Meningococcal polysaccharide diphtheria toxoid conjugate

Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR). Seroconversion was defined as post-vaccination antibody titers of ≥ 4-fold increase from pre-vaccination level.

Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR). Sero protection was defined as SBA-BR titer of ≥ 1:128.

Antibodies to Menactra vaccine were measured by the Serum bactericidal assay baby rabbit complement (SBA BR) Test.

Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.

Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.

Solicited injection site: Pain, Erythema (Redness), and Swelling. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia

Solicited injection (Inj.) site reactions: Tenderness/Pain (Grade 1: minor reaction when Inj. site touched; Grade 2: cries/protests when Inj. site touched; Grade 3: cries when injected limb moved, or the movement of the injected limb is reduced), Erythema and Swelling (Grade 1: \>0 to \<25 mm, Grade 2: \>=25 to \<50 mm, Grade 3: \>=50 mm). Number of participants with any of the Grade 1, 2 or 3 solicited injection-site reactions and Grade 3 solicited injection-site reactions were reported.

Solicited injection (Inj.) site reactions in children (2-11 years), adolescents and adults (12-55 years): Tenderness/Pain (Grade 1: easily tolerated \[children\], no interference with activity \[adolescents and adults\]; Grade 2: sufficiently discomforting \[children\], some interference\[adolescents and adults\]; Grade 3: unable to perform usual activities\[children\]; significant interference with daily activities \[adolescents and adults\]), Erythema and Swelling (Grade 1: \>0 to\<25 mm \[children\], \>=25 to \<=50 mm \[adolescents and adults\]; Grade 2: \>=25 to \<50 mm \[children\], \>=51 to \<=100 mm \[adolescents and adults\], Grade 3: \>=50 mm \[children\]; \>100 mm\[adolescents and adults\]). Number of participants with any of Grade 1, 2 or 3 solicited injection-site reactions and Grade 3 solicited injection-site reactions were reported.

Solicited systemic reactions: Fever (Grade 1: \>=38.0 degree Celsius to \<=38.5 degree Celsius; Grade 2: \>38.5 degree Celsius to \<=39.5 degree Celsius; Grade 3: \>39.5 degree Celsius), Vomiting (Grade 1: 1 episode per 24 hours, Grade 2: 2-5 episodes per 24 hours, Grade 3: \>=6 episodes per 24 hours), Crying abnormal (Grade 1: \<1 hour; Grade 2: 1-3 hours; Grade 3: \>3 hours), Drowsiness (Grade 1: sleepier than usual or less interested in surroundings; Grade 2: Not interested in surroundings or did not wake up for a feed / meal; Grade 3: Sleeping most of the time or difficult to wake up), Appetite loss (Grade 1: eating less than normal; Grade 2: missed 1 or 2 feeds / meals completely; Grade 3: refuses \>=3 feeds / meals or refuses most feeds / meals), Irritability (Grade 1: easily consolable; Grade 2: requiring increased attention; Grade 3: inconsolable). Number of participants with any of the Grade 1, 2 or 3 systemic reactions and Grade 3 systemic reactions were reported.

Solicited systemic reactions: Fever (Grade 1: \>=38.0 degree Celsius to \<=38.4 degree Celsius; Grade 2: \>=38.5 degree Celsius to \<=38.9 degree Celsius; Grade 3: \>=39.0 degree Celsius), headache, malaise and myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any of the Grade 1, 2 or 3 systemic reactions and Grade 3 systemic reactions were reported.

Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC). Bactericidal antibody persistence to meningococcal serogroups was defined as as pre-vaccination titers of ≥1:4 and ≥1:8. Booster response to a single Menactra vaccine dose was defined as antibody titers of ≥1:4 and ≥1:8 30 days post-booster vaccination.

Groups 1 and 2 received booster vaccination, Groups 3 and 4 received primary vaccination. Serum bactericidal activity for each Menactra® vaccine serogroups were at pre-vaccination and at 28 days post-booster or post-primary vaccination.

Geometric mean titers and their 95% confidence interval of serum bactericidal activity for the 4 vaccine serogroups before vaccination, at 8 days post- and 28 days post-booster dose of Menactra vaccine or a primary dose of Menactra vaccine in the meningococcal vaccine-naïve Control group.