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A Study to Learn About the Safety of PENBRAYA During Pregnancy

NCT07768163 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-08-17

No results posted yet for this study

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

Interventions

BIOLOGICAL

PENBRAYA

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
10 Years
Max Age
25 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-03
Primary Completion
2032-04-30
Completion
2032-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07768163 on ClinicalTrials.gov