To Evaluate the Immunogenicity and Safety of Two Different Immunization Schedules of Rabies Vaccine (Vero Cell) (rabies)

Hualan Biological Bacterin

Status and phase: Completed; Phase 3

Conditions: Rabies Human

Treatments: Biological: Experimental vaccine; Biological: Control vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06177249

2014L00266

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,956 patients

Sex: All

Ages: 9 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,956 participants in 2 patient groups

Experimental vaccines and vaccine

Active Comparator group

Description:

A total of 1956 subjects were randomly divided into three groups at a ratio of 1:1:1, 652 subjects in each group were vaccinated with the test vaccine or the control vaccine on a schedule of 0, 3, 7, 14, 28 days (a total of 5 doses). Blood samples were collected from the subjects for antibody detection on 0, 7/14, 35/42 days, respectively.

Treatment:

Biological: Control vaccine

Biological: Experimental vaccine

experimental vaccines

Active Comparator group

Description:

An additional group of 652 people received the trial vaccine in a 0 -, 7 -, and 21-day schedule (two first doses for a total of four doses). Blood samples were collected at 0, 7/14 and 35/42 days for antibody detection, and all subjects were systematically observed for safety.

Treatment:

Biological: Experimental vaccine