A Phase 1, Observer-Blind, Randomized, Active Controlled Trial to Evaluate the Safety and Immunogenicity of An Investigational Pneumococcal Vaccine in Adults 50 To 64 Years of Age
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 5
- 主要终点
- Number of Participants with Each Solicited Administration Site (Local) Event
研究概览
简要总结
This clinical study is designed to evaluate an investigational pneumococcal vaccine named Pn-MAPS30plus. The vaccine is designed to stimulate the immune system to produce antibodies against various serotypes of the S. pneumoniae bacteria, potentially aiding the body in fighting infection upon exposure. Pn-MAPS30plus aims to broaden protection by covering more serotypes than currently licensed pneumococcal vaccines. The study's purpose is to determine whether the vaccine is safe, well-tolerated, and effective in inducing immune responses against S. pneumoniae.
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)
盲法说明
This trial will be conducted in an observer-blind manner.
入排标准
- 年龄范围
- 50 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any trial-specific procedure.
- •Healthy male and female participants between and including 50 through 64 YOA at the time of Informed consent form (ICF) signature.
- •Female participants of childbearing potential may be enrolled if they practice adequate contraception and have a negative pregnancy test prior to study intervention administration.
排除标准
- •History of microbiologically proven Invasive Pneumococcal Disease (IPD) caused by S. pneumoniae within the past 3 years.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition.
- •Hypersensitivity to latex.
- •Clinical conditions representing a contraindication to intramuscular vaccination, and blood collection.
- •Documented history of Human immunodeficiency virus (HIV)-positive participant.
- •Acute or unstable chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, or metabolic conditions as determined by the investigator.
- •Recurrent history of uncontrolled neurological or any neuroinflammatory disorders.
- •Any behavioural or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with trial participation.
- •History of potential immune-mediated disorders (pIMDs).
- •Any other clinical condition that, might pose additional risk to the participant.
- •Use of any investigational or non-registered product other than the study interventions during the period beginning 30 days before the study intervention administration.
- •History of previous vaccination with any pneumococcal vaccine.
- •Receipt of blood or plasma products or immunoglobulins, from 90 days before study intervention administration, or planned receipt within 30 days of study intervention administration.
- •Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the trial.
- •Pregnant or lactating female participant.
- •History of chronic alcohol consumption and/or drug abuse, based on investigator judgment.
研究组 & 干预措施
PCV20 Group
Participants receive a single dose of PCV20 on Day 1.
干预措施: PCV20 (Combination Product)
Pn-MAPS30plus Group
Participants receive a single dose of Pn-MAPS30plus on Day 1.
干预措施: Pn-MAPS30plus (Biological)
结局指标
主要结局
Number of Participants with Each Solicited Administration Site (Local) Event
时间窗: Day 1 (post-vaccination) to Day 7
Number of Participants with Each Solicited Systemic Event
时间窗: Day 1 (post-vaccination) to Day 7
Number of Participants with Any Unsolicited Adverse Events (AEs)
时间窗: Day 1 (post-vaccination) to Day 30
Number of Participants with Serious AEs (SAEs), Adverse Events of Special Interest (AESIs) and AEs Leading to Withdrawal
时间窗: Day 1 up to trial end (Month 6)
Number of Participants with Hematological and Biochemical Laboratory Abnormalities
时间窗: On Day 8
次要结局
未报告次要终点