A Randomized, Observer-blind, Active-controlled Study to Describe the Safety of Recombinant Acellular Pertussis (aP) Vaccine When Administered to Healthy Adults Aged of 18-75 Years Old
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,399
- 试验地点
- 3
- 主要终点
- Incidence and percentages of participants reporting any adverse drug reactions (ADRs)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •An adult participant will be eligible for inclusion if ALL of the following criteria are met at the time of screening:
- •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.
排除标准
- •A participant with ANY of the following criteria at study entry will not be eligible for participation:
- •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;
- •History of a severe allergic reaction to any vaccine (including its components);
- •History of serious adverse event or neurological adverse event to any vaccination;
- •Receipt of any investigational product or licensed vaccine within 30 days prior to enrollment (3 months for live-attenuated vaccines);
- •Plan to receive tetanus, diphtheria or pertussis vaccine or plan to participate in other clinical trial during the study period;
- •Having experienced physician-diagnosed pertussis within 5 year prior to enrollment;
- •Receipt of diphtheria or tetanus or pertussis vaccine within 5 years prior to enrollment;
- •Having any progressive or severe neurologic disorder, seizure disorder or recent history of Guillain-Barré syndrome;
- •Medically significant cancer (except for benign or localized skin cancer, cancer in remission for ≥10 years);
- •A known bleeding diathesis or any condition that may be associated with a prolonged bleeding time resulting in a problem with intramuscular injection;
- •Suspected or known alcoholism and/or illicit drug abuse within the past 5 years;
- •Administration of immunoglobulins and/or any blood products within 3 months preceding study entry or planned administration during the study period;
- •History of receiving immunosuppressive drugs or systemic corticosteroid (>0.5 mg/kg of prednisolone or equivalent for more than 14 days) within 3 months prior to study entry;
- •Has any active clinically significant finding or life-threatening disease that, in the opinion of the investigator, would increase the risk of the individual's having an adverse outcome by participating in this study.
研究组 & 干预措施
Boostrix
Licensed tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine
干预措施: Pertussis containing vaccine (Biological)
Recombinant acellular pertussis (aP) vaccine
Licensed recombinant acellular pertussis (aP) vaccine (containing 5 µg of PTgen and 5 µg of FHA)
干预措施: Pertussis containing vaccine (Biological)
结局指标
主要结局
Incidence and percentages of participants reporting any adverse drug reactions (ADRs)
时间窗: 28 days after vaccination
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.
次要结局
- Incidence, severity, and percentages of participants reporting adverse events (AEs)(28 days following vaccination)
- Incidence, severity, and percentages of participants reporting serious adverse events (SAEs)(28 days after vaccination)
- Duration of AEs, ADRs, and SAEs(28 days after vaccination)
- Categorization of ADRs by System Organ Class and Preferred Term(28 days after vaccination)