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NCT Number: NCT07768163

A Study to Learn About the Safety of PENBRAYA During Pregnancy

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.

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Key information

Conditions

Meningococcal Disease Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Meningococcal Infections Neisseriaceae Infections

Age range

10 year–25 year

Sex eligibility

Female

Study type

Observational

Primary location

Pfizer New York

New York, 10001, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PENBRAYA

Biological

Pregnant participants who are exposed to PENBRAYA at any time during pregnancy or within 30 days prior to last menstrual period

Other names: PF-06886992

Primary outcomes

  1. Percentage of Major congenital malformations

    Time frame: 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.

  2. Percent of participants with spontaneous abortions

    Time frame: 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

  3. Percent of participants with an elective termination.

    Time frame: 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

  4. Percent of participants with stillbirths

    Time frame: 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.

  5. Percent of participants with of preterm birth

    Time frame: Enrollment until 12 months after delivery

    A live birth occurring at <37 gestational weeks.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PREGNANCY REGISTRY STUDY TO EVALUATE THE SAFETY OF PENBRAYA™ MENINGOCOCCAL VACCINE EXPOSURE DURING PREGNANCY

Important dates

Study start
2024
Primary completion
2032
Study completion
2032
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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