A Phase 1, Double-blinded, Randomised, Active Controlled, Clinical Trial to Assess the Reactogenicity, Safety and Immunogenicity of a Recombinant Poliomyelitis Vaccine (rPV) in Comparison With IPOL Vaccine in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The incidence, severity and relationship of solicited adverse events (AEs) during 7-day and unsolicited AEs during 30-day follow-up period after rPV and IPOL vaccination
研究概览
简要总结
The primary purpose of this study is to test a new experimental recombinant Poliomyelitis vaccine (rPV) in comparison to the commercially available inactivated poliovirus vaccine. The design of the study is double-blinded, randomised and active controlled. The active controlled product is considered the commercially available vaccine (IPOL).
详细描述
This study is a double-blinded, randomised, active controlled, Phase 1 clinical study, to determine the safety, tolerability, and reactogenicity of Serum Institute of India Pvt Ltd (SIIPL) rPV vaccine in comparison to the commercially available inactivated poliovirus vaccine (IPOL®, Sanofi) in up to 36 healthy adults aged between 18 and 60 years. This study will be conducted at a single study site in Australia.
Participants will be randomised in a 2:1 ratio, to receive either investigational vaccine (rPV) or comparator vaccine (IPOL), respectively. The study vaccine will be administered as a single intramuscular (IM) injection into the deltoid muscle of the non-dominant upper arm. The participants will be followed for 30 days post vaccination.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
immunogenicity laboratory
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers aged between 18 to 60 years inclusive.
- •Good physical and mental health based on medical history, physical examination, clinical laboratory,electrocardiogram (ECG), and vital signs, as judged by the Investigator.
- •Participants must refrain from strenuous exercise within 96 hours (4 days) prior to Screening, Day 1, Day 8,and Day 30..
- •Willing and able to comply with restrictions of nicotine (i.e., tobacco and nicotine products) usethroughout the study is not permitted from within 48 hours (2 days) prior to Screening, from Day 1 until Day8, and within 48 hours (2 days) prior to the end of study visit.
- •Participants must agree to use highly effective contraception from Day 1 until 90 days after the last studyvisit.
排除标准
- •History of Polio
- •Any vaccination received 30 days before Screening and Day 30
- •Pregnant or lactating females
- •BMI >35.0kg/m2
- •History of alcohol abuse or drug addiction
- •Have received any polio vaccines within 6 months prior to screening.
- •History of major surgeries
- •History of receipt of a blood transfusion, other blood products, or immunoglobulins in 3 months prior tostudy vaccination
- •any confirmed or suspected congenital or acquired immunosuppressive or immunodeficient condition.
研究组 & 干预措施
Recombinant Poliomyelitis Vaccine (rPV)
干预措施: Recombinant Poliomyelitis Vaccine (rPV) (Biological)
Inactivated Poliomyelitis Vaccine (IPOL)
干预措施: Inactivated Poliomyelitis Vaccine (IPOL) (Biological)
结局指标
主要结局
The incidence, severity and relationship of solicited adverse events (AEs) during 7-day and unsolicited AEs during 30-day follow-up period after rPV and IPOL vaccination
时间窗: 30 days
次要结局
- Percentage of participants achieving seroprotection/seroconversion for poliovirus Types 1, 2 and 3, on Day 30.(30 days)