red alone, followed by a second Menactra vaccine dose given alone (N=404), or with MMRV vaccine (N=302), or with PCV7 (N=422). For all participants, sera were obtained approximately 30 days after last vaccination. There were no substantive differences in demographic characteristics between the vaccine groups. The median age range for administration of the first dose of Menactra was 278-279 days of age.
Table 5: Bactericidal Antibody Responses* 30 Days Following a Second Dose of Menactra Vaccine Administered Alone or Concomitantly Administered with MMRV or PCV7 Vaccines at 12 Months of Age Vaccinations administered at 12 months of age following a dose of Menactra at 9 months of age
Menactra vaccine Menactra + MMRV vaccines Menactra + PCV7 vaccines
(N=272-277)† (N=177-180)† (N=264-267)†
Serogroup (95% CI)‡ (95% CI)‡ (95% CI)‡
*
Serum Bactericidal Assay with an exogenous human complement (SBA-H) source.
†
N=Number of participants with at least one valid serology result from a blood sample obtained between Days 30 to 44 post vaccination.
‡
95% CIs for the proportions are calculated based on the Clopper-Pearson Exact method and normal approximation for that of the GMTs.
§
The proportion of participants achieving at least an SBA-H titer of 1:8 thirty days after the second dose of Menactra.
A % ≥1:8§ 95.6 (92.4; 97.7) 92.7 (87.8; 96.0) 90.5 (86.3; 93.8)
GMT 54.9 (46.8; 64.5) 52.0 (41.8; 64.7) 41.0 (34.6; 48.5)
C % ≥1:8§ 100.0 (98.7; 100.0) 98.9 (96.0; 99.9) 97.8 (95.2; 99.2)
GMT 141.8 (123.5; 162.9) 161.9 (136.3; 192.3) 109.5 (94.1; 127.5)
Y %≥1:8§ 96.4 (93.4; 98.2) 96.6 (92.8; 98.8) 95.1 (91.8; 97.4)
GMT 52.4 (45.4; 60.6) 60.2 (50.4; 71.7) 39.9 (34.4; 46.2)
W-135 %≥1:8§ 86.4 (81.8; 90.3) 88.2 (82.5; 92.5) 81.2 (76.0; 85.7)
GMT 24.3 (20.8; 28.3) 27.9 (22.7; 34.3) 17.9 (15.2; 21.0)
Serum Bactericidal Assay with an exogenous human complement (SBA-H) source.
†
N=Number of participants with at least one valid serology result from a blood sample obtained between Days 30 to 44 post vaccination.
‡
95% CIs for the proportions are calculated based on the Clopper-Pearson Exact method and normal approximation for that of the GMTs.
§
The proportion of participants achieving at least an SBA-H titer of 1:8 thirty days after the second dose of Menactra.
A % ≥1:8§ 95.6 (92.4; 97.7) 92.7 (87.8; 96.0) 90.5 (86.3; 93.8)
GMT 54.9 (46.8; 64.5) 52.0 (41.8; 64.7) 41.0 (34.6; 48.5)
C % ≥1:8§ 100.0 (98.7; 100.0) 98.9 (96.0; 99.9) 97.8 (95.2; 99.2)
GMT 141.8 (123.5; 162.9) 161.9 (136.3; 192.3) 109.5 (94.1; 127.5)
Y %≥1:8§ 96.4 (93.4; 98.2) 96.6 (92.8; 98.8) 95.1 (91.8; 97.4)
GMT 52.4 (45.4; 60.6) 60.2 (50.4; 71.7) 39.9 (34.4; 46.2)
W-135 %≥1:8§ 86.4 (81.8; 90.3) 88.2 (82.5; 92.5) 81.2 (76.0; 85.7)
GMT 24.3 (20.8; 28.3) 27.9 (22.7; 34.3) 17.9 (15.2; 21.0)
Administration of Menactra to children at 12 months and 15 months of age was eva luated in a US study. Prior to the first dose, 33.3% [n=16/48] of participants had an hSBA titer ≥1:8 to Serogroup A, and 0-2% [n=0-1 of 50-51] to Serogroups C, Y and W-135. After the second dose, percentages of participants with an hSBA titer ≥1:8 were: 85.2%, Serogroup A [n=46/54]; 100.0%, Serogroup
