Rabies (Healthy Volunteers)Phase 3NCT07416110
Phase IIIb Clinical Trial to Evaluate Lot-to-lot Consistency of Sinovac Rabies Vaccine
A Phase 3 study testing Sinovac rabies vaccine in people with Rabies (Healthy Volunteers), run by Sinovac Biotech Co., Ltd at 2 sites in China.
Trial summary
To evaluate immunogenicity consistency between three consecutive batches of commercial-scale productions for Sinovac Rabies vaccine Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies (Healthy Volunteers)
- What is being tested?
- Sinovac rabies vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 912 participants
- Where
- 2 sitesChina
- Study dates
- 4 Mar 2026to 30 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants are able to understand and voluntarily sign the Informed Consent Form;
- Able to provide legal identity documents;
- Age 18 to 45 years;
- Stable health status (defined as stable underlying disease status within 3 months prior to enrollment, i.e., no change in original treatment or hospitalization due to disorder aggravation);
- Female participants of childbearing potential must voluntarily adopt effective contraception measures from the signing of the Informed Consent Form until 2 months after the last dose of the investigational Vaccine in the primary immunization series, and have no plans to donate eggs; male participants have no plans to donate sperm; female participants of childbearing potential must also have adopted effective contraception measures within 2 weeks prior to Enrollment.
Who cannot join
- For subjects with pyrexia on the scheduled vaccination day, axillary temperature >37.3℃ before vaccination;
- Previous use of anti-Rabies Passive immunization preparations (including but not limited to equine-derived Immunoglobulin ERIG, human-derived Immunoglobulins HRIG, and rabies monoclonal antibody preparations, etc.) or previous Vaccination with human Rabies Vaccine;
- Individuals with mammalian animal bites/scratches (e.g., dog/cat) and broken skin (i.e., Category II or higher exposure) within the past year.;
- Female participants who are lactating or pregnant (including those with a positive urine pregnancy test).
- Known allergy to any component of the trial Vaccine, or a history of severe allergies (such as anaphylactic shock, allergic laryngeal edema, allergic purpura, severe urticarial rash, dyspnea, angioneurotic edema, etc.);
- Presence of autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, asplenia, functional asplenia, splenectomy);
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- Poorly controlled chronic diseases or history of severe diseases, including but not limited to cardiovascular disorders (e.g., uncontrolled hypertension: systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg), metabolic diseases (e.g., poorly controlled diabetes), hematological diseases, liver and kidney diseases, digestive system diseases, respiratory system disorders, history of major organ transplantation, malignant neoplasms within the past five years, or any other diseases or physiological conditions that the investigator believes may interfere with the trial results.
- History of encephalopathy with significant recovered with sequelae or dysfunction, or current encephalopathy (e.g., congenital cerebral dysgenesis, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarct, brain infection, chemical drug poisoning, etc., causing brain nerve tissue injury); history of convulsions, epilepsy, mental illness or family history of mental illness, or other serious neurological diseases;
- Presence of physician-diagnosed coagulation abnormalities (e.g., coagulation factor deficiency, coagulation disorders, platelet abnormalities);
- Systemic immunosuppressive agents or other immunomodulatory therapy for ≥14 days within the past 6 months (prednisone ≥20 mg/day or ≥2 mg/(kg·day), or equivalent), cytotoxic therapy, or planned receipt of such therapy during the study period;
- Received Immunoglobulins or other blood products within 3 months prior to receiving the investigational Vaccine, or plans to receive such treatment during the study period;
- Received other Study Drug or Vaccine within the past 30 days, or plans to receive such drug or Vaccine during the study period;
- Within 14 days prior to receiving the investigational vaccine, vaccination with a live attenuated vaccine, or within 7 days, vaccination with subunit, inactivated, or other types of vaccines.
- Currently participating in other Vaccine or drug Clinical Studies, or planning to participate in other Clinical Trials during the study period;
- Subjects with skin injuries, inflammation, ulcers, skin rash, or scars at the Vaccination site that may interfere with dosing or the observation of local reactions.
- Within 3 days prior to vaccination, any acute disease or acute exacerbation of a chronic disease, or known or suspected active infection;
- Based on the Investigator's judgment, the participant has any other discomfort or factors suitable for participating in the clinical trial.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Mianzhu Municipal Center for Disease Control and Prevention
Deyang
Qingchun Meng, +86 15883415011, 441318794@qq.com
Neijiang Municipal Center for Disease Control and Prevention
Neijiang
Xuemei Li, +86 18981439866, 416948377@qq.com
About this study
Official title: Lot-to-lot Consistency and Safety of Rabies Vaccine (Vero Cell) for Human Use, Freeze-dried in Healthy Individuals Aged 18-45 Years: A Randomized, Double-Blind Phase IIIb Clinical Trial
To evaluate immunogenicity consistency between three consecutive batches of commercial-scale productions for Sinovac Rabies vaccine
Read the detailed description
This clinical trial employed a randomized, double-blind design, enrolling a total of 912 participants aged 18 to 45 years. The investigational vaccine was the serum-free rabies vaccine produced by Sinovac. Eligible participants were enrolled and randomized in a 1:1:1 ratio into Trial group 1, Trial group 2, and Trial group 3, with 304 participants in each group. They received vaccination according to the Essen regimen (1-1-1-1-1) on days 0, 3, 7, 14, and 28, for a total of 5 doses of tjhree commercially scaled batches of the rabies vaccine.
Blood samples will be collection at baseline before the first dose of immunization (D0), 14 days after the first dose (D14, before the third vaccination), and 14 days after the full course of immunization (D42), as well as 3, 6, and 12 months after the full course of immunization. All participants were required to complete immediate reaction observation within 30 minutes after each vaccine dose, and adverse events and serious adverse events were collected from the first dose of baseline immunization vaccination until 30 days after the last dose.
- Conditions
- Rabies (Healthy Volunteers)
- Being tested
- Sinovac rabies vaccine
- Keywords
- rabies vaccine, serum-free, lot-to-lot consistency
- 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
Three batchs of Rabies Vaccine (Serum-free Vero Cell), Freeze-dried using five doses of PEP schedules
| Study group | Role | What they receive |
|---|---|---|
| Sinovac rabies vaccine - Batch 1 | Experimental | Subjects will be randomly assigned to receive 5 doses of Sinovac rabies vaccine (Batch 1) on Day 0,3,7,14,28 Receives: Biological: Sinovac rabies vaccine |
| Sinovac rabies vaccine - Batch 2 | Experimental | Subjects will be randomly assigned to receive 5 doses of Sinovac rabies vaccine (Batch 2) on Day 0,3,7,14,28 Receives: Biological: Sinovac rabies vaccine |
| Sinovac rabies vaccine - Batch 3 | Experimental | Subjects will be randomly assigned to receive 5 doses of Sinovac rabies vaccine (Batch 3) on Day 0,3,7,14,28 Receives: Biological: Sinovac rabies vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Concentration (GMC) of rabies neutralizing antibodies among susceptible participants (RVNA titer <0.5 IU/mL before vaccination) in each group
Measured: Day 14 after the first-dose vaccination
Secondary outcomes (5)
GMC of rabies neutralizing antibody
Measured: Day 14 after the first-dose vaccination and at Day 14 after the full-course vaccination
Seroconversion Rate of rabies neutralizing antibody
Measured: Day 14 after the first-dose vaccination and at Day 14 after the full-course vaccination
Incidence of adverse reactions
Measured: Up to 30 days after the last-dose vaccination
Incidence of serious adverse events
Measured: Up to 30 days after the last-dose vaccination
Seropositive Rate of rabies neutralizing antibody
Measured: Month 3, 6, and 12 after the full-course vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start4 Mar 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
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
- 912 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416110
- Sponsor's protocol ID
- PRO-PVRV-sf-3005
- Status last verified
- Jan 2026
- First submitted
- 10 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lot-to-lot Consistency and Safety of Rabies Vaccine (Vero Cell) for Human Use, Freeze-dried in Healthy Individuals Aged 18-45 Years: A Randomized, Double-Blind Phase IIIb Clinical Trial
- ClinicalTrials.gov ID
- NCT07416110
- Acronym / sponsor ID
- PRO-PVRV-sf-3005
- Conditions
- Rabies (Healthy Volunteers)
- Keywords
- rabies vaccine, serum-free, lot-to-lot consistency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 912 participants (estimated)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 17 Feb 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.
To evaluate immunogenicity consistency between three consecutive batches of commercial-scale productions for Sinovac Rabies vaccine
Detailed description
This clinical trial employed a randomized, double-blind design, enrolling a total of 912 participants aged 18 to 45 years. The investigational vaccine was the serum-free rabies vaccine produced by Sinovac. Eligible participants were enrolled and randomized in a 1:1:1 ratio into Trial group 1, Trial group 2, and Trial group 3, with 304 participants in each group. They received vaccination according to the Essen regimen (1-1-1-1-1) on days 0, 3, 7, 14, and 28, for a total of 5 doses of tjhree commercially scaled batches of the rabies vaccine.
Blood samples will be collection at baseline before the first dose of immunization (D0), 14 days after the first dose (D14, before the third vaccination), and 14 days after the full course of immunization (D42), as well as 3, 6, and 12 months after the full course of immunization. All participants were required to complete immediate reaction observation within 30 minutes after each vaccine dose, and adverse events and serious adverse events were collected from the first dose of baseline immunization vaccination until 30 days after the last dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sinovac rabies vaccine - Batch 1 | Experimental | Biological: Sinovac rabies vaccineSubjects will be randomly assigned to receive 5 doses of Sinovac rabies vaccine (Batch 1) on Day 0,3,7,14,28 |
| Sinovac rabies vaccine - Batch 2 | Experimental | Biological: Sinovac rabies vaccineSubjects will be randomly assigned to receive 5 doses of Sinovac rabies vaccine (Batch 2) on Day 0,3,7,14,28 |
| Sinovac rabies vaccine - Batch 3 | Experimental | Biological: Sinovac rabies vaccineSubjects will be randomly assigned to receive 5 doses of Sinovac rabies vaccine (Batch 3) on Day 0,3,7,14,28 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants are able to understand and voluntarily sign the Informed Consent Form;
- Able to provide legal identity documents;
- Age 18 to 45 years;
- Stable health status (defined as stable underlying disease status within 3 months prior to enrollment, i.e., no change in original treatment or hospitalization due to disorder aggravation);
- Female participants of childbearing potential must voluntarily adopt effective contraception measures from the signing of the Informed Consent Form until 2 months after the last dose of the investigational Vaccine in the primary immunization series, and have no plans to donate eggs; male participants have no plans to donate sperm; female participants of childbearing potential must also have adopted effective contraception measures within 2 weeks prior to Enrollment.
Key exclusion criteria (17 listed)
- For subjects with pyrexia on the scheduled vaccination day, axillary temperature >37.3℃ before vaccination;
- Previous use of anti-Rabies Passive immunization preparations (including but not limited to equine-derived Immunoglobulin ERIG, human-derived Immunoglobulins HRIG, and rabies monoclonal antibody preparations, etc.) or previous Vaccination with human Rabies Vaccine;
- Individuals with mammalian animal bites/scratches (e.g., dog/cat) and broken skin (i.e., Category II or higher exposure) within the past year.;
- Female participants who are lactating or pregnant (including those with a positive urine pregnancy test).
- Known allergy to any component of the trial Vaccine, or a history of severe allergies (such as anaphylactic shock, allergic laryngeal edema, allergic purpura, severe urticarial rash, dyspnea, angioneurotic edema, etc.);
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 vaccineThree batchs of Rabies Vaccine (Serum-free Vero Cell), Freeze-dried using five doses of PEP schedules | Biological | Sinovac rabies vaccine - Batch 1, Sinovac rabies vaccine - Batch 2, Sinovac rabies vaccine - Batch 3 |
Primary outcome
Geometric Mean Concentration (GMC) of rabies neutralizing antibodies among susceptible participants (RVNA titer <0.5 IU/mL before vaccination) in each group
Time frame: Day 14 after the first-dose vaccination
5 secondary outcomes
GMC of rabies neutralizing antibody
Time frame: Day 14 after the first-dose vaccination and at Day 14 after the full-course vaccination
Seroconversion Rate of rabies neutralizing antibody
Time frame: Day 14 after the first-dose vaccination and at Day 14 after the full-course vaccination
Incidence of adverse reactions
Time frame: Up to 30 days after the last-dose vaccination
Incidence of serious adverse events
Time frame: Up to 30 days after the last-dose vaccination
Seropositive Rate of rabies neutralizing antibody
Time frame: Month 3, 6, and 12 after the full-course vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 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
Immunogenicity and Safety of Rabies Vaccine (Serum-free Vero Cell) in a Simulated Post-exposure Prophylaxis Regimen
Rabies (Healthy Volunteers)
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.
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 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 17 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: opening soon, as of the sponsor's last update on 17 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ting Huang (+86 13330993324, cocoht@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric Mean Concentration (GMC) of rabies neutralizing antibodies among susceptible participants (RVNA titer <0.5 IU/mL before vaccination) in each group (time frame: Day 14 after the first-dose vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2026.