Safety of 4CMenB Exposure During Pregnancy
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Infectious Disease, Women's Studies |
| Therapuetic Areas: | Immunology / Infectious Diseases, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/14/2019 |
| Start Date: | January 31, 2016 |
| End Date: | November 30, 2019 |
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.
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.
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).
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