Safety in pregnancy of PENBRAYA when given during pregnancy or just before
Official title: A PREGNANCY REGISTRY STUDY TO EVALUATE THE SAFETY OF PENBRAYA™ MENINGOCOCCAL VACCINE EXPOSURE DURING PREGNANCY
Run by Pfizer · NCT07768163 · Data updated 2026-11-12
This registry looks at whether PENBRAYA given during pregnancy or just before the last period is safe for both the mother and her baby.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 10 Years to 25 Years |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | May 3, 2024 |
| Main results expected | April 30, 2032 |
| Study ends | April 30, 2032 |
| Registry record updated | August 17, 2026 |
| Trial ID | NCT07768163 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals who are currently or recently pregnant and received at least one PENBRAYA dose during pregnancy or within 30 days before their last menstrual period.
✕Probably not a fit
Participants who did not receive PENBRAYA during the exposure window or whose pregnancy outcomes show no notable safety signals may not benefit from the study findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational pregnancy registry designed to collect safety data on PENBRAYA when administered during pregnancy or within 30 days before the last menstrual period. Information is gathered remotely from enrolled participants and their healthcare providers at several time points, including enrollment, around 27 weeks, at delivery, and during infancy at 4 and 12 months. The study aims to capture pregnancy outcomes and infant health in the first year of life to understand potential safety signals associated with exposure. Participation requires informed consent and data sharing from the patient and their clinicians, with enrollment open to those currently or recently pregnant who received PENBRAYA.
Why it matters
Potential benefit: If successful, the registry could provide important safety information for PENBRAYA exposure during pregnancy to help guide care for mothers and infants.
How similar studies have gone: Pregnancy exposure registries for vaccines are commonly used to monitor safety and have produced informative results in other contexts, though specific PENBRAYA data in pregnancy may be limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Pfizer New York
New York, New York, United States Recruiting
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.