CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 300 enrolled
Drug / intervention
Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28) +3 morebiological
Likely dose
Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28) 0.5 mLfrom 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/NCT00621764
NCT00621764Phase 2Completed
CompareCT.gov

A Controlled Study of the Safety and Immunogenicity of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children

Sanofi Pasteur, a Sanofi Company·interventional·Posted Feb 22, 2008·Updated Oct 2, 2014

In Brief

A Phase 2 clinical trial evaluating Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28) and Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28) for Japanese Encephalitis and Hepatitis A. Completed, enrolled 300 participants across 3 sites.

Detailed Summary

Safety: To describe the safety profiles following vaccination. Immunogenicity: To describe the immune response after a single dose of vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsJapanese Encephalitis, Hepatitis A
CountriesThailand
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 22, 2008
Enrollment StartMar 1, 2008
Primary CompletionDec 1, 2009
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.4 years ago

Interventions

Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)biological

≥4.0 Log10 Plaque forming units (PFU), Subcutaneous (SC; Day 0); 0.5 mL intramuscular (IM; Day 28)

Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)biological

0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)

Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)biological

≥4.0 Log10 PFU SC (Day 0); 0.5 mL IM (Day 28)

Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)biological

0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)