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Flucelvax (TIVc or QIVc) Pregnancy Registry

Sponsor
Seqirus (Industry)
Overall Status
Completed
CT.gov ID
NCT03438487
Collaborator
(none)
692
Enrollment
1
Location
40
Actual Duration (Months)
17.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Flucelvax Trivalent Influenza Vaccine
  • Biological: Flucelvax Quadrivalent Influenza Vaccine

Study Design

Study Type:
Observational
Actual Enrollment :
692 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Sep 1, 2017
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Flucelvax Trivalent or Quadrivalent Influenza Vaccine

Flucelvax Trivalent or Quadrivalent exposure in pregnancy

Biological: 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)
Other Names:
  • Flucelvax

    • 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)
    Other Names:
  • Flucelvax Quadrivalent

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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]

    3. 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]

    4. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Syneos Health Wilmington North Carolina United States 28405

    Sponsors and Collaborators

    • Seqirus

    Investigators

    • Study Director: Head Epidemiology, Seqirus

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seqirus
    ClinicalTrials.gov Identifier:
    NCT03438487
    Other Study ID Numbers:
    • V130_11OB
    First Posted:
    Feb 19, 2018
    Last Update Posted:
    Mar 19, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Influenza, Human
    Congenital Abnormalities
    Vaccines

    Study Results

    No Results Posted as of Mar 19, 2021