180
Participants
Start Date
June 20, 2017
Primary Completion Date
July 4, 2017
Study Completion Date
July 31, 2017
Pertagen (aP BioNet)
"Pertagen (aP BioNet) was produced with a recombinant B pertussis strain that was genetically inactivated by the introduction of mutations (Arg9Lys and Glu129Gly) in the ptx operon of the S1 gene. Each 0.5 mL dose of Pertagen (aP BioNet) contained 5 µg PTgen, 5 µg FHA, and 0.3 mg as aluminium cation.~The study vaccine was presented in a single-dose prefilled syringe. Each subject was received one intramuscular injection in the non-dominant deltoid region in parent protocol TDA202."
Boostagen (TdaP BioNet)
"Boostagen (TdaP BioNet) was produced with a recombinant B pertussis strain that was genetically inactivated by the introduction of mutations (Arg9Lys and Glu129Gly) in the ptx operon of the S1 gene. Each 0.5 mL dose of Boostagen (TdaP BioNet) contained 5 µg PTgen, 5 µg FHA, and 0.3 mg as aluminium cation. TDaP dose additional contained at least 7.5 Lf tetanus toxoid and at least 2.0 Lf diphtheria toxoid.~The study vaccine was presented in a single-dose prefilled syringe. Each subject was received one intramuscular injection in the non-dominant deltoid region in parent protocol TDA202."
Adacel
"Comparator vaccine, Adacel (Sanofi-Pasteur, North York, ON, Canada) was produced chemically inactivated pertussis toxin. Each 0.5 mL dose of Adacel (as comparator vaccine) contained 2.5 µg PTchem, 5 µg FHA, 3 µg pertactin, 5 µg fimbriae types 2 and 3, 5.0 Lf tetanus toxoid, 2.0 Lf diphtheria toxoid and 0.33 mg as aluminium cation.~The study vaccine was presented in a single-dose prefilled syringe. Each subject was received one intramuscular injection in the non-dominant deltoid region in parent protocol TDA202"
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, 420/6 Ratchawithi Road, Ratchathewi,, Bangkok
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University,, Bangkok
Mahidol University
OTHER