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Clinical trial

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

ID
Name
V130_11OB
Description
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.
Trial arms
Trial start
2017-09-01
Estimated PCD
2020-12-31
Trial end
2020-12-31
Status
Completed
Treatment
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)
Arms:
Flucelvax Trivalent or Quadrivalent Influenza Vaccine
Other names:
Flucelvax
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)
Arms:
Flucelvax Trivalent or Quadrivalent Influenza Vaccine
Other names:
Flucelvax Quadrivalent
Size
692
Primary endpoint
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
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
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 692, 'type': 'ACTUAL'}}
Updated at
2022-11-04

1 organization

2 products

4 indications

Organization
Seqirus
Product
Flucelvax Quadrivalent
Indication
Influenza
Indication
Human
Indication
Pregnancy
Indication
Congenital Anomaly
Product
Flucelvax Trivalent Influenza Vaccine