MedTrace Logo

Safety and Immunogenicity Study of Recombinant Human Rabies Immunoglobin (rhRIG) in Combination With Rabies Vaccine for Human Use With Human Rabies Immune Globulin (HRIG) in Combination With Rabies Vaccine for Human Use in Healthy Adult Subjects.

NCT02559921 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2016-01-20

No results posted yet for this study

Summary

This study evaluates the rabies virus neutralizing antibody (RVNA) activities ,safety and tolerability of rhRIG vs. HRIG in combination with rabies vaccine for human use (Vero cells) in healthy adult subjects.The study has 7 groups.Subjects will receive rhRIG（20 IU/kg）only, rhRIG（40 IU/kg）only,HRIG（20 IU/kg）only, rhRIG（20 IU/kg）in combination with rabies vaccine for human use, rhRIG（40 IU/kg）in combination with rabies vaccine for human use,HRIG（20 IU/kg）in combination with rabies vaccine for human use,and placebo in combination with rabies vaccine for human use,respectively.

Conditions

  • Rabies

Interventions

BIOLOGICAL

rhRIG（20 IU/kg）

BIOLOGICAL

rhRIG（40 IU/kg）

BIOLOGICAL

HRIG（20 IU/kg）

BIOLOGICAL

rhRIG（20 IU/kg） and vaccine

BIOLOGICAL

rhRIG（40 IU/kg） and vaccine

BIOLOGICAL

HRIG（20 IU/kg） and vaccine

BIOLOGICAL

placebo and vaccine

Sponsors & Collaborators

  • Beijing Chaoyang District Centre for Disease Control and Prevention

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-08-31
Completion
2015-12-31

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 NCT02559921 on ClinicalTrials.gov