ClinicalTrials.gg
Not yet recruitingNCT07416110Updated Feb 17, 2026

Phase IIIb Clinical Trial to Evaluate Lot-to-lot Consistency of Sinovac Rabies Vaccine

A Phase 3 interventional study of Sinovac rabies vaccine in Rabies (Healthy Volunteers), sponsored by Sinovac Biotech Co., Ltd. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-17.

Sponsored by Sinovac Biotech Co., Ltd · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
912
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Rabies (Healthy Volunteers)

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Keywords

  • rabies vaccine
  • serum-free
  • lot-to-lot consistency
03

In context

Rabies

114 studies on the registry are indexed under Rabies; 15 are open to participants now.

This study's planned enrollment of 912 is above the median of 201 across 104 interventional studies indexed under Rabies.

Browse Rabies studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  1. Participants are able to understand and voluntarily sign the Form;
  2. Able to provide legal identity documents;
  3. Age 18 to 45 years;
  4. 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);
  5. Female participants of must voluntarily adopt effective measures from the signing of the Informed Consent Form until 2 months after the last dose of the 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.

Exclusion criteria

Exclusion Criteria:

  1. For subjects with pyrexia on the scheduled vaccination day, axillary temperature >37.3℃ before vaccination;
  2. 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;
  3. Individuals with mammalian animal bites/scratches (e.g., dog/cat) and broken skin (i.e., Category II or higher exposure) within the past year.;
  4. Female participants who are lactating or pregnant (including those with a positive urine pregnancy test).
  5. 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.);
  6. Presence of diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, asplenia, functional asplenia, splenectomy);
  7. 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.
  8. 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;
  9. Presence of physician-diagnosed coagulation abnormalities (e.g., coagulation factor deficiency, coagulation disorders, abnormalities);
  10. Systemic 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;
  11. Received Immunoglobulins or other blood products within 3 months prior to receiving the Vaccine, or plans to receive such treatment during the study period;
  12. Received other Study Drug or Vaccine within the past 30 days, or plans to receive such drug or Vaccine during the study period;
  13. Within 14 days prior to receiving the investigational vaccine, vaccination with a , or within 7 days, vaccination with subunit, inactivated, or other types of vaccines.
  14. Currently participating in other Vaccine or drug Clinical Studies, or planning to participate in other Clinical Trials during the study period;
  15. 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.
  16. Within 3 days prior to vaccination, any acute disease or acute exacerbation of a chronic disease, or known or suspected active infection;
  17. Based on the Investigator's judgment, the participant has any other discomfort or factors suitable for participating in the clinical trial.
Terms in these criteria, in plain language(8)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

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.

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.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

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.

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.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
912 participants (estimated)

Study arms

  • Experimental
    Sinovac rabies vaccine - Batch 1

    Subjects will be randomly assigned to receive 5 doses of Sinovac rabies vaccine (Batch 1) on Day 0,3,7,14,28

    Biological: Sinovac rabies vaccine

  • Experimental
    Sinovac rabies vaccine - Batch 2

    Subjects will be randomly assigned to receive 5 doses of Sinovac rabies vaccine (Batch 2) on Day 0,3,7,14,28

    Biological: Sinovac rabies vaccine

  • Experimental
    Sinovac rabies vaccine - Batch 3

    Subjects will be randomly assigned to receive 5 doses of Sinovac rabies vaccine (Batch 3) on Day 0,3,7,14,28

    Biological: Sinovac rabies vaccine

Interventions

  • BiologicalSinovac rabies vaccine

    Three batchs of Rabies Vaccine (Serum-free Vero Cell), Freeze-dried using five doses of PEP schedules

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. GMC of rabies neutralizing antibody

    Time frame: Day 14 after the first-dose vaccination and at Day 14 after the full-course vaccination

  2. Seroconversion Rate of rabies neutralizing antibody

    Time frame: Day 14 after the first-dose vaccination and at Day 14 after the full-course vaccination

  3. Incidence of adverse reactions

    Time frame: Up to 30 days after the last-dose vaccination

  4. Incidence of serious adverse events

    Time frame: Up to 30 days after the last-dose vaccination

  5. Seropositive Rate of rabies neutralizing antibody

    Time frame: Month 3, 6, and 12 after the full-course vaccination

07

Study locations

2 sites
  • Mianzhu Municipal Center for Disease Control and Prevention
    Deyang, China
  • Neijiang Municipal Center for Disease Control and Prevention
    Neijiang, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2026; primary completion for Sep 2026, 6 months later.

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 planned 6 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 10, 2026
First posted
Feb 17, 2026
StartEst.
Mar 4, 2026
Primary completionEst.
Sep 30, 2026
CompletionEst.
Jun 30, 2027
Last update
Feb 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07416110
Responsible party
Sponsor
First posted
Feb 17, 2026
Start date
Mar 4, 2026 (estimated)
Primary completion
Sep 30, 2026 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Feb 17, 2026

Study contacts

Ting Huang
Contact
cocoht@163.com
+86 13330993324

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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