A Phase III, Partially Blind, Randomized Study to Evaluate the Immunogenicity, Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Tritanrix™-HepB and GSK Biologicals Kft's DTPw-HBV Vaccines as Compared to Concomitant Administration of Commonwealth Serum Laboratory's (CSL's) DTPw (Triple Antigen™) and GSK Biologicals' HBV (Engerix™-B), When Co-administered With GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine, to Healthy Infants at 3, 4½ and 6 Months of Age, After a Birth Dose of Hepatitis B Vaccine.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- Seroprotection Status for Anti-diphteria (Anti-DT) Antibodies
研究概览
简要总结
To compare the two formulations of GSK Biologicals' DTPw-HBV vaccine to concomitant administration of CSL's DTPw vaccine and GSK Biologicals' HBV with respect to the antibody response to the diphtheria antigen after a three-dose primary vaccination course.
详细描述
Randomized study with five groups to receive one of the following vaccination regimens:
One of the two formulations of GSK Biologicals' DTPw-HBV + GSK Biologicals' HRV One of the two formulations of GSK Biologicals' DTPw-HBV + Placebo CSL's DTPw + GSK Biologicals' HBV
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
- 3 Weeks 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tritanrix™-HepB+Rotarix™ Group
Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
干预措施: Tritanrix™-HepB (Biological)
Tritanrix™-HepB+Rotarix™ Group
Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
干预措施: Rotarix™ (Biological)
Tritanrix™-HepB+Placebo Group
Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
干预措施: Tritanrix™-HepB (Biological)
Tritanrix™-HepB+Placebo Group
Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
干预措施: Placebo (Drug)
Zilbrix™+Rotarix™ Group
Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
干预措施: Rotarix™ (Biological)
Zilbrix™+Rotarix™ Group
Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age.
干预措施: Zilbrix™ (Biological)
Zilbrix™+Placebo Group
Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
干预措施: Zilbrix™ (Biological)
Zilbrix™+Placebo Group
Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age.
干预措施: Placebo (Drug)
Triple Antigen™+Engerix™-B Group
Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
干预措施: Triple Antigen™ (Biological)
Triple Antigen™+Engerix™-B Group
Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively.
干预措施: Engerix™-B (Biological)
结局指标
主要结局
Seroprotection Status for Anti-diphteria (Anti-DT) Antibodies
时间窗: At one month post dose 3 [PIII(M4)]
Seroprotection status (SP) defined vaccinated subjects with antibody concentrations greater than or equal to (≥) 0.1 international units per millitre (IU/mL) as assessed by the Enzyme-linked Immunosorbent Assay (ELISA) or ≥ 0.016 IU/mL by neautralization assay on Vero cells in subjects seronegative for ELISA.
次要结局
- Number of Subjects With Vaccine Response to BPT Antigen(At one month post dose 3 [PIII(M4)])
- Concentrations of Anti-RV Antibodies(At 2.5 months post dose 2 of Rotarix [PIII(M4)])
- Number of Subjects With Any Solicited General Symptoms(During the 8-day period (Days 0-7) post-vaccination)
- Number of Seropositive Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations ≥ the Established Cut-off Values(At one month post dose 3 [PIII(M4)])
- Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3)(At one month post dose 3 [PIII(M4)])
- Number of Seroprotected Subjects for Anti-DT Antibodies as Assessed by ELISA(At one month post dose 3 [PIII(M4)])
- Number of Seroprotected Subjects for Anti-Hepatitis B (Anti-HBs) Antibodies(At one most post dose 3 [PIII(M4)])
- Concentrations of Anti-DT Antibodies(At one month post dose 3 [PIII(M4)])
- Anti-Polio Type 1, 2, 3 Antibody Titers(At one month post dose 3 [PIII(M4)])
- Number of Seropositive Subjects With Anti-rotavirus (Anti-RV) Antibodies Above the Cut-off Values(At 2.5 months after dose 2 of Rotarix [PIII(M4)])
- Number of Seroprotected Subjects for Anti-Tetanus (Anti-T) Antigen(At one month post dose 3 [PIII(M4)])
- Number of Subjects With Solicited Local Symptoms(During the 8-Day (Days 0-7) follow-up period)
- Concentrations of Anti-HBs Antibodies(At one month post dose 3 [PIII(M4)])
- Concentrations of Anti-T Antibodies(At one month post dose 3 [PIII(M4)])
- Concentrations of Anti-BPT Antibodies(At one month post dose 3 [PIII(M4)])
- Number of Subjects With Unsolicited Adverse Events (AEs)(During the 31-day (Days 0-30) follow-up period)
- Number of Subjects With Serious Adverse Events (SAEs)(From Month 0 to Month 4)