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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01354730

Enrollment

398

Registered

2011-05-17

Start date

2010-06-30

Completion date

2011-05-31

Last updated

2011-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Drug Reactions

Keywords

incidence, nature, seriousness, ADRs, vaccination

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Outcome results