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 the TIVc or QIVc vaccine during pregnancy.
Interventions
BIOLOGICALFlucelvax Trivalent Influenza Vaccine
Flucelvax is a cell culture seasonal trivalent influenza vaccine that contains the following influenza hemagglutinin antigens: 1) A/H1N1-like virus, 2) A/(H3N2)-like virus, 3) B/Yamagata lineage or B/Victoria lineage Vaccine exposure in routine care (no vaccination per protocol)
BIOLOGICALFlucelvax Quadrivalent Influenza Vaccine
Flucelvax Quadrivalent is a cell culture seasonal quadrivalent influenza vaccine that contains the following influenza hemagglutinin antigens: 1) A/H1N1-like virus, 2) A/(H3N2)-like virus, 3) B/Yamagata lineage, 4) B/Victoria lineage 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 the seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) 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 | Number of cases for pregnancy outcomes will be reported as one of the following: live birth, stillbirth, spontaneous abortion and elective termination |
| Safety Objective: Number of cases with major congenital malformations among women immunized as part of routine care with the seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) 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 with events of preterm birth among women immunized as part of routine care with the seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) 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 with low birth weight among women immunized as part of routine care with the seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) 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