TRUMENBA

Trumenba Generic Name & Formulations

Legal Class

General Description

Neisseria meningitidis recombinant lipidated factor H binding protein (fHBP) variants 120mcg of Group B (subfamily A + subfamily B); per 0.5mL; susp for IM inj; contains polysorbate 80.

Pharmacological Class

Meningitis vaccine.

How Supplied

Single-dose prefilled syringe—1, 5, 10

Manufacturer

Pfizer Inc.

Mechanism of Action

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

Trumenba Indications

Indications

N. meningitidis serogroup B immunization.

Trumenba Dosage and Administration

Adults and Children

<10yrs: not established. Give by IM inj into deltoid muscle of upper arm. 10–25yrs: 0.5mL. 3-dose series: give at 0, 1–2, and 6mos. 2-dose series: give at 0 and 6mos; if 2^nd dose given too early, give a 3^rd dose ≥4mos after the 2^nd dose.

Trumenba Contraindications

Contraindications

Severe allergic reaction after a previous dose of Trumenba.

Trumenba Boxed Warnings

Not Applicable

Trumenba Warnings/Precautions

Warnings/Precautions

Not interchangeable with other MenB vaccines. Have epinephrine inj readily available. Immunosuppressed. Complement deficiency. Eculizumab therapy. Elderly. Pregnancy. Nursing mothers.

Pregnancy Considerations

Risk Summary

Available human data is insufficient to inform of vaccine-associated risks in pregnancy.

Nursing Mother Considerations

Risk Summary

Available human data is insufficient to assess the effects of Trumenba on the breastfed infant or on milk production/excretion.
Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for Trumenba and any potential adverse effects on the breastfed child from Trumenba or from the underlying maternal condition.

Pediatric Considerations

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

Geriatric Considerations

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

Trumenba Pharmacokinetics

See Literature

Trumenba Interactions

Interactions

Concomitant other vaccines: see Clinical Trials.

Trumenba Adverse Reactions

Adverse Reactions

Inj site pain, fatigue, headache, muscle pain, nausea; syncope.

Trumenba Clinical Trials

Clinical Trials

The approval was based on immunogenicity data from four clinical trials:

Following the two-dose schedule (0 and 6 months) in subjects 10 through 25 years of age in the U.S. and Europe (Study 1057);
Following the three-dose schedule (0, 2, and 6 months) in subjects 10 through 25 years of age in the U.S., Canada, and Europe (Studies 1009 and 1016); and
Following the two-dose (0 and 6 months) and three-dose schedules (0, 1–2, and 6 months) in subjects 11 through 18 years of age in Europe (Study 1012).

82% of patients who received 3 doses of Trumenba demonstrated antibodies in their blood that killed 4 N. meningitidis serogroup B strains, as compared to the <1% before vaccination.

Concomitant Vaccine Administration

Study B1971011 (Study 1011)

The study evaluated the immunogenicity of concomitantly administered Trumenba and Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant (HPV4) (Merck & Co, Inc.).
Patients 11 through 17 years of age were randomly assigned to receive: Trumenba + HPV4 (Group 1; N=992), Trumenba + saline (Group 2; N=990), or saline + HPV4 (Group 3; N=501). The vaccines were administered based on the 0-, 2-, and 6-month schedule.
Results showed that the noninferiority criteria for the comparisons of GMTs [lower limit of the 2-sided 95% confidence interval (CI) of the GMT ratio (Group 1/Group 3 for HPV and Group 1/Group 2 for meningococcal serogroup B strains) >0.67] were met for three HPV types (6, 11 and 16) and for the meningococcal serogroup B strains tested.

Study B1971015 (Study 1015)

The study evaluated the immunogenicity of concomitantly administered Trumenba and Meningococcal (Serogroups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (MenACWY) (Sanofi Pasteur Inc.) and Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) (Sanofi Pasteur Ltd.) vaccines.
Patients 10 through 12 years of age were randomly assigned to receive:

Trumenba at 0, 2, and 6 months, and MenACWY and Tdap with the first Trumenba dose (Group 1);
Saline at 0, 2, and 6 months, and MenACWY and Tdap with the first saline injection (Group 2);
Trumenba at 0, 2, and 6 months, and saline with the first Trumenba dose (Group 3).

The noninferiority criteria for the comparisons of GMTs [lower limit of the 2-sided 95% CI of the GMT ratio (Group 1/Group 3 for meningococcal serogroup B strains and Group 1/Group 2 for MenACWY and Tdap) >0.67] were met for all antigens.

Trumenba Note