• Vaccines

Bexsero Generic Name & Formulations

General Description

Neisseria meningitidis recombinant proteins 50mcg each of Neisserial adhesin A (NadA), Neisserial Heparin Binding Antigen (NHBA), and factor H binding protein (fHbp), 25mcg of Outer Membrane Vesicles (OMV); per 0.5mL; susp for IM inj.

Pharmacological Class

Meningitis vaccine.

How Supplied

Single-dose prefilled syringes—10

How Supplied

Bexsero is supplied as:

  • a 0.5-mL suspension in a glass prefilled syringe (packaged without needles). The tip caps of the prefilled syringes contain natural rubber latex; the plungers are not made with natural rubber latex.
    • Carton of 10 prefilled syringes


Store refrigerated, at 36° F to 46° F (2° C to 8° C).

Protect from light.

Do not freeze. Discard if the vaccine has been frozen.


Generic Availability


Mechanism of Action

Protection against invasive meningococcal disease is conferred mainly by complement-mediated antibody-dependent killing of N. meningitidis. The effectiveness of Bexsero was assessed by measuring serum bactericidal activity using human complement (hSBA).

Bexsero Indications


Meningitis B immunization.

Bexsero Dosage and Administration

Adults and Children

<10yrs: not established. Give by IM inj in deltoid muscle of upper arm. 10–25yrs: 2 doses (0.5mL each) given at least 1 month apart.


Shake the syringe immediately before use to form a homogeneous suspension.

Do not use the vaccine if it cannot be resuspended.

Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if particulate matter or discoloration is found.

Bexsero Contraindications


Severe allergic reaction after a previous dose of Bexsero.

Bexsero Boxed Warnings

Not Applicable

Bexsero Warnings/Precautions


May not protect against all meningococcal serogroup B strains. Have epinephrine inj available. Immunosuppressed. Latex allergy. Elderly. Pregnancy. Nursing mothers.


Preventing and Managing Allergic Reactions

  • Observe appropriately; have medical treatment readily available in case of an anaphylactic reaction following the administration of the vaccine.


  • Syncope (fainting) can occur with administration of Bexsero.
  • Ensure procedures are in place to avoid injury from falling associated with syncope.


  • The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions.

Limitation of Vaccine Effectiveness

  • Bexsero may not protect all vaccine recipients and may not provide protection against all meningococcal serogroup B strains.

Altered Immunocompetence

  • Some individuals with altered immunocompetence may have reduced immune responses to Bexsero.

Complement Deficiency

Persons with certain complement deficiencies or receiving treatment that inhibits terminal complement activation (eg, eculizumab) are at increased risk for invasive disease caused by N. meningitidis serogroup B even if they develop antibodies following vaccination with Bexsero. 

Pregnancy Considerations

There are no adequate and well-controlled studies of Bexsero in pregnant women in the U.S.

Available human data on Bexsero administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.

Nursing Mother Considerations

It is not known whether the vaccine components of Bexsero are excreted in human milk. Available data are not sufficient to assess the effects of Bexsero on the breastfed infant or on milk production/excretion. 

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Bexsero and any potential adverse effects on the breastfed child from Bexsero or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.

Pediatric Considerations

Safety and effectiveness of Bexsero have not been established in children <10 years.

Geriatric Considerations

Safety and effectiveness of Bexsero have not been established in adults >65 years.

Bexsero Pharmacokinetics

See Literature

Bexsero Interactions


Concomitant other vaccines: see full labeling.

Bexsero Adverse Reactions

Adverse Reactions

Inj site pain, myalgia, erythema, fatigue, headache, induration, nausea, arthralgia; syncope.

Bexsero Clinical Trials

Clinical Trials

The immunogenicity of Bexsero following 2 doses was evaluated in individuals aged 11–24 years. Serum bactericidal antibodies were measured with hSBA assays using 3 strains selected to measure responses to 1 of 3 vaccine antigens, either fHbp, NadA, or PorA P1.4, prevalent among strains in the US. A suitable strain for assessing bactericidal activity of NHBA-specific antibodies was not available.

Studies evaluated the proportion of subjects who achieved a 4-fold or greater increase in hSBA titer for each of the 3 strains, and the proportion of subjects with a titer greater than or equal to the lower limit of quantitation (LLOQ) of the assay for all 3 strains (composite response). The LLOQ was defined as the lowest amount of the antibody in a sample that can be reliably quantified. Available data showed that baseline antibody titers across populations vary.

In the Canada/Australia clinical trial, adolescents aged 11–17 years received 2 doses of Bexsero 1 month apart.

  • The hSBA responses 1 month after the second dose are shown below:
    • Strain:
      • H44/76 (fHbp):  98% (95% CI, 95–99)
      • 5/99 (NadA):  99% (95% CI, 98–100)
      • NZ98/254 (PorA P1.4):  39% (95% CI, 33–44)
    • Composite hSBA Response:
      • Time Point (Baseline [pre-vaccination]):  0%
      • Time Point (1 Month Post Dose 2):  63% (95% CI, 57–68)

In the randomized, controlled clinical trial conducted in the UK among university students aged 18–24 years, hSBA responses in a subset of participants who received Bexsero were measured 1 month and 11 months after the second dose.

  • The hSBA responses are shown below:
    • Strain:
      • H44/76 (fHbp):  78% (95% CI, 71–85)
      • 5/99 (NadA):  94% (95% CI, 89–97)
      • NZ98/254 (PorA P1.4):  67% (95% CI, 58–74)
    • Composite hSBA Response:
      • Time Point (Baseline [pre-vaccination]):  24% (95% CI, 18–30)
      • Time Point (1 Month Post Dose 2):  88% (95% CI, 82–93)
      • Time Point (11 Months Post Dose 2):  66% (95% CI, 58–72)

Bexsero Note

Not Applicable

Bexsero Patient Counseling

Patient Counseling

Inform patients, parents, or guardians about:

  • The importance of completing the immunization series.
  • Reporting any adverse reactions to their healthcare provider.