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Immunogenicity and Safety Study of A New Chromatographically Purified Vero Cell Rabies Vaccine With ID Regimen and ERIG

NCT01137045 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2018-04-06

No results posted yet for this study

Summary

A comparative,randomized (1:1)study to evaluate the safety and immunogenicity of a new chromatographically purified vero cell rabies vaccine (SPEEDA) and chromatographically purified vero cell rabies vaccine (SPEEDA)which is filled by Queen Saovabha Memorial Institute (TRCS SPEEDA)vs. reference vaccine (purified vero cell vaccine; VERORAB)when using with post-exposure rabies intradermal vaccination with or without equine rabies immunoglobulin.

Conditions

  • Rabies

Interventions

BIOLOGICAL

SPEEDA and TRCS SPEEDA

For modified TRC-ID regimen,0.1 ml of SPEEDA, TRCS SPEEDA or VERORAB will be given at each of two sites,intradermally on upper arms on days 0,3,7 and 28. For ESSEN regimen, 1 vial of SPEEDA will be given intramuscularly at upper arm on days 0,3,7,14 and 28. For ERIG,it would be given in a single dose 40 IU/Kg at the same time as the first dose of vaccine. ERIG will be infiltrated around and into all wounds as recommended by WHO for patients in group IV and injected intramuscular at each of both gluteal areas for participants in group III,V,VI

Sponsors & Collaborators

  • Queen Saovabha Memorial Institute

    lead OTHER

Principal Investigators

  • Terapong Tantawichien, MD.,Prof · Queen Saovabha Memorial Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • Thailand

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 NCT01137045 on ClinicalTrials.gov