The purpose of this study is to assess the safety and immunogenicity of a single dose of Menactra® vaccine to support registration. Primary Objectives: * To describe the antibody titers measured by serum bactericidal activity using baby rabbit complement (SBA-BR) before and after Menactra® vaccination. * To describe the safety profile of participants after one dose of Menactra®.
Participants will be enrolled in three age cohorts: Children: 2 - 11 years of age; Adolescents: 12 - 17 years of age, and Adults: 18 - 55 years of age to receive a single dose of Menactra®. They will be followed for a duration of 30 days after vaccination.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
300
0.5 mL, Intramuscular
Unnamed facility
Bangalore, India
Unnamed facility
Mumbai, India
Unnamed facility
New Delhi, India
Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination
Antibodies to Menactra vaccine were measured by the Serum bactericidal assay baby rabbit complement (SBA BR) Test.
Time frame: Baseline and 21 days post-vaccination
Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination
Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.
Time frame: Day 0 and Day 30 post-vaccination
Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination
Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.
Time frame: Day 0 to 30 post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination
Solicited injection site: Pain, Erythema (Redness), and Swelling. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia
Time frame: Day 0 to 7 post-vaccination
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