The purpose of study Td519 is to demonstrate that Adacel® vaccine (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed) is safe and immunogenic in persons 10 years of age. Primary Objectives: * To compare pertussis antibody responses induced by Adacel® in persons 10 to \<11 years of age to those induced by Adacel in persons 11 to \<12 years of age. * To compare the booster responses against pertussis antigens induced by Adacel in persons 10 to \<11 years of age to those induced by Adacel in persons 11 to \<12 years of age. * To compare booster responses against tetanus and diphtheria induced by Adacel in persons 10 to \<11 years of age to those induced by Adacel in persons 11 to \<12 years of age. Secondary Objective: * To compare seroprotection rates against tetanus and diphtheria induced by Adacel in persons 10 to \<11 years of age to those induced by Adacel in persons 11 to \<12 years of age.
Study participants will receive a single dose of study vaccine and will then be monitored for safety from the day of vaccination for up to 30 days post-vaccination.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,302
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Unnamed facility
Chandler, Arizona, United States
Unnamed facility
Jonesboro, Arkansas, United States
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Sacramento, California, United States
Unnamed facility
Longmont, Colorado, United States
Unnamed facility
Norwich, Connecticut, United States
Unnamed facility
Miami Beach, Florida, United States
Unnamed facility
Marietta, Georgia, United States
Unnamed facility
Woodstock, Georgia, United States
Unnamed facility
Bardstown, Kentucky, United States
...and 24 more locations
Summary of Geometric Mean Titers of Anti-Pertussis Titers Following a Single Dose of Adacel® Vaccine
Anti-Pertussis titers (Pertussis toxoid \[PT\], Filamentous hemagglutinin \[FHA\], Pertactin \[PRN\], Fimbriae types 2 and 3 \[FIM\]) geometric mean titers were assessed by enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 30 post-vaccination
Summary of Anti-Pertussis Booster Response Following a Booster Dose of Adacel® Vaccine
Anti-Pertussis booster responses were assessed by enzyme linked immunosorbent assay (ELISA). For pertussis antigens (Pertussis toxoid \[PT\], filamentous hemagglutinin \[FHA\], pertactin \[PRN\], fimbriae types 2 and 3 \[FIM\]), a booster response rate was defined as a four-fold increase in pre- to post-vaccination titers for participants with pre vaccination titers ≤ 93 ELISA Unit (EU)/mL for PT, ≤ 170 EU/mL for FHA, ≤ 115 EU mL for PRN, and ≤ 285 EU/mL for FIM. If the pre-vaccination titers were \> 93 EU/mL for PT, \> 170 EU/mL for FHA, \> 115 EU mL for PRN, or \> 285 EU/mL for FIM then a two-fold increase in the antibody titer was defined as a booster response.
Time frame: 30 days post-vaccination
Summary of Anti-Tetanus and Anti-Diphtheria Booster Response Following a Booster Dose of Adacel® Vaccine
Anti-tetanus booster responses were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-diphtheria booster responses were assessed by a toxin neutralization test. Booster response rate was defined as a four-fold increase in pre- to post-vaccination for subjects with pre-vaccination titers ≤ 2.56 EU/mL for diphtheria and ≤ 2.7 EU/mL for tetanus. If the pre-vaccination titers were \> 2.56 EU/mL for diphtheria or \> 2.7 EU/mL for tetanus, then a two-fold increase in response rate was defined as a booster response.
Time frame: 30 days post-vaccination
Percentage of Participants With Seroprotection to Tetanus and Diphtheria Following a Single Dose of Adacel Vaccine
Anti-tetanus seroprotection rates were assessed by enzyme-linked immunosorbent assay (ELISA). Anti-diphtheria seroprotection was assessed by a toxin neutralization test. Seroprotection was defined as post-vaccination antibody titers ≥0.1 IU/mL.
Time frame: Day 0 (pre-vaccination) and 30 days post-vaccination
Summary of Anti-Pertussis Geometric Means of Titers Before and Post-Vaccination With a Single Dose of Adacel Vaccine
Anti-Pertussis titers (Pertussis toxoid \[PT\], Filamentous hemagglutinin \[FHA\], Pertactin \[PRN\], Fimbriae types 2 and 3 \[FIM\]) geometric mean titers were assessed by enzyme linked immunosorbent assay (ELISA).
Time frame: Day 0 (pre-vaccination) and Day 30 post-vaccination
Percentage of Participants Reporting a Solicited Injection-site or Systemic Reactions Following Injection With a Single Dose of Adacel Vaccine
Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Headache, Malaise, and Myalgia. Grade 3 Solicited Injection-site reactions: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥50 mm. Grade 3 Solicited systemic reactions: Fever, ≥39.0˚C or ≥102.1˚F; Headache, Malaise, and Myalgia Significant, prevents daily activity.
Time frame: Day 0 up to Day 7 post-vaccination
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