Immunogenicity Study of the Japanese Encephalitis Vaccine IC51

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH
ClinicalTrials.gov Identifier:
NCT00604708
First received: January 4, 2008
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention Phase
Japanese Encephalitis
Biological: IC51
Biological: JE-VAX
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Observer Blinded, Randomized Phase 3 Study to Investigate the Non-Inferiority of IC51 vs. JE-VAX as Vaccines for Japanese Encephalitis in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Valneva Austria GmbH:

Primary Outcome Measures:
  • SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56 [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
    SCR: anti-JEV neutralizing antibody titer ≥1:10

  • GMT (Geometric Mean Titer) of IC51 Compared to JE-VAX at Day 56 [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
    GMT: geometric mean of PRNT50


Secondary Outcome Measures:
  • Safety and Adverse Events [ Time Frame: until Day 56 ] [ Designated as safety issue: Yes ]
  • Immunogenicity at Day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Immunogenicity at Day 56 for North America vs. Europe [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
  • Immunogenicity at Day 56 for Subjects Older vs. Younger Than 50 Years of Age [ Time Frame: Day 56 ] [ Designated as safety issue: No ]

Enrollment: 867
Study Start Date: September 2005
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IC51
6 mcg (microgram) i.m. (intramuscular) on Day0, 14 and 28
Biological: IC51
IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28
Other Name: Japanese Encephalitis purified inactivated vaccine
Active Comparator: JE-VAX
given s.c. on Day 0, 7 and 28
Biological: JE-VAX
JE-VAX, 1mL s.c. injection, 3 vaccinations, days 0, 7 and 28

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • History of clinical manifestation of any flavivirus infection
  • History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever (an anti-JEV neutralizing antibody titer >= 1:10 at baseline is acceptable for inclusion, these subjects will be part of the safety population, but will not be analyzed for immunogenicity in the per-protocol analysis)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604708

Sponsors and Collaborators
Valneva Austria GmbH
Investigators
Study Director: Astrid Kaltenboeck, Ph.D. Valneva Austria GmbH
  More Information

No publications provided

Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT00604708     History of Changes
Other Study ID Numbers: IC51-301
Study First Received: January 4, 2008
Results First Received: May 24, 2012
Last Updated: October 31, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Encephalitis, Arbovirus
Arbovirus Infections
Encephalitis, Viral
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on September 18, 2014