Flucelvax (TIVc or QIVc) Pregnancy Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

692 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-01

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Influenza, Human Pregnancy Birth Defect

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Flucelvax Trivalent or Quadrivalent Influenza Vaccine

Flucelvax Trivalent or Quadrivalent exposure in pregnancy

Flucelvax Trivalent Influenza Vaccine

Intervention Type BIOLOGICAL

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)

Flucelvax Quadrivalent Influenza Vaccine

Intervention Type BIOLOGICAL

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)

Interventions

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Flucelvax 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)

Intervention Type BIOLOGICAL

Flucelvax 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)

Intervention Type BIOLOGICAL

Other Intervention Names

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Flucelvax Flucelvax Quadrivalent

Eligibility Criteria

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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