A Prospective Observational Safety Study on Pregnancy Outcomes in Women Immunized With Afluria, a Seasonal Influenza Vaccine, During Pregnancy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Influenza, Human
- Sponsor
- Seqirus
- Enrollment
- 490
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
- Not provided
Outcomes
Primary Outcomes
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.
Time Frame: 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.
Time Frame: 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 for pregnancy outcomes among women immunized as part of routine care with Afluria, a seasonal influenza vaccine, during pregnancy.
Time Frame: 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.
Time Frame: From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks