Meningococcal Polysaccharide Tetanus Protein Conjugate Vaccine

Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.

Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.

Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by hSBA assay method. Seroresponse was defined as post-vaccination hSBA titers ≥1:8 for participants with pre-vaccination hSBA titers less than (\<) 1:8, or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers ≥1:8.

GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.

GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.

Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method.

Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method.

Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by rSBA assay method. Seroresponse was defined as post-vaccination rSBA titers ≥1:8 for participants with pre-vaccination rSBA titers \<1:8, or at least a 4-fold increase in rSBA titers from pre- to post-vaccination for participants with pre-vaccination rSBA titers ≥1:8.

GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method.

GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method.

An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of symptom and/or onset post-vaccination. Unsolicited AEs includes both serious and non-serious unsolicited AEs. A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF.

A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (symptom and onset) prelisted in the CRF. Solicited injection site reactions included: pain, erythema, and swelling. Solicited systemic reactions included: fever, headache, malaise and, myalgia.

An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRF in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. Non-serious AE (AE excluding SAE) which was significant and prevented daily activity was considered as Grade 3 unsolicited non-serious AE.