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

Adimmune

Status: Completed

Conditions: Adverse Drug Reactions

Study type: Observational

Funder types: Industry

Identifiers

NCT01354730

FLU10001

Details and patient eligibility

About

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.

Enrollment: 398 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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.

Trial design

398 participants in 2 patient groups

Exposed cohort

Description:

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

Description:

The woman was gestation after April 2009.