Immunogenicity and Safety of ADACEL POLIO (TdcP-IPV Vaccine) Administered at 6 to 8 Years of Age as a Fifth Dose in Healthy Children in Taiwan
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Number of Participants With Seroprotection to Vaccine Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.
研究概览
简要总结
The present study is designed to meet the requirements of the Taiwanese Health Authorities for registration of ADACEL POLIO in Taiwan.
Subjects will receive one dose of the study vaccine at 6 to 8 years of age. Blood samples will be taken for antibody titration. The expected total duration of follow-up for each subject will be 28 days.
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
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 6 to 8 years on the day of inclusion
- •Informed consent form signed by the parent(s) or another legally acceptable representative
- •Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures
- •Written documentation of complete primary series and fourth dose of diphtheria, tetanus, pertussis (DTP) and Polio vaccines
- •Parent(s)/legal representative present or fully completed pre-inclusion medical questionnaire.
排除标准
- •Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination
- •Planned participation in another clinical trial during the present trial period
- •Known or suspected 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
- •Known systemic hypersensitivity to any of the vaccine components (or residues carried over from manufacture, such as formaldehyde, glutaraldehyde, streptomycin, neomycin and polymyxin B ) or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances with specific focus on subjects who had, after previous administration of DTP vaccine, one of the pre-listed adverse events.
- •Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
- •Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, progressive encephalopathy
- •Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
- •Receipt of any vaccine in the 4 weeks preceding the trial vaccination
- •Planned receipt of any vaccine in the 4 weeks following the trial vaccination
- •Known Human Immunodeficiency Virus (HIV), Hepatitis B surface (HBs) antigen, or Hepatitis C seropositivity
- •History of diphtheria and/or tetanus and/or pertussis and/or poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
- •Previous fifth vaccination against diphtheria and/or tetanus and/or pertussis and/or poliomyelitis diseases with either the trial vaccine or another vaccine
- •Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination
- •Subject at high risk for diphtheria and/or tetanus and/or pertussis and/or poliomyelitis infection during the trial
- •Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw
- •Febrile illness (temperature ≥ 37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment
结局指标
主要结局
Number of Participants With Seroprotection to Vaccine Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.
时间窗: Day 28 post-vaccination
Diphtheria concentrations determined by diphtheria toxin neutralization assay (Dip SN); Tetanus concentrations determined by enzyme-linked immunosorbent assay (ELISA). Seroprotection titer levels were defined as: Anti-diphtheria antibody titers ≥0.1 international unit (IU) per milliliter (mL); Anti-tetanus antibody titers ≥0.01 IU/mL and ≥0.1 IU/mL; Anti-Polio (≥ 8 1/dilution).
Number of Participants With Booster Response to Vaccine Pertussis Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.
时间窗: Day 28 post-vaccination
The anti-Pertussis concentration were determined by ELISA. The criteria for demonstrating booster response are: (i) Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) for each anti-pertussis antibody (PT, FHA, FIM, and PRN) but a post-vaccination levels ≥ 4 x LLOQ; or (ii) Pre-vaccination antibody concentrations ≥ LLOQ but \< 4 x LLOQ with a 4-fold rise rate; or (iii) Pre-vaccination antibody concentrations ≥ 4 x LLOQ but with a 2-fold rise rate.
Geometric Mean Titers (GMTs) of Antibodies to ADACEL Polio Vaccine Antigens Following Vaccination
时间窗: Day 28 post-vaccination
Diphtheria antibody concentrations determined by diphtheria toxin neutralization assay; Tetanus antibody concentrations determined by enzyme-linked immunosorbent assay (ELISA).
Geometric Mean Titers of Antibodies to Pertussis Antigens Following Vaccination With ADACEL Polio
时间窗: Day 0 (pre-vaccination) and Day 28 post-vaccination
Pre- and post-vaccination GMTs for the Pertussis toxoid (PT), Pertussis filamentous hemagglutinin (FHA), Pertussis pertactin (PRN), and Pertussis Fimbriae types 2 and 3 (FIM), all determined by enzyme-linked immunosorbent assay (ELISA).
次要结局
- Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine(Day 0 up to Day 7 post-vaccination)