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Flucelvax Pregnancy Registry

NCT ID: NCT02258178

Last Updated: 2017-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2020-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Pregnant Women, Influenza

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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1, Flucelvax

Flucelvax exposure in pregnancy

Flucelvax (cTIV)

Intervention Type BIOLOGICAL

vaccine exposure in routine care (no vaccination per protocol)

Interventions

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Flucelvax (cTIV)

vaccine exposure in routine care (no vaccination per protocol)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Seqirus

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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PPD

Wilmington, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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V58_36OB

Identifier Type: -

Identifier Source: org_study_id