This pivotal safety trial aims to extend the safety database for BioNet recombinant acellular pertussis (aP) vaccine (Pertagen®) in a larger population of adults and evaluate the incidence and characteristics of adverse drug reactions (ADRs), including uncommon events, to provide robust safety data. The study focuses on identifying and describing all ADRs following vaccination with BioNet recombinant acellular pertussis (aP) vaccine, ensuring the vaccine's safety is well-characterized in a large population. This study will also describe the lot-to-lot consistency between three lots of BioNet recombinant acellular pertussis (aP) vaccine across safety outcomes.
This is a pivotal, multi-site, observer-blind, randomized, active-controlled vaccine trial in which 2400 healthy adults aged 18 to 75 years will be recruited at approximately 7:1 ratio from three sites in Bangkok, Thailand. As the aim of this trial is to extend the safety database for recombinant acellular pertussis (aP) vaccine in a larger population of adults, the active-controlled arm is added mainly to reduce selection and measurement bias through randomization and blinding methods.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
2,399
Recombinant acellular pertussis (aP) vaccine (containing 5 µg of geneticallydetoxified pertussis toxin (PTgen),
Chula Clinical Research Center (Chula CRC)
Bangkok, Bangkok, Thailand
Queen Saovabha Memorial Institute, Thai Red Cross Society
Bangkok, Bangkok, Thailand
Thai Red Cross AIDS and Infectious Diseases Research Centre
Bangkok, Bangkok, Thailand
Incidence and percentages of participants reporting any adverse drug reactions (ADRs)
Incidence and percentages of participants reporting any adverse drug reactions (ADRs) within 28 days following a single booster dose of recombinant acellular pertussis (aP) vaccine.
Time frame: 28 days after vaccination
Incidence, severity, and percentages of participants reporting adverse events (AEs)
Incidence, severity, and percentages of participants reporting adverse events (AEs) during 28 days following vaccination
Time frame: 28 days following vaccination
Incidence, severity, and percentages of participants reporting serious adverse events (SAEs)
Incidence, severity, and percentages of participants reporting serious adverse events (SAEs) during the study period.
Time frame: 28 days after vaccination
Duration of AEs, ADRs, and SAEs
Duration of AEs, ADRs, and SAEs, categorized by severity and MedDRA System Organ Class.
Time frame: 28 days after vaccination
Categorization of ADRs by System Organ Class and Preferred Term
Categorization of ADRs by System Organ Class and Preferred Term, based on MedDRA coding.
Time frame: 28 days after vaccination
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