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
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.
研究组 & 干预措施
Oral Polio Vaccine
Opvero™ (oral) is a trivalent, live attenuated poliomyelitis virus vaccine containing at least 6.0 log 50% cell culture infective dose (CCID50) of LS c2ab strain of live attenuated polio virus type 1, 5.0 log CCID50 of P712, Ch, 2ab strain of live attenuated polio virus type 2, 5.8 log CCID50 Leon I2aIb strain of polio virus type 3. Excipients: human albumin, HEPES buffer solution, magnesium chloride solution (containing polysorbate 80 and phenol red), hydrochloric acid or sodium hydroxide for pH adjustment.
The vaccine is presented as a suspension for oral administration. One dose of vaccine (0.1 ml) is contained in two drops which are delivered from the dropper supplied with the multidose container.
干预措施: Oral Polio Vaccine (Biological)
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)