NCT00258908已完成3 期
Immunogenicity and Safety of ADACEL™ (TdcP Vaccine) as Fifth Dose in Children 6-8 Years of Age.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination
研究概览
简要总结
To assess the immunogenicity profile of ADACEL™, Tetanus and Diphtheria Toxoids Adsorbed combined with Component Pertussis Vaccine (TdcP Vaccine) one month after administration.
To describe the safety profile of ADACEL™ (TdcP Vaccine) when given as a fifth dose.
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
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged from 6 to 8 years on the day of inclusion
- •Informed consent form (ICF) signed by parent(s)/legal representative
- •Able to attend all scheduled visits and to comply with all trial procedures
- •Written documentation of complete primary series and fourth dose of Diphtheria, Tetanus toxoids and whole cell Pertussis vaccine (DTP)
- •Parent(s)/legal representative present or fully completed pre-inclusion medical questionnaire
排除标准
- •Participation in another clinical trial in the 4 weeks preceding the trial vaccination
- •Planned participation in another clinical trial during the present trial period
- •Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or 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 with specific focus on subjects who had, after previous administration of DTP or diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine, one of the following adverse events
- •encephalopathy not attributable to another identifiable cause within 7 days of administration of a previous dose
- •temperature of > 40.5 °C within 48 hours not due to another identifiable cause
- •collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours
- •persistent, inconsolable crying lasting > 3 hours, occurring within 48 hours
- •seizure with or without fever occurring within 3 days
- •Chronic illness at a stage that could interfere with trial conduct or completion.
- •Blood or blood-derived products received in the past 3 months
- •Any vaccination in the 4 weeks preceding the trial vaccination (except Oral Poliomyelitis Vaccine [OPV])
- •Any vaccination planned during the present trial period (except OPV)
- •History of diphtheria and/or tetanus and/or pertussis infection (confirmed either clinically, serologically or microbiologically)
- •Previous fifth vaccination against diphtheria and/or tetanus and/or pertussis infection with the trial vaccine or another vaccine
- •Clinical or serological evidence of systemic illness including Hepatitis B, C or Human Immunodeficiency Virus (HIV)
- •Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- •History of/current seizures
- •Febrile illness (axillary temperature ≥ 37.4 °C) or acute illness on the day of inclusion
结局指标
主要结局
Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination
时间窗: Day 0 and Day 28 Post-vaccination
Immunogenicity profile of ADACEL™ (TdcP vaccine) antibody (anti-diphtheria, anti-tetanus, and anti-pertussis) responses at Day 0 and Day 28 Post-vaccination.
Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination
时间窗: Day 0 and Day 28 post-vaccination
GMTs and 95% confidence intervals of anti-diphtheria, anti-tetanus, and anti-pertussis toxoids responses at Day 0 and Day 28 Post-vaccination.
次要结局
- Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination(Within 8 days of vaccination)
研究者
研究点 (1)
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