Birth Defect, Influenza, Human, Pregnancy
Conditions
Brief summary
The study is a population based prospective cohort study designed to collect data on pregnancy outcomes and events of interest among women immunized with Afluria during pregnancy.
Interventions
BIOLOGICALAfluria Influenza Vaccine
Afluria is a seasonal influenza vaccine Vaccine exposure in routine care (no vaccination per protocol)
Sponsors
Seqirus
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
Enrollment and data collection will be coordinated through a coordination center (CC). The minimum eligibility criteria required for enrollment are as follows: * Sufficient information to confirm that the exposure of interest occurred during pregnancy and at which date. * Sufficient information to determine whether it concerns a prospectively enrolled subject, since retrospective cases are ineligible for enrollment. * Reporter (e.g. HCP) contact information to allow for follow-up
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Objective: Number of cases for pregnancy outcomes among women immunized as part of routine care with Afluria, a seasonal influenza vaccine, during pregnancy. | From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks | Pregnancy outcomes will be reported as one of the following: live birth, stillbirth, spontaneous abortion and elective termination |
| Safety Objective: Number of cases with events of major congenital malformations among women immunized as part of routine care with Afluria, a seasonal influenza vaccine, during pregnancy. | From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks | — |
| Safety Objective: Number of cases of events of preterm birth among women immunized as part of routine care with Afluria, a seasonal influenza vaccine, during pregnancy. | From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks | — |
| Safety Objective: Number of cases of events of low birth weight among women immunized as part of routine care with Afluria, a seasonal influenza vaccine, during pregnancy. | From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks | — |
Countries
United States
Outcome results
None listed