Prevention of Rabies With Four Doses of Rabies Vaccine

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)

Status

Enrolling by invitation

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05545371

Enrollment

2100

Registered

2022-09-19

Start date

2022-06-18

Completion date

2024-12-30

Last updated

2024-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibody, Rabies Human

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).

Interventions

BIOLOGICALimmunization procedures

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

10 Years to 60 Years

Healthy volunteers

Yes

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;

Design outcomes

Primary

Measure	Time frame	Description
Serious Adverse Events (SAE) incidence within 6 months	12 months	\- Incidence rate of SAE within 6 months from the first dose of inoculation to the full course of inoculation.
Antibody Geometric Mean Titer (GMT) of 14 days	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	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	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;
Positive conversion rate of 14 days	6 months	\- 14 days after the first dose of inoculation, the positive conversion rate of serum neutralizing antibody.

Secondary

Measure	Time frame	Description
Antibody GMT of 42 days	6 months	The serum neutralized antibody GMT 42 days after the first dose of inoculation;
Antibody test within 12 months	18months	The serum neutralizing antibody was detected in 3 timepoints within 12 months after the whole vaccination.
Antibody test of 28 days	6 months	Detection of serum neutralizing antibody 28 days after the first dose of inoculation

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026