Clinical trial NCT00596271: Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Japanese Encephalitis
Lead sponsor: Valneva Austria GmbH
Sponsor class: INDUSTRY
First posted: 2008-01-16
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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 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

Primary outcomes:
measure: Geometric Mean Titer (GMT) at Day 56 for Anti-JEV Neutralizing Antibodies
timeFrame: Day 56
measure: GMT for Hepatitis A Virus (HAV) Antibody at Day 28
timeFrame: Day 28
Secondary outcomes:
measure: Seroconversion Rate (SCR) at Day 56 for Plaque Reduction Neutralization Assay (PRNT) and HAV at Day 28
timeFrame: day 28 and 56
measure: GMT and SCR for PRNT at Day 28 and HAV at Day 56
timeFrame: day 28 and 56
measure: Safety
timeFrame: until 6 month after last vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Valneva Austria GmbH
name: Astrid Kaltenboeck, Ph.D.
role: STUDY_DIRECTOR
References: