A Study to Learn About the Safety of PENBRAYA During Pregnancy
Purpose
This study is a pregnancy registry designed to learn more about the safety of the study vaccine PENBRAYA (a vaccine that protects against meningitis causing bacteria) when it is given during pregnancy or within 30 days before the last menstrual period (the first day of your last period). Because this vaccine has not been studied in pregnant individuals, the registry collects information on pregnancy outcomes and infant health during the first year of life. People may join the registry if they: - are pregnant now (or recently pregnant), - are 10 to 25 years old, and - received at least one dose of study vaccine during pregnancy or within 30 days before their last period. The registry collects information from participants and their doctors at different times: - at enrollment, - around 27 weeks of pregnancy, - at the end of pregnancy, and - for infants, at 4 months and 12 months of age. All the information is collected remotely (phone, online forms, email, fax, or mail) by a coordinating center. No new medical tests or office visits are required beyond routine care.
Condition
- Meningococcal Disease
Eligibility
- Eligible Ages
- Between 10 Years and 25 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- Yes
Criteria
Inclusion
- Currently or recently pregnant (recently pregnant defined as enrollment within 1
year of pregnancy outcome)
- Received at least one dose of PENBRAYA during pregnancy or within 30 days prior to
last menstrual period (LMP)
- Personally signed and dated informed consent document or, upon waiver of written
consent by the relevant IRB/independent ethics committee, verbal consent, indicating
that the individual (or a legally acceptable representative) has been informed of
all pertinent aspects of the study
- Authorization for the enrolled participants' health care provider(s) (HCP[s]) to
provide data to the registry
- Contact information (for participant and HCPs)
Exclusion
- None
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Pregnant participants exposed to PENBRAYA during pregnancy | Pregnant participants who are exposed to PENBRAYA at any time during pregnancy or within 30 days prior to last menstrual period |
|
Recruiting Locations
New York, New York 10001
More Details
- Status
- Recruiting
- Sponsor
- Pfizer