Meningococcal group B vaccine

Provide the Vaccine Information Statement. These are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).

Inform patients, parents or guardians about:

• The importance of completing the immunization series.
• Reporting any adverse reactions to their healthcare provider.
• Register women who receive BEXSERO while pregnant in the pregnancy registry by calling 1-877-683-4732. [see Use in Specific Populations]

Mechanism Of Action

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

fHBP is one of many proteins found on the surface of meningococci and contributes to the ability of the bacterium to avoid host defenses. fHBPs can be categorized into two immunologically distinct subfamilies, A and B.1 The susceptibility of serogroup B meningococci to complement-mediated antibody-dependent killing following vaccination with Trumenba is dependent on both the antigenic similarity of the bacterial and vaccine fHBPs, as well as the amount of fHBP expressed on the surface of the invading meningococci.

Clinical Studies

In two randomized studies, the immunogenicity of Trumenba was evaluated in individuals 11 to < 18 years of age in the US (Study 1) and in individuals 11 to < 19 years of age in Europe (Study 2). Serum bactericidal antibodies were measured with hSBA assays that used each of four meningococcal group B strains. The four test strains express fHBP variants representing the two subfamilies (A and B) and, when taken together, are representative of prevalent strains in the US and Europe. The studies assessed the proportions of subjects with a 4-fold or greater increase in hSBA titer for each of the four strains, and the proportion of subjects who achieved a titer greater than or equal to the lower limit of quantitation (LLOQ) of the assay for all four strains (composite response). The LLOQ was defined as the lowest amount of the antibody in a sample that can be reliably quantified.

Immunogenicity

In Study 1, Group 1 received Trumenba + HPV4, Group 2 received Trumenba + Saline, and Group 3 received Saline + HPV4 [see ADVERSE REACTIONS]. The hSBA responses observed after the second dose and completion of the 3-dose series are presented in Table 3.

Table 3: Percentage of US Individuals 11 to < 18 Years of Age With a ≥ 4-Fold Increase in hSBA Titer and Composite Response*,†

In Study 2, Trumenba was administered according to the following schedules: Group 1 (0, 1 and 6 months); Group 2 (0, 2 and 6 months); Group 3 (0 and 6 months); Group 4 (0 and 2 months); Group 5 (0 and 4 months) [see ADVERSE REACTIONS]. The hSBA responses observed after the second dose in Groups 1, 2 and 3, and completion of the 3-dose series in Group 1 and 2 are presented in Table 4.

Table 4: Percentage of European Individuals 11 to < 19 Years of Age With a ≥ 4-Fold Increase in hSBA Titer and Composite Response*,†

Concomitant Vaccine Administration

In Study 1 conducted in the US, the immunogenicity of concomitantly administered Trumenba and HPV4 was evaluated in adolescents 11 to < 18 years of age [see Clinical Studies and ADVERSE REACTIONS]. Immune responses were evaluated by comparisons of geometric mean titer [GMT] for each HPV type at 1 month after the third HPV4 vaccination (Group 1 vs. Group 3), and hSBA GMTs using two meningococcal serogroup B strains [variants A22 and B24] 1 month after the third Trumenba vaccination (Group 1 vs. Group 2).

The noninferiority criteria for comparisons of the GMT ratio (lower limit of the 2-sided 95% confidence interval of the GMT ratio > 0.67) were met for three HPV types (6, 11 and 16) and for the meningococcal serogroup B strains. For HPV-18, the lower bound of the 95% confidence interval (CI) for the GMT ratio was 0.62 at one month after the third HPV4 vaccination.

REFERENCES

1. Wang X, et al. Prevalence and genetic diversity of candidate vaccine antigens among invasive Neisseria meningitidis isolates in the United States. Vaccine 2011; 29:4739-4744.

Meningococcal Group B Vaccine is used to prevent disease caused by Neisseria meningitidis serogroup B in individuals aged 10 through 25 years of age.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

You should not receive this vaccine if you have ever had an allergic reaction to meningococcal group B vaccine.

Inactivated (recombinant) vaccine.1 2 Meningococcal group B (MenB) vaccine is commercially available in the US as 2 different vaccines: MenB-4C (Bexsero) and MenB-FHbp (Trumenba).1 2 MenB-4C contains 3 recombinant cell surface proteins (neisserial adhesion A [NadA], neisserial heparin-binding antigen [NHBA], factor H-binding protein [FHbp]) and outer membrane vesicles (OMV) containing outer membrane protein PorA (serosubtype P1.4).1 15 MenB-FHbp contains 2 FHbp variants, one from FHbp subfamily A (A05) and one from FHbp subfamily B (B01).2

• Prior to administration of each vaccine dose, provide a copy of the appropriate CDC Vaccine Information Statement (VIS) to the patient or patient’s parent or guardian (VISs are available at ).1 2 5

• Advise patient and/or patient’s parent or guardian of the risks and benefits of vaccination with MenB vaccine.1 2

• Importance of completing vaccination series using the recommended number of doses of MenB-4C or MenB-FHbp, unless contraindicated.1 2

• Advise patient and/or patient’s parent or guardian that MenB vaccine may not provide protection in all vaccinees.1

• Advise patient and/or patient’s parent or guardian that fainting (sometimes resulting in falling with injury) reported following vaccination, especially in adolescents and young adults;1 105 134 patient should sit or lie down during and for 15 minutes after vaccine administration.1 105 134

• Importance of informing clinicians of a history of allergic reactions to MenB vaccine, any vaccine component, or packaging component (e.g., latex).1

• Importance of informing clinicians if any adverse reactions (including allergic reactions) occur with MenB vaccine.1 2 Clinicians or individuals can report any adverse reactions that occur following vaccination to VAERS at 800-822-7967 or .1 2

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.1 2

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 2

• Importance of informing patients of other important precautionary information.1 2 (See Cautions.)

• It is used to prevent meningococcal disease.

• If you have an allergy to meningococcal group B vaccine or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have an infection or an illness with a fever.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take meningococcal group B vaccine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may not protect all people who use it. Talk with the doctor.
• If you have a latex allergy, talk with your doctor. Some products have latex.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using meningococcal group B vaccine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• Vaccine
• Vaccine, Inactivated (Bacterial)

Bexsero: Induces immunity against meningococcal disease caused by serogroup B Neisseria meningitidis (MenB) via the formation of antibodies directed toward the recombinant protein antigens combined together with outer membrane vesicles (OMV) from a group B strain.

Trumenba: Protection against invasive meningococcal disease is conferred mainly by complement-mediated antibody-dependent killing of N. meningitidis.

Efficacy:

Bexsero: Composite hSBA titer response one month after the second dose: 63% to 88%

Trumenba: 84% of adolescents had a ≥4-fold rise in hSBA titer and composite response after the third dose.

Bexsero: Store between 2°C to 8°C (36°F to 46°F). Do not freeze; discard if frozen. Protect from light.

Trumenba: Store between 2°C to 8°C (36°F to 46°F). Do not freeze; discard if frozen. Store syringes in the refrigerator horizontally (laying flat on the shelf) to minimize the redispersion time.

Respiratory function for 48 to 72 hours following vaccination in premature infants (particularly if born ≤28 weeks gestation or if prior history of respiratory immaturity). Monitor for syncope for 15 minutes following administration (NCIRD/ACIP 2011). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.