Clinical trial NCT03438487: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza, Human
Pregnancy
Birth Defect
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2018-02-19
Enrollment: 692
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: 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.
timeFrame: From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks
measure: 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.
timeFrame: From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks
measure: 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.
timeFrame: From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks
measure: 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.
timeFrame: From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Syneos Health
state: North Carolina
Study officials:
affiliation: Seqirus
name: Head Epidemiology
role: STUDY_DIRECTOR
References: