Infections, Meningococcal
Conditions
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.
Interventions
BIOLOGICAL4CMenB
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.
Sponsors
GlaxoSmithKline
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Congenital Malformation (MCM) | At registry enrollment |
| Preterm Birth | At registry enrollment |
| Low Birth Weight (LBW) | At registry enrollment |
Secondary
| Measure | Time frame |
|---|---|
| Spontaneous Abortions and Still Births | At registry enrollment |
Countries
United States
Participant flow
Recruitment details
At the end of recruitment of this pregnancy registry for Bexsero, there were only 2 registrations. Of these,1 subject withdrew the consent and the other subject did not return for a follow up, hence considered as lost to follow up. Therefore, no pregnancy outcome data are available for this study.
Participants by arm
| Arm | Count |
|---|---|
| Pregnant Women Exposed to 4CMenB Pregnant women within the United States (US) who received at least 1 dose of 4CMenB vaccine within 30 days prior to Last Menstrual Period (LMP) or at any time during pregnancy | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Pregnant Women Exposed to 4CMenB |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Race/Ethnicity, Customized Hispanic ethinicity | 2 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Low Birth Weight (LBW)
Time frame: At registry enrollment
Population: Data was not collected for this outcome measure as the enrolled participants did not complete the study
Primary
Major Congenital Malformation (MCM)
Time frame: At registry enrollment
Population: Data was not collected for this outcome measure as the enrolled participants did not complete the study
Primary
Preterm Birth
Time frame: At registry enrollment
Population: Data was not collected for this outcome measure as the enrolled participants did not complete the study
Secondary
Spontaneous Abortions and Still Births
Time frame: At registry enrollment
Population: Data was not collected as the enrolled participants did not complete the study