sessed using a 10% non-inferiority margin and a one-sided Type 1 error rate of 0.025.
A % ≥1:8§ 73 (59,84) 64 (50,77) 81 (71,89) 55 (44,66)
GMT 10 (8,13) 10 (7,12) 19 (14,26) 7 (6,9)
C % ≥1:8§ 63 (48,76) 38 (25,53) 79 (68,87) 48 (37,59)
GMT 27 (14,52) 11 (5,21) 28 (19,41) 12 (7,18)
Y % ≥1:8§ 88 (75,95) 73 (59,84) 99 (94,100) 92 (84,97)
GMT 51 (31,84) 18 (11,27) 99 (75,132) 46 (33,66)
W-135 % ≥1:8§ 63 (47,76) 33 (20,47) 85 (75,92) 79 (68,87)
GMT 15 (9,25) 5 (3,6) 24 (18,33) 20 (14,27)
In the subset of participants 2 through 3 years of age with undetectable pre-vaccination titers (ie, <1:4 at Day 0), seroconversion rates (defined as ≥1:8 at Day 28) were similar between the Menactra vaccine and Menomune – A/C/Y/W-135 vaccine recipients. Menactra vaccine participants achieved seroconversion rates of: 57%, Serogroup A (n=12/21); 62%, Serogroup C (n=29/47); 84%, Serogroup Y (n=26/31); 53%, Serogroup W-135 (n=20/38). The seroconversion rates for Menomune – A/C/Y/W-135 vaccine recipients were: 55%, Serogroup A (n=16/29); 30%, Serogroup C (n=13/43); 57%, Serogroup Y (n=17/30); 26%, Serogroup W-135 (n=11/43).
In the subset of participants 4 through 10 years of age with undetectable pre-vaccination titers (ie, <1:4 at Day 0), seroconversion rates (defined as ≥1:8 at Day 28) were similar between the Menactra vaccine and Menomune – A/C/Y/W-135 vaccine recipients. Menactra vaccine participants achieved seroconversion rates of: 69%, Serogroup A (n=11/16); 81%, Serogroup C (n=50/62); 98%, Serogroup Y (n=45/46); 69%, Serogroup W-135 (n=27/39). The seroconversion rates for Menomune – A/C/Y/W-135 vaccine recipients were: 48%, Serogroup A (n=10/21); 38%, Serogroup C (n=19/50); 84%, Serogroup Y (n=38/45); 68%, Serogroup W-135 (n=26/38).
Immunogenicity in Adolescents 11 through 18 Years of Age
Results from the comparative clinical trial conducted in 881 adolescents aged 11 through 18 years showed that the immune responses to Menactra vaccine and Menomune – A/C/Y/W-135 vaccine were similar for all four serogroups (Table 7).
In participants with undetectable pre-vaccination titers (ie, less than 1:8 at Day 0), seroconversion rates (defined as a ≥4-fold rise in Day 28 SBA-BR titers) were similar between the Menactra vaccine and Menomune – A/C/Y/W-135 vaccine recipients. Menactra vaccine participants achieved seroconversion rates of: 100%, Serogroup A (n=81/81); 99%, Serogroup C (n=153/155); 98%, Serogroup Y (n=60/61); 99%, Serogroup W-135 (n=161/164). The seroconversion rates for Menomune – A/C/Y/W-135 vaccine recipients were: 100%, Serogroup A (n=93/93); 99%, Serogroup C (n=151/152); 100%, Serogroup Y (n=47/47); 99%, Serogroup W-135 (n=138/139).
Immunogenicity in Adults 18 through 55 Years of Age
Results from the comparative clinical trial conducted in 2554 adults aged 18 through 55 years showed that the immune responses to Menactra vaccine and Menomune – A/C/Y/W-135 vaccine were similar for all four serogroups (Table 7).
Table 7: Comparison of Bactericidal Antibody Responses* to Menactra Vaccine and Menomune – A/C/Y/W-135 Vaccine 28 Days after Vaccination for Participants 11 through 18 Years of Age and 18 through 55 Years of Age Ages 11 through 18 Years Ages 18 through 55 Years
Menactra vaccine Menomune – A/C/Y/W-135 vaccine Menactra vaccine Menomune – A/C/Y/W-1
