Study will evaluate the persistence of antibodies approximately three years after an initial dose of Menactra® vaccine in toddlers who participated in study MTA26 (NCT00643916) and age-matched Menactra naive participants. Objectives: * To assess the persistence of antibody responses three years after one or two doses of Menactra® vaccine in subjects who participated in study MTA26. * To describe the antibody responses to a single dose of Menactra® vaccine in subjects who had previously received one or two doses of Menactra® vaccine and in Menactra® vaccine-naïve subjects. * To describe the safety profile of a single dose of Menactra® vaccine in subjects.
Subjects that received Menactra® vaccine in study MTA26 (NCT00643916) and age-matched Menactra naive participants will receive a single dose of Menactra® on Day 0. They will be evaluated for immunogenicity and safety post-vaccination.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
181
0.5 mL, IM
0.5 mL, IM
0.5 mL, IM
Unnamed facility
Marietta, Georgia, United States
Unnamed facility
Woodstock, Georgia, United States
Unnamed facility
Bardstown, Kentucky, United States
Unnamed facility
Annapolis, Maryland, United States
Unnamed facility
Frederick, Maryland, United States
Unnamed facility
Woburn, Massachusetts, United States
Unnamed facility
Greenville, Pennsylvania, United States
Unnamed facility
Harleysville, Pennsylvania, United States
Unnamed facility
Pittsburgh, Pennsylvania, United States
Unnamed facility
Pittsburgh, Pennsylvania, United States
...and 3 more locations
Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers ≥ 1:4 and ≥ 1:8 Before and Following Vaccination With Menactra®
Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC). Bactericidal antibody persistence to meningococcal serogroups was defined as as pre-vaccination titers of ≥1:4 and ≥1:8. Booster response to a single Menactra vaccine dose was defined as antibody titers of ≥1:4 and ≥1:8 30 days post-booster vaccination.
Time frame: Day 0 (pre-vaccination) and Day 30 post-vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.