NCT04618939已完成3 期
Double Blind, Randomized Phase III Study to Evaluate the Immunogenicity and Safety of 'BR-TD-1001' Administered Intramuscularly in Healthy Children
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 9
- 主要终点
- The seroprotection rate of anti-diphtheria toxoid (DT) and anti-tetanus toxoid (TT) at 28 days after vaccination with the investigational products
研究概览
简要总结
The purpose of this study is to evaluate immunogenicity by measuring the seroprotection rate against diphtheria and tetanus at 28 days after vaccination with BR-TD-1001 and Td-pur-inj.
详细描述
Primary objective:
To evaluate immunogenicity by measuring the seroprotection rate against diphtheria and tetanus at 28 days after vaccination with BR-TD-1001 and Td-pur-inj.
Secondary objectives:
- To evaluate immunogenicity by measuring the geometric mean titer (of diphtheria and tetanus antitoxins at 28 days after vaccination with BR-TD-1001 and Td-pur-inj.
- To evaluate a boosting response by comparing before and after the administration through measurement of diphtheria and tetanus antitoxin titers at 28 days after vaccination with BR-TD-1001 and Td-pur-inj.
- To evaluate safety by observing solicited local and systemic adverse events that have occurred for 7 days after vaccination with BR-TD-1001 and Td-pur-inj.
- To evaluate safety by observing unsolicited adverse events that have occurred for 28 days after vaccination with BR-TD-1001 and Td-pur-inj.
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
- Double (Participant, Investigator)
盲法说明
double-blind
入排标准
- 年龄范围
- 10 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy boys and girls aged 10 to 12 years
- •Those who received primary immunization (5 doses of diphtheria and tetanus vaccination until the age of 6)
- •Voluntary written consent of the subject and the legally acceptable representative(LAR) to participate in this clinical study
排除标准
- •2 weeks have not passed since recovery from an acute disease
- •Temporary thrombocytopenia or neurological complications due to diphtheria or tetanus vaccination
- •History of a severe allergy to any component of the investigational product
- •History of a severe adverse event due to administration of diphtheria, tetanus, or diphtheria tetanus combined vaccine
- •Administration of tetanus, diphtheria, or diphtheria tetanus combined vaccine within 5 years
- •Unable to verify diphtheria and tetanus vaccination completed until the age of 6
- •History of infection with diphtheria or tetanus (if clinically, serologically or microbiologically confirmed)
- •Current chronic disease that impedes implementation or completion of the clinical study
- •Scheduled surgery during the study period
- •Acute fever with a tympanic temperature exceeding 38.0ºC within 72 hours before administration of the investigational vaccine
- •Administration of other vaccines within 28 days before screening
- •Use of immunosuppressants or immune modifying drugs within 3 months before screening
- •Those who have received immunoglobulin therapies or blood derived products within 3 months before screening, or are expected to receive them during the study period
- •Use of antipyretics/analgesics/nonsteroidal anti inflammatory drugs within 4 hours before administration of the investigational vaccine
- •Participation in other clinical studies within 28 days before screening
- •Those who were determined by the investigator to be ineligible for other reasons
结局指标
主要结局
The seroprotection rate of anti-diphtheria toxoid (DT) and anti-tetanus toxoid (TT) at 28 days after vaccination with the investigational products
时间窗: 28 days after vaccination
Seroprotection was defined as anti-DT and anti-TT antibody concentrations ≥ 0.1 IU/mL (ELISA)
次要结局
- The geometric mean titer (GMT) of anti-DT and anti-TT at 28 days after vaccination with the investigational products(28 days after vaccination)
- The boosting response for antitoxins of diphtheria and tetanus at 28 days after vaccination with the investigational product(28 days after vaccination)
研究者
研究点 (9)
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