Study Evaluating the Safety of a Recombinant Acellular Pertussis Vaccine in Adults (NCT06798831) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study Evaluating the Safety of a Recombinant Acellular Pertussis Vaccine in Adults
Thailand2,399 participantsStarted 2025-02-08
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Aged 18 to 75 years (less than 76 years full of age) on the day of inclusion;
✓. Can provide written informed consent;
✓. Healthy, as established by pertinent medical history and physical examination;
✓. Capable of complying with the study protocol and procedures;
✓. For women with childbearing potential (i.e., urine pregnancy test will not be performed in females who have undergone sterilization, hysterectomy or who are post-menopausal.), must have a negative urine pregnancy test at enrollment.
Exclusion criteria
✕. History of significant medical illness such as but not limited to immune deficiency, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic, renal, splenic or thymic functional abnormality as determined by the investigator based on medical history and physical examination. For those cases that are clinically stable, the investigator may include them as deemed per medical judgement.
✕. Breastfeeding women or female participants who intend to become pregnant during the study period;
What they're measuring
1
Incidence and percentages of participants reporting any adverse drug reactions (ADRs)