A Pharmacovigilance Study for AdimFlu-S (A/H1N1) Influenza Vaccine in Pregnant Women
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
- 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 |
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.
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 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 Toxicity Poisoning Substance-Related Disorders |
ClinicalTrials.gov processed this record on May 19, 2013