Changchun Zhuoyi Biological Co., Ltd
Changchun, Jilin, 130000, China
Enrolling by Invitation
NCT Number: NCT05545371
Prevention of Rabies With Four Doses of Rabies Vaccine
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.
Enrolling by Invitation
Interested in participating?
Request InfoKey information
Conditions
Age range
10 year–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
About this study
- 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).
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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;
Treatment and study plan
immunization procedures
BiologicalThe subjects were vaccinated with rabies vaccine according to different immunization procedures
Primary outcomes
-
Positive conversion rate of 14 days
Time frame: 6 months
- 14 days after the first dose of inoculation, the positive conversion rate of serum neutralizing antibody.
-
Antibody Geometric Mean Titer (GMT) of 14 days
Time frame: 6 months
- 14 days after the first dose of inoculation, the Geometric Mean Titer (GMT) of serum neutralizing antibody .
-
Positive conversion rate of 42 days
Time frame: 6 months
- The seroconversion rate of serum neutralizing antibody that 42 days after the first dose of inoculation.
-
Advertise Events (AE) incidence within 1 month
Time frame: 6 months
- 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
Time frame: 12 months
- Incidence rate of SAE within 6 months from the first dose of inoculation to the full course of inoculation.
Secondary outcomes
-
Antibody test of 28 days
Time frame: 6 months
Detection of serum neutralizing antibody 28 days after the first dose of inoculation
-
Antibody GMT of 42 days
Time frame: 6 months
The serum neutralized antibody GMT 42 days after the first dose of inoculation;
-
Antibody test within 12 months
Time frame: 18months
The serum neutralizing antibody was detected in 3 timepoints within 12 months after the whole vaccination.
Sponsors and collaborators
Lead sponsor
Changchun Zhuoyi Biological Co., Ltd
Other
Registry information
Official study 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)
Important dates
- Study start
- 2022
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- Sep 19, 2022
- Registry last updated
- Jul 10, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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