This is a descriptive study to evaluate the safety and immunogenicity of ADACEL® and BOOSTRIX® vaccines among US adolescents.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
647
0.5 mL, IM
0.5 mL, IM
Unnamed facility
Annapolis, Maryland, United States
Unnamed facility
Baltimore, Maryland, United States
Unnamed facility
Frederick, Maryland, United States
Unnamed facility
Durham, North Carolina, United States
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Within 7 Days Following Vaccination With Adacel® or Boostrix®
Solicited injection site reactions: Pain, Erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. Grade 3 reaction definitions: Pain = Incapacitating, unable to perform usual activities; Erythema and swelling = ≥ 5 cm; Fever = temperature ≥ 39.1°C or ≥ 102.3°F; Headache, Malaise, and Myalgia = Prevents daily activities.
Time frame: Day 0 to 7 post-vaccination
Percentage of Participants With Tetanus Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.
Time frame: Day 0 and 28 days post-vaccination
Percentage of Participants With Diphtheria Antitoxin Concentrations ≥ 0.1 IU/mL Pre- and Post-Vaccination With Adacel® or Boostrix®.
Time frame: Day 0 and 28 days post-vaccination
Geometric Mean Concentration of Antibody to Pertussis Antigens Pre- and Post-Vaccination With Adacel® or Boostrix®.
Time frame: Day 0 and 28 days post-vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Durham, North Carolina, United States
Unnamed facility
Franklin, Tennessee, United States
Unnamed facility
Bellevue, Washington, United States
Unnamed facility
Mercer Island, Washington, United States
Unnamed facility
Sammamish, Washington, United States
Unnamed facility
Seattle, Washington, United States