A Phase IIIb, Controlled, Open Label, Single-Center, Persistency, Extension Study in Chinese Children After a 2+1 Dose Series of Either CRM197-Conjugate Haemophilus Influenzae Type b Vaccine or Tetanus Toxoid-Conjugate Haemophilus Influenzae Type b Vaccine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 426
- 试验地点
- 1
- 主要终点
- Geometric Mean Anti-PRP (Polyribosyl Ribitol Phosphate) Concentrations at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1)
研究概览
简要总结
Evaluate the persistency of immune response against Haemophilus influenzae type b by assessing anti-PRP antibody levels in children vaccinated with either Hib-CRM197 or Hib-TT booster vaccine approximately 4 years before.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children previously enrolled in V37_07E1 study and who received the appropriate vaccination.
- •Children whose parent(s) or legal guardian(s) had given written consent after the nature of the study was explained according to local regulatory requirements.
排除标准
- •Any confirmed or suspected current immunosuppressive or immunodeficient condition since the end of V37_07E1 study, based on medical history and physical examination (no laboratory testing required).
- •Treatment with corticosteroids or other immunosuppressive/immunostimulant drugs as defined below:
- •i) chronic use of oral and parenteral immunosuppressants (>= 15 days of use) or other immune-modifying drugs within 60 days prior to the blood sampling (short term usage of topical, inhaled and/or intranasal corticosteroids were allowed) ii) receipt of immunostimulants within 60 days prior to Visit 1
- •Administration of immunoglobulins and/or any blood products up to 3 months before enrollment.
- •Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the blood sampling.
- •Any condition, which, in the opinion of the investigator, might be a contraindication to the execution of the blood draw.
研究组 & 干预措施
Hib CRM197
Subjects treated with 3 doses of CRM 197 -conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).
No vaccine was administered during this trial
干预措施: Hib-CRM197 (Biological)
Hib TT
Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).
No vaccine was administered during this trial
干预措施: Hib-TT (Biological)
结局指标
主要结局
Geometric Mean Anti-PRP (Polyribosyl Ribitol Phosphate) Concentrations at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1)
时间窗: At Day 1 (4 years post booster dose administered in study V37_07E1)
Immunogenicity was measured as geometric mean of Anti- PRP Concentrations, approximately 4 years after booster vaccination with either Hib-CRM197 or Hib-TT in children participating in previous V37_07E1 trial.
次要结局
- Percentages of Subjects With Anti-PRP Concentrations ≥1.0 μg/mL and ≥0.15 μg/mL at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1)(At Day 1 (4 years post booster dose administered in study V37_07E1))