Recruiting

PENBRAYAA Study to Learn About the Safety of PENBRAYA During Pregnancy

Sponsor:

Pfizer

Code:

NCT07768163

Conditions

Meningococcal Disease

Eligibility Criteria

Sex: Female

Age: 10 - 25

Healthy Volunteers: Accepted

Interventions

PENBRAYA

Study Details

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.

Conditions

Meningococcal Disease

Study ID

NCT07768163

Start date

May 3, 2024

Status verified date

Aug, 2026

Completion date

Apr 30, 2032

Anticipated

Primary completion date

Apr 30, 2032

Anticipated

Eligibility Criteria

Sex: Female

Age: 10 - 25

Healthy Volunteers: Accepted

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

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

PENBRAYA

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

Primary outcome measure

Percentage of Major congenital malformations [ Time Frame: Enrollment until 12 months after delivery ]
Percent of participants with spontaneous abortions [ Time Frame: Enrollment until end of pregnancy (up to 20 gestational weeks) ]
Percent of participants with an elective termination. [ Time Frame: Enrollment until end of pregnancy (up to 9 months) ]
Percent of participants with stillbirths [ 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 [ Time Frame: Enrollment until 12 months after delivery ]
Percent of participants with children born small for gestational age (SGA) [ Time Frame: Enrollment until 12 months after delivery ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Pfizer New York

Recruiting

New York, New York, United States, 10001

More Information

Sponsor

Pfizer

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

pregnancy
infant
PENBRAYA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pfizer on 2026-08-17.