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HomeDisease EducationDisease EducationDisease EducationDisparitiesEfficacy and SafetyEfficacy and SafetyHow TRUMENBA WorksImmunogenicitySafetyDosing and AdministrationResourcesResourcesOrdering TRUMENBARequest a Representative MaterialsVideos
Prescribing InformationIndicationPENBRAYARequest a Rep
Safety profile1Study 1057 adverse reactions within 7 days after each vaccination1

Adverse reactions and use of antipyretic medications within 7 days after each vaccination

Scroll left to view table
  TRUMENBA® + MenACWY-CRM* TRUMENBA 
Systemic adverse reactions† Dose 1 (%)
(n=1044)		 Dose 2 (%)
(n=903)
Vomiting 3.7 2.8
Fever (≥38°C) 6.7 3.2
Diarrhea 14.1 10.6
Chills 18.5 18.5
Use of antipyretic medications 18.6 14.4
Joint pain 19.6 18.7
Muscle pain (other than at the injection site)‡ 28.4 21.4
Headache 46.5 41.6
Fatigue 51.9 45.2
Local adverse reactions† Dose 1 (%)
(n=1044)		 Dose 2 (%)
(n=903)
Redness 16.9 14.7
Swelling 17.0 14.3
Pain 85.0 82.2
TRUMENBA and MenACWY·CRM were administered separately at month 0, followed by TRUMENBA alone at 6 months.1 Any 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.1 Other than muscle pain at the injection site.1TRUMENBA study design1

Study 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.

LLOQ=lower limit of quantitation.

References:TRUMENBA® (Meningococcal Group B Vaccine). Prescribing information. Pfizer, Inc.; 2026.Collins JP, Crowe SJ, Ortega-Sanchez IR, et al. Use of the Pfizer pentavalent meningococcal vaccine among persons aged ≥10 years: recommendations of the Advisory Committee on Immunization Practices — United States, 2023. MMWR Morb Mortal Wkly Rep. 2024;73(15):345-350.Schillie S, Loehr J, Chen WH, et al. New dosing interval and schedule for the Bexsero MenB-4C vaccine: updated recommendations of the Advisory Committee on Immunization Practices — United States, October 2024. MMWR Morb Mortal Wkly Rep. 2024;73(49):1124-1128.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.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.Quick linksDosing recommendations

Proven and trusted MenB protection in 2 doses (at 0 and 6 months).1-3

 See dosing LoadingDiverse strain coverage

Only TRUMENBA provides a targeted mechanism of immune protection against a key virulence factor found in >99% of disease-causing strains.1,4,5

 How TRUMENBA works Loading Order, track, and pay for TRUMENBA with Pfizer Prime Order now Loading

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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.