NCT01031303已完成4 期
Immunogenicity and Safety of the Sanofi Pasteur's DTacP-IPV Combined Vaccine (TETRAXIM™) Given as a Booster Dose at 4 to 6 Years of Life in Children Previously Vaccinated With PENTAXIM™ in the Study E2I34
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- To provide information concerning the immunogenicity of TETRAXIM™ after booster vaccination.
研究概览
简要总结
The purpose of this study is to provide further immunogenicity and safety information of sanofi pasteur's DTacP-IPV combined vaccine (TETRAXIM™) as a booster dose during the 4th and 6th year of life in children that previously received in Study E2I34 (NCT 00255021), sanofi pasteur DTacP-IPV// PRP~T vaccine (PENTAXIM™) as a three-dose primary and booster vaccinations.
Primary Objective :
- To assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/vaccine response rates to acellular Pertussis antigens (Pertussis toxoid [PT], Filamentous Haemagglutinin [FHA]) of sanofi pasteur's DTacP-IPV (Tetraxim™) vaccine, one month after the booster dose given at 4 to 6 years of age.
Secondary Objectives :
- To describe the antibody persistence in terms of anti-pertussis antibody levels (anti-PT, and -FHA) and in terms of seroprotection rates and GMTs for Diphtheria, Tetanus, and Poliovirus types 1, 2 and 3, just before administration of the booster dose (at Visit 1) in all subjects at 4-6 years of age.
- To assess immunogenicity in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3) and seroconversion/ vaccine response rates to acellular Pertussis antigens (PT, FHA) of sanofi pasteur's DTacP-IPV (Tetraxim™) vaccine, one month after administration of the booster dose given at 4 to 6 years of age.
- To describe the safety after the booster dose of the study vaccine.
详细描述
All participants that previously completed the three-dose primary and the booster vaccinations in the study E2I34 (NCT 00255021) will be contacted to enroll in this study to receive sanofi pasteur's DTacP IPV combined vaccine (Tetraxim™) at 4 to 6 years of age.
Participants will receive the study vaccine [sanofi pasteur's DTacP-IPV vaccine (TETRAXIM™)] at 4 to 6 years of age (at visit 1).
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
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 4-6 years inclusive on the day of inclusion
- •Child having completed the three-dose vaccination and the booster vaccination with DTacP-IPV//PRP~T combined vaccine (PENTAXIM™) of the study E2I34
- •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
- •Participation in another clinical trial in the 4 weeks preceding the trial inclusion
- •Planned participation in another clinical trial during the present trial period
- •Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- •Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances
- •Chronic illness at a stage that could interfere with trial conduct or completion
- •Blood or blood-derived products received in the past or current or planned administration during the trial (including immunoglobulins)
- •Any vaccination in the 4 weeks preceding the trial vaccination
- •History of diphtheria, tetanus, pertussis, poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
- •Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human immunodeficiency virus (HIV) infection
- •Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases infection with the trial vaccine or another vaccine after completion of previous study E2I34
- •Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- •History of/current major neurological diseases or seizures
- •Febrile illness (temperature ≥ 38°C) or acute illness on the day of inclusion.
- •Serious or severe reaction after a previous dose of any vaccine containing pertussis antigen, such as
- •encephalopathy (with or without convulsions) in the 7days following previous administration of a pertussis containing vaccine,
- •temperature more than 39.5°C within 48 hours following vaccine injection, not due to another identifiable cause
- •inconsolable crying equal or more than 3 hours within 48 hours following vaccine injection,
- •hypotonic hyporesponsive episode within 48 hours following vaccine injection,
- •seizures with or without fever within 3 days following vaccine injection.
研究组 & 干预措施
Study Group
Experimental
干预措施: DTacP-IPV combined vaccine (TETRAXIM™) (Biological)
结局指标
主要结局
To provide information concerning the immunogenicity of TETRAXIM™ after booster vaccination.
时间窗: 30 days post-vaccination
次要结局
- To provide information concerning the safety after booster administration of TETRAXIM™.(30 days post-vaccination and entire study period)
研究者
研究点 (2)
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