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
- •Aged 2 to 11 years on the day of inclusion.
- •Participant in good health, based on medical history, physical examination and laboratory parameters.
- •Provision of Assent Form signed by the participants (for participants >=8 years old) and Informed Consent Form signed by the parents or another legally acceptable representative (and by an independent witness for illiterate parent[s]).
- •Participant and parents/legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures.
- •For a female participant of child-bearing potential (girls post-menarche), avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to first vaccination, until at least 4 weeks after the last vaccination.
- •Documented receipt of yellow fever vaccine since at least one month before the first vaccination.
排除标准
- •Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
- •For a female participant of child-bearing potential (girls post-menarche), known pregnancy.
- •For a female participant of child-bearing potential (girls post-menarche), known pregnancy or positive pregnancy test in blood sample taken at Screening.
- •Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
- •Planned participation in another clinical trial during the trial.
- •Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
- •Known systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.
- •Systemic hypersensitivity to YF vaccine or history of a life-threatening reaction to YF vaccine.
- •Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
- •Current or past alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures.
- •Receipt of any blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response.
- •Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
- •Planned receipt of any vaccine in the 4 weeks following the first trial vaccination.
- •Human Immunodeficiency Virus, hepatitis B antigen, or hepatitis C seropositivity in blood sample taken at Screening.
- •Clinically significant laboratory abnormalities (as determined by the Investigator) in blood sample taken at Screening.
- •Known previous vaccination with pneumococcal polysaccharide vaccine.
研究组 & 干预措施
CYD Dengue vaccine group
Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).
干预措施: CYD Dengue Vaccine Serotypes 1, 2, 3, and 4 (Biological)
Control group
Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).
干预措施: Pneumococcal polysaccharide vaccine (Biological)
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)