CompletedNCT05549908Updated Mar 13, 2024

Vaccine Prevention of Rabies Adopts 4-shot Immunization Method

A Phase 3 interventional study of rabies vaccine in Rabies Human and Antibody Titer, 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 2024-03-13.

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

From the registry’s dates

Registered 2 years 1 month after the study started (first participant enrolled Jul 2020, registered Sep 2022).

Phase: Phase 3
Study type: Interventional
Enrollment: 1,800
Allocation: Randomized
Ages: 10 Years to 60 Years
Sex: All

Study summary

A phase III clinical trial to evaluate the immunogenicity and safety of freeze-dried human rabies vaccine (Vero cell) developed by Changchun Zhuoyi Biological Co., Ltd. inoculated in a 4-dose procedure (2-1-1)

Read the detailed description

It is to prove that the freeze-dried human rabies vaccine (Vero cell) in the population aged 10-60 years, the four dose vaccination program is not inferior to the five dose vaccination program, and the safty、antibody positive conversion rate and geometric mean concentration of the four dose group of the test vaccine are not inferior to the five dose program group 14 days after the first dose vaccination.

To compare the immunogenicity of people aged 10-60 years old who were vaccinated 6 and 12 months after the whole vaccination, so as to evaluate the antibody positive rate and GMT 6 and 12 months after the test vaccine was vaccinated.

Conditions studied

Rabies Human
Antibody Titer

Browse trials for

Rabies 114

In context

Rabies

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

This study's enrollment of 1,800 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.

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

The age is 10-60 years old;
Underarm temperature ≤ 37.0 ℃.

Exclusion criteria

Exclusion Criteria:

Have a history of rabies vaccine immunization or use of rabies virus passive immunization agents；
Has been diagnosed with congenital or acquired immunodeficiency disease；
Pregnancy (including positive urine pregnancy test) or lactation, planned pregnancy preparation within 2 months.

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 1,800 participants (actual)

Study arms

Experimental
Experimental 4 doses
Inoculate experimental vaccine according to 2-1-1 immunization procedure
Biological: rabies vaccine
Experimental
Experimental 5 doses
Inoculate experimental vaccine according to 1-1-1-1-1 immunization procedure
Biological: rabies vaccine
Active comparator
SPEEDA® 4 doses
Inoculate SPEEDA® according to 2-1-1 immunization procedure
Biological: rabies vaccine

Interventions

Biologicalrabies vaccine
The subjects were vaccinated with rabies vaccines with different immunization procedures, and the safety and immunogenicity were compared

What researchers measure

Primary outcomes

Antibody positive conversion rate of experimental groups
- Compare the Antibody positive conversion rate between two experimental groups 14 days after the first dose of inoculation.
Time frame: 3 months
Antibody positive conversion rate of 4 doses groups
-Compare the Antibody positive conversion rate between the SPEEDA 4 doses group and experimental 4 doses group 14 days after the first dose of inoculation.
Time frame: 3 months
Compare the GMT between two experimental groups
- Compare the GMT between two experimental groups 14 days after the first dose of inoculation.
Time frame: 3 months
Geometric Mean Titer (GMT) of 4 doses groups
- Compare the GMT between the SPEEDA 4 doses group and the experimental 4 doses group 14 days after the first dose inoculation.
Time frame: 3 months
Safety within 30 minutes
- Incidence rate of any local and systemic adverse events (AE) within 30 minutes after each dose of inoculation;
Time frame: 3 months
Safety within 0-7 days
- Incidence rate of collected AE within 0-7 days after each dose of inoculation;
Time frame: 3 months
Safety within 6 months
- Incidence rate of all serious adverse events (SAE) within 6 months from the first dose of inoculation to the full course of inoculation.
Time frame: 9months

Secondary outcomes

Antibody test of 7 days.
- Antibody test 7 days after the first dose of inoculation.
Time frame: 3 months
Antibody test after whole vaccination.
- Antibody test 14days after the whole vaccination.
Time frame: 3 months
Persistent observation within 12 months
- Antibody test in different points within 12 months after the whole vaccination.
Time frame: 16 months

Study locations

1 site

Changchun Zhuoyi Biological Co., Ltd
Changchun, Jilin 130000, China

References and documents

Individual participant data

Plan to share: Yes — all results.

Supporting information: Study protocol

Time frame: before December 2023.

Access criteria: public for all.

No publications or documents are linked to this record.

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

Ran from Jul 2020 to primary completion in Oct 2021, 15 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 15 months is close to that.

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

Registered: Sep 14, 2022
First posted: Sep 22, 2022
StartActual: Jul 22, 2020
Primary completionActual: Oct 31, 2021
CompletionActual: Apr 20, 2023
Last update: Mar 13, 2024

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 Mar 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05549908
Lead sponsor: Changchun Zhuoyi Biological Co., Ltd
Responsible party: Sponsor
First posted: Sep 22, 2022
Start date: Jul 22, 2020
Primary completion: Oct 31, 2021
Completion: Apr 20, 2023
Last update: Mar 13, 2024

Study contacts

Li Miao, Dr

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 ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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