A Prospective Observational Safety Study on Pregnancy Outcomes in Women Immunized With Afluria, a Seasonal Influenza Vaccine, During Pregnancy
| Registry | NCT03442582 |
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| Status | Completed |
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| Study type | Observational |
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| Enrollment | 490 (Actual) |
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| Sponsor | Seqirus (Industry) |
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| Conditions | Influenza, Human, Pregnancy, Birth Defect |
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| Interventions | Afluria Influenza Vaccine (Biological) |
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| Dates | start 2017-09-08, primary completion 2021-09-14, completion 2021-09-14, first posted 2018-02-22, last updated 2022-02-09 |
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| Locations | 1 site in United States |
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-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Afluria | | Biological: Afluria Influenza Vaccine | Afluria exposure in pregnancy |
- Afluria Influenza Vaccine (Biological), also known as Afluria: Afluria is a seasonal influenza vaccine
Vaccine exposure in routine care (no vaccination per protocol)
+Outcome measures
Primary outcomes
- 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]
+Eligibility
Sex: Female, accepts healthy volunteers
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
+Locations (1)
| Facility | City | Country | Status |
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| Syneos Health | Wilmington, North Carolina | United States | |
+Investigators
- Head Epidemiology, Study director, Seqirus