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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

About this trial

This is an interventional prevention trial for Japanese Encephalitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

NCT ID

NCT00596271

First Posted

January 4, 2008

Last Updated

April 9, 2014

Sponsor

Valneva Austria GmbH

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

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

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

Time Frame

until 6 month after last vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

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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