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
- 进行中（未招募）
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Number of Participants with Solicited Administration Site Adverse Events (AEs)
研究概览
简要总结
This study will evaluate the safety and immune response of a new formulation of pneumococcal vaccine, PnMAPS30plus, in healthy adults aged 50 to 64 years. Participants will receive a single dose of either the investigational vaccine or an approved pneumococcal vaccine (PCV20) and will be monitored for approximately six months. The study aims to determine if PnMAPS30plus is safe and well-tolerated and whether it helps the body produce antibodies that protect against pneumococcal disease.
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 comply with the requirements (e.g., completion of the electronic diary [eDiary], return for follow-up visits).
- •Written or witnessed/thumb printed informed consent obtained before any trial-specific procedure.
- •Healthy or medically stable adults confirmed by medical history and clinical examination at screening. Participants with stable medical conditions can be enrolled at the discretion of the investigator.
- •Male and female participants aged 50 and 64 years of age (YOA) at the time of Informed consent form (ICF) signature.
- •Female participants of childbearing potential (POCBP) may enrol 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 3 years before study intervention administration.
- •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 HIV-positive status.
- •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 the participant's ability to participate in the trial.
- •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 within 30 days before the study intervention administration.
- •History of previous vaccination with any pneumococcal vaccine.
- •Administration of immunoglobulins or other blood products or plasma derivatives within 90 days before or planned within 30 days after study intervention.
- •Chronic administrations 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 and/or current chronic alcohol consumption and/or drug abuse, based on investigator judgment.
研究组 & 干预措施
Group 1: Pn- MAPS30plus
Participants receive a single dose of Pn-MAPS30plus vaccine at Day 1.
干预措施: Pn-MAPS30plus (Biological)
Group 2: PCV20
Participants receive a single dose of PCV20 (20-valent pneumococcal conjugate vaccine) at Day 1.
干预措施: PCV20 (Combination Product)
结局指标
主要结局
Number of Participants with Solicited Administration Site Adverse Events (AEs)
时间窗: Day 1 to Day 7
The solicited administration site AEs considered are pain, redness and swelling.
Number of Participants with Solicited Systemic AEs
时间窗: Day 1 to Day 7
The solicited systemic AEs considered are fever, headache, fatigue (tiredness), myalgia (muscle pain), and arthralgia (joint pain).
Number of Participants with Unsolicited AEs
时间窗: Day 1 to Day 30
An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Number of Participants with Serious Adverse Events (SAEs)
时间窗: From Day 1 to Day 181 (study end)
SAE is an AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or other situations that are considered serious per medical or scientific judgment.
Number of Participants with Adverse Events of Special Interest (AESIs)
时间窗: From Day 1 to Day 181 (study end)
Number of Participants with AEs Leading to withdrawal from the study
时间窗: From Day 1 to Day 181 (study end)
Number of Participants with any Laboratory abnormalities
时间窗: Day 8 compared to Screening Visit (up to Day -14)
次要结局
未报告次要终点