A Phase III Study to Assess Immunogenicity and Safety of 4th LBVH0101 Vaccination Compared With 4th Hiberix™ Vaccination in Healthy Toddlers Who Completed Primary Vaccination in LG-VHCL002 Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Percentage of the subjects who obtained protective Ab response with anti-PRP Ab titer ≥ 1 ㎍/mL after 4th vaccination
研究概览
简要总结
This is a multi-center, comparative, two-arm, parallel-group, single-blind, phase III study to assess immunogenicity and safety of 4th LBVH0101 (Haemophilus influenzae type b tetanus toxoid conjugate vaccine) vaccination compared with 4th Hiberix™ vaccination after the same vaccination with primary one in healthy toddlers who completed the primary vaccination with LBVH0101 or Hiberix™ in LG-VHCL002 study.
详细描述
Primary objective: This study was purposed to compare and assess immunogenicity of 4th LBVH0101 or Hiberix™ vaccination in toddlers who completed the primary vaccination with LBVH0101 or Hiberix™, respectively, in LG-VHCL002 study.
Secondary objective: This study was purposed to compare and assess safety of 4th LBVH0101 or Hiberix™ vaccination in toddlers who completed primary vaccination with LBVH0101 or Hiberix™ in LG-VHCL002 study. It was also purposed to assess persistence of immunogenicity prior to 4th vaccination in toddlers who completed the primary vaccination with LBVH0101 or Hiberix™, respectively, in LG-VHCL002 study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 15 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Were vaccinated with LBVH0101 or Hiberix™ three times in LG-VHCL002 study
- •Healthy male and female infants at the age of 12 to 15 months from birth
- •The infants and their parents/legally acceptable representative could comply with all of the scheduled visits in the study
- •The parents/legally acceptable representative signed the written consent form.
排除标准
- •Subject had been vaccinated with 4th shot of Haemophilus influenzae type b
- •Subject is scheduled to be administered with any vaccine other than those specified in the protocol as allowed according to the Standard Immunization Schedule, between the 4th vaccination and Completion Visit
- •Subject had suffered from any infectious disease caused by Haemophilus influenzae type b
- •Subject has fever of ≥ 37.5°C (axillary temperature) at the day of vaccination
- •There is a clear or suspected immune function disorder
- •Systemic corticosteroid (prednisolone or equivalent > 0.5 mg/kg/day) was administered for more than 14 days within 30 days prior to administration of the test vaccine or any systemic immunosuppressant was used
结局指标
主要结局
Percentage of the subjects who obtained protective Ab response with anti-PRP Ab titer ≥ 1 ㎍/mL after 4th vaccination
时间窗: at 4 weeks after 4th vaccination
次要结局
- Percentage of the subjects who maintained preventive Ab response with anti-PRP Ab titer ≥ 1㎍/mL prior to 4th vaccination
- Percentage of the subjects who maintained preventive Ab response with anti-PRP Ab titer ≥ 0.15㎍/mL prior to 4th vaccination
- Percentage of the subjects who obtained preventive Ab response with anti-PRP Ab titer ≥ 0.15㎍/mL after 4th vaccination