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Safety of 4CMenB Exposure During Pregnancy | Clinical Trials | Clareo Health

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COMPLETEDNCT02640677

Safety of 4CMenB Exposure During Pregnancy

4CMenB was approved by the Food and Drug Administration (FDA) in the United States in January 2015 for people aged 10 through 25 years of age. 4CMenB should be used during pregnancy only if clearly ne...

Lead sponsor: GlaxoSmithKline•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

GlaxoSmithKline

Age

All ages

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Any pregnant women within the US who received at least 1 dose 4CMenB vaccine within 30 days prior to LMP or at any time during pregnancy where:
•Sufficient evidence to confirm that exposure to a meningococcal B vaccine (confirmed or possible 4CMenB exposure) occurred within 30 days prior to LMP or at any time during pregnancy
•Sufficient information to determine whether the pregnancy is prospectively or retrospectively registered (i.e., whether the outcome of pregnancy was known at the time of first contact with the registry)
•Date the pregnancy exposure is registered
•Full reporter (i.e., HCP) contact information to allow for follow-up (name, address, etc.)

Exclusion Criteria

•Pregnant women vaccinated with a different brand of Meningococcal B vaccine will not be included. (Of note: In the event that it cannot be ascertained to which meningococcal B vaccine the woman was exposed, an unknown exposure cohort will be established and analyzed separately).

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: September 3, 2020Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment2

Start dateJan 2016

Last updatedSep 3, 2020

Condition

Infections, Meningococcal

Locations shown

GSK Investigational Site

Wilmington, North Carolina

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 3, 2020Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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