A Phase IV, Single-blind, Randomized, Controlled, Monocentric Study to Assess the Interchangeability of Quinvaxem (DTwP-HepB-Hib) as the 2nd and 3rd Dose After Initial Vaccination With Tritanrix HB+Hib (DTwP-HepB/Hib) With Respect to Safety and Immunogenicity in Healthy Infants at 6, 10 and 14 Weeks of Age
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Seroprotection Rate: Anti-PRP Antibodies
研究概览
简要总结
This is a study to show that vaccination with 1 dose of Tritanrix HB+Hib followed by Quinvaxem vaccine as the 2nd and 3rd dose is not inferior to vaccination with Quinvaxem for all 3 doses, with respect to protection against all antibodies (anti-hepatitis B surface antibodies, anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and anti-Bordetella pertussis) 1 month after completion of the 6-10-14 week vaccination course.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 42 Days 至 64 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female between, and including, 42 and 64 days of age at the time of the first vaccination
- •Written informed consent obtained from parents/legal guardian of the subject
- •Free of obvious health problems as established by medical history and/or clinical examination before entering the study
- •Hepatitis B vaccination at birth (within 48 hours) Available for all scheduled study visits
排除标准
- •Use of any investigational drug or any investigational vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and safety follow-up
- •Planned administration of a vaccine not foreseen by the study protocol
- •Known or suspected impairment of immune function, known Human immunodeficiency virus (HIV)-positivity, receiving immunosuppressive therapy, or having received systemic immunosuppressive therapy within 1 month prior to study entry (note: inhaled and topical steroids are allowed)
- •Administration of parenteral immunoglobulin preparation and/or blood products since birth
- •Previous vaccination against Haemophilus influenzae type b (Hib) and/or diphtheria, tetanus, pertussis (DTP)
- •History of anaphylaxis, or any serious vaccine reaction, or allergy to any vaccine component or to products containing mercury compounds, such as sodium ethylmercuro-thiosalicylate
- •Significant acute infection
- •Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
- •Participation in another clinical study
结局指标
主要结局
Seroprotection Rate: Anti-PRP Antibodies
时间窗: 1 month after the third vaccination
Percentage of subjects with an anti-PRP titer ≥0.15 µg/mL (i.e. seroprotection rate)
Seroprotection Rate: Anti-hepatitis B Surface Antibodies
时间窗: 1 month after the third vaccination
Percentage of subjects with an anti-hepatitis B surface antibody titer ≥10 IU/L (i.e. seroprotection rate)
Seroprotection Rate: Anti-diphtheria Toxoid Antibodies
时间窗: 1 month after the third vaccination
Percentage of subjects with antibody levels against diphtheria toxoid ≥0.1 IU/mL (i.e. seroprotection rate)
Seroprotection Rate: Anti-tetanus Toxoid Antibodies
时间窗: 1 month after the third vaccination
Percentage of subjects with antibody levels against tetanus toxoid ≥0.1 IU/mL (i.e. seroprotection rate)
Seroprotection Rate: Anti-B. Pertussis Antibodies
时间窗: 1 month after the third vaccination
Percentage of subjects with an anti-B. pertussis antibody titer ≥20 EU/mL or a 4-fold increase over baseline (i.e. seroconversion rate)
次要结局
未报告次要终点