Meningococcal Disease
Conditions
Keywords
pregnancy, infant, PENBRAYA
Brief summary
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.
Interventions
BIOLOGICALPENBRAYA
Pregnant participants who are exposed to PENBRAYA at any time during pregnancy or within 30 days prior to last menstrual period
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
10 Years to 25 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Major congenital malformations | Enrollment until 12 months after delivery | An abnormality of body structure or function that is present at birth, is of prenatal origin (i.e., birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention. |
| Percent of participants with spontaneous abortions | Enrollment until end of pregnancy (up to 20 gestational weeks) | An involuntary fetal loss or the expulsion of the products of conception occurring at \<20 gestational weeks |
| Percent of participants with an elective termination. | Enrollment until end of pregnancy (up to 9 months) | A voluntary fetal loss or interruption of pregnancy that occurs for any reason, including but not limited to for the preservation of maternal health or due to fetal abnormalities |
| Percent of participants with stillbirths | From start of pregnancy until 12 month post delivery between 05 March 2024 and 30 April 2032 | An involuntary fetal loss occurring at ≥20 gestational weeks or, if gestational age is unknown, a fetus weighing ≥350 g. |
| Percent of participants with of preterm birth | Enrollment until 12 months after delivery | A live birth occurring at \<37 gestational weeks. |
| Percent of participants with children born small for gestational age (SGA) | Enrollment until 12 months after delivery | Birthweight \<10th percentile for sex and gestational age using standard growth charts for full and preterm live born infants. |
Countries
United States
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed