Rapid Immunization Study of the Japanese Encephalitis Vaccine IC51

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH
ClinicalTrials.gov Identifier:
NCT00595790
First received: January 4, 2008
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

The study investigates a rapid immunization regime of the Japanese Encephalitis vaccine IC51 (JE-PIV) in healthy subjects aged > or = 18 years


Condition Intervention Phase
Japanese Encephalitis
Biological: IC51
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Phase 3 Study to Compare a Rapid Immunization Regime With the Standard Regime of IC51 as Vaccine for Japanese Encephalitis

Resource links provided by NLM:


Further study details as provided by Valneva Austria GmbH:

Primary Outcome Measures:
  • SCR (Seroconversion Rate) at Day 56 [ Time Frame: day 56 ] [ Designated as safety issue: No ]
    Seroconversion rate: percentage of subjects with >= 1:10 anti-JEV neutralizing antibody titer


Secondary Outcome Measures:
  • SCR at Day 10, 28 and 35 [ Time Frame: Day 10, 28 and 35 ] [ Designated as safety issue: No ]
  • GMT at Day 10, 28, 35 and 56 [ Time Frame: Day 10, 28, 35 and 56 ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
    AEs, Local and systemic tolerability, Safety laboratory parameters


Enrollment: 374
Study Start Date: September 2005
Study Completion Date: November 2007
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IC51 2 x 6 mcg
2 x 6 mcg (microgram)
Biological: IC51
Other Name: Japanese Encephalitis purified inactivated vaccine
Active Comparator: IC51 1 x 12 mcg
1 x 12 mcg (microgram)
Biological: IC51
Other Name: Japanese Encephalitis purified inactivated vaccine
Active Comparator: IC51 1 x 6 mcg
1 x 6 mcg (microgram)
Biological: IC51
Other Name: Japanese Encephalitis purified inactivated vaccine

Detailed Description:

This is a multicenter, observer blinded, controlled, randomized phase 3 study. The study population consists of healthy male and female volunteers, aged at least 18 years.

Approximately 375 volunteers will be enrolled at approximately 2 to 3 sites.

  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: NCT00595790

Sponsors and Collaborators
Valneva Austria GmbH
Investigators
Study Director: Susanne Eder, Mag. Valneva Austria GmbH
  More Information

No publications provided

Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT00595790     History of Changes
Other Study ID Numbers: IC51-304
Study First Received: January 4, 2008
Results First Received: December 5, 2013
Last Updated: April 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Encephalitis, Japanese
Encephalitis
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 July 24, 2014