Immunogenicity and Safety of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years Previously Vaccinated Against Yellow Fever in Peru
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
研究概览
简要总结
The aim of the trial was to evaluate the use of a tetravalent vaccine, CYD dengue vaccine, against dengue disease.
Primary Objectives:
- To describe the humoral immune response to dengue before and after each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years) previously vaccinated with yellow fever (YF) vaccine.
- To evaluate the safety of each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years).
- To describe viremia after the first and second vaccinations with dengue vaccine in a subgroup of 130 randomized participants (100 participants in Dengue Vaccine Group and 30 participants in Control Group) in two age cohorts of children (6 to 11 years and 2 to 5 years).
详细描述
Participants were randomized to receive either three injections of CYD dengue vaccine or two injections of placebo, and one injection of a pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively.
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)
盲法说明
The observer-blind design was implemented. The person who performed vaccinations knew which product was administered while neither the participant nor the Investigator in charge of safety evaluation knew which product was injected. To maintain the blind and minimize any potential bias, the control group used the same route and schedule as the study vaccine.
入排标准
- 年龄范围
- 2 Years 至 11 Years（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
Percentage of Participants (Aged 6 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
时间窗: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: \>= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: \> 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.
Percentage of Participants (Aged 2 to 5 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection With CYD Dengue Vaccine or Placebo
时间窗: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: \>= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: \> 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.
Percentage of Participants (Aged 2 to 11 Years) Reporting Solicited Injection-site and Systemic Reactions Following Each Injection (Inj.) With CYD Dengue Vaccine or Placebo
时间窗: Day 0 (Post-Injection) up to Day 14 after injection 1, 2 and 3
Solicited injection site reactions: Pain, Erythema, and Swelling. Pain: Grade 3: incapacitating, unable to perform usual activities. Erythema and Swelling: Grade 3: \>= 5 cm. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever: Grade 3: \> 39.0°C; Headache, Malaise, Myalgia, and Asthenia: Grade 3: prevents daily activities.
次要结局
- Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo(Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3)
- Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo(Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3)
- Percentage of Participants (Aged 2 to 5 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo(Pre-Injection 1 and 28 days Post-Injection 2 and 3)
- Percentage of Participants (Aged 2 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo(Pre-Injection 1 and 28 days Post-Injection 2 and 3)
- Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo(Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3)
- Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine(Pre-Injection 1 and 28 days Post-Injection 2 and 3)
- GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With CYD Dengue Vaccine or Placebo(Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3)
- Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine or Placebo(Pre-Injection 1 and 28 days Post-Injection 2 and 3)
- Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo(Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3)
- Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype in Dengue-Immune Participants Before and After Injection With CYD Dengue Vaccine or Placebo(Pre-Injection 1 and 28 days Post-Injection 2 and 3)
- GMTs of Antibodies Against Yellow Fever Virus Before and Following First Injection With CYD Dengue Vaccine or Placebo(Pre-Injection 1 and 28 days Post-Injection 1)
- Percentage of Participants (Aged 6 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine(Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3)
- Percentage of Participants (Aged 2 to 11 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine(Pre-Injection 1 and 28 days Post-Injection 2 and 3)
- Percentage of Participants (Aged 6 to 11 Years) Seropositive for Dengue Virus Serotypes Before and After Each Vaccination With CYD Dengue Vaccine or Placebo(Pre-Injection 1, 2, 3 and 28 days Post-Injection 1, 2 and 3)
- Percentage of Participants (Aged 2 to 5 Years) Seropositive for at Least One, Two, Three or Four Dengue Virus Serotypes Before and After Vaccination With CYD Dengue Vaccine(Pre-Injection 1 and 28 days Post-Injection 2 and 3)
- Percentage of Participants Seropositive for Yellow Fever Antibodies Before and Following First Injection With CYD Dengue Vaccine or Placebo(Pre-Injection 1 and 28 days Post-Injection 1)