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

CompletedOBSERVATIONAL
Enrollment

181

Participants

Timeline

Start Date

June 26, 2018

Primary Completion Date

July 31, 2018

Study Completion Date

August 27, 2018

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 will be presented in a single-dose prefilled syringe. Each subject will be received one intramuscular injection in the non-dominant deltoid region."

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 will be presented in a single-dose prefilled syringe. Each subject will be received one intramuscular injection in the non-dominant deltoid region."

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 will be presented in a single-dose prefilled syringe. Each subject will be received one intramuscular injection in the non-dominant deltoid region."

Trial Locations (1)

10400

Vaccine Trial Centre, Faculty of Tropical Medicine, Mhahidol University, 420/6 Ratchawithi Road, Ratchathewi,, Bangkok

All Listed Sponsors
lead

Mahidol University

OTHER

NCT04102137 - 3-year Follow-up After a Single Dose Acellular Pertussis Vaccination | Biotech Hunter | Biotech Hunter