Clinical trial
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
Name
2014L00266
Description
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.
Trial arms
Trial start
2015-03-15
Estimated PCD
2015-12-16
Trial end
2016-05-01
Status
Completed
Phase
Early phase I
Treatment
Control vaccine
A group of 652 subjects were vaccinated with the control vaccine at 0, 3, 7, 14 and 28 days (5 doses in total). Blood samples were collected from the subjects at 0, 7/14 and 35/42 days for antibody detection.
Arms:
Experimental vaccines and vaccine
Experimental vaccine
A total of 652 subjects received 5 doses of the vaccine at 0, 3, 7, 14 and 28 days. Blood samples were collected on 0, 7/14 and 35/42 days for antibody detection.
Arms:
Experimental vaccines and vaccine, experimental vaccines
Size
1956
Primary endpoint
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
Every needle 30 days after vaccination
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
Vaccinations 31 days to 180 days
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.
Every needle 30 days after vaccination
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.
Vaccinations 31 days to 180 days
Eligibility criteria
Inclusion Criteria:
* 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 Criteria:
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Lyophilized rabies vaccine for human use (Vero cell) and control vaccine', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'double blind', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 1956, 'type': 'ACTUAL'}}
Updated at
2023-12-20
1 organization
2 products
1 indication
Organization
Hualan Biological BacterinProduct
Control vaccineIndication
Rabies HumanProduct
Experimental vaccine