The purpose of this study was to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and Tdap vaccine in adolescents aged 11 to 17 years. Primary Objective: To determine whether concomitant administration of two vaccines, Tdap and Menactra®, induces antibody responses that are similar to those observed when each vaccine is given separately. Secondary Objective: To compare the rates of injection site reactions at the Tdap injection site after Tdap and Menactra® vaccines are administered concomitantly to the corresponding rates of reactions when Tdap vaccine is administered alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,345
Day 0: 0.5 mL (T dap)+ Placebo, Intramuscular; Day 28: 0.5 mL (Menactra®) Intramuscular
Day 0: 0.5 mL (T dap) + 0.5 mL (Menactra®) Intramuscular; Day 28: Placebo 0.5 mL Intramuscular
Day 0: 0.5 mL (Menactra®)+0.5 mL Placebo, Intramuscular; Day 28: 0.5 mL (T dap) Intramuscular
Unnamed facility
Jonesboro, Arkansas, United States
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Boulder, Colorado, United States
Unnamed facility
Marietta, Georgia, United States
Unnamed facility
Woodstock, Georgia, United States
Unnamed facility
Bardstown, Kentucky, United States
Unnamed facility
Baltimore, Maryland, United States
Unnamed facility
Woburn, Massachusetts, United States
Unnamed facility
Albuquerque, New Mexico, United States
Unnamed facility
Syracuse, New York, United States
...and 10 more locations
Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine.
Time frame: Day 0 to Day 28 post-vaccination
Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.
Time frame: Day 0 and Day 28 post-vaccination
Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.
Time frame: Day 0 and Day 28 Post-vaccination
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Solicited injection sites reactions: Erythema, swelling, and pain. Solicited systemic reactions: Fever (temperature), headache, malaise, and myalgia.
Time frame: 0 to 7 days post-vaccination
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