A Phase IIb Randomized, Double-blind, Controlled Study of the Safety, Immunogenicity and Proof-of-concept of RTS,S/AS02D, a Candidate Malaria Vaccine, When Incorporated Into an Expanded Program on Immunization (EPI) Regimen That Includes DTPw/Hib in Infants Living in a Malaria-endemic Region.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Concentrations of Antibodies Against Hepatitis B (Anti-HB)
研究概览
简要总结
GSK Biologicals in partnership with the Malaria Vaccine Initiative at PATH is developing a candidate malaria vaccine GSK 257049 for the routine immunization of infants and children living in malaria endemic areas. The vaccine would offer protection against malaria disease due to the parasite Plasmodium falciparum. The vaccine would also provide protection against infection with hepatitis B virus (HBV).
In order to integrate the malaria vaccine into the EPI regimen in malaria-endemic regions, a new variant RTS,S/AS02D (0.5 mL dose) has been developed.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
详细描述
This is a phase 2b trial designed to evaluate the safety and immunogenicity of RTS,S/AS02D when co-administered with a multivalent DTPw/Hib (Aventis Pasteur's TETRActHib vaccine). Infants randomized to the control group will receive a licensed hepatitis B vaccine, Engerix-B in place of RTS,S/AS02D.
Data pertaining to RTS,S/AS02D or Engerix-B will be collected in a double blinded manner; data relating to TETRActHib will be collected in an open fashion.
Oral polio vaccine (OPV) will be administered at birth, 8, 12, 16 weeks in co-administration with other vaccines and will not be administered as part of this protocol. Antibody titers to OPV will not be assessed as part of this protocol.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Weeks 至 10 Weeks（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
结局指标
主要结局
Concentrations of Antibodies Against Hepatitis B (Anti-HB)
时间窗: Prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3.
Concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The cut-off of the assay was the seroprotection cut-off of 10 mIU/mL. Month 3 results are the specific results for this primary outcome measure.
Concentrations of Anti-Bordetella Pertussis Toxin Antibodies (Anti-BPT).
时间窗: Prior to vaccination at Week 0 (PRE), and at Month 3.
Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off of 15 EL.U/mL. Month 3 results are the specific results for this primary outcome measure.
Number of Subjects With Anti-diphtheria Antibody (Anti-D) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value
时间窗: Prior to vaccination at Week 0 (PRE), and at Month 3.
Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seroprotection cut-off value was 0.1 international unit per milliliter (IU/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.
Number of Subjects With Anti-tetanus Antibody (Anti-T) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value
时间窗: Prior to vaccination at Week 0 (PRE), and at Month 3.
Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seroprotection cut-off value was 0.1 international unit per milliliter (IU/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.
Number of Subjects With Hepatitis B Antibody (Anti-HB) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value
时间窗: Prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3.
The seroprotection cut-off value was 10 milli-international units per milliliter (mIU/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3. Month 3 results are the specific results for this primary outcome measure.
Concentrations of Anti-polyribosyl Ribitol Phosphate Antibodies (Anti-PRP).
时间窗: Prior to vaccination at Week 0 (PRE), and at Month 3.
Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The cut-off of the assay is the seroprotection cut-off value of 0.15 µg/mL. Month 3 results are the specific results for this primary outcome measure.
Number of Subjects With Serious Adverse Events (SAEs)
时间窗: From Month 9 to Month 20.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Concentrations of Antibodies Against Tetanus (Anti-T)
时间窗: Prior to vaccination at Week 0 (PRE), and at Month 3.
Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The cut-off of the assay was the seroprotection cut-off of 0.1 IU/mL. Month 3 results are the specific results for this primary outcome measure.
Concentrations of Antibodies Against Diphtheria (Anti-D)
时间窗: Prior to vaccination at Week 0 (PRE), and at Month 3.
Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The cut-off of the assay was the seroprotection cut-off of 0.1 IU/mL. Month 3 results are the specific results for this primary outcome measure.
Number of Subjects With Anti-polyribosyl Ribitol Phosphate Antibody (Anti-PRP) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value
时间窗: Prior to vaccination at Week 0 (PRE), and at Month 3.
Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seroprotection cut-off value was 0.15 microgram per milliliter (µg/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.
Number of Subjects With Anti-Bordetella Pertussis Toxin Antibody (Anti-BPT) Concentrations Equal to or Above (>=) the Seropositivity Cut-off Value
时间窗: Prior to vaccination at Week 0 (PRE), and at Month 3.
Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seropositivity cut-off value was 15 ELISA units per milliliter (EL.U/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.
次要结局
- Number of Subjects With Solicited Local Symptoms.(Within 7 days (Days 0-6) after vaccination with the TETRActHib vaccine.)
- Concentrations of Anti-Circumsporozoite Protein (Anti-CS) Antibodies(Prior to vaccination at Week 0 (PRE), at Month 2, at Month 3 and at Month 9.)
- Number of Subjects With Solicited General Symptoms.(Within 7 days (Days 0-6) after vaccination)
- Number of Subjects With Serious Adverse Events (SAEs)(Throughout the entire study, from Week 0 to Month 20.)
- Time to First Malaria Infection(Over the period starting 14 days after Dose 3 of RTS,S or HBV vaccine and extending for 6 months thereafter (from Month 2.5 up to Month 9).)
- Number of Subjects Prevalent for Parasitemia(At Month 9)
- Number of Subjects With Unsolicited Adverse Events (AEs).(Within 30 days (Days 0-29) after vaccination)
- Plasmodium Falciparum (P. Falciparum) Parasite Density in Subjects Prevalent for Parasitemia(At Month 9)