Safety of 4CMenB Exposure During Pregnancy

4CMenB Pregnancy Registry: an Observational Study of the Safety of 4CMenB Exposure in Pregnant Women and Their Offspring.

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.

Study Overview

• Status: Completed
• Conditions: Infections, Meningococcal
• Intervention / Treatment: Biological: 4CMenB

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Wilmington, North Carolina, United States, 28401-3331
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will include 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant women exposed to 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	Biological: 4CMenB; This study is strictly observational; Administration of BEXSERO, the schedule of office visits and all treatment regimens will be determined by the treating health care provider in the context of routine clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Major Congenital Malformation (MCM)	At registry enrollment
Preterm Birth	At registry enrollment
Low Birth Weight (LBW)	At registry enrollment

Secondary Outcome Measures

Outcome Measure	Time Frame
Spontaneous Abortions and Still Births	At registry enrollment

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2016
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: December 21, 2015
• First Submitted That Met QC Criteria: December 23, 2015
• First Posted (Estimate): December 29, 2015

Study Record Updates

• Last Update Posted (Actual): September 3, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Meningococcal Infections
• Other Study ID Numbers: 205533; V72_82OB (Other Identifier: Novartis); EUPAS 12183 (Registry Identifier: EU PAS)