Prevention of Rabies With Four Doses of Rabies Vaccine

Rabies Human Clinical Trial

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05545371
• Other study ID #: ZY202106001
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: June 18, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: Changchun Zhuoyi Biological Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2100
• Est. completion date: December 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 60 Years

Eligibility

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;

Related Conditions & MeSH terms

• Rabies
• Rabies Human

Intervention

Biological:
• immunization procedures
The subjects were vaccinated with rabies vaccine according to different immunization procedures

Locations

Country	Name	City	State
China	Changchun Zhuoyi Biological Co., Ltd	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Changchun Zhuoyi Biological Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive conversion rate of 14 days	- 14 days after the first dose of inoculation, the positive conversion rate of serum neutralizing antibody.	6 months
Primary	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 .	6 months
Primary	Positive conversion rate of 42 days	- The seroconversion rate of serum neutralizing antibody that 42 days after the first dose of inoculation.	6 months
Primary	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;	6 months
Primary	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.	12 months
Secondary	Antibody test of 28 days	Detection of serum neutralizing antibody 28 days after the first dose of inoculation	6 months
Secondary	Antibody GMT of 42 days	The serum neutralized antibody GMT 42 days after the first dose of inoculation;	6 months
Secondary	Antibody test within 12 months	The serum neutralizing antibody was detected in 3 timepoints within 12 months after the whole vaccination.	18months