A Multinational, Multicenter, Randomized, Comparative, Open-label, Phase 3 Study to Assess the Immunogenicity and Safety of DTaP-IPV (Diphtheria-tetanus-acellular Pertussis-inactivated Poliovirus) Vaccine Administered to Healthy Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 476
- 试验地点
- 20
- 主要终点
- Vaccine response rate
研究概览
简要总结
The objective of this study is to assess the immunogenicity and safety of the DTaP-IPV combination vaccine compared with those of separate DTaP and IPV vaccines administered to healthy infants at 2, 4, and 6 months of age.
详细描述
A multinational, multicenter, randomized, comparative, open-label, phase 3 study
Primary Objective: To assess the vaccine response rates after the three-dose primary vaccination Secondary Objectives: To measure the antibody titer after the three-dose primary vaccination and to assess the safety of the investigational products
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
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 7 Weeks 至 10 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent/guardian (legally authorized representative) has given voluntary written consent to the subject's participation after being fully informed of the purpose, methods, risks, and benefits of the study.
- •Male and female infants reaching at least 7 weeks of age on the day of first dose of investigational product.
- •Male and female infants who are identified to be healthy based on physical examination and medical history.
排除标准
- •Subjects who have acute febrile illness with tympanic temperature of ≥38.0 ℃ on the day of vaccination.
- •Subjects who have moderate or severe acute disease (regardless of fever).
- •Subjects who have any history of diphtheria, tetanus, pertussis, or poliomyelitis.
- •Subjects who have major congenital defects.
- •Subjects who show any evidence of continuous hematologic, hepatic, cardiac, re-nal, or respiratory disease.
- •Subjects who have abnormalities in the immune system, or congenital/acquired immune deficiency.
- •Subjects who received immunosuppressive dose of systemic corticosteroids thera-py within 30 days before the vaccination.
- •Subjects who are likely to have adverse side effects on central nervous system be-cause of the subjects' family history of genetic diseases in central nervous system such as progressive neurological problems or epilepsy.
- •Subjects who are allergic to the ingredients of the investigational products.
- •Subjects who have received immunoglobulins or blood products or plan to get those medications.
- •Subjects who have received vaccines other than those allowed in the protocol or plan to get those prohibited vaccines during the study period.
- •Subjects who are currently participating or planning to participate in other clinical studies during the study period.
- •Other ineligible conditions judged at the discretion of principal investigators or subinvestigators.
结局指标
主要结局
Vaccine response rate
时间窗: 4 weeks after the three-dose primary vaccination
Vaccine response rate of anti-diphtheria, anti-tetanus, anti-PT, anti-FHA, and anti-poliovirus type 1, 2, 3 at 4 weeks after the completion of the final vaccination Criteria of vaccine response rate Anti-diphtheria: Antibody titer after the completion of the final vaccination ≥ 0.1 IU/mL anti-tetanus: Antibody titer after the completion of the final vaccination ≥ 0.1 IU/mL anti-PT, anti-FHA: Antibody titer at 4 weeks after the completion of the final vaccination is at least 4 times the baseline antibody titer anti-poliovirus type 1, 2, 3: Serum neutralizing antibody dilution ratio after the completion of the final vaccination ≥ 1:8
次要结局
- Geometric mean titer (GMT)(4 weeks after the three-dose primary vaccination)