A Study to Learn About the Safety of PENBRAYA During Pregnancy

Pfizer50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Meningococcal Disease

Interventions

PENBRAYABIOLOGICAL

Eligibility

Sex: FEMALEMin age: 10 YearsMax age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percentage of Major congenital malformations

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.

Time frame: Enrollment until 12 months after delivery

Percent of participants with spontaneous abortions

An involuntary fetal loss or the expulsion of the products of conception occurring at \<20 gestational weeks

Time frame: Enrollment until end of pregnancy (up to 20 gestational weeks)

Percent of participants with an elective termination.

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

Time frame: Enrollment until end of pregnancy (up to 9 months)

Percent of participants with stillbirths

An involuntary fetal loss occurring at ≥20 gestational weeks or, if gestational age is unknown, a fetus weighing ≥350 g.

Time frame: From start of pregnancy until 12 month post delivery between 05 March 2024 and 30 April 2032

Percent of participants with of preterm birth

A live birth occurring at \<37 gestational weeks.

Time frame: Enrollment until 12 months after delivery

Percent of participants with children born small for gestational age (SGA)

Birthweight \<10th percentile for sex and gestational age using standard growth charts for full and preterm live born infants.

Time frame: Enrollment until 12 months after delivery

A Study to Learn About the Safety of PENBRAYA During Pregnancy

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts