MENACTRA Rx

Children 9 through 12 Months of Age

• The approval was based on data from a randomized, multicenter US-trial which included children who received two doses of Menactra at 9 months and 12 months of age. The first Menactra dose was administered alone, followed by a second Menactra dose given alone, or with MMRV, or with PCV7. Sera was obtained approximately 30 days after the last vaccination for all participants. 

• Findings showed that Menactra given 3 months apart elicited a robust immune response against the serogroups included in the vaccine. The studies also showed that the measles-mumps-rubella-varicella vaccine (MMRV) and pneumococcal conjugate vaccine (PCV7) can be administered concomitantly with Menactra in children.

• Menactra was also evaluated when given to children at 12 months and 15 months of age. Prior to the first dose,  33.3% [n=16/48] of participants had a serum bactericidal assay with an exogenous human complement (SBA-H) 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 SBA-H titer ≥1:8 were: 85.2%, Serogroup A [n=46/54]; 100.0%, Serogroup C [n=54/54]; 96.3%, Serogroup Y [n=52/54]; 96.2%, Serogroup W-135 [n=50/52].

Individuals 2 through 55 Years of Age 

• Approval was based on three comparative, randomized, US, multicenter, active-controlled clinical trials that included 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 (N=2526) or Menomune – A/C/Y/W-135 (N=2317). For all age groups studied, sera were obtained before and approximately 28 days after vaccination.

Immunogenicity in Children 2 through 10 Years of Age 

• Of 1408 enrolled children 2 through 10 years of age, Menactra elicited comparable immune responses to Menomune A/C/Y/W-135 for all 4 serogroups.

• In a subset of children 2 through 3 years of age with undetectable pre-vaccination titers, seroconversion rates were similar between Menactra and Menomune A/C/Y/W-135.

• In a subset of children 4 through 10 years of age with undetectable pre-vaccination titers, seroconversion rates were similar between Menactra and Menomune A/C/Y/W-135.

Immunogenicity in Adolescents 11 through 18 Years of Age 

• In a comparative clinical trial, 881 adolescents 11 through 18 years of age showed similar immune responses for all 4 serogroups between Menactra and Menomune A/C/Y/W-135.

• In participants with undetectable pre-vaccination titers, seroconversion rates were similar between Menactra and Menomune A/C/Y/W-135.

Immunogenicity in Adults 18 through 55 Years of Age

• In a comparative clinical trial, 2552 adults 18 through 55 years of age showed similar immune responses for all 4 serogroups between Menactra and Menomune A/C/Y/W-135.

• In participants with undetectable pre-vaccination titers, seroconversion rates were similar between Menactra and Menomune A/C/Y/W-135.

Immunogenicity in Adolescents and Adults Following Booster Vaccination

• Prior to revaccination, the percentage of participants (n=781) with an SBA-H titer ≥1:8 were 64.5%, 44.2%, 38.7%, and 68.5% for Serogroups A, C, Y and W-135, respectively. Among the subset of trial participants (n=112) for whom SBA-H responses at Day 6 were assessed, 86.6%, 91.1%, 94.6%, and 92.0% achieved a ≥4-fold rise in SBA-H titer for Serogroups A, C, Y and W-135, respectively. The proportions of participants (n=781) who achieved a ≥4-fold rise in SBA-H titer by Day 28 were 95.0%, 95.3%, 97.1%, and 96% for Serogroups A, C, Y and W-135, respectively. The proportions of participants who achieved an SBA-H titer ≥1:8 by Day 28 were >99% for each serogroup.