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Prescribing InformationIndicationsTRUMENBARequest a RepLoading

MenACWY

MenB

Tab Number 4

Tab 5

PENBRAYA® (Meningococcal Groups A, B, C, W, and Y Vaccine) demonstrated non-inferior* immunogenicity against serogroups A, C, W, and Y compared to MenACWY-CRM1

In a Phase 3 clinical trial with 2 doses of PENBRAYA vs 1 dose of MenACWY-CRM in participants previously exposed to MenACWY

In at least 93% of participants,

PENBRAYA elicited strong seroresponses at 1 month post-vaccination against serogroups A, C, W, and Y and demonstrated non-inferiority1*†

Non-inferiority was demonstrated (using 10% margin) post-vaccination by assessing the difference between vaccination groups.1 The LLOQ is an hSBA titer=1:16 for A22 and 1:8 for A56, B24, and B44 and serogroups A, C, W, and Y. Seroresponse is defined as the 4-fold increase as follows: (1) For participants with a baseline hSBA titer <1:4 (LOD), a 4-fold response was defined as an hSBA titer ≥1:16. (2) For participants with a baseline hSBA titer ≥LOD and <LLOQ, a response is defined as an hSBA titer ≥4 times the LLOQ. (3) For participants with a baseline hSBA titer ≥LLOQ, a response is defined as an hSBA titer ≥4 times the baseline titer.1

Study 1 results: MenACWY-exposed participants1‡

Demonstrated similar seroresponse§ to MenACWY-CRM1

MenACWY seroresponse rate 1-month post-vaccination, 2 doses of PENBRAYA vs 1 dose of MenACWY-CRM1‖¶

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Evaluable immunogenicity populations.1 Seroresponse is defined as a 4-fold increase as follows: (1) For participants with a baseline hSBA titer <1:4 (LOD), a 4-fold response was defined as an hSBA titer ≥1:16. (2) For participants with a baseline hSBA titer ≥LOD and <LLOQ, a response is defined as an hSBA titer ≥4 times the LLOQ. (3) For participants with a baseline hSBA titer ≥LLOQ, a response is defined as an hSBA titer ≥4 times the baseline titer.1MenACWY-CRM is sold and licensed under the trade name Menveo®.Non-inferiority was demonstrated (using 10% margin) post-vaccination by assessing the difference between vaccination groups.1

CI=confidence interval; hSBA=human serum bactericidal assay; LLOQ=lower limit of quantitation; LOD=limit of detection.

PENBRAYA study design1,2

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 4 serogroup B strains (composite response) were assessed
     
  • For serogroups A, C, W, and Y, 1 strain was utilized per group
     
  • For serogroup B, 4 meningococcal serogroup B strains expressing different fHbp variants (subfamilies A and B) that represent strains causing invasive disease in the US and Europe were utilized
Safety was evaluated including local and systemic adverse reactions. 

Participants were 10 through 25 years of age in the US 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
References:PENBRAYA® (Meningococcal Groups A, B, C, W, and Y Vaccine). Prescribing information. Pfizer Inc.; 2026.Ostergaard L, Czajka H, Roque-Guerrero L, et al. Immunogenicity and safety of a pentavalent meningococcal MenABCWY vaccine in healthy adolescents and young adults: a phase 3, multicountry, randomised, observer-blinded, active-controlled non-inferiority trial. Lancet Child Adolesc Health. 2026;10(8):584-596.
PENBRAYA® (Meningococcal Groups A, B, C, W, and Y Vaccine) demonstrated robust immune response against disease-causing MenB strains1

In a Phase 3 clinical trial with 2 doses of PENBRAYA vs 2 doses of TRUMENBA® (Meningococcal Group B Vaccine)

 4 MenB strains tested

4 MenB strains tested covering both subfamilies of fHbp [A22, A56, B24, B44]1*

 4 non-inferior† seroresponses‡ achieved

compared to TRUMENBA 
1 month post-vaccination1

 Diverse strain coverage

The MenB component in PENBRAYA, TRUMENBA, covers both subfamilies of fHbp, A and B, that have been found on 99% of MenB disease-causing strains.1-3

Percent of participants receiving PENBRAYA with a seroresponse against serogroup B by strain tested: A22 83.0%, A56 95.9%, B24 68.1%, and B44 86.5%.1 Non-inferiority was demonstrated (using 10% margin) post-vaccination by assessing the difference between vaccination groups.1 The LLOQ is an hSBA titer=1:16 for A22 and 1:8 for A56, B24, and B44 and serogroups A, C, W, and Y. Seroresponse is defined as the 4-fold increase as follows: (1) For participants with a baseline hSBA titer <1:4 (LOD), a 4-fold response was defined as an hSBA titer ≥1:16. (2) For participants with a baseline hSBA titer ≥LOD and <LLOQ, a response is defined as an hSBA titer ≥4 times the LLOQ. (3) For participants with a baseline hSBA titer ≥4 times the baseline titer.1 Explore the MenB immunogenicity for PENBRAYA

Study 1 results: MenB seroresponse and composite response among MenB-naïve participants, 1-month post vaccination1§

Demonstrated non-inferior∥ or greater immunogenic responses to MenB test strains compared to individual MenB vaccination1

MenB seroresponse and composite response 1-month post-vaccination, 2 doses of PENBRAYA vs 2 doses of MenB1||

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Evaluable immunogenicity populations.1Non-inferiority was demonstrated (using 10% margin) post-vaccination by assessing the difference between vaccination groups.1The LLOQ is an hSBA titer=1:16 for A22 and 1:8 for A56, B24, and B44 and serogroups A, C, W, and Y. Seroresponse is defined as the 4-fold increase as follows: (1) For participants with a baseline hSBA titer <1:4 (LOD), a 4-fold response was defined as an hSBA titer ≥1:16. (2) For participants with a baseline hSBA titer ≥LOD and <LLOQ, a response is defined as an hSBA titer ≥4 times the LLOQ. (3) For participants with a baseline hSBA titer ≥4 times the baseline titer.1 Composite response=hSBA ≥LLOQ for all 4 primary meningococcal B strains.1PENBRAYA study design1,4

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 4 serogroup B strains (composite response) were assessed
     
  • For serogroups A, C, W, and Y, 1 strain was utilized per group
     
  • For serogroup B, 4 meningococcal serogroup B strains expressing different fHbp variants (subfamilies A and B) that represent strains causing invasive disease in the US and Europe were utilized

Safety was evaluated including local and systemic adverse reactions.

Participants were 10 through 25 years of age in the US 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
CI=confidence interval; fHbp=factor H binding protein; hSBA=human serum bactericidal assay; LLOQ=lower limit of quantitation; LOD=limit of detection.References:PENBRAYA® (Meningococcal Groups A, B, C, W, and Y Vaccine). Prescribing information. Pfizer Inc.; 2026.TRUMENBA® (Meningococcal Group B Vaccine). Prescribing information. Pfizer Inc.; 2026.Murphy E, Andrew L, Lee K-L, et al. Sequence diversity of the factor H binding protein vaccine candidate in epidemiologically relevant strains of serogroup B Neisseria meningitidis. J Infect Dis. 2009;200(3):379-389.Ostergaard L, Czajka H, Roque-Guerrero L, et al. Immunogenicity and safety of a pentavalent meningococcal MenABCWY vaccine in healthy adolescents and young adults: a phase 3, multicountry, randomised, observer-blinded, active-controlled non-inferiority trial. Lancet Child Adolesc Health. 2026;10(8):584-596.
Efficacy and Safety
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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