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HomeDisease EducationDisease EducationDisease EducationDisparitiesEfficacy and SafetyEfficacy and SafetyHow TRUMENBA WorksImmunogenicitySafetyDosing and AdministrationResourcesResourcesOrdering TRUMENBARequest a Representative MaterialsVideos
Prescribing InformationIndicationPENBRAYARequest a Rep
Demonstrated immunogenicity against serogroup B1

In a Phase 3 clinical trial, following 2 doses of TRUMENBA® at 0 and 6 months:

67% to 95%

of participants who received TRUMENBA achieved a ≥4-fold rise in hSBA titer against the 4 MenB strains tested1*

Proven robust immune responses across subfamilies A and B1*Percentage of participants achieving ≥4-fold rise in hSBA titer against the 4 primary strains1
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  • 67% to 95% of participants achieved a ≥4-fold rise in hSBA titers against the 4 primary strains following 2 doses of TRUMENBA1‡§||
  • The subfamily A and B fHbp variants in the tested strains were heterologous (not identical) to those included in the vaccine, allowing for an objective assessment of immune response1
Elicited immune responses for up to 4 years2¶
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The percentage of subjects with antibodies (hSBA titers ≥LLOQ) evaluated against 4 prevalent MenB strains peaked at 1 month post-vaccine series completion, then declined sharply over the course of 12 months after completion of primary vaccination, and then remained stable for up to 4 years2 ReferencesPercentage of participants receiving TRUMENBA with a seroresponse against serogroup B by strain tested: A22 73.8%, A56 95.0%, 824 67.4%, and 844 86.4%.1Exact 2-sided confidence interval (Clopper-Pearson method) based upon the observed proportion of subjects.1In the clinical trial, TRUMENBA was evaluated when administered in a 2-dose schedule at 0 and 6 months.1For the second dose, serum was obtained approximately 1 month after vaccination.1Evaluable immunogenicity populations.1All subjects were enrolled in and completed 3 Phase 2 studies (NCT01323270, NCT01299480, and NCT01461980), before participating in this extension study.2In the clinical trials of 4052 participants, an extension study followed 698 participants, 623 of whom completed the persistence stage (N=116 [0 and 6 months]), and LLOQs were 1:16 for A22 and 1:8 for A56, B44, and B24.2Tested against 14 prevalent MenB strains1

The effectiveness of TRUMENBA was validated in clinical studies against a diverse panel of MenB strains1
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TRUMENBA elicited robust immune response after 2 doses against 14 diverse invasive MenB disease-causing strains found in the US and Europe1

Extended panel of 10 test strainsA robust immune response against a panel of diverse strains1

In a Phase 3 clinical trial following 2 doses of TRUMENBA at 0 and 6 months:71% to 97%
of participants vaccinated with TRUMENBA achieved a strong immune response against the entire panel of 10 additional test strains1** ReferencesPercentage of participants receiving TRUMENBA with a seroresponse against serogroup B by strain tested: A06 89.3%, A07 96.8%, A12 83.4%, A15 89.1%, A19 90.4%, A29 95.2%, B03 74.4%, B09 71.1%, B15 85.0%, and B16 77.4%.1Demonstrated robust immune responses†† against 10 additional MenB strains with a 2-dose schedule1

Immune responses against 10 additional MenB strains, post-Dose 21
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  • 71% to 97% of participants achieved an hSBA titer ≥LLOQ‡‡ against 10 additional MenB strains following 2 doses of TRUMENBA1
  • The subfamily A and B fHbp variants in the tested strains were heterologous (not identical) to the ones included in the vaccine, allowing for an objective assessment of immune response1
TRUMENBA study design1Study 1057 was a Phase 3, randomized, observer-blinded trial in subjects 10 to 25 years of age (N=1057)

Study 1057 was conducted in the US and Europe. In Study 1057, subjects received at least 1 dose of TRUMENBA on a 0- and 6-month schedule.
  • The effectiveness of TRUMENBA was assessed by measuring antibodies with assays that used human complement to assess serum bactericidal activity (hSBA)
  • Study 1057 assessed the proportions of subjects with a 4-fold or greater increase in hSBA titer for each of the 4 primary strains (A22, A56, B24, B44). The study also assessed the composite response to the 4 primary strains combined (proportion of subjects who achieved a hSBA titer greater than or equal to 1:8 [3 strains] and 1:16 [1 strain])
  • To assess the effectiveness of the 2-dose schedule of TRUMENBA against diverse meningococcal serogroup B strains, the proportion of subjects achieving a defined hSBA titer (≥LLOQ) following completion of the 2-dose series was evaluated against a panel of 10 additional strains, each expressing a different fHbp variant
  • LLOQ=1:16 for A06, A12, and A19; 1:8 for A07, A15, A29, B03, B09, B15, and B16

Safety was evaluated including local and systemic adverse reactions. TRUMENBA was coadministered with Meningococcal (Groups A, C, Y, W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MenACWY) (GSK Vaccines, SRL) for the first dose.

ReferencesBased on demonstrated effectiveness against 14 diverse strains representative of prevalent MenB strains.1,3,4LLOQ=1:16 for A06, A12, and A19; 1:8 for A07, A15, A29, B03, B09, B15, and B16.1CI=confidence interval; fHbp=factor H binding protein; hSBA=human serum bactericidal assay; LLOQ=lower limit of quantitation.ReferencesTRUMENBA® (Meningococcal Group B Vaccine). Prescribing information. Pfizer Inc.; 2026.Østergaard L, Vesikari T, Senders SD, et al. Persistence of hSBA titers elicited by the meningococcal serogroup B vaccine menB-FHbp for up to 4 years after a 2- or 3-dose primary series and immunogenicity, safety, and tolerability of a booster dose through 26 months. Vaccine. 2021;39(32):4545-4554.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.Wang X, Cohn A, Comanducci M, et al. Prevalence and genetic diversity of candidate vaccine antigens among invasive Neisseria meningitidis isolates in the United States. Vaccine. 2011;29(29-30):4739-4744.Quick links Request a representative 

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Indication
  • TRUMENBA is a vaccine 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
  • Severe allergic reaction (eg, anaphylaxis) to any component of Trumenba is a contraindication
  • Some individuals with altered immunocompetence may have reduced immune responses to Trumenba
  • Persons with certain complement deficiencies and persons receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis serogroup B even if they develop antibodies following vaccination with Trumenba
  • Vaccination with Trumenba may not protect all vaccine recipients against N meningitidis serogroup B infections
  • Syncope (fainting) can occur in association with administration of injectable vaccines, including Trumenba. Procedures should be in place to avoid injury from fainting
  • In clinical studies, 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
  • Safety and effectiveness have not been established in pregnant women
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 TRUMENBA.Indication
  • TRUMENBA is a vaccine 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
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 TRUMENBA.