Meningococcal DiseaseNCT07768163
A Study to Learn About the Safety of PENBRAYA During Pregnancy
An observational study of Meningococcal Disease, run by Pfizer at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Disease
- What is being tested?
- PENBRAYA
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2024to 30 Apr 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: 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
Who may be able to join
- 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)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Pfizer New York
New York, New York, 10001
About this study
Official title: A PREGNANCY REGISTRY STUDY TO EVALUATE THE SAFETY OF PENBRAYA™ MENINGOCOCCAL VACCINE EXPOSURE DURING PREGNANCY
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:
Read more
- 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
- Being tested
- PENBRAYA
- Keywords
- pregnancy, infant, PENBRAYA
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENBRAYABiological
Also called PF-06886992
Pregnant participants who are exposed to PENBRAYA at any time during pregnancy or within 30 days prior to last menstrual period
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: PENBRAYA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Enrollment until 12 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start3 May 2024
- Primary completion30 Apr 2032 (estimated)
- Study completion30 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningococcal DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768163
- Sponsor's protocol ID
- C3511007
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PREGNANCY REGISTRY STUDY TO EVALUATE THE SAFETY OF PENBRAYA™ MENINGOCOCCAL VACCINE EXPOSURE DURING PREGNANCY
- ClinicalTrials.gov ID
- NCT07768163
- Acronym / sponsor ID
- C3511007
- Conditions
- Meningococcal Disease
- Keywords
- pregnancy, infant, PENBRAYA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 3 May 2024 (actual)
- Primary completion
- 30 Apr 2032 (estimated)
- Study completion
- 30 Apr 2032 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant participants exposed to PENBRAYA during pregnancy | – | Biological: PENBRAYAPregnant participants who are exposed to PENBRAYA at any time during pregnancy or within 30 days prior to last menstrual period |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 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
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PENBRAYAAlso: PF-06886992Pregnant participants who are exposed to PENBRAYA at any time during pregnancy or within 30 days prior to last menstrual period | Biological | Pregnant participants exposed to PENBRAYA during pregnancy |
Primary outcome
Percentage of Major congenital malformations
Time frame: Enrollment until 12 months after delivery
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.
Percent of participants with spontaneous abortions
Time frame: Enrollment until end of pregnancy (up to 20 gestational weeks)
An involuntary fetal loss or the expulsion of the products of conception occurring at <20 gestational weeks
Percent of participants with an elective termination.
Time frame: Enrollment until end of pregnancy (up to 9 months)
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
Percent of participants with stillbirths
Time frame: From start of pregnancy until 12 month post delivery between 05 March 2024 and 30 April 2032
An involuntary fetal loss occurring at ≥20 gestational weeks or, if gestational age is unknown, a fetus weighing ≥350 g.
Percent of participants with of preterm birth
Time frame: Enrollment until 12 months after delivery
A live birth occurring at <37 gestational weeks.
Percent of participants with children born small for gestational age (SGA)
Time frame: Enrollment until 12 months after delivery
Birthweight <10th percentile for sex and gestational age using standard growth charts for full and preterm live born infants.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- The goal of The Penbraya™ Pregnancy Registry is to help doctors, patients, and researchers better understand the safety of Penbraya™ use during pregnancy.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningococcal Disease, run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Major congenital malformations (time frame: Enrollment until 12 months after delivery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.