Flucelvax (TIVc or QIVc) Pregnancy Registry

Study 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 the TIVc or QIVc vaccine during pregnancy.

Official Title
-----------------
A Prospective Observational Safety Study on Pregnancy Outcomes in Women Immunized With Seasonal Cell Culture Influenza Trivalent (TIVc) or Quadrivalent (QIVc) Vaccine During Pregnancy

Conditions
-----------------
Influenza, Human, Pregnancy, Birth Defect

Intervention / Treatment
-----------------
* Biological: Flucelvax Trivalent Influenza Vaccine
* Biological: Flucelvax Quadrivalent Influenza Vaccine


Participation Criteria
=================
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: N/A
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Flucelvax Trivalent or Quadrivalent Influenza Vaccine<br>Flucelvax Trivalent or Quadrivalent exposure in pregnancy | Biological: Flucelvax Trivalent Influenza Vaccine<br>* 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)<br>* Other names: Flucelvax;Biological: Flucelvax Quadrivalent Influenza Vaccine<br>* 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)<br>* Other names: Flucelvax Quadrivalent;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Number of cases for pregnancy outcomes will be reported as one of the following: live birth, stillbirth, spontaneous abortion and elective termination | 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 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 |