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HomeAbout AboutWhy PENBRAYA?Risks of Meningococcal DiseaseGaps in Vaccination CoverageDosing & Recommendations Effectiveness & Safety Effectiveness
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Prescribing InformationIndicationsPatient SiteRequest a RepLoading
PENBRAYA safety profile was similar to separate MenACWY and MenB vaccinations1*

Study 1 adverse reactions and use of antipyretic medications within 7 days after each vaccination
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   PENBRAYA Trumenba (Meningococcal Group B Vaccine) + MenACWY-CRM*
Any systemic adverse reactions† Dose 1
N=1739-1740
%		 Dose 2
N=1459
%		 Dose 1
N=638
%		 Dose 2
N=532
%
Fever (≥38°C) 5.9 2.4 5.8 1.5
Vomiting 3.2 1.5 3.0 0.9
Diarrhea 11.0 8.2 13.5 8.5
Headache 46.8 39.8 46.9 37.8
Fatigue 52.1 47.6 54.7 43.6
Chills 20.1 16.4 19.6 16.2
Muscle pain‡ 25.7 22.8 27.4 22.2
Joint pain 20.2 18.3 22.6 15.6
Use of antipyretic medications  29.5 25.1 28.1 20.5
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   PENBRAYA
Any systemic adverse reactions† Dose 1
N=1739-1740
%		 Dose 2
N=1459
%
Fever (≥38°C) 5.9 2.4
Vomiting 3.2 1.5
Diarrhea 11.0 8.2
Headache 46.8 39.8
Fatigue 52.1 47.6
Chills 20.1 16.4
Muscle pain‡ 25.7 22.8
Joint pain 20.2 18.3
Use of antipyretic medications  29.5 25.1
Scroll left to view table
  Trumenba (Meningococcal Group B Vaccine) + MenACWY-CRM*
Any systemic adverse reactions† Dose 1
N=638
%		 Dose 2
N=532
%
Fever (≥38°C) 5.8 1.5
Vomiting 3.0 0.9
Diarrhea 13.5 8.5
Headache 46.9 37.8
Fatigue 54.7 43.6
Chills 19.6 16.2
Muscle pain‡ 27.4 22.2
Joint pain 22.6 15.6
Use of antipyretic medications  28.1 20.5
Scroll left to view table
   PENBRAYA Trumenba + MenACWY-CRM*
Any local adverse reactions† Dose 1
N=1724-1725
%		 Dose 2
N=1456
%		 Dose 1
N=630-631
%		 Dose 2
N=529
%
Pain 89.3 84.4 85.1 78.6
Redness 25.9 23.2 19.5 14.7
Swelling 25.0 24.2 21.4 14.7
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   PENBRAYA
Any local adverse reactions† Dose 1
N=1724-1725
%		 Dose 2
N=1456
%
Pain 89.3 84.4
Redness 25.9 23.2
Swelling 25.0 24.2
Scroll left to view table
  Trumenba  + MenACWY-CRM*
Any local adverse reactions† Dose 1
N=630-631
%		 Dose 2
N=529
%
Pain 85.1 78.6
Redness 19.5 14.7
Swelling 21.4 14.7
Trumenba and MenACWY-CRM were administered at 0 month, followed by Trumenba alone at 6 months. Local reactions were recorded only for PENBRAYA and Trumenba injection sites.Any local adverse reaction recorded regardless of severity unless where noted. “Any” is defined as the cumulative frequency of participants who reported a reaction as “mild,” “moderate,” or “severe” within 7 days of vaccination.Other than muscle pain at the injection site.Study description1,2PENBRAYA clinical studyPENBRAYA clinical study

Study 1 was a Phase 3, randomized, active-controlled, observer-blinded, multicenter study.

  • The effectiveness of PENBRAYA was assessed by measuring antibodies with assays that used human complement to assess serum bactericidal activity (hSBA)
     
    • The proportions of subjects with a 4-fold or greater increase in hSBA titer for each strain (seroresponse), and the proportion of subjects with a titer greater than or equal to the lower limit of quantitation (LLOQ) of the assay for all four serogroup B strains (composite response) were assessed
       
    • For serogroups A, C, W, and Y, one strain was utilized per group
       
    • For serogroup B strains expressing different fHbp variants (subfamilies A and B) that represent strains causing invasive disease in the U.S. and Europe were utilized
       
  • Safety was evaluated including local and systemic adverse reactions
     
  • Participants were 10 through 25 years of age in the United States and Europe
     
    • Participants received either PENBRAYA at 0 and 6 months or Trumenba (Meningococcal Group B Vaccine) at 0 and 6 months and MenACWY-CRM at 0 months
       
    • All participants were MenB vaccine-naïve
       
    • Both MenACWY conjugate vaccine-naïve (N=821) and MenACWY conjugate vaccine-exposed (N=786) participants (received 1 dose of MenACWY conjugate vaccine at least 4 years prior to enrollment) were part of the study
       
Quick linksTRUMENBA® (Meningococcal Group B Vaccine) logo TRUMENBA

Get information about TRUMENBA (Meningococcal Group B Vaccine)
 

 Learn moreLoadingIcon of an arrow hitting a target Immunogenicity

PENBRAYA elicited a robust immune response for serogroups A, B, C, W, and Y

 Learn moreLoadingIcon representing a simplified combination Simplified Combination

See how PENBRAYA can help streamline meningococcal vaccination in your practice 

 Learn more Loadingtrumenba logo TRUMENBA

Get information about TRUMENBA (Meningococcal Group B Vaccine)

 Learn moreLoadingCircle icon with target and arrow representing immunogenicity Immunogenicity

PENBRAYA elicited a robust immune response for serogroups A, B, C, W, and Y

 Learn moreLoadingCircle icon with arrow symbol representing a simplified vaccination experience Simplified Combination

See how PENBRAYA can help streamline meningococcal vaccination in your practice 

 Learn more Loading
References: 1. PENBRAYA [prescribing information]. New York, NY: Pfizer Inc.; 2023. 2. MenABCWY noninferiority study in healthy participants ≥10 to <26 years of age. ClinicalTrials.gov identifier: NCT04440163. Updated April 18, 2023. Accessed October 27, 2023. https://classic.clinicaltrials.gov/ct2/show/NCT04440163

To report an adverse event, please call 1-800-438-1985

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Indications
  • PENBRAYA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. PENBRAYA is approved for use in individuals 10 through 25 years of age
  • TRUMENBA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. TRUMENBA is approved for use in individuals 10 through 25 years of age 
Important Safety Information
  • Do not administer PENBRAYA or TRUMENBA to individuals with a history of severe allergic reaction (eg, anaphylaxis) to any component of PENBRAYA or TRUMENBA. Appropriate medical treatment used to manage allergic reactions must be available in the event an anaphylactic reaction occurs immediately following administration of PENBRAYA or TRUMENBA
  • Syncope (fainting) may occur in association with administration of injectable vaccines, including PENBRAYA or TRUMENBA. Procedures should be in place to avoid injury from fainting
  • Some individuals with altered immunocompetence may have reduced immune responses to PENBRAYA or TRUMENBA
  • Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation are at increased risk for invasive disease caused by N. meningitidis groups A, B, C, W, and Y, even if they develop antibodies following vaccination with PENBRAYA
  • Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation are at increased risk for invasive disease caused by N. meningitidis group B, even if they develop antibodies following vaccination with TRUMENBA
  • Vaccination with PENBRAYA or TRUMENBA may not protect all vaccine recipients
  • Vaccination with PENBRAYA does not substitute for vaccination with a tetanus toxoid–containing vaccine to prevent tetanus
  • Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration of another US-licensed meningococcal quadrivalent polysaccharide conjugate vaccine. The decision by the healthcare professional to administer PENBRAYA to individuals with a history of GBS should take into account the expected benefits and potential risks 
  • For PENBRAYA, the most commonly reported (≥15%) solicited adverse reactions after Dose 1 and Dose 2, respectively, were pain at the injection site (89% and 84%), fatigue (52% and 48%), headache (47% and 40%), muscle pain (26% and 23%), injection site redness (26% and 23%), injection site swelling (25% and 24%), joint pain (20% and 18%), and chills (20% and 16%)
  • For TRUMENBA, the most common solicited adverse reactions in adolescents and young adults were pain at injection site (≥85%), fatigue (≥60%), headache (≥55%), and muscle pain (≥35%)
  • Data are not available on the safety and effectiveness of using TRUMENBA and other meningococcal group B vaccines interchangeably to complete the vaccination series
  • The safety and effectiveness of PENBRAYA or TRUMENBA have not been established in pregnant individuals
     
Patients should always ask their healthcare providers for medical advice about adverse events. You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit http://www.vaers.hhs.gov or call 1-800-822-7967.

Please see full Prescribing Information for PENBRAYA and full Prescribing Information for TRUMENBA.Indications
  • PENBRAYA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. PENBRAYA is approved for use in individuals 10 through 25 years of age
  • TRUMENBA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. TRUMENBA is approved for use in individuals 10 through 25 years of age