Safety of 4CMenB Exposure During Pregnancy

Completed

• Conditions: Infections, Meningococcal
• Interventions: Biological: 4CMenB

• Registration Number: NCT02640677
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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 needed and sometimes, inadvertent exposure during pregnancy may also occur - before the woman knows she is pregnant, for example. The objective of this study is to evaluate the safety of 4CMenB during pregnancy and to help us learn more about the health of women who have been vaccinated with 4CMenB within 30 days prior to their last menstrual period (LMP) or at any time during pregnancy, and the health of their infants. Pregnant women within the US who received at least 1 dose 4CMenB vaccine within 30 days prior to their last menstrual period or at any time during pregnancy are eligible to participate. A woman may self-enroll in the registry by calling the pregnancy registry telephone number directly or their healthcare provider (HCP) can, with their consent, enroll them on their behalf. Alternatively HCPs may report anonymous data on pregnancy exposures and outcomes occurring within their network/health maintenance organization (HMO). The health of the woman and her infant will be followed up until the end of the pregnancy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-21
• Study First Submitted QC: 2015-12-23
• Study First Posted: 2015-12-29
• Study Start: 2016-01-31
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30
• Results First Submitted: 2020-08-04
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-02
• Last Update Submitted: 2020-09-02
• Results First Posted: 2020-09-03
• Last Update Posted: 2020-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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.)

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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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women exposed to 4CMenB	4CMenB	Pregnant women within the United States (U.S) who received at least 1 dose of 4CMenB vaccine within 30 days prior to Last Menstrual Period (LMP) or at any time during pregnancy

Primary Outcome Measures

Name	Time	Method
Major Congenital Malformation (MCM)	At registry enrollment
Preterm Birth	At registry enrollment
Low Birth Weight (LBW)	At registry enrollment

Secondary Outcome Measures

Name	Time	Method
Spontaneous Abortions and Still Births	At registry enrollment

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Wilmington, North Carolina, United States