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

Adverse Drug Reactions Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01354730
• Other study ID #: FLU10001
• Status: Completed
• Phase: Phase 4
• First received: May 15, 2011
• Last updated: May 16, 2011
• Start date: June 2010
• Est. completion date: May 2011

Study information

• Verified date: May 2011
• Source: Adimmune Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Taiwan Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 398
• Est. completion date: May 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Adverse Drug Reactions
• Drug-Related Side Effects and Adverse Reactions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Adimmune Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes