Multicenter, Randomized, Double-blind, Placebo-Controlled Phase IIIa Clinical Trial on the Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell) in Children Aged 6 to 71 Months.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 6,000
- 试验地点
- 5
研究概览
简要总结
This multicenter, randomized, double-blind, placebo-controlled phase IIIa clinical trial aims to evaluate the protective efficacy , immunogenicity and safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell) in Children aged 6 to 71 months.
Participants will be randomly assigned in a 1:1 ratio to the trial group and the placebo group, receiving two doses of experimental vaccine or placebo , with a one-month interval between the two doses.
详细描述
This trial employs a multicenter, randomized, double-blind, placebo-controlled design.With informed consent, 6000 children participants aged 6 to 71 months will be enrolled, with 2800 participants aged 6 to 23 months and 3200 participants aged 24 to 71 months, maintaining a balanced gender ratio. All participants will be randomly assigned to the trial and placebo groups at a 1:1 ratio, receiving two doses of experimental vaccine or placebo , with a one-month interval between the two doses.
Protective Efficacy Assessment: Each participant enters the case monitoring period after receiving the first dose of vaccination, which lasts until the end of two consecutive hand, foot and mouth disease (HFMD) epidemic seasons (i.e., the peak incidence period; bimodal epidemics occurring within the same year shall be regarded as one single epidemic season).
The valid case monitoring period commences on Day 15 after the second dose, and the period prior thereto is defined as the surveillance window period. During case monitoring , suspected cases identified through active follow-up by investigators or spontaneous reports from participants' guardians shall be subjected to nucleic acid testing using pharyngeal swabs and/or anal swabs collected once within 3 days after the initial onset of symptoms, with subsequent follow-up and specimen sampling conducted according to test results.
Safety Assessment: Adverse events (AEs) occurring within 30 minutes after each vaccination shall be collected from all participants. Serious adverse events (SAEs) will be monitored from the first dose administration until 6 months after the last dose, with SAE follow-up visits conducted once monthly. All AEs identified via spontaneous reports from participants' guardians or any other sources from the first dose up to 30 days after the last dose will be closely monitored, truthfully recorded and included in the analysis.
A total of 3000 participants will be enrolled in the reactogenicity subgroup, including 1400 children aged 6-23 months and 1600 children aged 24-71 months. On the basis of the above safety observations, participants in the reactogenicity subgroup shall record solicited and unsolicited AEs within 0 to 7 days after each vaccination using diary cards, and collect AEs occurring from Day 8 to Day 30 after each vaccination via contact cards.
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
- 6 Months 至 71 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children aged 6 to 71 months.
- •Guardians who can understand and voluntarily sign the informed consent form
- •Willing and able to comply with all visit schedules, sample collection, vaccinations, and other trial procedures。
- •Provide legal identification for the participant and their guardian
排除标准
- •A known history of HFMD/HA
- •Uncontrolled chronic diseases or a history of severe illnesses, including but not limited to cardiovascular diseases, blood disorders, liver or kidney diseases, digestive system diseases, respiratory system diseases, malignant tumors, or a history of major functional organ transplantation.
- •Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection).
- •Abnormal coagulation function (such as coagulation factor deficiencies,and platelet abnormalities).
- •Suffering from/having a history of severe neurological diseases (epilepsy, convulsions, or seizures [excluding a history of febrile seizures]) ,psychiatric disorders, or a family history of psychiatric disorders
- •Various acute diseases or exacerbations of chronic diseases within the last 3 days.
- •Having been vaccinated with a vaccine containing any of the components EV71, CA16, CA10, CA
- •Having received ≥14 days of immunosuppressive or other immunomodulatory treatment (prednisone ≥2mg/kg/day, or its equivalent; local or inhaled corticosteroids excluded) within the past 6 months, or cytotoxic treatment, or planning to receive such treatment during the trial.
- •Having received immunoglobulin or other blood products(excluding hepatitis B immunoglobulin) within the past 6 months, or planning to receive such treatment during the trial.
- •Having received other investigational drugs or vaccines within the past 30 days, or planning to receive such drugs or vaccines during the trial.
- •Having received live attenuated vaccines or nucleic acid vaccines within the past 14 days, or subunit or inactivated vaccines within the past 7 days.
- •Known allergy to any component of the investigational vaccine (inactivated EV71 virus, inactivated CA16 virus, , inactivated CA10 virus,, inactivated CA6 virus,aluminum hydroxide, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate, injectable water).
- •On the day of planned vaccination with the investigational vaccine, having an axillary temperature ≥37.3°C before vaccination, or other vital sign measurements outside the normal range,or the physical examination is not qualified.
- •According to the investigator's judgment, participants have any other factors that make them unsuitable for participation in the clinical trial.