Status:
COMPLETED
To Evaluate the Immunogenicity and Safety of Two Different Immunization Schedules of Rabies Vaccine (Vero Cell)
Lead Sponsor:
Hualan Biological Bacterin Co. Ltd.
Collaborating Sponsors:
Henan Center for Disease Control and Prevention
Conditions:
Rabies Human
Eligibility:
All Genders
9-65 years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
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 posi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 15 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
1956 Patients enrolled
Trial Details
Trial ID
NCT06177249
Start Date
March 15 2015
End Date
May 1 2016
Last Update
December 20 2023
Active Locations (1)
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1
Xia Shengli
Zhengzhou, Henan, China, 450000