NCT07357545

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,040

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 27, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2023

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

January 5, 2026

Last Update Submit

January 21, 2026

Conditions

Rabies (Healthy Volunteers)

Keywords

rabies vaccineserum-free

Outcome Measures

Primary Outcomes (3)

  • Seroconversion rate of rabies neutralizing antibodies in pre-vaccination negative subjects of each group

    Day 14 after the first dose vaccination

  • Seroconversion rate of serum rabies neutralizing antibody in pre-vaccination negative subjects of each group

    Day 42 after the first dose vaccination

  • GMC of rabies neutralizing antibodies in pre-vaccination negative subjects of each group

    Day 14 after the first dose vaccination

Secondary Outcomes (7)

  • GMC of serum rabies neutralizing antibody in pre-vaccination negative subjects of each group

    Day 42 after the first dose vaccination

  • Seroconversion rate of serum rabies neutralizing antibody in pre-vaccination negative subjects of each group

    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

    Months 3 and 6 post-full-course vaccination

  • Incidence of adverse events.

    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

    Day 28 after the first dose vaccination.

  • +2 more secondary outcomes

Study Arms (4)

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

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

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

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

Biological: Marketed rabies vaccine

Interventions

Sinovac rabies vaccineBIOLOGICAL

Rabies Vaccine (Serum-free Vero Cell), Freeze-dried using three types of PEP schedules

Sinovac rabies vaccine - 4-1 dosesSinovac rabies vaccine - 4-2 dosesSinovac rabies vaccine - 5 doses
Marketed rabies vaccineBIOLOGICAL

A markted Rabies Vaccine using 5 doses of PEP schedules

Marketed rabies vaccine - 5 doses

Eligibility Criteria

Age10 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dazhu County Center for Disease Control and Prevention

Dazhou, China

Location

Yuechi County Center for Disease Control and Prevention

Guang’an, China

Location

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

Rhabdoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blind
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 22, 2026

Study Start

August 27, 2021

Primary Completion

September 21, 2022

Study Completion

June 21, 2023

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)