The purpose of this study is to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and DAPTACEL® vaccine. The main objectives are: Immunogenicity: To evaluate the antibody responses to both vaccines when Menactra vaccine is given concomitantly with DAPTACEL® compared to when either vaccine is given alone. Safety: To evaluate the rate of local and systemic reactions when DAPTACEL® and Menactra vaccines are administered concomitantly compared to when each vaccine is given alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
882
0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30)
0.5 mL, IM of each vaccine. (DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30)
0.5 mL, IM of each vaccine (Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30)
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Boulder, Colorado, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Layton, UT 84041, Georgia, United States
Unnamed facility
Bardstown, Kentucky, United States
Unnamed facility
Woburn, Massachusetts, United States
Unnamed facility
Bridgeton, Missouri, United States
Unnamed facility
St Louis, Missouri, United States
Unnamed facility
Albuquerque, New Mexico, United States
Unnamed facility
Rochester, New York, United States
...and 16 more locations
Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination
Serum antibody titers were assessed for diphtheria by a seroneutralization assay and for tetanus by enzyme linked immunosorbent assay.
Time frame: Day 30 post-vaccination (Visit 1)
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1.
Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)
Time frame: Day 30 post-vaccination (Visit 1)
Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1
Serum antibody titers against pertussis were assessed for pertussis toxoid (PT), filamentous hemagglutinin (FHA), Fimbriae types 2 and 3 (FIM), and pertactin (RN) by enzyme linked immunosorbent assay (ELISA).
Time frame: Day 30 post-vaccination 1
Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination
Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)
Time frame: Day 30 post-vaccination
Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine
Fever was defined as a maximum oral temperature of ≥ 100.4ºF.
Time frame: Day 0 through Day 7 post-vaccination at Visit 1
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