A First in Human Double-blind, Randomized Study to Assess the Safety, Tolerability and Immunogenicity of a Single Dose of a Trivalent Inactivated Poliovirus Vaccine Based on Sabin Strains (sIPV) Given Intramuscularly in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of Participants With Solicited Systemic Adverse Events (AEs)
研究概览
简要总结
The main purpose of this study is to assess the safety and tolerability of a single dose of JNJ-64152348, inactivated poliovirus vaccine produced from Sabin poliovirus strains on PER.C6 cells (sIPV) in healthy adults, using conventional inactivated poliovirus vaccine produced from Salk poliovirus strains (cIPV) as reference.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Declared healthy by the investigator on the basis of physical examination, medical history, vital signs and clinical laboratory tests performed at screening. If the results of the serum chemistry panel or hematology are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
- •Heterosexual male participants must not engage in intercourse with a female partner of childbearing potential who is not using a highly effective contraceptive method
- •All female participants of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and immediately prior to study vaccine administration
- •Willing and able to adhere to the prohibitions and restrictions specified in this protocol
- •Agrees not to donate blood until the Week 4 visit
排除标准
- •Clinically significant neuro-psychiatric, cardiovascular, pulmonary, liver or renal insufficiency (estimated creatinine clearance below 60 milliliter per minute (mL/min) using the Cockcroft-Gault Equation); metabolic, gastrointestinal, urologic, or endocrine disease that is - in the opinion of the investigator - uncontrolled
- •Any history of malignancy (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
- •Previous severe allergic reaction after vaccination with polio vaccine
- •Known allergies, hypersensitivity, or intolerance to one of the excipients of JNJ-64152348, inactivated poliovirus vaccine produced from Sabin poliovirus strains on PER.C6 cells (sIPV) or conventional inactivated poliovirus vaccine produced from Salk poliovirus strains (cIPV)
- •Received any polio vaccine within 6 months before study inclusion
研究组 & 干预措施
Group 1: sIPV
Participants will receive single intramuscular injection of the trivalent inactivated poliovirus vaccine based on Sabin strains produced on PER.C6 cells (sIPV) on Day 1.
干预措施: sIPV (Biological)
Group 2: cIPV
Participants will receive single intramuscular injection of the currently used trivalent inactivated poliovirus vaccine IMOVAX POLIO, based on the conventional Salk poliovirus strains produced on Vero cells (cIPV) on Day 1.
干预措施: cIPV (Biological)
结局指标
主要结局
Number of Participants With Solicited Systemic Adverse Events (AEs)
时间窗: Up to Day 8
Participants will be requested to record any occurrences of solicited AEs on a daily basis in a diary on the day of dosing and during the 7 days thereafter (up to Day 8). Solicited systemic AEs include fatigue, headache, nausea, myalgia and fever.
Number of Participants With Solicited Local Adverse Events (AEs)
时间窗: Up to Day 8
Participants will be requested to record any occurrences of solicited AEs on a daily basis in a diary on the day of dosing and during the 7 days thereafter (up to Day 8). Solicited local AEs include erythema, swelling/induration and pain/tenderness. If erythema or swelling/induration is present, the diameters will be measured using the ruler supplied and the largest diameter recorded.
Number of Participants With Unsolicited AEs
时间窗: Up to Week 4
Unsolicited adverse events will include all adverse events for which the participant is not specifically questioned in the participant diary.
Number of Participants With Serious Adverse Events (SAEs)
时间窗: Up to Week 26
An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
次要结局
- Poliovirus Type- and Strain-specific Neutralizing Antibody (NAb) Responses(Up to Week 4)