The aim of the study is to assess the immunogenicity and safety profile of ADACEL compared to local adsorbed diphtheria and tetanus combined vaccine (local DT or local Td vaccine in participants in China. Primary objective: * To describe diphtheria and tetanus seroprotection rates and pertussis booster response rates induced by each of the study vaccines: ADACEL vaccine (in all study age groups), local DT vaccine (in children), and local Td vaccine (in adolescents and adults). Secondary Objectives: * To further describe in each group the immunogenicity of the study vaccines at baseline and 1 month after vaccination. * To describe the safety of the study vaccines
Study participants will receive a single booster dose of ADACEL (Tdap vaccine) or a single booster dose of local DT or local Td vaccine, depending on the age subgroup. Immunogenicity will be assessed before and 28 days post-vaccination; safety profile will be assessed in all subjects up to Day 35 post vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,440
0.5 mL, Intramuscular
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Unnamed facility
Yandu, China
Percentage of participants with anti-diphtheria antibody concentrations ≥ 0.1 international unit (IU)/mL
Anti-diphtheria antibody concentrations will be determined by enzyme-linked immunosorbent assay (ELISA)
Time frame: 28 Days post-vaccination
Percentage of participants with anti-tetanus antibody concentrations ≥ 0.1 IU/mL
Anti-tetanus antibody concentrations will be determined by enzyme-linked immunosorbent assay (ELISA)
Time frame: 28 Days post-vaccination
Percentage of participants with a booster response for antibodies to Pertussis Toxoid (PT), Filamentous hemagglutinin (FHA), pertactin (PRN), Fimbriae types 2 and 3 (FIM) following vaccination with ADACEL or Local DT or Local Td Vaccine
Booster response for antibodies to Pertussis Toxoid (PT), Filamentous hemagglutinin (FHA), pertactin (PRN), Fimbriae types 2 and 3 (FIM) will be determined by enzyme-linked immunosorbent assay (ELISA)
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of participants with anti diphtheria antibody concentrations ≥ 0.1 international unit (IU)/mL at baseline
Anti-diphtheria antibody concentrations will be determined by enzyme-linked immunosorbent assay (ELISA)
Time frame: Day 0 (pre-vaccination)
Percentage of participants with anti-tetanus antibody concentrations ≥ 0.1 IU/mL at baseline
Anti-tetanus antibody concentrations will be determined by enzyme-linked immunosorbent assay (ELISA)
Time frame: Day 0 (pre-vaccination)
Percentage of participants with anti-diphtheria antibody concentrations ≥ 1.0 international unit (IU)/mL at baseline and post booster vaccination
Anti-diphtheria antibody concentrations will be determined by enzyme-linked immunosorbent assay (ELISA)
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of participants with anti-tetanus antibody concentrations ≥ 1.0 IU/mL at baseline and post booster vaccination
Anti-tetanus antibody concentrations will be determined by enzyme-linked immunosorbent assay (ELISA)
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Geometric mean of individual antibody concentrations at baseline and post-booster vaccination
Antibody concentrations to all vaccine antigens will be determined by enzyme-linked immunosorbent assay (ELISA)
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Number of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited adverse reactions, and serious adverse events occurring during the trial
Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia
Time frame: Day 0 up to Day 28 post-vaccination
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