Clinical trial NCT06177249: To Evaluate the Immunogenicity and Safety of Two Different Immunization Schedules of Rabies Vaccine (Vero Cell)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rabies Human
Keywords: Antibody Titer
Lead sponsor: Hualan Biological Bacterin Co. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Henan Center for Disease Control and Prevention
First posted: 2023-12-20
Enrollment: 1956
Sex: ALL
Minimum age (years): 9
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Lyophilized rabies vaccine for human use (Vero cell) and control vaccine
Primary purpose: HEALTH_SERVICES_RESEARCH

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 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.

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.

Primary outcomes:
measure: 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
timeFrame: Every needle 30 days after vaccination
measure: 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
timeFrame: Vaccinations 31 days to 180 days
measure: 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.
timeFrame: Every needle 30 days after vaccination
measure: 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.
timeFrame: Vaccinations 31 days to 180 days
Secondary outcomes:
measure: The immunogenicity was tested by immunofluorescence staining
timeFrame: 5 agent group gathering subjects were 0, 7, 14, 42 days of blood samples
measure: The immunogenicity was tested by immunofluorescence staining
timeFrame: Blood samples were collected on day 0, 7, 14 and 35 in the 4-dose group
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Xia Shengli
state: Henan
Study officials:
References: