MedTrace Logo

A Clinical Trial of Freeze-dried Human Rabies Vaccine (MRC-5 Cells)

NCT06078423 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1880

Last updated 2023-10-11

No results posted yet for this study

Summary

This trial is a randomized, blind, similar vaccine controlled, single center, non-inferiority design phase III clinical trial, with a study population of 10 to 60 years old, conducted in two stages.Phase 1 and Phase 2

Conditions

  • Rabies Vaccine Adverse Reaction

Interventions

BIOLOGICAL

Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 5-dose program

Inoculate 1 dose of Investigational vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm

BIOLOGICAL

Freeze-dried human rabies vaccine (MRC-5 cells) Zhifeilongkoma - 4-dose program

Inoculate 1 dose of Investigational vaccine each on both arms on day 0, and 1 dose each on day 7 and 21, by intramuscular injection of deltoid muscle of upper arm

BIOLOGICAL

Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 5-dose program

Inoculate 1 dose of Investigational vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm

BIOLOGICAL

Freeze-dried human rabies vaccine (MRC-5 cells) Kanghua - 4-dose program

Inoculate 1 dose of Investigational vaccine each on both arms on day 0, and 1 dose each on day 7 and 21, by intramuscular injection of deltoid muscle of upper arm

Sponsors & Collaborators

  • Sponsor GmbH

    collaborator OTHER

  • Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Fangjun Li, Bachelor · Hunan Provincial Center for Disease Control and Prevention

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
2019-10-19
Primary Completion
2021-07-21
Completion
2022-09-26

Countries

  • China

Study Locations

More Related Trials

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 NCT06078423 on ClinicalTrials.gov