Individuals 2 through 55 Years of Age

Immunogenicity was eva luated in three comparative, randomized, US, multi-center, active controlled clinical trials that enrolled children (2 through 10 years of age), adolescents (11 through 18 years of age), and adults (18 through 55 years of age). Participants received a single dose of Menactra vaccine (N=2526) or Menomune – A/C/Y/W-135 vaccine (N=2317). For all age groups studied, sera were obtained before and approximately 28 days after vaccination. [Blinding procedures for safety assessments are described in Adverse Reactions (6).]

In each of the trials, there were no substantive differences in demographic characteristics between the vaccine groups, between immunogenicity subsets or the overall study population. In the study of children 2 through 10 years of age, the median age of participants was 3 years; 95% completed the study. In the adolescent trial, the median age for both groups was 14 years; 99% completed the study. In the adult trial, the median age for both groups was 24 years; 94% completed the study.

Immunogenicity in Children 2 through 10 Years of Age

Of 1408 enrolled children 2 through 10 years of age, immune responses eva luated in a subset of Menactra vaccine participants (2 through 3 years of age, n=52; 4-10 years of age, n=84) and Menomune – A/C/Y/W-135 vaccine participants (2 through 3 years of age, n=53; 4-10 years of age, n=84) were comparable for all four serogroups (Table 6).

Table 6: Comparison of Bactericidal Antibody Responses* to Menactra Vaccine and Menomune – A/C/Y/W-135 Vaccine 28 Days after Vaccination for a Subset of Participants 2 through 3 Years of Age and 4 through 10 Years of Age   Ages 2 through 3 Years Ages 4 through 10 Years
  Menactra vaccine  Menomune – A/C/Y/W-135 vaccine Menactra vaccine Menomune – A/C/Y/W-135 vaccine
  N†=48-52 N†=50-53 N†=84 N†=84
Serogroup   (95% CI)‡  (95% CI)‡  (95% CI)‡  (95% CI)‡
*
Serum Bactericidal Assay with an exogenous human complement (SBA-H) source.
†
N=Number of subset participants with at least one valid serology result at Day 0 and Day 28.
‡
The 95% CI for the Geometric Mean Titer (GMT) was calculated based on an approximation to the normal distribution.
§
The proportion of participants achieving at least an SBA-H titer of 1:8 was assessed 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)
Serum Bactericidal Assay with an exogenous human complement (SBA-H) source.
†
N=Number of subset participants with at least one valid serology result at Day 0 and Day 28.
‡
The 95% CI for the Geometric Mean Titer (GMT) was calculated based on an approximation to the normal distribution.
§
The proportion of participants achieving at least an SBA-H titer of 1:8 was as