Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440
Primary Purpose
Japanese Encephalitis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
IC51
HAVRIX
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Japanese Encephalitis
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
IC51 and Placebo
HAVRIX and placebo
IC51 and HAVRIX
Arm Description
6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0)
HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)
IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)
Outcomes
Primary Outcome Measures
Geometric Mean Titer (GMT) at Day 56 for Anti-JEV Neutralizing Antibodies
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
Secondary Outcome Measures
Seroconversion Rate (SCR) at Day 56 for Plaque Reduction Neutralization Assay (PRNT) and HAV at Day 28
GMT and SCR for PRNT at Day 28 and HAV at Day 56
Safety
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00596271
Brief Title
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
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valneva Austria GmbH
4. Oversight
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Japanese Encephalitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
192 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IC51 and Placebo
Arm Type
Active Comparator
Arm Description
6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0)
Arm Title
HAVRIX and placebo
Arm Type
Active Comparator
Arm Description
HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)
Arm Title
IC51 and HAVRIX
Arm Type
Active Comparator
Arm Description
IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)
Intervention Type
Biological
Intervention Name(s)
IC51
Other Intervention Name(s)
Japanese Encephalitis purified inactivated vaccine
Intervention Type
Biological
Intervention Name(s)
HAVRIX
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Geometric Mean Titer (GMT) at Day 56 for Anti-JEV Neutralizing Antibodies
Description
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
Time Frame
Day 56
Title
GMT for Hepatitis A Virus (HAV) Antibody at Day 28
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Seroconversion Rate (SCR) at Day 56 for Plaque Reduction Neutralization Assay (PRNT) and HAV at Day 28
Time Frame
day 28 and 56
Title
GMT and SCR for PRNT at Day 28 and HAV at Day 56
Time Frame
day 28 and 56
Title
Safety
Description
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)
Time Frame
until 6 month after last vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Astrid Kaltenboeck, Ph.D.
Organizational Affiliation
Valneva Austria GmbH
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440
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