NCT07473427尚未招募3 期
Immunogenicity and Safety of Varicella Vaccine, Live in Healthy Vietnamese Children Aged 1~12 Years: A Single-armed Bridging Clinical Trial
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The seroresponse rate of varicella-zoster virus (VZV) antibodies among susceptible population without varicella immunization history
研究概览
简要总结
This is a single armed, Phase 3 study to assess the immunogenicity and safety of the varicella vaccine manufactured by Sinovac. A total of 300 healthy participants aged 1-12 years will be enrolled. All participants will receive a single dose of varicella vaccine manufactured by Sinovac.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children aged 1-12 years;
- •Vaccination history:
- •Participants aged 1 year old: no vaccination history with any varicella containing vaccine;
- •Participants aged 2~12 years old: no vaccination history with any varicella containing vaccine, or have received 1 dose of varicella vaccine at least 3 months before enrollment;
- •Participants and/or their legal guardians are able to understand and sign the informed consent/assent 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 history of VZV infection;
- •Have been exposed to VZV at home, day care, school, etc. within 4 weeks before enrollment;
- •Known allergy to vaccines or vaccine ingredients, or serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
- •Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection);
- •Coagulation disorders (e.g. factor deficiency, platelet disorders), or history of bleeding, hematoma, or bruising following intramuscular injections or venipuncture;
- •Poorly controlled chronic illnesses or history of severe diseases that, including but not limited to cardiovascular diseases, hematological disorders, liver and kidney diseases, digestive system disorders, respiratory diseases, malignancies, and a history of major organ transplantation;
- •Any confirmed or suspected syphilis, hepatitis B or hepatitis C infection;
- •Current or history of severe neurological diseases (epilepsy, convulsions or seizures [excluding history of febrile seizures]) or psychiatric disorders, or presence of a family history of psychiatric disorders;
- •Receipt of ≥14 days of immunosuppressive or other immunomodulatory therapy (prednisone ≥20mg/day, or prednisone ≥2mg/kg/day, or its equivalent), cytotoxic therapy within 180 days prior to screening, or plans for such treatment during the trial;
- •Receipt of blood products or immunoglobulins within 180 days prior to screening, or plans to receive these treatments in the trial;
- •Receipt of other investigational drugs/vaccines within 30 days prior to screening, or plans to receive such drugs or vaccines during the study period;
- •Receipt of attenuated live vaccines or nucleic acid vaccines within 28 days prior to screening, or subunit or inactivated vaccines within 7 days prior to screening;
- •Fever on vaccination day, with axillary temperature >37.2°C pre-vaccination, or vital signs outside normal range, or failure to pass physical examination;
- •Presence of skin injuries, inflammation, ulcers, rashes, scars, or other conditions at the intended injection site that may interfere with drug administration or observation of local reactions;
- •Acute onset of various acute diseases or chronic diseases within the past 7 days, or known or suspected active infections;
- •Any other factors considered by the investigator to make the participant unsuitable for participation in the trial.
研究组 & 干预措施
No vaccination history group
Experimental
Participants aged 1-12 years with no vaccination history of varicella-containing vaccine
干预措施: Varicella Vaccine (Biological)
Vaccination history group
Experimental
Participants aged 2-12 years have received 1 dose of varicella vaccine
干预措施: Varicella Vaccine (Biological)
结局指标
主要结局
The seroresponse rate of varicella-zoster virus (VZV) antibodies among susceptible population without varicella immunization history
时间窗: 42 days after vaccination
次要结局
- The Geometric Mean Concentration(GMC) of VZV antibodies among susceptible population without varicella immunization history(42 days after vaccination)
- The Geometric Mean Concentration(GMC) of VZV antibodies in total population(42 days after vaccination)
- The seropositive rate of VZV antibodies in total population(42 days after vaccination)
- The geometric mean fold rise (GMFR) of VZV antibodies in total population(42 days after vaccination)
- The geometric mean fold rise (GMFR) of VZV antibodies among population with varicella immunization history(42 days after vaccination)
- The geometric mean concentration (GMC) of VZV antibodies among population with varicella immunization history(42 days after vaccination)
- The seropositive rate of VZV antibodies among population with varicella immunization history(42 days after vaccination)
研究者
研究点 (1)
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