Immunogenicity and Safety of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Viet Nam
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period
研究概览
简要总结
This trial evaluated the use of a tetravalent vaccine against dengue.
Primary objectives:
- To describe the humoral immune response to dengue before and after each vaccination with tetravalent dengue vaccine in adults, adolescents, and children.
- To evaluate the safety of each vaccination with tetravalent dengue vaccine in the 4 age cohorts.
- To evaluate the persistence of antibodies against dengue during 5 years after the first vaccination with tetravalent dengue vaccine in the 4 age cohorts.
详细描述
Safety assessments included solicited reactions within 7 or 14 days after each injection, unsolicited adverse events within 28 days after each injection, and serious adverse events during the study period.
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 (Participant, Investigator, Outcomes Assessor)
盲法说明
The first and second vaccinations were administered in a blind-observer manner. The third vaccination was planned to be administered in a single-blind manner; however, due to the cancellation of the statistical analysis after the second vaccination, the third vaccination was also administered in a blind- observer manner. To ensure the blind-observer design of the 3 vaccinations, the product was prepared in a separate room whether neither the Investigator nor participant had access.
入排标准
- 年龄范围
- 2 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 2 to 45 years on the day of inclusion.
- •Provision of Informed Consent/Assent Form signed by the participant (and/or by the parent or another legally acceptable representative for participants <18 years).
- •Participant (and parent/guardian for participants <18 years) able to attend all scheduled visits and to comply with all trial procedures.
- •For a female participant of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to the first vaccination, until at least 4 weeks after the last vaccination.
- •Participant in good health, based on medical history, physical examination and laboratory parameters.
排除标准
- •Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
- •For a female participant of child-bearing potential, known pregnancy or positive serum pregnancy test at Screening.
- •For a female participant of child-bearing potential, known pregnancy or positive urine pregnancy test on the day of the first injection.
- •Breast-feeding female participant.
- •Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
- •Human immunodeficiency virus, hepatitis B, or hepatitis C seropositivity in the blood sample taken at screening.
- •Planned participation in another clinical trial during the first year of the study.
- •Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the past 6 months, or long-term systemic corticosteroids therapy.
- •Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.
- •Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
- •Current alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures.
- •Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response.
- •Participant deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
- •Laboratory abnormalities of at least moderate severity or clinically significant according to the Investigator 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 receipt of any vaccine in the 4 weeks following the first trial vaccination.
- •Familial atopy medical history (parents, brothers, or sisters).
- •Previous vaccination with meningococcal A+C or typhoid vaccines within 3 years prior to inclusion.
- •History of meningococcal or typhoid infections (confirmed either clinically, serologically or microbiologically).
研究组 & 干预措施
CYD Dengue Vaccine Group
Participants who received CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections. Participants were followed for 4 years after the third injection.
干预措施: CYD dengue vaccine serotypes (1, 2, 3, 4). (Biological)
Control Vaccine Group
Participants who received the Meningococcal Polysaccharide Vaccine A + C, placebo, and Typhoid Vi polysaccharide vaccine as the first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections, respectively. Participants were followed for 4 years after the third injection.
干预措施: Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide (Biological)
结局指标
主要结局
Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain During the Follow-up Period
时间窗: Year 1, Year 2, Year 3 and Year 4 after the Third Injection
GMT against each serotype of the parental dengue virus strains were assessed using the dengue PRNT.
Geometric Mean Titers (GMTs) of Antibodies Against Each Serotype of the Parental Dengue Virus Strain Before and Following Injection (Inj.) With CYD Dengue Tetravalent Vaccine
时间窗: Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3
Geometric mean titers against each serotype of the parental dengue virus strains were assessed using the dengue Plaque Reduction Neutralization Test (PRNT).
Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine During the Follow-up Period
时间窗: Year 1, Year 2, Year 3 and Year 4 after the Third Injection
Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT.
Percentage of Participants With Antibody Titers >= 10 (1/Dil) Against Each Serotypes of the Parental Dengue Virus Strains Following Inj. With CYD Dengue Tetravalent Vaccine
时间窗: Pre-Inj. 1, 2, and 3 and 28 days Post-Inj. 1, 2, and 3
Antibody titer levels against each serotype of the parental dengue virus strains were assessed using the PRNT.
Percentage of Participants With Solicited Systemic Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
时间窗: 14 days post-each injection
Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Fever:- Grade 1: \>=37.5 degree Celsius (°C) to \<=38.0°C, Grade 2: \>38.0°C to \<=39.0°C, Grade 3: \>39.0°C. Headache, malaise, myalgia and asthenia: Grade 1: noticeable but does not interfere with daily activities, Grade 2: interferes with daily activities, Grade 3: prevents daily activities.
Percentage of Participants With Solicited Inj. Site Reactions Following Any and Each Inj. With CYD Dengue Tetravalent Vaccine
时间窗: 7 days post-each injection
Solicited Inj. site reactions: Pain, Erythema, and Swelling. Pain:- Grade 1: easily tolerated, Grade 2: sufficiently discomforting to interfere with normal behavior or activities, Grade 3: Incapacitating, unable to perform usual activities. Erythema and Swelling:- Grade 1: \<2.5 cm, Grade 2: \>=2.5 to \<5 cm, Grade 3: \>= 5 cm.
次要结局
未报告次要终点