Immunogenicity and Safety of Enterovirus Type 71 Vaccine, Inactivated in Healthy Children Aged 6~71 Months: A Single-armed Bridging Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Seroconversion rate of Enterovirus Type 71 (EV71) neutralizing antibodies
研究概览
简要总结
The purpose of this study is to evaluate the immunogenicity and safety of an inactivated Enterovirus Type 71 (EV71) vaccine, manufactured by Sinovac, in healthy Vietnamese children aged 6 to 71 months.
Hand, Foot, and Mouth Disease (HFMD) is a common infectious disease in children, and EV71 is a major cause of severe complications and outbreaks in the Asia-Pacific region, including Vietnam. While this vaccine has demonstrated high efficacy and a favorable safety profile in previous clinical trials conducted in China, this study aims to generate specific bridging data for the Vietnamese pediatric population.
This is a single-armed bridging clinical trial that plans to enroll approximately 320 healthy participants. Each participant will receive two doses of the EV71 vaccine administered intramuscularly on a 0 and 30-day schedule. The primary objective is to assess the seroconversion rate of neutralizing antibodies 30 days after the second dose. Safety will be assessed by monitoring the incidence of adverse reactions and serious adverse events (SAEs) throughout the study duration (approximately 2 months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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 6~71 months when receiving the first dose of investigational EV71 vaccine;
- •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, be reachable by the investigator and must be able to contact the investigator throughout the study period.
排除标准
- •Prior history of hand, foot and mouth disease (HFMD);
- •Have been exposed to a case with laboratory-confirmed (virological diagnosis, e.g., via PCR or virus isolation) HFMD at home, day care, or other settings within 2 weeks before enrollment;
- •Prior participated in clinical trial of EV71 vaccine and received any investigational EV71 vaccine;
- •Known allergy to vaccines or vaccine ingredients, or serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
- •Any known or history of autoimmune diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, etc.) or immunodeficiency/immunosuppression (such as HIV infection, organ transplantation), asplenia;
- •Received immunosuppressive for ≥14 days (e.g., prednisone equivalent of ≥2 mg/kg), or cytotoxic drug before enrollment, or plans to receive these treatments during the study participation.
- •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 other vaccines within 14 days prior to vaccination in this study;
- •Presence of any acute disease (moderate to severe illness, with or without fever) or an acute exacerbation of a chronic condition within the 7 days prior to vaccination in this study.
- •Has fever on the day of vaccination, with the axillary temperature ≥ 37.5 celsius before vaccination;
- •Is participating in or planning to participate in other vaccine or drug clinical trials;
- •According to the investigator's judgment, the participant 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
EV71 Vaccine Group
All participants will receive two intramuscular doses of the inactivated Enterovirus Type 71 (EV71) vaccine (0.5 mL per dose) on a 0 and 30-day schedule.
干预措施: EV71 vaccine (Biological)
结局指标
主要结局
Seroconversion rate of Enterovirus Type 71 (EV71) neutralizing antibodies
时间窗: 30 days after the second dose of vaccination
Seroconversion is defined as: (1) a post-vaccination neutralizing antibody titer of ≥ 1:8 in participants with a pre-vaccination titer of \< 1:8; or (2) at least a four-fold increase in neutralizing antibody titer in participants with a pre-vaccination titer of ≥ 1:8.
次要结局
- Seropositive rate, GMT and GMFR of neutralizing antibodies(30 days after the second dose of vaccination)
- Safety endpoints(From the first dose vaccination until 30 days after the second dose vaccination)
- Seropositive rate of Enterovirus Type 71 (EV71) neutralizing antibodies(30 days after the second dose of vaccination)
- GMT of Enterovirus Type 71 (EV71) neutralizing antibodies(30 days after the second dose of vaccination)
- GMFR of Enterovirus Type 71 (EV71) neutralizing antibodies(30 days after the second dose of vaccination)
- Incidence of adverse reactions within 30 days(30 days after each dose vaccination)
- Incidence of adverse reactions within 7 days(7 days after each dose vaccination)
- Incidence of SAE(From the first dose vaccination until 30 days after the second dose vaccination)