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Rapid Immunization Study of the Japanese Encephalitis Vaccine IC51

Primary Purpose

Japanese Encephalitis

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

IC51

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
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)
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
Immunodeficiency including post-organ-transplantation or immunosuppressive therapy
A family history of congenital or hereditary immunodeficiency
History of autoimmune disease
Any acute infections within 4 weeks prior to enrollment
Infection with HIV, Hepatitis B or Hepatitis C
Pregnancy, lactation or unreliable contraception in female subjects

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

IC51 2 x 6 mcg

IC51 1 x 12 mcg

IC51 1 x 6 mcg

Arm Description

2 x 6 mcg (microgram)

1 x 12 mcg (microgram)

1 x 6 mcg (microgram)

Outcomes

Primary Outcome Measures

SCR (Seroconversion Rate) at Day 56

Seroconversion rate: percentage of subjects with >= 1:10 anti-JEV neutralizing antibody titer

Secondary Outcome Measures

SCR at Day 10, 28 and 35

GMT at Day 10, 28, 35 and 56

Safety

AEs, Local and systemic tolerability, Safety laboratory parameters

Full Information

NCT ID

NCT00595790

First Posted

January 4, 2008

Last Updated

April 9, 2014

Sponsor

Valneva Austria GmbH

1. Study Identification

Unique Protocol Identification Number

NCT00595790

Brief Title

Rapid Immunization Study of the Japanese Encephalitis Vaccine IC51

Official Title

Phase 3 Study to Compare a Rapid Immunization Regime With the Standard Regime of IC51 as Vaccine for Japanese Encephalitis

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

February 2006 (Actual)

Study Completion Date

November 2007 (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 study investigates a rapid immunization regime of the Japanese Encephalitis vaccine IC51 (JE-PIV) in healthy subjects aged > or = 18 years

Detailed Description

This is a multicenter, observer blinded, controlled, randomized phase 3 study. The study population consists of healthy male and female volunteers, aged at least 18 years. Approximately 375 volunteers will be enrolled at approximately 2 to 3 sites.

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

374 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IC51 2 x 6 mcg

Arm Type

Active Comparator

Arm Description

2 x 6 mcg (microgram)

Arm Title

IC51 1 x 12 mcg

Arm Type

Active Comparator

Arm Description

1 x 12 mcg (microgram)

Arm Title

IC51 1 x 6 mcg

Arm Type

Active Comparator

Arm Description

1 x 6 mcg (microgram)

Intervention Type

Biological

Intervention Name(s)

IC51

Other Intervention Name(s)

Japanese Encephalitis purified inactivated vaccine

Primary Outcome Measure Information:

Title

SCR (Seroconversion Rate) at Day 56

Description

Seroconversion rate: percentage of subjects with >= 1:10 anti-JEV neutralizing antibody titer

Time Frame

day 56

Secondary Outcome Measure Information:

Title

SCR at Day 10, 28 and 35

Time Frame

Day 10, 28 and 35

Title

GMT at Day 10, 28, 35 and 56

Time Frame

Day 10, 28, 35 and 56

Title

Safety

Description

AEs, Local and systemic tolerability, Safety laboratory parameters

Time Frame

Study duration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: At least 18 years of age 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) 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 Immunodeficiency including post-organ-transplantation or immunosuppressive therapy A family history of congenital or hereditary immunodeficiency History of autoimmune disease Any acute infections within 4 weeks prior to enrollment Infection with HIV, Hepatitis B or Hepatitis C Pregnancy, lactation or unreliable contraception in female subjects

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susanne Eder, Mag.

Organizational Affiliation

Valneva Austria GmbH

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

Rapid Immunization Study of the Japanese Encephalitis Vaccine IC51

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