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Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00596271
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : May 13, 2014
Last Update Posted : May 13, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The objective is to investigate the immunogenicity of the Japanese Encephalitis vaccine IC51 (JE-PIV) single and concomitant with HAVRIX® 1440

Condition or disease Intervention/treatment Phase
Japanese Encephalitis Biological: IC51 Biological: HAVRIX Other: Placebo Phase 3

Detailed Description:

This is a randomized, controlled, multi-center, single-blind phase 3 study. The study population consists of male and female healthy subjects, aged at least 18 years.

192 subjects will be enrolled at 2 sites in Europe.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Concomitant Vaccination With IC51 and HARVIX® 1440 in Healthy Subjects. A Single-blind Randomized, Controlled Phase 3 Study
Study Start Date : September 2005
Primary Completion Date : July 2006
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Encephalitis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: IC51 and Placebo
6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0)
Biological: IC51
Other Name: Japanese Encephalitis purified inactivated vaccine
Other: Placebo
Active Comparator: HAVRIX and placebo
HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)
Biological: HAVRIX Other: Placebo
Active Comparator: IC51 and HAVRIX
IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)
Biological: IC51
Other Name: Japanese Encephalitis purified inactivated vaccine
Biological: HAVRIX


Outcome Measures

Primary Outcome Measures :
  1. Geometric Mean Titer (GMT) at Day 56 for Anti-JEV Neutralizing Antibodies [ Time Frame: Day 56 ]
    anti-JEV Neutralizing Antibodies were tabulated for IC51 groups only; for HAV GMTs (co-primary endpoint GMT for Hepatitis A Virus (HAV) Antibody at Day 28), please refer to "Outcome 2" within outcome measure section

  2. GMT for Hepatitis A Virus (HAV) Antibody at Day 28 [ Time Frame: Day 28 ]

Secondary Outcome Measures :
  1. Seroconversion Rate (SCR) at Day 56 for Plaque Reduction Neutralization Assay (PRNT) and HAV at Day 28 [ Time Frame: day 28 and 56 ]
  2. GMT and SCR for PRNT at Day 28 and HAV at Day 56 [ Time Frame: day 28 and 56 ]
  3. Safety [ Time Frame: until 6 month after last vaccination ]
    Rate of Adverse Events (AEs), Serious Adverse Events (SAEs) and medically attended AEs, local and systemic tolerability, changes in safety laboratory parameters (hematology, serum chemistry, urinalysis)


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • In female subjects either childbearing potential terminated by surgery or one year post-menopausal, or a negative serum pregnancy test during screening and the willingness not to become pregnant during the study period and 30 days after the last vaccination by practicing reliable methods of contraception
  • 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)
  • History of any previous Hepatitis A vaccination and 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
  • Planned administration of another vaccine during the study period
  • Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
  • A family history of congenital or hereditary immunodeficiency
  • History of autoimmune disease
  • Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.
  • Any acute infections within 4 weeks prior to enrollment
  • Infection with human immunodeficiency virus (HIV), Hepatitis B (HBsAg) or Hepatitis C
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00596271


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

Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT00596271     History of Changes
Other Study ID Numbers: IC51-308
First Posted: January 16, 2008    Key Record Dates
Results First Posted: May 13, 2014
Last Update Posted: May 13, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs