NCT02580201已完成4 期
A Phase 4 Study to Evaluate the Safety and Immunogenicity of Trivalent Oral Polio Vaccine in Healthy Polio Vaccinated Children 1 to 5 Years of Age and in Healthy Unvaccinated Infants at 6 Weeks of Age in the Dominican Republic
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 154
- 主要终点
- SAEs and AEs G3
研究概览
简要总结
The purpose of this study is to assess the safety (serious adverse events [SAEs]), and severe adverse events [AEs] (grade 3 according to CTCAE 4.03) after one dose of SABIN tOPV in 1-5 year-old children and three doses of SABIN tOPV in 6 week-old infants, and immunogenicity (seroprotection rates for all 3 serotypes) 28 days after three doses of SABIN tOPV in vaccine-naïve infants.
详细描述
This will be a single center, open study in children (aged 1 to 5 years) and vaccine-naïve infants, as follows: 50 OPV-vaccinated children aged 1 to 5 years to receive 1 dose of tOPV (Group 1); 104 vaccine-naïve infants to receive 3 doses of tOPV administered 28 days apart (Group 2)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Weeks 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group 1- Children aged 1-5 years, previously vaccinated with ≥ 3 doses of OPV. Group 2- Infants aged 6 weeks (-7 to +14 days) with no previous polio vaccinations.
- •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 guardians as per Dominican Republic regulations.
排除标准
- •Previous Vaccinations:
- •Group 1: Previous vaccination against poliovirus outside of the national immunization schedule and any vaccine in the previous 4 weeks.
- •Group 2: Any vaccination against poliovirus
- •Group 2: Infants with birth weight (BW) < 2,500 gm.
- •Any confirmed or suspected immunosuppressive or known 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 or to any antibiotics.
- •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, or is scheduled to receive OPV during the study period.
- •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
SAEs and AEs G3
时间窗: 6 months
Number of subjects experiencing SAEs and severe AEs grade 3 considered consistent with a causal association to study vaccine 28 days after three doses of SABIN tOPV in vaccine-naïve infants in Dominican Republic.
Seroprotection Rate
时间窗: 3 months
Seroprotection rate of type-specific polio neutralizing antibodies at Day 84, 28 days after the third dose of SABIN tOPV in infants (Group 2).
次要结局
- Neutralizing Antibodies 1(3 months)
- Seroconversion Rate(3 months)
- Neutralizing Antibodies 2(3 months)
- Seroprotection Rates(4 weeks)
研究者
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