The aim of the study is to assess safety and immunogenicity of a single dose of Menactra® in support of registration of the vaccine in South Korea. Primary Objective: * To demonstrate that the seroconversion rate is higher than 60% for serogroups A, C, Y and W-135, 28 days after a single dose of Menactra®. Secondary objectives: * To demonstrate the superiority of Menactra® versus Adacel® in terms of seroconversion rate for serogroups A, C, Y, and W-135, 28 days after a single dose of vaccine * To describe the safety profile after 1 dose of Menactra® or Adacel® vaccine. * To describe the Serum Bactericidal Assay Using Baby Rabbit (SBA-BR) Complement titers before and 28 days after a single dose of Menactra® or Adacel® vaccine.
All participants will receive a single dose of vaccine, and will be assessed for immunogenicity at baseline (pre-vaccination) and at 28 days post-vaccination. Safety data, including serious adverse events (SAEs) will be collected for Day 0 through Day 28 post-vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
300
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Unnamed facility
Incheon, Chung gu, South Korea
Unnamed facility
Gyeonggi-do, Dongan Gu Anyang, South Korea
Unnamed facility
Seoul, Dongdaemun gu, South Korea
Unnamed facility
Seoul, Seodaemun gu, South Korea
Unnamed facility
Seoul, Seongbuk gu, South Korea
Unnamed facility
Gyeonggi-do, Suwon, South Korea
Unnamed facility
Gangwon Do, Wonju, South Korea
Percentage of Participants With Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine
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.
Time frame: 28 Days post-vaccination
Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination
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) at ≥ 1:8 dilution.
Time frame: Day 0 (pre-vaccination) and 28 days post-vaccination
Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination.
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) at ≥ 1:128 dilution.
Time frame: Day 0 (pre-vaccination) and 28 days post-vaccination
Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination
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).
Time frame: Day 0 (pre-vaccination) and 28 days post-vaccination
Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine
Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection site reactions: Pain - Significant, prevents daily activity; Redness and Swelling - \> 100 mm. Grade 3 Systemic reactions: Fever - ≥ 39.0°C; Headache, Malaise, and Myalgia - Significant, prevents daily activity.
Time frame: Day 0 up to Day 28 post-vaccination
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