Immunogenicity Study of the Japanese Encephalitis Vaccine IC51

NCT00604708 | Completed Phase 3 Results DMC

• 1 other identifier: IC51-301
• Study Type: interventional
• Target: 867
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective is to demonstrate the non-inferiority of the Japanese Encephalitis vaccine IC51 compared to JE-VAX in healthy subjects aged \> or = 18 years

Conditions

Japanese Encephalitis

Outcome Measures

Primary Outcomes (2)

• SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56

  SCR: anti-JEV neutralizing antibody titer ≥1:10

  Day 56

• GMT (Geometric Mean Titer) of IC51 Compared to JE-VAX at Day 56

  GMT: geometric mean of PRNT50

  Day 56

Secondary Outcomes (4)

• Safety and Adverse Events

  until Day 56

• Immunogenicity at Day 28

  Day 28

• Immunogenicity at Day 56 for North America vs. Europe

  Day 56

• Immunogenicity at Day 56 for Subjects Older vs. Younger Than 50 Years of Age

  Day 56

Study Arms (2)

IC51

EXPERIMENTAL

6 mcg (microgram) i.m. (intramuscular) on Day0, 14 and 28

Biological: IC51

JE-VAX

ACTIVE COMPARATOR

given s.c. on Day 0, 7 and 28

Biological: JE-VAX

Interventions

IC51 BIOLOGICAL

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

Also known as: Japanese Encephalitis purified inactivated vaccine

IC51

JE-VAX BIOLOGICAL

JE-VAX, 1mL s.c. injection, 3 vaccinations, days 0, 7 and 28

JE-VAX

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:

• History of clinical manifestation of any flavivirus infection
• 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
• Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
• A family history of congenital or hereditary immunodeficiency
• History of autoimmune disease
• Any acute infections within 4 weeks prior to enrollment
• Infection with HIV, Hepatitis B or Hepatitis C
• 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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2008
• First Posted: January 30, 2008
• Study Start: September 1, 2005
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: March 21, 2024
• Results First Posted: November 29, 2012

Record last verified: 2024-03