NCT01389687已完成3 期
Immunogenicity and Safety of the SP059 Given Subcutaneously as a Three-dose Primary and Booster Vaccination in Infants in Japan
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- A description of the anti-Polio 1, 2 and 3 antibody titers post-vaccination
研究概览
简要总结
The aim of the study is to assess the immunogenicity and safety of SP059 as a three-dose primary and booster vaccination in Japanese infants aged 3 through 68 months.
Primary objective:
- To assess that the seroprotection rates against polio types 1, 2 and 3 are over 90% approximately one month following the three dose primary vaccination series with inactivated polio vaccine (IPV).
Secondary objective:
- To describe the immunogenicity (in terms of seroprotection / seroconversion vaccine response rates and Geometric Mean Titers) of IPV before and after the primary vaccination and before and after the booster vaccination.
- To describe the safety after each dose of IPV.
详细描述
Study participants will receive three doses of inactivated polio vaccine (IPV) (at each visit and given 3-8 weeks apart) as a three-dose primary vaccination starting at 3-68 months of age and followed by a single dose of IPV as a booster vaccination 6-18 months after completion of the three-dose primary vaccination.
Subjects will be observed by the Investigator or sub-Investigator for 30 minutes following the vaccine injection.
The duration of each participant's participation in the trial will be approximately 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 68 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 3 to 68 months inclusive (recommended 3 to 8 months) on the day of inclusion
- •Informed consent form signed by the parent(s) or other legal representative
- •Able to attend all scheduled visits and to comply with all trial procedures
排除标准
- •Fever ≥ 37.5°C (axillary temperature) on the day of inclusion
- •Any serious disease whether acute or chronic
- •History of poliomyelitis infection
- •History of a life threatening reaction to a vaccine containing the same substances of the study vaccine
- •History of anaphylaxis or allergy to any of the study vaccine components
- •Previous vaccination against the poliomyelitis diseases infection with a trial vaccine or another vaccine
- •Congenital or current/ previous acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- •Participation in another clinical trial preceding the trial inclusion
- •Planned participation in another clinical trial during the present trial period
- •Blood or blood-derived products received in the past or current or planned administration during the trial (including immunoglobulins).
- •Any vaccination with live vaccines within the past 27 days preceding the first trial vaccination.
- •Any vaccination with inactivated vaccines within the past 6 days preceding the first trial vaccination.
- •Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or human immunodeficiency virus infection
- •Subject ineligible according to the investigator's clinical judgment.
结局指标
主要结局
A description of the anti-Polio 1, 2 and 3 antibody titers post-vaccination
时间窗: 1 month post-vaccination 3
Anti-Polio 1, 2 and 3 antibody titers will be determined by the Seroneutralization assay.
次要结局
- Immunogenicity (in terms of seroprotection and Geometric Mean Titers) of inactivated polio vaccine (IPV) before and after the primary vaccination and before and after the booster vaccination.(Day 0 and 1 month post-vaccination)
- Description of the safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with IPV(Day 0 up to 12 months post-vaccination)
- Immunogenicity (in terms of anti-Polio 1, 2, and 3 titers ≥ 8 [1/dilution], individual antibodies' titers and Geometric Mean Titers) of inactivated polio vaccine (IPV) after the booster vaccination.(1 month post-booster vaccination)
研究者
研究点 (2)
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