A Open-label Phase I Study to Evaluate Safety of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Adults, Children, and Infants, and a Blinded, Randomized and Controlled Phase II to Evaluate Safety and Immunogenicity of it in Infants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 708
- 试验地点
- 1
- 主要终点
- The geometric mean fold increase (GMI) of each group after three-dose regimen
研究概览
简要总结
The purpose of this study is to evaluate the safety of sIPVs of different dosages in adults, children and infants in a phase I open-label study, and then assess its immunogenicity and safety in healthy infants between 60 and 90 days old in a phase II blind, randomized, and controlled study.
详细描述
This study is a combination of phases I and II. Phase I study is open-label, and only collect safety information of the investigational sIPVs in adults, children and infants. Phase II study is double-blind, randomized, controlled study of the immunogenicity and safety of the investigational vaccines and two other commercialized inactivated poliovirus vaccines in healthy infants.
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
- Single (Participant)
入排标准
- 年龄范围
- 2 Months 至 49 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer between 60-90 days old, 6-12 years old, or 18-49 years old;
- •Healthy volunteers who fulfill all the required conditions for receiving the investigational vaccine as established by medical history and clinical examination and determined by investigators;
- •Proven legal identity;
- •Participants (≥ 18 years old), or guardians of the participants (< 18 years old) should be capable of understanding the written consent form, and such form should be signed prior to enrolment;
- •Complying with the requirement of the study protocol;
- •Axillary temperature ≤ 37.0 °C;
排除标准
- •Breast feeding, pregnant, or expected to conceive in the next 60 days;
- •History of allergy to any vaccine, or any ingredient of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;
- •Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
- •Autoimmune disease or immunodeficiency/immunosuppressive;
- •serious chronic diseases, serious cardiovascular disease, hypertension or diabetes that cannot be stabilized by medication, liver or kidney disease, malignancy, etc;
- •severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;
- •History of thyroidectomy, asplenia, functional asplenia, or any condition resulting in the absence or removal the spleen;
- •Bleeding disorder diagnosed by a doctor (e.g., coagulation factor deficiency, coagulation disorder, or platelet disorder) , or significant bruising or coagulopathy;
- •Long term history of alcoholism or drug abuse;
- •Receipt of any of the following products:
- •Any subunit or inactivated vaccine within the past 7 day;
- •Any live attenuated vaccine within the past 14 days;
- •Any other investigational medicine(s) within the past 30 days;
- •Any blood product within the past 3 months;
- •Any immunosuppressant, cytotoxic medications, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within the past 6 month prior to study entry;
- •Acute illness or acute exacerbation of chronic disease within the past 7 days;
- •Axillary temperature > 37.0 °C;
- •Infant participants with prior vaccination of poliovirus;
- •Any other factor that, in the judgment of the investigator, suggesting the volunteer is unsuitable for this study;
结局指标
主要结局
The geometric mean fold increase (GMI) of each group after three-dose regimen
时间窗: 90 days
The GMI is the increase of post-immune GMT from pre-immune GMT.
The seroconversion rates (SCRs) of each group of the phase II trial after three-dose regimen
时间窗: 90 days
Subjects whose pre-immune antibody level \< 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted.
The post-immune geometric mean titer (GMT) of each group of the phase II trial after three-dose regimen
时间窗: 90 days
GMT of each group of the phase II trial 30 days after three-dose regimen which lasts 60 days.
次要结局
- The incidences of solicited adverse events (AEs) of each group in both phase I and II trials(7 days)
- The incidences of serious adverse events (SAEs) of each group in both phase I and II trials(30 days)
- The incidences of unsolicited adverse events (AEs) of each group in both phase I and II trials(30 days)