Safety and Tolerability of the Japanese Encephalitis Vaccine IC51

NCT00605085 | Completed Phase 3 Results

• 1 other identifier: IC51-302
• Study Type: interventional
• Target: 2,675
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability up to Day 56

  calculation based on safety population, numbers provide percentages of participants with Adverse Events (AEs)

  Day 56

Secondary Outcomes (3)

• 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

Study Arms (2)

1

EXPERIMENTAL

IC51

Biological: Japanese Encephalitis purified inactivated vaccine (IC51)

2

PLACEBO COMPARATOR

Placebo

Biological: Placebo

Interventions

Japanese Encephalitis purified inactivated vaccine (IC51) BIOLOGICAL

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

1

Placebo BIOLOGICAL

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Valneva Austria GmbH: lead

MeSH Terms

Conditions

Encephalitis, Japanese

Condition Hierarchy (Ancestors)

Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Mosquito-Borne Diseases; Virus Diseases; RNA Virus Infections; Flavivirus Infections; Flaviviridae Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Results Point of Contact

• Title: Senior Manager Clinical Research
• Organization: Intercell AG

kdubischar-kastner@intercell.com

+43 1 206 20

Study Officials

• Astrid Kaltenboeck, Ph.D.

  Valneva Austria GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 4, 2008
• First Posted: January 30, 2008
• Study Start: October 1, 2005
• Study Completion: November 1, 2006
• Last Updated: March 21, 2024
• Results First Posted: November 20, 2012

Record last verified: 2024-03