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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH
ClinicalTrials.gov Identifier:
NCT00596271
First received: January 4, 2008
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Japanese Encephalitis
Biological: IC51
Biological: HAVRIX
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Valneva Austria GmbH:

Primary Outcome Measures:
  • Geometric Mean Titer (GMT) at Day 56 for Anti-JEV Neutralizing Antibodies [ Time Frame: Day 56 ] [ Designated as safety issue: No ]
    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

  • GMT for Hepatitis A Virus (HAV) Antibody at Day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Seroconversion Rate (SCR) at Day 56 for Plaque Reduction Neutralization Assay (PRNT) and HAV at Day 28 [ Time Frame: day 28 and 56 ] [ Designated as safety issue: No ]
  • GMT and SCR for PRNT at Day 28 and HAV at Day 56 [ Time Frame: day 28 and 56 ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: until 6 month after last vaccination ] [ Designated as safety issue: Yes ]
    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)


Enrollment: 192
Study Start Date: September 2005
Study Completion Date: August 2008
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  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
  • 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
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: NCT00596271

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: NCT00596271     History of Changes
Other Study ID Numbers: IC51-308
Study First Received: January 4, 2008
Results First Received: November 12, 2013
Last Updated: April 9, 2014
Health Authority: Germany: Paul-Ehrlich-Institut
Austria: Agency for Health and Food Safety
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 August 28, 2014