To explore the potential benefit of the administration of Menactra vaccine as a two-dose regimen to children. Primary Objective: To assess, by age group, the immune response to Menactra vaccine after each vaccine injection.
This is an open-label trial designed to explore the immune response to a two-dose schedule of Menactra vaccine compared with a standard one-dose schedule in children.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
333
0.5 mL, 2 doses Intramuscular
0.5 mL, 2 doses Intramuscular
0.5 mL, 1 dose Intramuscular
Unnamed facility
Jonesboro, Arkansas, United States
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Boca Raton, Florida, United States
Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)
Time frame: 30 days post-vaccination
Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)
Time frame: 30 days post-vaccination
Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)
Time frame: 30 days post-vaccination
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.
Time frame: 7 days post-vaccination 1
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.
Time frame: 7 days post-vaccination 2
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Unnamed facility
Viera, Florida, United States
Unnamed facility
Woburn, Massachusetts, United States
Unnamed facility
Las Vegas, Nevada, United States
Unnamed facility
Cleveland, Ohio, United States
Unnamed facility
Pittsburgh, Pennsylvania, United States
Unnamed facility
Charleston, South Carolina, United States
Unnamed facility
Kingsport, Tennessee, United States
...and 5 more locations