Prevention of Rabies With Four Doses of Rabies Vaccine

Changchun Zhuoyi Biological

Status and phase

Invitation-only

Phase 3

Conditions

Rabies Human

Antibody

Treatments

Biological: immunization procedures

Study type

Interventional

Funder types

Other

Identifiers

NCT05545371

ZY202106001

Details and patient eligibility

About

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.

Full 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).

Enrollment

2,100 estimated patients

Sex

All

Ages

10 to 60 years old

Volunteers

Accepts Healthy Volunteers

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;