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A Study to Learn About the Safety of PENBRAYA During Pregnancy

Pfizer · NCT07768163

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 10–25 · Women only
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
50
US sites recruiting
1
Study start
May 3, 2024
Record last updated
August 17, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: PENBRAYA

Conditions: Meningococcal Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

Study contacts (from the official record)

  • Pfizer CT.gov Call Center · 1-800-718-1021 · ClinicalTrials.gov_Inquiries@pfizer.com
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A Study to Learn About the Safety of PENBRAYA During Pregnancy (NCT07768163) | Bored Studies