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Compare the efficacy and safety of rhRIG and HRIG combined with human rabies vaccine: A randomized, blind, positive controlled trial

Evaluation of the efficacy and safety of rhRIG combined with rabies vaccine and the marketed HRIG combined with rabies vaccine: A randomized, blind, positive controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021478
Enrollment
Unknown
Registered
2019-02-23
Start date
2019-03-31
Completion date
Unknown
Last updated
2019-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rabies

Interventions

Test Group:rhRIG+vaccine
Control Group:HRIG+vaccine

Sponsors

Yunnan Center for Diseases Control and Prevention
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18-55 years; 2) Can provide legal identification; 3) Can understand the research procedure, the subject himself signed a written informed consent form; 4) Can participate in all planned follow-ups and be able to follow all research procedures Participate in the visit); 5) Non-pregnant and lactating women of childbearing age; no male or female patients have no birth planning within 6 months and agree to take effective contraceptive measures.

Exclusion criteria

Exclusion criteria: 1) Have used rabies vaccine or rabies immunoglobulin before; 2) Those who have had a history of severe allergies in previous vaccinations and who are known to be allergic to any of the ingredients contained in the test drug/vaccine; 3) According to the investigator's clinical judgment, the subject has clinically significant acute febrileness or Infectious disease within 2 weeks prior to the first dose; 4) After consulting the medical history, found heart, liver, kidney, blood, digestive tract, nervous system, mental abnormalities and metabolic abnormalities, etc.The medical history influence the research evaluation which is judged by the researcher ; 5) Have a history of convulsions, epilepsy, mental and nervous system, or a family history of epilepsy; 6) Other vaccines, antiserum, human immunoglobulin and other products are used within 1 month before the test drug/vaccine Or plan to use during the study; 7) Any research or unregistered product other than the research product is used before the application of the test drug/vaccine Products (drugs, vaccines, biological products or devices), or intended for use during the study within 1 month; 8) Drug abuse, alcohol abuse or drug addicts; 9) Any other circumstances that the investigator believes may affect the evaluation of the trial.

Design outcomes

Primary

MeasureTime frame
neutralizing antibody activity;

Countries

China

Contacts

Public ContactLiu Xiaoqiang
lxq7611@126.com+86 15911568282

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026