Evaluation With Rabies Vaccine (Vero Cell) of Two Different Immune Procedure in the Healthy Crowd the Immunogenicity and Safety of Randomized, Blinded, Similar Vaccine Against Ⅲ Phase of Clinical Trials
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,956
- 试验地点
- 1
- 主要终点
- 1956 subjects accept the observation of systemic adverse reactions according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention.
研究概览
简要总结
To evaluate the safety and immunogenicity of lyophilized human rabies vaccine (Vero cell) developed by Hualan Biological in healthy people aged 9 to 65 years with two different immunization schedules.
详细描述
The trial to assess the rabies vaccine (Vero cells) in healthy group of 9 ~ 65 years old after inoculation, the first dose after 14 days and 14 days after inoculation 5 agent group turn antibody positive rate of bad effect on 5 agent in the control group; The safety profile, seroconversion rate, and geometric mean concentration of the four-dose vaccine were noninferior to those of the five-dose regimen at 14 days after the first dose. More people aged 9-65 in the first agent free after 7 days, 14 days and 14 days after inoculation, 5 patients and 5 doses in the control group, four patients and 5 doses group antibody positive rate, GMC and GMC growth multiples have differences. To evaluate whether the seroconversion rate of subjects in the 4-dose experimental group reached 100% 14 days after the whole course of vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blind
入排标准
- 年龄范围
- 9 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •9 to 65 years old healthy residents;
- •volunteered for the experiment and signed informed consent;
- •the subjects or their guardians can comply with the requirements of the clinical trial protocol;
- •have not received rabies vaccination at any time;
- •nearly six months has not been mammals bite, scratch;
- •not participating in clinical trials of other drugs;
- •No use of human immunoglobulin or other products in the past six months.
排除标准
- •First needle exclusion:
- •have allergies, convulsions, seizures, mental and nervous system, such as history, or family history of epilepsy;
- •Allergic to the main ingredient of the investigational vaccine;
- •known to people with poor immune function damage or the tumor, spleen;
- •Axillary temperature >38.0℃ within 7 days due to acute febrile illness;
- •Patients with axillary body temperature > 37.0℃;
- •Severe chronic diseases such as congenital malformation, developmental disorder or severe cardiovascular disease, diabetes mellitus, hypertension that cannot be stabilized by drugs, liver and kidney diseases, and malignant tumors;
- •patients with acute and chronic infectious diseases, active infections, severe asthma, infectious skin diseases;
- •pregnant and lactating women; Any circumstances that the investigator believes may affect the assessment of the trial.
- •Subsequent needle exclusions:
- •any serious adverse event causally related to vaccination;
- •new findings that meet the "first dose exclusion criteria";
- •the researchers think that may affect test evaluation of any situation.
结局指标
主要结局
1956 subjects accept the observation of systemic adverse reactions according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention.
时间窗: Vaccinations 31 days to 180 days
Fever, allergy, headache, fatigue, nausea and vomiting, diarrhea, muscle pain, arthralgia and so on were observed
1956 subjects accept the observation of local adverse reaction according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention
时间窗: Vaccinations 31 days to 180 days
Tenderness, pruritus, induration, redness, swelling and its degree of size and disturbance of body activity at the inoculation site
次要结局
- The immunogenicity was tested by immunofluorescence staining(Blood samples were collected on day 0, 7, 14 and 35 in the 4-dose group)