Back to resultsPrevention of Rabies With Four Doses of Rabies Vaccine
Primary Purpose
Rabies Human, Antibody
Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
immunization procedures
Sponsored by
About this trial
This is an interventional prevention trial for Rabies Human
Eligibility Criteria
Inclusion Criteria:
- People aged 10-60；
- Body temperature on the day of enrollment<37.3℃ (axillary temperature)
Exclusion Criteria:
- Have a history of rabies vaccine immunization or use of rabies virus passive immunization agents；
- People with congenital or acquired immunodeficiency or other autoimmune diseases；
- Female urine pregnancy test is positive, or during pregnancy and lactation, or she has a birth plan during the study period;
Sites / Locations
- Changchun Zhuoyi Biological Co., Ltd
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
4 doses
5 doses
Arm Description
Inoculate rabies vaccine according to 1-1-1-1 immunization procedure
Inoculate rabies vaccine according to 1-1-1-1-1 immunization procedure
Outcomes
Primary Outcome Measures
Positive conversion rate of 14 days
- 14 days after the first dose of inoculation, the positive conversion rate of serum neutralizing antibody.
Antibody Geometric Mean Titer (GMT) of 14 days
- 14 days after the first dose of inoculation, the Geometric Mean Titer (GMT) of serum neutralizing antibody .
Positive conversion rate of 42 days
- The seroconversion rate of serum neutralizing antibody that 42 days after the first dose of inoculation.
Advertise Events (AE) incidence within 1 month
- The distribution of AE incidence in different time periods (including all, within 30 minutes, 0-3 days, 0-7 days, 8-30 days) after each dose of inoculation;
Serious Adverse Events (SAE) incidence within 6 months
- Incidence rate of SAE within 6 months from the first dose of inoculation to the full course of inoculation.
Secondary Outcome Measures
Antibody test of 28 days
Detection of serum neutralizing antibody 28 days after the first dose of inoculation
Antibody GMT of 42 days
The serum neutralized antibody GMT 42 days after the first dose of inoculation;
Antibody test within 12 months
The serum neutralizing antibody was detected in 3 timepoints within 12 months after the whole vaccination.
Full Information
NCT ID
NCT05545371
First Posted
September 14, 2022
Last Updated
February 6, 2023
Sponsor
Changchun Zhuoyi Biological Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05545371
Brief Title
Prevention of Rabies With Four Doses of Rabies Vaccine
Official Title
Randomized, Blind and Positive Control Design: a Phase III Clinical Trial to Evaluate the Consistency Between Batches of 5 Doses of Freeze-dried Rabies Vaccine (Vero Cell) and the Immunogenicity and Safety of 4 Doses of Vaccine (1-1-1-1)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 18, 2022 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changchun Zhuoyi Biological Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the non inferiority of the immunogenicity of the test vaccine inoculated according to the four dose immunization program over the five dose immunization program and the batches consistency of immunogenicity according to five dose immunization procedures.
Detailed Description
In the population aged 10-60 years, evaluate the non inferiority of the immunogenicity of the test vaccine inoculated according to the four dose immunization program (0, 3, 7, 14/28 days) over the five dose immunization program (0, 3, 7, 14, 28 days)；
To evaluate the consistency of immunogenicity between batches of freeze-dried human rabies vaccine (Vero cell) inoculated according to five dose immunization procedures (0, 3, 7, 14, 28 days).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rabies Human, Antibody
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
4 doses
Arm Type
Experimental
Arm Description
Inoculate rabies vaccine according to 1-1-1-1 immunization procedure
Arm Title
5 doses
Arm Type
Experimental
Arm Description
Inoculate rabies vaccine according to 1-1-1-1-1 immunization procedure
Intervention Type
Biological
Intervention Name(s)
immunization procedures
Intervention Description
The subjects were vaccinated with rabies vaccine according to different immunization procedures
Primary Outcome Measure Information:
Title
Positive conversion rate of 14 days
Description
- 14 days after the first dose of inoculation, the positive conversion rate of serum neutralizing antibody.
Time Frame
6 months
Title
Antibody Geometric Mean Titer (GMT) of 14 days
Description
- 14 days after the first dose of inoculation, the Geometric Mean Titer (GMT) of serum neutralizing antibody .
Time Frame
6 months
Title
Positive conversion rate of 42 days
Description
- The seroconversion rate of serum neutralizing antibody that 42 days after the first dose of inoculation.
Time Frame
6 months
Title
Advertise Events (AE) incidence within 1 month
Description
- The distribution of AE incidence in different time periods (including all, within 30 minutes, 0-3 days, 0-7 days, 8-30 days) after each dose of inoculation;
Time Frame
6 months
Title
Serious Adverse Events (SAE) incidence within 6 months
Description
- Incidence rate of SAE within 6 months from the first dose of inoculation to the full course of inoculation.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Antibody test of 28 days
Description
Detection of serum neutralizing antibody 28 days after the first dose of inoculation
Time Frame
6 months
Title
Antibody GMT of 42 days
Description
The serum neutralized antibody GMT 42 days after the first dose of inoculation;
Time Frame
6 months
Title
Antibody test within 12 months
Description
The serum neutralizing antibody was detected in 3 timepoints within 12 months after the whole vaccination.
Time Frame
18months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
People aged 10-60；
Body temperature on the day of enrollment<37.3℃ (axillary temperature)
Exclusion Criteria:
Have a history of rabies vaccine immunization or use of rabies virus passive immunization agents；
People with congenital or acquired immunodeficiency or other autoimmune diseases；
Female urine pregnancy test is positive, or during pregnancy and lactation, or she has a birth plan during the study period;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Miao
Organizational Affiliation
Changchun Zhuoyi Biological Co., Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Changchun Zhuoyi Biological Co., Ltd
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
safety and antibody results.
IPD Sharing Time Frame
before December 2024.
IPD Sharing Access Criteria
public to all.
Learn more about this trial
Prevention of Rabies With Four Doses of Rabies Vaccine
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