Prevention of Rabies With Four Doses of Rabies Vaccine

NCT05545371 | Enrolling By Invitation Phase 3

• 1 other identifier: ZY202106001
• Study Type: interventional
• Target: 2,100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rabies Human; Antibody

Outcome Measures

Primary Outcomes (5)

• Positive conversion rate of 14 days

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

  6 months

• 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 .

  6 months

• Positive conversion rate of 42 days

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

  6 months

• 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;

  6 months

• 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.

  12 months

Secondary Outcomes (3)

• Antibody test of 28 days

  6 months

• Antibody GMT of 42 days

  6 months

• Antibody test within 12 months

  18months

Study Arms (2)

4 doses

EXPERIMENTAL

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

Biological: immunization procedures

5 doses

EXPERIMENTAL

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

Biological: immunization procedures

Interventions

immunization procedures BIOLOGICAL

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

4 doses; 5 doses

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Have a history of rabies vaccine immunization or use of rabies virus passive immunization agents；
• People with congenital or acquired immunodeficiency or other autoimmune diseases；
• Female urine pregnancy test is positive, or during pregnancy and lactation, or she has a birth plan during the study period;

Sponsors & Collaborators

• Changchun Zhuoyi Biological Co., Ltd: lead

Study Sites (1)

Changchun Zhuoyi Biological Co., Ltd

Changchun, Jilin, 130000, China

Location

Study Officials

• Li Miao

  Changchun Zhuoyi Biological Co., Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 19, 2022
• Study Start: June 18, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: before December 2024.
• Access Criteria: public to all.

Locations

CN (1)