Immunogenicity & Persistence

*In a randomized, placebo-controlled, single-blinded, multicenter trial conducted in Europe, 1713 adolescents 11 through 18 years of age were assigned randomly into 5 groups to receive 2 or 3 doses of TRUMENBA: 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).1,2

To achieve a 4-fold increase in immune response to TRUMENBA, a minimum hSBA (serum bactericidal activity using human complement) titer of 1:16 was measured if baseline hSBA titer was <1:4; in subjects with a baseline hSBA titer ≥1:4, an hSBA titer ≥4 times an hSBA titer ≥1:8 (1:16 for strain A22) or ≥4 times the baseline titer, whichever was higher.

Study 1 was a Phase 3, randomized, active-controlled, observer-blinded trial in adolescents 10 to 18 years of age (n=2693), and Study 2 was a Phase 3, randomized, placebo-controlled, observer-blinded trial in young adults 18 to 25 years of age (n=2471). Studies 1 and 2 were conducted in the United States, Canada, and Europe. In both studies, subjects received 3 doses of TRUMENBA on a 0, 2, and 6 months schedule.

§To achieve a 4-fold increase in immune response to TRUMENBA, a minimum hSBA (serum bactericidal activity using human complement) titer of 1:16 was measured if baseline hSBA titer was <1:4; in subjects with a baseline titer of ≥1:4, an hSBA titer ≥4 times an hSBA titer ≥1:8 (1:16 for strain A22) or ≥4 times the baseline titer, whichever was higher.

||1:8 for A07, A15, A29, B03, B09, B15 and B16; 1:16 for A06, A12, A19.

TRUMENBA can help protect adolescents and young adults during their peak risk years3,4
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