Reactogenicity of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by number of subjects with at least one severe solicited AE within 7 days after vaccination. Solicited AEs included tenderness, erythema, induration, irritability, sleepiness, change in eating habits, vomiting, diarrhea and fever.

Analysis was done on the solicited safety data set (all subjects in the exposed set who provided post vaccination reactogenicity data: MenACWY-CRM 99; MenACWY-TT 101).

Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with hSBA titer ≥ 8 directed against Neisseria meningitidis (N. meningitidis) serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune responses was measured by the percentages of subjects with hSBA titer ≥ 8 on Day 180 post-vaccination.

Analysis was done on Full Analysis Set (FAS) Day 29 (subjects who received the vaccine and provided immunogenicity data at Day 29: MenACWY-CRM 95; MenACWT-TT 97). Persistence of immune responses at Day 180 was analysed on FAS Day 180 (subjects who received the vaccine and provided immunogenicity data at Day 180: MenACWY-CRM 98; MenACWT-TT 97).

Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with seroresponse defined as for subjects with pre-vaccination hSBA titer < 4, post-vaccination hSBA titer ≥ 8; for subjects with pre-vaccination hSBA titer ≥ 4, an increase of at least four times the pre-vaccination hSBA directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence immune response was measured by the percentage of subjects with seroresponse at Day 180 after vaccination.

Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.

Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by hSBA GMTs directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by hSBA GMTs at Day 180 after vaccination.

Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.

Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with rSBA titer ≥ 8 directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by percentages of subjects with rSBA titer ≥ 8 on Day 180 after vaccination.

Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.

Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with rSBA titer ≥ 128 directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by percentages of subjects with rSBA titer ≥ 128 on Day 180 after vaccination.

Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.

Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with four-fold increase in rSBA titer directed against N. meningitides serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by the percentages of subjects with four-fold increase in rSBA titer on Day 180 after vaccination.

Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.

Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by rSBA GMTs directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune responses was measured by rSBA GMTs on Day 180.

Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.

Safety was assessed in terms of number of subjects (12 to 15 months old) reporting any and each of solicited local and systemic AEs reported from Day 1 to 7 after vaccination with one dose of either MenACWY-CRM or comparator MenACWY-TT vaccine.

Analysis was done on solicited safety data set. MedDRA version v.3.0 was used for the analyses (in the AEs section, MedDRA version v.17.01 was used, leading to a different terminology to describe some of the events reported in this outcome).

Safety was assessed in terms of number of subjects (12 to 15 months old) reporting unsolicited AEs (day 1 to day 29), SAEs, medically attended AEs, AEs leading to premature study withdrawal (Day 1 to Day 180) after vaccination with one dose of either MenACWY-CRM or comparator MenACWY-TT vaccine.

Analysis was done on unsolicited safety data set ie, all subjects in the exposed set who had post-vaccination unsolicited adverse event records.