Indications for: TRUMENBA
N. meningitidis serogroup B immunization.
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.
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 2nd dose given too early, give a 3rd dose ≥4mos after the 2nd dose.
Severe allergic reaction after a previous dose of Trumenba.
Not interchangeable with other MenB vaccines. Have epinephrine inj readily available. Immunosuppressed. Complement deficiency. Eculizumab therapy. Elderly. Pregnancy. Nursing mothers.
Concomitant other vaccines: see Clinical Trials.
Inj site pain, fatigue, headache, muscle pain, nausea; syncope.
Single-dose prefilled syringe—1, 5, 10