CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 123 enrolled
Drug / intervention
smallpox vaccine CJ-50300biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00607243
NCT00607243Phase 3Completed
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Randomized, Double Blind, a Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of CJ-50300 in Healthy Volunteers

Seoul National University Hospital·interventional·Posted Feb 5, 2008·Updated Jul 9, 2013

In Brief

A Phase 3 clinical trial evaluating smallpox vaccine CJ-50300 for Smallpox. Completed, enrolled 123 participants across 1 site.

Detailed Summary

The currently available stock of smallpox vaccine would be insufficient in the face of an incident of smallpox attack. Thus, new manufacturing methods for smallpox vaccine are urgently needed because previous manufacturing methods using calf lymph are no longer acceptable in the view of current standards. Recently, CJ corporation in Republic of Korea has developed cell-culture derived smallpox vaccine (CJ-50300) which was manufactured by infecting MRC-5 cells. The aim of this clinical trial were to assess safety, reactogenicity, and immunogenicity of CJ-50300.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmallpox
CountriesSouth Korea
CollaboratorsHK inno.N Corporation

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 5, 2008
Enrollment StartJan 1, 2008
Primary CompletionJun 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 18.4 years ago

Interventions

smallpox vaccine CJ-50300biological

Conventional dose group: 2.5 x 10 5 pfu/dose Diluted dose group:2.5 x 10 4 pfu/dose