Rabies (Healthy Volunteers)Phase 3NCT07357545

Immunogenicity and Safety Assessment of Rabies Vaccine (Vero Cell) for Human Use, Freeze-dried

A Phase 3 study testing Sinovac rabies vaccine and Marketed rabies vaccine in people with Rabies (Healthy Volunteers), run by Sinovac Biotech Co., Ltd at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 10 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Rabies (Healthy Volunteers)
What is being tested?: Sinovac rabies vaccine and Marketed rabies vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,040 participants
Where: 2 sitesChina
Study dates: 27 Aug 2021to 21 Jun 2023
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 60 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Aged 10-60 years at enrollment;
Volunteers and/or their guardians voluntarily agree to participate in the study and sign the ICF.
Volunteers and their families can comply with the protocol requirements for study follow-up (no plans for long-term absence or relocation from the study area);
Female volunteers are not pregnant or lactating (negative urine pregnancy test before vaccination) and have no pregnancy plan within 2 months after enrollment;
Axillary temperature ≤ 37.2°C.

Who cannot join

History of injection with rabies vaccine and specific passive immune preparations, or history of dog or other mammal bites/scratches (Category II exposure or above) within the past year;
History of severe allergies requiring medical intervention from previous vaccinations; other severe allergies, such as allergic shock, angioneurotic edema, allergic purpura, local allergic necrotic reaction (Arthus reaction), severe urticaria, and angioneurotic edema;
Pyrexia (axillary temperature > 38.5°C) within 3 days before the first dose vaccination; suffering from acute or chronic infectious diseases (active tuberculosis, viral hepatitis) or in the acute exacerbation phase of any chronic disease;
Having received blood/blood-related products or immunoglobulins within 3 months before the first dose vaccination; or planning to use such products within 1 month after the last dose vaccination;
Having received live attenuated vaccine within 14 days or any vaccine within 7 days before the first dose vaccination;
Any condition (e.g., splenectomy) leading to asplenia or functional asplenia;

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Diagnosed with congenital or acquired immunodeficiency (HIV), or received immunosuppressant therapy within 3 months (e.g., long-term systemic glucocorticoid use ≥ 14 days, dose ≥ 2 mg/kg/day or ≥ 20 mg/day prednisone or equivalent);
Severe congenital anomaly, autoimmune disease, genetic disease; severe heart disorder, kidney disease, diabetes, or other severe chronic disease;
History of convulsion, epilepsy, or psychotic disorder;
Contraindications for intramuscular injection (e.g., diagnosed thrombocytopenia, any coagulopathy, or anticoagulant therapy);
Hypertension unable to be controlled with drugs, such as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg during physical examination before enrollment (for adults aged 18 and above);
Currently participating in a clinical study of another investigational or unregistered product (drug or vaccine) or planning to participate in other clinical studies before the end of this clinical study;
Any condition of the volunteer that may interfere with the assessment of the study purpose as deemed by the investigator.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Dazhu County Center for Disease Control and Prevention
Dazhou
Yuechi County Center for Disease Control and Prevention
Guang’an

Other trials in China

About this study

Official title: A Randomized, Double-blind and Active-controlled Phase Ⅰ/Ⅲ Clinical Trial to Evaluate Immunogenicity and Safety of Rabies Vaccine (Vero Cell) for Human Use, Freeze-dried, Administered With Different Immunization Schedules in Healthy Individuals Aged 10-60 Years

Read the detailed description

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.

Conditions: Rabies (Healthy Volunteers)
Being tested: Sinovac rabies vaccine, Marketed rabies vaccine
Keywords: rabies vaccine, serum-free
Medical subject headings: Rabies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sinovac rabies vaccineBiological
Rabies Vaccine (Serum-free Vero Cell), Freeze-dried using three types of PEP schedules
Marketed rabies vaccineBiological
A markted Rabies Vaccine using 5 doses of PEP schedules

Study groups in NCT07357545
Study group	Role	What they receive
Sinovac rabies vaccine - 5 doses	Experimental	Subjects will be randomly assigned to receive 5 doses of Sinovac rabies vaccine on Day 0,3,7,14,28 Receives: Biological: Sinovac rabies vaccine
Sinovac rabies vaccine - 4-1 doses	Experimental	Subjects will be randomly assigned to receive 4 doses of Sinovac rabies vaccine on Day 0,3,7,14 Receives: Biological: Sinovac rabies vaccine
Sinovac rabies vaccine - 4-2 doses	Experimental	Subjects will be randomly assigned to receive 4 doses of Sinovac rabies vaccine on Day 0,3,7,28 Receives: Biological: Sinovac rabies vaccine
Marketed rabies vaccine - 5 doses	Active comparator	Subjects will be randomly assigned to receive 5 doses of a marketed rabies vaccine in China on Day 0,3,7,14,28 Receives: Biological: Marketed rabies vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Seroconversion rate of rabies neutralizing antibodies in pre-vaccination negative subjects of each group
Measured: Day 14 after the first dose vaccination
Seroconversion rate of serum rabies neutralizing antibody in pre-vaccination negative subjects of each group
Measured: Day 42 after the first dose vaccination
GMC of rabies neutralizing antibodies in pre-vaccination negative subjects of each group
Measured: Day 14 after the first dose vaccination

Secondary outcomes (7)

GMC of serum rabies neutralizing antibody in pre-vaccination negative subjects of each group
Measured: Day 42 after the first dose vaccination
Seroconversion rate of serum rabies neutralizing antibody in pre-vaccination negative subjects of each group
Measured: 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
Measured: Months 3 and 6 post-full-course vaccination
Incidence of adverse events.
Measured: 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
Measured: 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
Measured: Months 3 and 6 post-full-course vaccination
Incidence of serious adverse events.
Measured: Up to 6 months after the last-dose vaccination for SAEs;

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Aug 202121 Jun 2023

First posted22 Jan 2026
Study start27 Aug 2021
Primary completion21 Sep 2022
Study completion21 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Rabies (Healthy Volunteers)Studies of the same condition, open and under way.
More trials run by Sinovac Biotech Co., LtdThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 2,040 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07357545
Sponsor's protocol ID: BA-CT-001; PRO-PVRV-sf-3001
Status last verified: Jan 2026
First submitted: 5 Jan 2026
Last updated: 22 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Boostability Assessment of Three Rabies Pre-Exposure Regimens in Healthy Volunteers 5 Years Following Priming.
Rabies (Healthy Volunteers)
Not yet recruitingPhase 2
A Phase II Trial of a Recombinant Human Anti-Rabies Virus Monoclonal Antibody
Rabies (Healthy Volunteers)
Not yet recruitingPhase 3
Phase IIIb Clinical Trial to Evaluate Lot-to-lot Consistency of Sinovac Rabies Vaccine
Rabies (Healthy Volunteers)
Not yet recruitingPhase 3
Immunogenicity and Safety of Rabies Vaccine (Serum-free Vero Cell) in a Simulated Post-exposure Prophylaxis Regimen
Rabies (Healthy Volunteers)

All Rabies (Healthy Volunteers) trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind and Active-controlled Phase Ⅰ/Ⅲ Clinical Trial to Evaluate Immunogenicity and Safety of Rabies Vaccine (Vero Cell) for Human Use, Freeze-dried, Administered With Different Immunization Schedules in Healthy Individuals Aged 10-60 Years
ClinicalTrials.gov ID: NCT07357545
Acronym / sponsor ID: BA-CT-001; PRO-PVRV-sf-3001
Conditions: Rabies (Healthy Volunteers)
Keywords: rabies vaccine, serum-free
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,040 participants (actual)
Lead sponsor: Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
Study start: 27 Aug 2021 (actual)
Primary completion: 21 Sep 2022 (actual)
Study completion: 21 Jun 2023 (actual)
First posted: 22 Jan 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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):

Part 2:

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Sinovac rabies vaccine - 5 doses	Experimental	Biological: Sinovac rabies vaccineSubjects will be randomly assigned to receive 5 doses of Sinovac rabies vaccine on Day 0,3,7,14,28
Sinovac rabies vaccine - 4-1 doses	Experimental	Biological: Sinovac rabies vaccineSubjects will be randomly assigned to receive 4 doses of Sinovac rabies vaccine on Day 0,3,7,14
Sinovac rabies vaccine - 4-2 doses	Experimental	Biological: Sinovac rabies vaccineSubjects will be randomly assigned to receive 4 doses of Sinovac rabies vaccine on Day 0,3,7,28
Marketed rabies vaccine - 5 doses	Active comparator	Biological: Marketed rabies vaccineSubjects will be randomly assigned to receive 5 doses of a marketed rabies vaccine in China on Day 0,3,7,14,28

Who may qualify

Ages: 10 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

Aged 10-60 years at enrollment;
Volunteers and/or their guardians voluntarily agree to participate in the study and sign the ICF.
Volunteers and their families can comply with the protocol requirements for study follow-up (no plans for long-term absence or relocation from the study area);
Female volunteers are not pregnant or lactating (negative urine pregnancy test before vaccination) and have no pregnancy plan within 2 months after enrollment;
Axillary temperature ≤ 37.2°C.

Key exclusion criteria (13 listed)

History of injection with rabies vaccine and specific passive immune preparations, or history of dog or other mammal bites/scratches (Category II exposure or above) within the past year;
History of severe allergies requiring medical intervention from previous vaccinations; other severe allergies, such as allergic shock, angioneurotic edema, allergic purpura, local allergic necrotic reaction (Arthus reaction), severe urticaria, and angioneurotic edema;
Pyrexia (axillary temperature > 38.5°C) within 3 days before the first dose vaccination; suffering from acute or chronic infectious diseases (active tuberculosis, viral hepatitis) or in the acute exacerbation phase of any chronic disease;
Having received blood/blood-related products or immunoglobulins within 3 months before the first dose vaccination; or planning to use such products within 1 month after the last dose vaccination;
Having received live attenuated vaccine within 14 days or any vaccine within 7 days before the first dose vaccination;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sinovac rabies vaccineRabies Vaccine (Serum-free Vero Cell), Freeze-dried using three types of PEP schedules	Biological	Sinovac rabies vaccine - 4-1 doses, Sinovac rabies vaccine - 4-2 doses, Sinovac rabies vaccine - 5 doses
Marketed rabies vaccineA markted Rabies Vaccine using 5 doses of PEP schedules	Biological	Marketed rabies vaccine - 5 doses

Primary outcome

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

7 secondary outcomes

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;

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
Individual participant dataSharing planned: No

Related trials for Rabies (Healthy Volunteers)

Not yet recruitingPhase 3
Boostability Assessment of Three Rabies Pre-Exposure Regimens in Healthy Volunteers 5 Years Following Priming.
Rabies (Healthy Volunteers)
Not yet recruitingPhase 2
A Phase II Trial of a Recombinant Human Anti-Rabies Virus Monoclonal Antibody
Rabies (Healthy Volunteers)
Not yet recruitingPhase 3
Phase IIIb Clinical Trial to Evaluate Lot-to-lot Consistency of Sinovac Rabies Vaccine
Rabies (Healthy Volunteers)
Not yet recruitingPhase 3
Immunogenicity and Safety of Rabies Vaccine (Serum-free Vero Cell) in a Simulated Post-exposure Prophylaxis Regimen
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sinovac rabies vaccine and Marketed rabies vaccine in people with Rabies (Healthy Volunteers), run by Sinovac Biotech Co., Ltd at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seroconversion rate of rabies neutralizing antibodies in pre-vaccination negative subjects of each group (time frame: Day 14 after the first dose vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07357545.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.