Phase II, Observer-blind, Randomized Study on the Safety, Reactogenicity, Immunogenicity and Impact on Intestinal Shedding of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) or a Single Dose of Standard Trivalent Inactivated Poliovirus Vaccine (t-IPV) When Given Concomitantly With the Third Dose of Bivalent Oral Poliovirus Vaccine (b-OPV) to Infants Early in Life
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
Phase II, observer-blind, randomized study on the safety, reactogenicity, immunogenicity and impact on intestinal shedding of a single dose of monovalent high-dose inactivated poliovirus type 2 vaccine (m-IPV2 HD) or a single dose of standard trivalent inactivated poliovirus vaccine (t-IPV) when given concomitantly with the third dose of bivalent oral poliovirus vaccine (b-OPV) to infants early in life
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Weeks 至 6 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 6 weeks (-7 to +14 days).
- •Healthy without obvious medical conditions that preclude the subject to be in the study as established by the medical history and physical examination.
- •Written informed consent obtained from 1 or 2 parents or legal guardian as per Panama regulations.
排除标准
- •Previous vaccination against poliovirus.
- •Low birth weight (BW <2,500 gm).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus (HIV) infection.
- •Family history of congenital or hereditary immunodeficiency.
- •Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
- •Known allergy to any component of the study vaccines.
- •Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Acute severe febrile illness at day of vaccination deemed by the Investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all in/exclusion criteria are met.).
- •Member of the subject's household (living in the same house or apartment unit) has received OPV in the last 3 months.
- •Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.
结局指标
主要结局
Efficacy
时间窗: 4 weeks
To determine whether 1 dose of a m-IPV2 HD vaccine given to infants is superior to 1 dose of t-IPV given at study week 8 (\~14 weeks of age) in inducing a humoral immune response to type 2 poliovirus when measured as seroconversion to type 2 poliovirus (type-specific titers ≥1:8 and \>4-fold over expected levels of maternally-derived antibody) and as median titers four weeks later at study week 12 (\~ 18 weeks of age).
Safety
时间窗: 6 weeks
To assess and compare descriptively the safety of a single dose of a m-IPV2 HD vaccine in healthy infants to that of a licensed t-IPV vaccine when given concomitantly with the third dose of b-OPV measured by the incidence of serious adverse events (SAEs) and important medical events (IMEs) from the day of vaccine administration until day of last visit at study week 15 (\~ week 21 of life).
次要结局
未报告次要终点