Immunogenicity and Safety of Live Attenuated Varicella Vaccine Co-administered with MMR Vaccine or DTaP Vaccine in Healthy Children Aged 18~24 Months: an Open-label, Randomized, Phase Ⅳ Study Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 720
- 试验地点
- 1
- 主要终点
- Varicella zoster virus (VZV) antibody seroconversion rate
研究概览
简要总结
This is a phase Ⅳ clinical trial of live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.The primary objective of this study is to evaluate the immunogenicity of live attenuated varicella vaccine co-administered with MMR vaccine or DTaP vaccine. The secondary objective is to evaluate the safety of the vaccines when administered simultaneously.
详细描述
A total of 720 children aged 18~24 months who have not received varicella vaccine, the second dose of MMR and the fourth dose of DTaP (or vaccines containing related ingredients) will be recruited and randomly assigned to one of three study groups (1:1:1 ratio): Group A, Group B and Group C. Participants in Group A will receive varicella vaccine and DTaP simultaneously on Day 0 and receive MMR on Day 30. Participants in Group B will varicella vaccine and MMR simultaneously on Day 0 and receive DTaP on Day 30. Participants in Group C will receive varicella vaccine only.
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
- None
入排标准
- 年龄范围
- 18 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants aged 18-24 months;
- •have completed 3 doses of DTaP for primary immunization in their first year of life without the fourth dose of Dtap-containing vaccine;
- •have completed the first dose of MMR in their first year of life without a second dose of MMR;
- •Guardians of participants who are able to understand and voluntarily sign informed consent;
- •Provision of legal proof of identity.
排除标准
- •Having a history of previous varicella vaccination;
- •Having a history of chickenpox, pertussis, diphtheria, tetanus, measles, mumps, and rubella;
- •Having a history of uncontrolled chronic or serious diseases, including but not limited to cardiovascular diseases, hematological diseases, liver and kidney diseases, digestive diseases, respiratory diseases, malignant tumors, major functional organ transplantation, etc.;
- •Presence of autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection);
- •Presence of abnormal coagulation function (e.g. coagulation factor deficiency, platelet abnormality);
- •Having/Previous having a severe neurological disorder (epilepsy, seizures, or convulsions) or psychosis, or have a family history of psychosis;
- •Acute onset of various acute or chronic illnesses within the last 7 days, or known or suspected active infection;
- •Receipt of > 14 days of immunosuppressive or other immunomodulatory therapy (prednisone ≥2 mg/kg/ day or its equivalent, except topical or inhaled corticosteroids), cytotoxic therapy within the past 6 months, or planned to receive such therapy during the trial;
- •Having received immune globulin or other blood products within the past 3 months or plan to receive such treatment during the trial;
- •Receipt of another study drug or vaccine within the past 30 days or plans to receive such drug or vaccine during the trial;
- •Administration of live attenuated vaccine within the past 28 days or subunit, inactivated, or other process vaccine within the past 7 days;
- •Known allergies to the vaccine or vaccine components, such as urticaria after vaccination, dyspnea, angioedema;
- •Having fever on the day of scheduled vaccination (axillary temperature > 37.0 ° C);
- •Failure of medical examination on the planned vaccination day;
- •Participants have any other factors that, in the judgment of the investigator, make them ineligible to participate in a clinical trial.
研究组 & 干预措施
Group A (Varicella vaccine and DTaP co-administration group )
Participants will receive a single dose of varicella vaccine and DTaP vaccine on Day 0 and a single dose of MMR on Day 30.
干预措施: Vaicella Vaccine+DTaP on Day 0, MMR on Day 30 (Biological)
Group B (Varicella vaccine and MMR co-administration group )
Participants will receive a single dose of varicella vaccine and MMR on Day 0 and DTaP vaccine on Day 30.
干预措施: Varicella vaccine+MMR on Day 0，DTaP on Day 30 (Biological)
Group C (Varicella vaccine group )
Participants will receive a single dose of varicella vaccine on Day 0.
干预措施: Varicella Vaccine (Biological)
结局指标
主要结局
Varicella zoster virus (VZV) antibody seroconversion rate
时间窗: Day 30 after the administration of varicella vaccine
Seroconversion rate of VZV antibody on Day 30 after the administration of varicella vaccine.
次要结局
- Seropositive rate of VZV antibody(Day 30 after the administration of varicella vaccine)
- Geometric mean titer (GMT) of VZV antibody(Day 30 after the administration of varicella vaccine)
- Geometric mean fold increase (GMI) of VZV antibody(Day 30 after the administration of varicella vaccine)
- Seroconversion rate of measles antibody, mumps antibody and rubella antibody(Day 30 after the administration of MMR)
- Seropositive rate of measles antibody, mumps antibody and rubella antibody(Day 30 after the administration of MMR)
- Geometric mean concentration (GMC) of measles antibody, mumps antibody and rubella antibody(Day 30 after the administration of MMR)
- GMI of measles antibody, mumps antibody and rubella antibody(Day 30 after the administration of MMR)
- Seroconversion rate of pertussis antibody, diphtheria antibody and tetanus antibody(Day 30 after the administration of DTaP)
- Seropositive rate of pertussis antibody, diphtheria antibody and tetanus antibody(Day 30 after the administration of DTaP)
- GMC of pertussis antibody, diphtheria antibody and tetanus antibody(Day 30 after the administration of DTaP)
- GMI of pertussis antibody, diphtheria antibody and tetanus antibody(Day 30 after the administration of DTaP)
- The incidence of adverse reactions within 0~14 days(0~14 days after each dose vaccination)
- The incidence of adverse reactions within 0~30 days(0~30 days after each dose vaccination)
- The incidence of serious adverse events (SAEs) within 0~30 days(0~30 days after each dose vaccination)