Safety of 4CMenB Exposure During Pregnancy

• ClinicalTrials.gov Identifier: NCT02640677
• Recruitment Status: Active, not recruiting
• First Posted: December 29, 2015
• Last Update Posted: June 5, 2019
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

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.

Condition or disease	Intervention/treatment
Infections, Meningococcal	Biological: 4CMenB

Study Design

• Study Type: Observational
• Actual Enrollment: 1 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: 4CMenB Pregnancy Registry: an Observational Study of the Safety of 4CMenB Exposure in Pregnant Women and Their Offspring.
• Actual Study Start Date: January 31, 2016
• Estimated Primary Completion Date: November 30, 2019
• Estimated Study Completion Date: November 30, 2019

Groups and Cohorts

Group/Cohort	Intervention/treatment
Pregnant women exposed to 4CMenB; Pregnant women within the US who received at least 1 dose of 4CMenB vaccine within 30 days prior to 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.

Outcome Measures

Primary Outcome Measures :

1. Major congenital malformation (MCM) [ Time Frame: at enrollment ]
2. Major congenital malformation (MCM) [ Time Frame: end of 2nd trimester (approx. 24 weeks' gestation) ]
3. Major congenital malformation (MCM) [ Time Frame: pregnancy outcome (delivery or early termination) ]
4. Preterm birth [ Time Frame: at enrollment. ]
5. Preterm birth [ Time Frame: end of 2nd trimester (approx. 24 weeks' gestation) ]
6. Preterm birth [ Time Frame: pregnancy outcome (delivery or early termination) ]
7. Low birth weight (LBW) [ Time Frame: at enrollment ]
8. Low birth weight (LBW) [ Time Frame: end of 2nd trimester (approx. 24 weeks' gestation) ]
9. Low birth weight (LBW) [ Time Frame: pregnancy outcome (delivery or early termination) ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

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).

Contacts and Locations

Locations

United States, North Carolina

GSK Investigational Site

Wilmington, North Carolina, United States, 28401-3331

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02640677 History of Changes
• Other Study ID Numbers: 205533; V72_82OB ( Other Identifier: Novartis ); EUPAS 12183 ( Registry Identifier: EU PAS )
• First Posted: December 29, 2015
• Last Update Posted: June 5, 2019
• Last Verified: June 2019

Additional relevant MeSH terms:

Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections