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Clinical Trial of Freeze-dried Human Rabies Vaccine (Without Serum Vero Cells)

NCT05969626 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2460

Last updated 2023-08-09

No results posted yet for this study

Summary

This study was intended to explore the safety and immunogenicity of the test vaccine compared to the control vaccine. The trial consisted of two phases.

Phase I used an open-ended design. Phase II used a randomized, blinded, parallel-controlled non-inferiority design with the same type of active vaccine, in which the control vaccine 5-dose group and the test vaccine 5 group were kept blinded throughout, the test vaccine 4-dose B group was kept blinded from the other three groups until visit 4 （D14）, and the test vaccine 4-dose A group was kept blinded from the control vaccine 5-dose group and the test vaccine 5-dose group until visit 5 （D28）.

Conditions

  • Rabies

Interventions

BIOLOGICAL

5-dose group of test vaccine

Subjects will be vaccinated on days 0, 3, 7, 14, and 28

BIOLOGICAL

5-dose group of control vaccine

Subjects will be vaccinated on days 0, 3, 7, 14, and 28

BIOLOGICAL

4-dose A group of test vaccine

Subjects will be vaccinated on days 0, 3, 7, 14

BIOLOGICAL

4-dose B group of test vaccine

Subjects will be vaccinated on days 0, 3, 7, 28

Sponsors & Collaborators

  • Ningbo Rongan Biological Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-31
Primary Completion
2024-04-30
Completion
2024-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05969626 on ClinicalTrials.gov