NCT06314724已完成3 期
Immunogenicity and Safety of Varicella Vaccine, Live in Healthy Children Aged 12~15 Months in the Philippines: a Randomized, Double-blind, Active-controlled Phase Ⅲ Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 642
- 试验地点
- 2
- 主要终点
- Seroresponse rate of varicella-zoster virus (VZV) antibody
研究概览
简要总结
This is a Phase Ⅲ, randomized, double-blind, active-controlled study to assess the immunogenicity and safety of the varicella vaccine,Live (hereinafter referred to as "varicella vaccine")manufactured by Sinovac (Dalian) Vaccine Technology Co., LTD.(hereinafter referred to as "Sinovac").
详细描述
A total of 642 healthy participants aged 12~15 months will be enrolled. All participants will be randomized at a 1:1 ratio to receive a single dose of varicella vaccine either manufactured by Sinovac (Group A) or Merck Sharp & Dohme (MSD, Group B).
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)
入排标准
- 年龄范围
- 12 Months 至 15 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children aged 12~15 months;
- •Participants' legal guardians are able to understand and sign the informed consent voluntarily;
- •Participants are able to comply with the study procedures based on the assessment of the investigator;
- •Participants should provide verifiable identification, to be contacted, and to contact the investigator during the study period.
排除标准
- •Prior vaccination with any varicella containing vaccines;
- •Prior history of VZV infection;
- •Known allergy to vaccines or vaccine ingredients, or serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
- •Autoimmune diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, etc.) or immunodeficiency/immunosuppression (such as HIV infection, organ transplantation), asplenia;
- •Receipt of blood products or immunoglobulins within the past 3 months before enrollment in this study, or scheduled to receive these treatments during the study period;
- •Receipt of other investigational vaccines within 30 days prior to vaccination in this study;
- •Receipt of attenuated live vaccines within 28 days prior to vaccination in this study;
- •Receipt of inactivated or subunit vaccines within 7 days prior to vaccination in this study;
- •Acute onset of various acute diseases or chronic diseases within 7 days prior to vaccination in this study;
- •Has fever on the day of vaccination, with the axillary temperature >37°C before vaccination;
- •Is participating in or planning to participate in other vaccine or drug clinical trials;
- •Any confirmed or suspected syphilis, hepatitis B or hepatitis C infection;
- •According to the investigator's judgment, the subject has any other factors that might interfere with the clinical trial results or pose additional risk to the participant due to participation in the study.
研究组 & 干预措施
Varicella vaccine group
Experimental
Participants will receive a single dose of investigational varicella vaccine on Day 0.
干预措施: Varicella Vaccine (Biological)
Varivax
Active Comparator
Participants will receive a single dose of Varivax on Day 0.
干预措施: Varivax (Biological)
结局指标
主要结局
Seroresponse rate of varicella-zoster virus (VZV) antibody
时间窗: Day 42 after vaccination
The seroresponse rate of VZV antibodies on Day 42 after vaccination among susceptible population.
次要结局
- Geometric mean fold rise (GMFR) from before vaccination of VZV antibody(Day 42 after vaccination)
- Incidence of adverse reactions within 0~14 days after vaccination(Within 0~14 days after vaccination)
- Incidence of serious adverse events (SAE) within 0~42 days after vaccination(Within 0~42 days after vaccination)
- seropositive rate(Day 42 after vaccination)
- Geometric mean concentrations (GMCs) of VZV antibody(Day 42 after vaccination after vaccination)
- GMC of VZV antibody(Day 42 after vaccination)
- Incidence of adverse reactions within 0~42 days after vaccination(Within 0~42 days after vaccination)
研究者
研究点 (2)
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