lead

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 15, 2011
• First Posted: May 17, 2011
• Study Start: June 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 17, 2011

Record last verified: 2011-05