Flucelvax (TIVc or QIVc) Pregnancy Registry

Completed

• Conditions: Birth Defect; Pregnancy; Influenza, Human
• Interventions: Biological: Flucelvax Trivalent Influenza Vaccine; Biological: Flucelvax Quadrivalent Influenza Vaccine

• Registration Number: NCT03438487
• Lead Sponsor: Seqirus

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 available

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2018-02-16
• Study First Posted: 2018-02-19
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 692

Inclusion Criteria

Not provided

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Flucelvax Trivalent or Quadrivalent Influenza Vaccine	Flucelvax Trivalent Influenza Vaccine	Flucelvax Trivalent or Quadrivalent exposure in pregnancy
Flucelvax Trivalent or Quadrivalent Influenza Vaccine	Flucelvax Quadrivalent Influenza Vaccine	Flucelvax Trivalent or Quadrivalent exposure in pregnancy

Primary Outcome Measures

Name	Time	Method
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 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 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
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

Trial Locations

Locations (1)

Syneos Health; 🇺🇸 Wilmington, North Carolina, United States