Status:
COMPLETED
Flucelvax (TIVc or QIVc) Pregnancy Registry
Lead Sponsor:
Seqirus
Conditions:
Influenza, Human
Pregnancy
Eligibility:
FEMALE
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 the TIVc or QIVc vaccine during pregnancy.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
692 Patients enrolled
Trial Details
Trial ID
NCT03438487
Start Date
September 1 2017
End Date
December 31 2020
Last Update
November 4 2022
Active Locations (1)
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1
Syneos Health
Wilmington, North Carolina, United States, 28405