Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine

Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with human complement serum bactericidal activity (hSBA) titers≥ 1:8 directed against N meningitidis serogroups A, C, W and Y.

Time frame: 21 months, 3 years and 5 years postvaccination

Population: Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline at any visit (21 months, 3 years and 5 years) and had no major protocol deviations.

Immune response of age-matched subjects with no previous meningococcal vaccination, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W and Y.

Time frame: day 1

Population: Analysis was done on PP persistence population (Naive subjects) - subjects who provided one evaluable serum sample at baseline and had no major protocol deviations.

Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the hSBA Geometric Mean Titers (GMTs) against N meningitidis serogroups A, C, W and Y.

Time frame: 21 months, 3 years and 5 years postvaccination

Population: Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline at any visit (21 months, 3 years and 5 years) and had no major protocol deviations.

Safety was assessed as the number of subjects who had previously been vaccinated in the parent study with MenACWY-CRM or licensed comparator who reported solicited local and systemic adverse events within 7 days after the administration of a booster dose of MenACWY-CRM conjugate vaccine at 3 year time point.

Time frame: Day 1 to Day 7

Population: Analysis was done on the solicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.

Safety was assessed in terms of number of subjects with medically attended AEs within 28 days after vaccination with one dose of either MenACWY-CRM conjugate or licensed comparator vaccine.

Time frame: 28 days postvaccination

Population: Analysis was done on safety population - subjects who received vaccination with MenACWY-CRM conjugate vaccine, provided post-baseline safety data and provide safety follow-up information for any period during the 28 day follow-up.

Safety was assessed in terms of number of subjects with new diagnoses of chronic diseases, among subjects who had previously received one dose of either MenACWY-CRM conjugate vaccine or licensed comparator vaccine.

Time frame: Day 1 to 5 years

Population: Analysis was done on safety follow-up population - subjects enrolled at 5 years were included in the safety follow-up for 24 hours after blood draw and for analysis of medical history to identify new onset of chronic diseases.

Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with hSBA titers≥ 1:4 against N meningitidis serogroups A, C, W and Y.

Time frame: 21 months, 3 years and 5 years postvaccination

Population: Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline at any visit (21 months, 3 years and 5 years) and had no major protocol deviations.

Immune response at one month after one dose of MenACWY-CRM conjugate vaccine in subjects who had previously received one dose of MenACWY-CRM conjugate vaccine or licensed comparator vaccine, as measured by percentages of subjects with hSBA Titers≥ 1:4 and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.

Time frame: 1 month post booster vaccination

Population: Analysis was done on PP post booster persistence population - subjects who provided one evaluable serum sample at baseline at any visit (3 years and 5 years) and had no major protocol deviations.

Persistence of immune response at two years following administration of one dose of MenACWY-CRM conjugate vaccine in subjects who previously received one dose of either MenACWY-CRM conjugate or licensed comparator vaccine, as measured by hSBA titers≥ 1:4 and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.

Time frame: 2 years postvaccination

Population: Analysis was done on PP post booster persistence population - subjects who provided one evaluable serum sample at baseline at any visit (3 years and 5 years) and had no major protocol deviations.

Immune response of age-matched naive subjects with no previous meningococcal vaccination, as measured by the percentages of subjects with hSBA titers≥ 1:4, and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.

Time frame: day 1

Population: Analysis was done on PP persistence population - subjects who provided one evaluable serum sample at baseline and had no major protocol deviations.

Persistence of immune response at two years following administration of one dose of MenACWY-CRM conjugate vaccine in subjects who previously received one dose of either MenACWY-CRM conjugate or licensed comparator vaccine, as measured by hSBA GMTs against N meningitidis serogroups A, C, W and Y.

Time frame: 2 years postvaccination

Population: Analysis was done on PP post booster persistence population - subjects who provided one evaluable serum sample at baseline at any visit (3 years and 5 years) and had no major protocol deviations.