Safety, Tolerability, and Immunogenicity of Four Different Formulations of a Liquid Hexavalent Combination Vaccine, HR5I (Haemophilus Influenzae Type b Conjugate, Recombinant Hepatitis B Surface Antigen, Diphtheria Toxoid, Tetanus Toxoid, 5-Component Acellular Pertussis Vaccine, and Inactivated Poliovirus Type 1, 2, and 3), When Administered to Healthy Hepatitis B Vaccine-Naïve Infants at 2, 3, 4, and 12 to 14 Months of Age
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 708
- 主要终点
- Percentage of participants with level of anti-PRP antibodies >1.0 μg/mL at the Postdose 3 time point
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and immunogenicity of 4 different formulations of the HR5I vaccine (Haemophilus influenzae type b conjugate, recombinant hepatitis B surface antigen, diphtheria, tetanus, 5-component acellular pertussis, and inactivated poliovirus Types 1, 2, and 3). The primary hypothesis is that at least 1 of the 4 formulations of HR5I administered as a primary series at 2, 3, and 4 months of age will be acceptable (similar to targeted rates) with respect to Postdose 3 antibody responses to all antigens.
详细描述
Participants will be randomized into 4 arms:
AR51 (12, 10): arm receiving vaccine formulation containing 12 mcg of polyribosylribitol phosphate (PRP) conjugates to tetanus toxoid (PRP-T) and 10 mcg of Hepatitis B surface antigen (HBsAg)
PR51 (3, 10): arm receiving vaccine formulation containing 3 mcg of PRP conjugated to the outer membrane protein complex of Neisseria meningitides (PRP-OMPC) and 10 mcg of HBsAg
PR51 (6, 10): arm receiving vaccine formulation containing 6 mcg of PRP-OMPC and 10 mcg of HBsAg
PR51 (6, 15): arm receiving vaccine formulation containing 6 mcg of PRP-OMPC and 15 mcg of HBsAg
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Weeks 至 9 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants 2 months of age who have not received prior vaccinations for Haemophilus influenzae type b (Hib), hepatitis B, Diptheria/Pertussis/Tetanus (DPT), or Polio
- •Exclusion Criteria :
- •Documented HIV infection (child or mother)
- •Documented HBsAg-seropositivity (child or mother)
- •History of invasive Hib disease, hepatitis B, diphtheria, tetanus, pertussis, or poliovirus infection
- •History of seizure disorder, developmental delay, or any other neurologic disorder
- •Underlying medical conditions such as inborn errors of metabolism, failure to thrive, or any major congenital abnormalities requiring surgery
- •Prior or anticipated receipt of immune globulin, blood, or blood products
- •Known hypersensitivity to any component of the investigational vaccines being administered in this protocol
- •Any history or condition that would exclude the child from receiving any vaccine administered under this protocol
- •Any condition that, in the opinion of the investigator, may interfere with the evaluation of the study objectives
排除标准
- 未提供
结局指标
主要结局
Percentage of participants with level of anti-PRP antibodies >1.0 μg/mL at the Postdose 3 time point
时间窗: At 5 months of age (1 month after 3rd vaccination)
Percentage of participants with level of anti-HBsAg antibodies ≥10 mIU/L at the Postdose 3 time point
时间窗: At 5 months of age (1 month after 3rd vaccination)
Percentage of participants with a ≥4-fold rise in levels of antibodies to pertussis antigens (toxoid [PTxd], Filamentous Hemagglutinin [FHA], Fimbria 2 & Fimbria 3 [FIM], and Pertactin [PRN]) at the Postdose 3 time point
时间窗: At 5 months of age (1 month after 3rd vaccination)
Percentage of participants with neutralizing anti-poliovirus antibodies (Types 1, 2, and 3) at ≥1:8 dilution at the Postdose 3 time point
时间窗: At 5 months of age (1 month after 3rd vaccination)
Percentage of participants with level of anti-diphtheria antibodies ≥0.01 IU/mL at the Postdose 3 time point
时间窗: At 5 months of age (1 month after 3rd vaccination)
Percentage of participants with level of anti-tetanus antibodies ≥0.01 IU/mL at the Postdose 3 time point
时间窗: At 5 months of age (1 month after 3rd vaccination)
次要结局
- Number of participants with at least 1 adverse event (AE)(From 1st vaccination up to 14 days following last vaccination (up to 14.5 months))
- Number of participants who discontinued study treatment due to an AE(From 1st vaccination up to 14 days following last vaccination (up to 14.5 months))