An observational study in Meningococcal Disease, sponsored by Pfizer. Recruiting at 1 site in United States. Open to female participants aged 10 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Pfizer · Observational
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:
The registry collects information from participants and their doctors at different times:
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.
243 studies on the registry are indexed under Meningococcal Infections; 8 are open to participants now.
This study's planned enrollment of 50 is below the median of 116 across 27 observational studies indexed under Meningococcal Infections.
Browse Meningococcal Infections studies →Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will include a single cohort of pregnant individuals in the US exposed to PENBAYA during pregnancy or within the 30 days prior to their last menstrual period
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion
- None
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pregnant participants who are exposed to PENBRAYA at any time during pregnancy or within 30 days prior to last menstrual period
Biological: PENBRAYA
Pregnant participants who are exposed to PENBRAYA at any time during pregnancy or within 30 days prior to last menstrual period
Also known as: PF-06886992
Percentage of Major congenital malformations
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.
Time frame: Enrollment until 12 months after delivery
Percent of participants with spontaneous abortions
An involuntary fetal loss or the expulsion of the products of conception occurring at \<20 gestational weeks
Time frame: Enrollment until end of pregnancy (up to 20 gestational weeks)
Percent of participants with an elective termination.
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
Time frame: Enrollment until end of pregnancy (up to 9 months)
Percent of participants with stillbirths
An involuntary fetal loss occurring at ≥20 gestational weeks or, if gestational age is unknown, a fetus weighing ≥350 g.
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
A live birth occurring at \<37 gestational weeks.
Time frame: Enrollment until 12 months after delivery
Percent of participants with children born small for gestational age (SGA)
Birthweight \<10th percentile for sex and gestational age using standard growth charts for full and preterm live born infants.
Time frame: Enrollment until 12 months after delivery
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Started May 2024 (actual). Primary completion is estimated for Apr 2032, 95 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.