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Trial record 2 of 4 for:    seqirus | QIVc

Flucelvax (TIVc or QIVc) Pregnancy Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03438487
Recruitment Status : Active, not recruiting
First Posted : February 19, 2018
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Seqirus

Tracking Information
First Submitted Date November 21, 2017
First Posted Date February 19, 2018
Last Update Posted Date February 25, 2020
Actual Study Start Date September 1, 2017
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 20, 2018)
  • 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks ]
Original Primary Outcome Measures
 (submitted: February 16, 2018)
  • 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. [ Time Frame: From time of enrollment during pregnancy to time of delivery or pregnancy termination ]
    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. [ Time Frame: From time of enrollment during pregnancy to time of delivery or pregnancy termination ]
  • 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. [ Time Frame: From time of enrollment during pregnancy to time of delivery or pregnancy termination ]
  • 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. [ Time Frame: From time of enrollment during pregnancy to time of delivery or pregnancy termination ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Flucelvax (TIVc or QIVc) Pregnancy Registry
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

The study population will include pregnant women within the US who were immunized with the TIVc or the QIVc vaccine as part of routine care at any time during pregnancy. Eligible pregnant women may self-enroll or voluntarily be enrolled by their HCP.

Women under 18 can be included in the study as long as parental consent can be obtained. De-identified data on minors will be accepted into the study if permitted by laws and regulations.

Condition
  • Influenza, Human
  • Pregnancy
  • Birth Defect
Intervention
  • 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 Name: 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 Name: Flucelvax Quadrivalent
Study Groups/Cohorts Flucelvax Trivalent or Quadrivalent Influenza Vaccine
Flucelvax Trivalent or Quadrivalent exposure in pregnancy
Interventions:
  • Biological: Flucelvax Trivalent Influenza Vaccine
  • Biological: Flucelvax Quadrivalent Influenza Vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: February 16, 2018)
660
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03438487
Other Study ID Numbers V130_11OB
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Seqirus
Study Sponsor Seqirus
Collaborators Not Provided
Investigators
Study Director: Head Epidemiology Seqirus
PRS Account Seqirus
Verification Date February 2020