Bexsero® pregnancy registry: an observational study of the safety of Bexsero® exposure in pregnant women and their offspring

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Post-authorization safety study
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Pregnancy Registry, Prospective, observational study

Study drug and medical condition

• Name of medicine:
  BEXSERO
• Study drug International non-proprietary name (INN) or common name:
  RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN

  RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN

  RECOMBINANT NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE

  OUTER MEMBRANE VESICLES FROM NEISSERIA MENINGITIDIS GROUP B (STRAIN NZ 98/254)
• Anatomical Therapeutic Chemical (ATC) code:
  (J07AH09) meningococcus B, multicomponent vaccine

  meningococcus B, multicomponent vaccine
• Medical condition to be studied:
  Pregnancy

Population studied

• Short description of the study population:
  The study population will include pregnant women within the US who received at least 1 dose of Bexsero® vaccine (confirmed or possible exposure) within 30 days prior to LMP or at any time during pregnancy. Bexsero® should be used during pregnancy only if clearly needed, but inadvertent exposure during pregnancy might be expected because the age group targeted for the vaccine includes young women of reproductive potential.; The minimum criteria required for enrollment into the registry are as follows:; 1. Sufficient evidence to confirm that exposure to a serogroup B meningococcal vaccine (confirmed or possible Bexsero® vaccination) occurred within 30 days prior to LMP or at any time during pregnancy; 2. 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); 3. Date the pregnancy exposure is registered; 4. Full reporter (i.e., HCP) contact information to allow for follow-up (name, address, etc.)
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  1

Study design details

• Main study objective:
  The objective of the 4CMenB Pregnancy Registry is to evaluate pregnancy outcomes among women immunized with the 4CMenB vaccine within 30 days prior to LMP or at any time during pregnancy.
• Outcomes:
  The primary outcomes of interest include major congenital malformation (MCM), preterm birth, and low birth weight (LBW). Other pregnancy outcomes including stillbirth, spontaneous abortion (SAB), induced abortion (IAB), ectopic pregnancy, molar pregnancy.
• Data analysis plan:
  A SAP will be completed before the study is started.Demographic and baseline characteristics will be summarized with simple descriptive statistics and data listings. The overall prevalence of MCM will be reported as well as the prevalence of preterm births and low birth weight infants. These prevalence estimates in exposed subjects will be compared with those of the Centres for Disease Control's (CDC) National Vital Statistics System (NVSS).

Documents

Study results

gsk-205533-clinical-study-report-redact