2-year Follow-up After a Single Dose Acellular Pertussis Vaccination

CompletedOBSERVATIONAL
Enrollment

180

Participants

Timeline

Start Date

June 20, 2017

Primary Completion Date

July 4, 2017

Study Completion Date

July 31, 2017

Conditions
Pertussis
Interventions
BIOLOGICAL

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."

BIOLOGICAL

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."

BIOLOGICAL

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"

Trial Locations (2)

10400

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

All Listed Sponsors
lead

Mahidol University

OTHER

NCT04113655 - 2-year Follow-up After a Single Dose Acellular Pertussis Vaccination | Biotech Hunter | Biotech Hunter