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

NCT06177249 | Completed Phase 3

• 1 other identifier: 2014L00266
• Study Type: interventional
• Target: 1,956
• Locations: 1 country
• Sites: 1

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.

Conditions

Rabies Human

Keywords

Antibody Titer

Outcome Measures

Primary Outcomes (4)

• 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

  Tenderness, pruritus, induration, redness, swelling and its degree of size and disturbance of body activity at the inoculation site

  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

  Tenderness, pruritus, induration, redness, swelling and its degree of size and disturbance of body activity at the inoculation site

  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.

  Fever, allergy, headache, fatigue, nausea and vomiting, diarrhea, muscle pain, arthralgia and so on were observed

  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.

  Fever, allergy, headache, fatigue, nausea and vomiting, diarrhea, muscle pain, arthralgia and so on were observed

  Vaccinations 31 days to 180 days

Secondary Outcomes (2)

• The immunogenicity was tested by immunofluorescence staining

  5 agent group gathering subjects were 0, 7, 14, 42 days of blood samples

• The immunogenicity was tested by immunofluorescence staining

  Blood samples were collected on day 0, 7, 14 and 35 in the 4-dose group

Study Arms (2)

Experimental vaccines and vaccine

ACTIVE COMPARATOR

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.

Biological: Control vaccine; Biological: Experimental vaccine

experimental vaccines

ACTIVE COMPARATOR

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.

Biological: Experimental vaccine

Interventions

Control vaccine BIOLOGICAL

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.

Experimental vaccines and vaccine

Experimental vaccine BIOLOGICAL

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.

Experimental vaccines and vaccine; experimental vaccines

Eligibility Criteria

• Age: 9 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• any serious adverse event causally related to vaccination;
• the researchers think that may affect test evaluation of any situation.

Sponsors & Collaborators

• Hualan Biological Bacterin Co. Ltd.: lead
• Henan Center for Disease Control and Prevention: collaborator

Study Sites (1)

Xia Shengli

Zhengzhou, Henan, 450000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Lyophilized rabies vaccine for human use (Vero cell) and control vaccine

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 20, 2023
• Study Start: March 15, 2015
• Primary Completion: December 16, 2015
• Study Completion: May 1, 2016
• Last Updated: December 20, 2023

Record last verified: 2015-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)