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CompletedNCT05545371Updated Sep 30, 2026

Prevention of Rabies With Four Doses of Rabies Vaccine

A Phase 3 interventional study of immunization procedures in Rabies Human and Antibody, sponsored by Changchun Zhuoyi Biological Co., Ltd. Completed at 1 site in China. Open to participants aged 10 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Changchun Zhuoyi Biological Co., Ltd · Phase 3, Interventional, and Prevention

Updated Sep 30, 2026Now CompletedPrimary completion moved+3 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
2,100
Allocation
Randomized
Ages
10 Years to 60 Years
Sex
All
01

Study summary

To evaluate the non inferiority of the immunogenicity of the test vaccine inoculated according to the four dose immunization program over the five dose immunization program and the batches consistency of immunogenicity according to five dose immunization procedures.

Read the detailed description
  • In the population aged 10-60 years, evaluate the non inferiority of the immunogenicity of the test vaccine inoculated according to the four dose immunization program (0, 3, 7, 14/28 days) over the five dose immunization program (0, 3, 7, 14, 28 days);
  • To evaluate the consistency of immunogenicity between batches of freeze-dried human rabies vaccine (Vero cell) inoculated according to five dose immunization procedures (0, 3, 7, 14, 28 days).
02

Conditions studied

  • Rabies Human
  • Antibody

Browse trials for

03

In context

Rabies

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

This study's enrollment of 2,100 is above the median of 201 across 104 interventional studies indexed under Rabies.

Browse Rabies studies →

Lead sponsor

Changchun Zhuoyi Biological Co., Ltd is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 60 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

  • People aged 10-60;
  • Body temperature on the day of enrollment\<37.3℃ (axillary temperature)

Exclusion criteria

Exclusion Criteria:

  • Have a history of rabies vaccine immunization or use of rabies virus passive immunization agents;
  • People with congenital or acquired immunodeficiency or other diseases;
  • Female urine pregnancy test is positive, or during pregnancy and lactation, or she has a birth plan during the study period;
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
2,100 participants (actual)

Study arms

  • Experimental
    4 doses

    Inoculate rabies vaccine according to 1-1-1-1 immunization procedure

    Biological: immunization procedures

  • Experimental
    5 doses

    Inoculate rabies vaccine according to 1-1-1-1-1 immunization procedure

    Biological: immunization procedures

Interventions

  • Biologicalimmunization procedures

    The subjects were vaccinated with rabies vaccine according to different immunization procedures

06

What researchers measure

Primary outcomes

  1. Positive conversion rate of 14 days

    \- 14 days after the first dose of inoculation, the positive conversion rate of serum neutralizing antibody.

    Time frame: 6 months

  2. Antibody Geometric Mean Titer (GMT) of 14 days

    \- 14 days after the first dose of inoculation, the Geometric Mean Titer (GMT) of serum neutralizing antibody .

    Time frame: 6 months

  3. Positive conversion rate of 42 days

    \- The seroconversion rate of serum neutralizing antibody that 42 days after the first dose of inoculation.

    Time frame: 6 months

  4. Advertise Events (AE) incidence within 1 month

    \- The distribution of AE incidence in different time periods (including all, within 30 minutes, 0-3 days, 0-7 days, 8-30 days) after each dose of inoculation;

    Time frame: 6 months

  5. Serious Adverse Events (SAE) incidence within 6 months

    \- Incidence rate of SAE within 6 months from the first dose of inoculation to the full course of inoculation.

    Time frame: 12 months

Secondary outcomes

  1. Antibody test of 28 days

    Detection of serum neutralizing antibody 28 days after the first dose of inoculation

    Time frame: 6 months

  2. Antibody GMT of 42 days

    The serum neutralized antibody GMT 42 days after the first dose of inoculation;

    Time frame: 6 months

  3. Antibody test within 12 months

    The serum neutralizing antibody was detected in 3 timepoints within 12 months after the whole vaccination.

    Time frame: 18months

07

Study locations

1 site
  • Changchun Zhuoyi Biological Co., Ltd
    Changchun, Jilin 130000, China
08

References and documents

Individual participant data

Plan to share: Yes — safety and antibody results.

Supporting information: Study protocol, Informed consent form

Time frame: before December 2024.

Access criteria: public to all.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar 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

Ran from Jun 2022 to primary completion in Nov 2022, 5 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 5 months is below that.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 30, 2026: primary completion Nov 2024 → Nov 2022 and completion Dec 2024 → Aug 2023.

Earlier changes are on the record history on ClinicalTrials.gov ↗

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

Registered
Sep 14, 2022
First posted
Sep 19, 2022
StartActual
Jun 18, 2022
Primary completionActual
Nov 27, 2022was Nov 2024
CompletionActual
Aug 14, 2023was Dec 2024
Last update
Sep 30, 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.
Status
Enrolling by invitation→Completed
changed Sep 30, 2026
Primary completion
Nov 30, 2024→Nov 27, 2022 (actual)
Sep 30, 2026
Study completion
Dec 30, 2024→Aug 14, 2023 (actual)
Sep 30, 2026
Primary outcomes
5 description edited
What changed in the outcomes
  • DescriptionAdvertise Events (AE) incidence within 1 month: how it is measured was reworded
  • DescriptionAntibody Geometric Mean Titer (GMT) of 14 days: how it is measured was reworded
  • DescriptionPositive conversion rate of 14 days: how it is measured was reworded
  • DescriptionPositive conversion rate of 42 days: how it is measured was reworded
  • DescriptionSerious Adverse Events (SAE) incidence within 6 months: how it is measured was reworded
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Enrolling by invitation→Completed
    Primary completion Nov 30, 2024→Nov 27, 2022 (now actual)
    Study completion Dec 30, 2024→Aug 14, 2023 (now actual)
    Primary outcomes 5 description edited
    What changed in the outcomes
    • DescriptionAdvertise Events (AE) incidence within 1 month: how it is measured was reworded
    • DescriptionAntibody Geometric Mean Titer (GMT) of 14 days: how it is measured was reworded
    • DescriptionPositive conversion rate of 14 days: how it is measured was reworded
    • DescriptionPositive conversion rate of 42 days: how it is measured was reworded
    • DescriptionSerious Adverse Events (SAE) incidence within 6 months: how it is measured was reworded
    + 2 other changes: index terms and verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05545371
Lead sponsor
Changchun Zhuoyi Biological Co., Ltd
Responsible party
Sponsor
First posted
Sep 19, 2022
Start date
Jun 18, 2022
Primary completion
Nov 27, 2022
Completion
Aug 14, 2023
Last update
Sep 30, 2026

Study contacts

Li Miao
study director · Changchun Zhuoyi Biological Co., Ltd

Oversight

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

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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