TRUMENBA Rx

• 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.