A Phase 3 interventional study of Sinovac rabies vaccine and Marketed rabies vaccine in Rabies (Healthy Volunteers), sponsored by Sinovac Biotech Co., Ltd. Completed at 2 sites in China. Open to participants aged 10 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by Sinovac Biotech Co., Ltd · Phase 3, Interventional, and Prevention
To evaluate the immunogenicity and safety of different post-exposure prophylaxis (PEP) schedules of Sinovac rabies vaccine, in comparison with a marked rabies vaccinein china, in subjects aged 10-60 years old.
This clinical trial is designed as a randomized, blinded, homologous vaccine-controlled and non-inferiority trial, which consists of two parts.
Part 1 (Pilot Study):
First, 20 subjects aged 18-60 years are enrolled to receive the trial vaccine (Sinovac rabies vaccine) according to the 5-dose schedule on Days 0, 3, 7, 14 and 28. A preliminary safety assessment is conducted on Day 7 after the third dose (before the fourth dose). If the incidence of Grade 3 and above AEs does not exceed 15%, and no death or life-threatening SAE related to vaccination occurs, another 20 subjects aged 10-17 years are enrolled. A safety assessment is performed again on Day 7 after full-course vaccination. If the incidence of Grade 3 and above AEs during the entire observation period does not exceed 15%, and no death or life-threatening SAE related to vaccination occurs, the trial proceeds to Part 2. All subjects are observed for safety up to 6 months after full-course vaccination.
Part 2:
A total of 2,000 subjects are enrolled, and randomized at a 1:1:1:1 ratio, 500 in the 5-dose trial group, 500 in the 5-dose control group, 500 in the 4-dose trial group 1, and 500 in the 4-dose trial group 2. The subjects in the 5-dose trial group and the 5-dose control group receive one dose of the trial vaccine or control vaccine (a marketed rabies vaccine in China) on Days 0, 3, 7, 14 and 28, respectively. The subjects in the 4-dose trial group 1 receive one dose of the trial vaccine on Days 0, 3, 7 and 14; and the subjects in the 4-dose test group 2 receive one dose of the trial vaccine on Days 0, 3, 7 and 28.
Blood samples were collected on Day 0, 14, 28, 42, as well as 3 and 6 months after the full-course vaccination, which was for testing serum neutralizing antibodies are detected using the Rapid Fluorescent Focus Inhibition Test (RFFIT). Solicited AEs within 0-7 days after each dose, unsolicited AEs from the first dose to 30 days after full-course vaccination, and all SAEs from the first dose to 6 months after full-course vaccination are collected.
114 studies on the registry are indexed under Rabies; 15 are open to participants now.
This study's enrollment of 2,040 is above the median of 201 across 104 interventional studies indexed under Rabies.
Browse Rabies studies →Sinovac Biotech Co., Ltd is the lead sponsor of 93 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will be randomly assigned to receive 5 doses of Sinovac rabies vaccine on Day 0,3,7,14,28
Biological: Sinovac rabies vaccine
Subjects will be randomly assigned to receive 4 doses of Sinovac rabies vaccine on Day 0,3,7,14
Biological: Sinovac rabies vaccine
Subjects will be randomly assigned to receive 4 doses of Sinovac rabies vaccine on Day 0,3,7,28
Biological: Sinovac rabies vaccine
Subjects will be randomly assigned to receive 5 doses of a marketed rabies vaccine in China on Day 0,3,7,14,28
Biological: Marketed rabies vaccine
Rabies Vaccine (Serum-free Vero Cell), Freeze-dried using three types of PEP schedules
A markted Rabies Vaccine using 5 doses of PEP schedules
Seroconversion rate of rabies neutralizing antibodies in pre-vaccination negative subjects of each group
Time frame: Day 14 after the first dose vaccination
Seroconversion rate of serum rabies neutralizing antibody in pre-vaccination negative subjects of each group
Time frame: Day 42 after the first dose vaccination
GMC of rabies neutralizing antibodies in pre-vaccination negative subjects of each group
Time frame: Day 14 after the first dose vaccination
GMC of serum rabies neutralizing antibody in pre-vaccination negative subjects of each group
Time frame: Day 42 after the first dose vaccination
Seroconversion rate of serum rabies neutralizing antibody in pre-vaccination negative subjects of each group
Time frame: Day 28 after the first dose vaccination.
Seropositive rate of serum rabies neutralizing antibody in Months 3 and 6 post-full-course vaccination for each group
Time frame: Months 3 and 6 post-full-course vaccination
Incidence of adverse events.
Time frame: Up to 30 days after the last-dose vaccination for AEs
GMC of serum rabies neutralizing antibody in pre-vaccination negative subjects of each group
Time frame: Day 28 after the first dose vaccination.
GMC of serum rabies neutralizing antibody in Months 3 and 6 post-full-course vaccination for each group
Time frame: Months 3 and 6 post-full-course vaccination
Incidence of serious adverse events.
Time frame: Up to 6 months after the last-dose vaccination for SAEs;
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2021 to primary completion in Sep 2022, 12 months.
Of 19 phase 3 interventional studies under Rabies, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 21. This study's 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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