Phase IIIb, Multicentre Study to Assess Safety & Immunogenicity of GSK Biologicals' Combined DTPa/Hib (Infanrix/Hib) Vaccine vs Separate Administration of DTPa (Infanrix) & Hib (Hiberix) Vaccines in Healthy Infants 3,4,&5 Months of Age as Compared With the Separate Administration of DTPa and Hib Vaccines at Different Injection Sites.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 660
- 试验地点
- 2
- 主要终点
- Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T)
研究概览
简要总结
This study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese infants 3, 4 & 5 months of age, in terms of safety and immunogenicity.
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
入排标准
- 年龄范围
- 90 Days 至 120 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female between, and including, 90 and 120 days of age at the time of the first vaccination,
- •written informed consent obtained from the parent or guardian of the subject
排除标准
- •Subjects with known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenzae disease can not participate,
- •Subjects who have received previous vaccination against diphtheria, tetanus, acellular pertussis and/or Haemophilus influenzae type b diseases can not participate.
结局指标
主要结局
Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T)
时间窗: At Month 3
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations higher than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP)
时间窗: At Month 3
A seroprotected subject was defined as a vaccinated subject with an anti-PRP antibody concentration higher than or equal to (≥) 0.15 microgram/milliliter (µg/mL).
Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies
时间窗: At Month 3
The vaccine response was defined as it follows: * for PT and FHA, an antibody concentration higher than or equal to (≥) 20 EL.U/mL at post-vaccination; * for PRN, at least a 4-fold increase in antibody concentration from pre-vaccination to post-vaccination time points.
次要结局
- Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1.0 µg/mL(At Month 3)
- Concentrations for Anti-D and Anti-T Antibodies(At Month 0 and Month 3)
- Concentrations for Anti-PRP Antibodies(At Month 0 and Month 3)
- Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies(At Month 3)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses)
- Number of Subjects With Unsolicited Adverse Events (AEs)(During the 31-day (Day 0-30) follow-up period after each vaccination)
- Number of Subjects With Serious Adverse Events (SAEs)(From receipt of first dose of study vaccine (Day 0) to study end (Month 3))