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Safety and Tolerability of the Japanese Encephalitis Vaccine IC51

NCT00605085 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2675

Last updated 2024-03-21

Study results available
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Summary

The objective is to investigate the safety and tolerability of Japanese Encephalitis vaccine IC51 with an inactive control in healthy subjects aged \> or = 18 years

Conditions

  • Japanese Encephalitis

Interventions

BIOLOGICAL

Japanese Encephalitis purified inactivated vaccine (IC51)

IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28

BIOLOGICAL

Placebo

Placebo: Phosphate-buffered saline (PBS) solution containing 0.1% aluminum hydroxide as an adjuvant, 0.5 mL, i.m. injection, 2 injections, days 0 and 28

Sponsors & Collaborators

  • Valneva Austria GmbH

    lead INDUSTRY

Principal Investigators

  • Astrid Kaltenboeck, Ph.D. · Valneva Austria GmbH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-10-31
Completion
2006-11-30

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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 NCT00605085 on ClinicalTrials.gov