Clinical trial NCT02258178: Flucelvax Pregnancy Registry
Official title: Flucelvax Pregnancy Registry: an Observational Study on the Safety of Flucelvax Exposure in Pregnant Women and Their Offspring
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pregnant Women, Influenza
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2014-10-07
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women aged 18 years or older within the US who were immunized with the Flucelvax vaccine at any time during pregnancy.The registry will allow eligible pregnant women to selfenroll and also allow HCPs to report de-identified data on pregnancy exposures and outcomes

Brief summary: The goal of the registry is to develop a better understanding of the safety of Flucelvax in women and their offspring who were exposed to the vaccine during pregnancy


Eligibility criteria: Inclusion Criteria:

* Pregnancy women pregnant women aged 18 years or older within the US who were immunized with the Flucelvax vaccine at any time during pregnancy.The registry will allow eligible pregnant women to selfenroll and also allow HCPs to report de-identified data on pregnancy exposures and outcomes.
* Sufficient evidence to confirm that Flucelvax exposure occurred during pregnancy
* Sufficient information to determine whether the pregnancy is prospectively or retrospectively registered (ie, whether the outcome of pregnancy was known at the time of first contact with the registry)
* Date the pregnancy exposure is registered
* Full reporter (ie, HCP) contact information to allow for follow-up (name, address,etc) The primary population for analysis will include prospectively enrolled pregnancies exposed to Flucelvax that are not lost to follow-up (ie, with outcome information that meet the minimum criteria for evaluation)

Exclusion Criteria:

* Invalid registry reports and pregnancies deemed lost to follow-up will be excluded from the primary analysis. Retrospective reports will not be included, although retrospective cases with MCMs will be reviewed and reported separately.

Primary outcomes:
measure: major congenital malformation
timeFrame: From time of enrollment during pregnancy to time of delivery or pregnancy termination
measure: preterm birth
timeFrame: From time of enrollment during pregnancy to time of delivery or pregnancy termination
measure: low birth weight
timeFrame: From time of enrollment during pregnancy to time of delivery or pregnancy termination
Secondary outcomes:
Other outcomes:
measure: Live birth
timeFrame: From time of enrollment during pregnancy to time of delivery or pregnancy termination
measure: stillbirth
timeFrame: From time of enrollment during pregnancy to time of delivery or pregnancy termination
measure: spontaneous abortion
timeFrame: From time of enrollment during pregnancy to time of delivery or pregnancy termination
measure: ectopic pregnancy
timeFrame: From time of enrollment during pregnancy to time of delivery or pregnancy termination
measure: molar pregnancy
timeFrame: From time of enrollment during pregnancy to time of delivery or pregnancy termination
Locations:
city: Wilmington
country: United States
facility: PPD
state: North Carolina
Study officials:
References: