This will be a Phase III, modified double-blind (open-label for toddlers in India), randomized, parallel-group, active-controlled, step-wise, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adults, adolescents, children, and toddlers in India and a modified double-blind, randomized, parallel-group, active-controlled, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adolescents and children in RSA.
Study duration per participant is approximately 31 to 45 days
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,328
Pharmaceutical form: solution for injection; Route of administration: intramuscular, 0.5 mL
Pharmaceutical form: sterile aqueous solution; Route of administration: intramuscular, 0.5 mL
Pharmaceutical form: reconstituted solution for injection; Route of administration: intramuscular, 0.5 mL
Investigational Site Number : 3560002
Bangalore, India
Investigational Site Number : 3560016
Belagavi, India
Investigational Site Number : 3560007
Chennai, India
Investigational Site Number : 3560004
Hyderabad, India
Investigational Site Number : 3560011
Kolkata, India
Investigational Site Number : 3560012
Mysore, India
Investigational Site Number : 3560015
Odisha, India
Investigational Site Number : 3560003
Pune, India
Investigational Site Number : 3560008
Pune, India
Investigational Site Number : 3560010
Punjab, India
...and 7 more locations
Group 5 + 7 and Group 6 + 8: Percentage of Participants Who Achieved Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). Percentages are rounded off to the tenth decimal place. As pre-specified in protocol, the endpoint was assessed in children and adolescents aged 2 to 17 years in India and RSA as combined groups: Group 5 + Group 7 and Group 6 + Group 8 as they received the same dose of MenACYW conjugate vaccine and Menactra® respectively.
Time frame: Day 30 (30 days post-vaccination on Day 0)
Group 1 and Group 2: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and serum bactericidal assay using baby rabbit complement (rSBA).
Time frame: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Group 1 and Group 2: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA. Percentages are rounded off to the tenth decimal place. Percentage of participants who achieved antibody titers ≥1:4 and ≥1:8 by hSBA and ≥1:8 and ≥1:128 by rSBA are reported.
Time frame: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Group 3 and Group 4: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA.
Time frame: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Group 3 and Group 4: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA. Percentages are rounded off to the tenth decimal place. Percentage of participants who achieved antibody titers ≥1:4 and ≥1:8 by hSBA and ≥1:8 and ≥1:128 by rSBA are reported.
Time frame: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Group 5 + 7 and Group 6 + 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA. As pre-specified in protocol, the endpoint was assessed in children and adolescents aged 2 to 17 years in India and RSA as combined groups: Group 5 + Group 7 and Group 6 + Group 8 as they received the same dose of MenACYW conjugate vaccine and Menactra® respectively.
Time frame: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Group 5 and Group 6: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA.
Time frame: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Group 5 and Group 6: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA. Percentages are rounded off to the tenth decimal place. Percentage of participants who achieved antibody titers ≥1:4 and ≥1:8 by hSBA and ≥1:8 and ≥1:128 by rSBA are reported.
Time frame: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Group 7 and Group 8: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA.
Time frame: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
Group 7 and Group 8: Percentage of Participants Who Achieved Antibody Titers ≥Pre-defined Thresholds Against Meningococcal Serogroups A, C, Y, and W
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by hSBA and rSBA. Percentages are rounded off to the tenth decimal place. Percentage of participants who achieved antibody titers ≥1:4 and ≥1:8 by hSBA and ≥1:8 and ≥1:128 by rSBA are reported.
Time frame: Day 0 (pre-vaccination) and Day 30 (30 days post-vaccination on Day 0)
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