Safety and Tolerability of the Japanese Encephalitis Vaccine IC51

Safety and Tolerability of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Placebo Controlled Phase 3 Study

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

Study Overview

• Status: Completed
• Conditions: Japanese Encephalitis
• Intervention / Treatment: Biological: Japanese Encephalitis purified inactivated vaccine (IC51); Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 2675
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• At least 18 years of age
• Written informed consent obtained prior to study entry

Exclusion Criteria:

• Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine
• History of any previous JE vaccination (e.g. JE-VAX®)
• Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
• A family history of congenital or hereditary immunodeficiency
• History of autoimmune disease
• Any acute infections within 2 weeks prior to enrollment
• Known or suspected HIV Infection
• Pregnancy, lactation or unreliable contraception in female subjects

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	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
Experimental: 1; IC51	Biological: Japanese Encephalitis purified inactivated vaccine (IC51); IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability up to Day 56	calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs)	Day 56

Secondary Outcome Measures

Outcome Measure	Time Frame
Rates of Serious Adverse Events and Medically Attended Adverse Events	until Day 56
Changes in Laboratory Parameters	until Day 56
SCR and GMT of Subjects With Concomitant Vaccinations	until Day 56

Collaborators and Investigators

• Sponsor: Valneva Austria GmbH
• Investigators: Study Director: Astrid Kaltenboeck, Ph.D., Valneva Austria GmbH

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Study Completion (Actual): November 1, 2006

Study Registration Dates

• First Submitted: January 4, 2008
• First Submitted That Met QC Criteria: January 16, 2008
• First Posted (Estimated): January 30, 2008

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Neuroinflammatory Diseases; Mosquito-Borne Diseases; Encephalitis, Japanese; Encephalitis
• Other Study ID Numbers: IC51-302