Rapid Immunization Study of the Japanese Encephalitis Vaccine IC51

April 9, 2014 updated by: Valneva Austria GmbH

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

374

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IC51 2 x 6 mcg
2 x 6 mcg (microgram)
Biological: IC51
Other Names:
  • Japanese Encephalitis purified inactivated vaccine
Active Comparator: IC51 1 x 12 mcg
1 x 12 mcg (microgram)
Biological: IC51
Other Names:
  • Japanese Encephalitis purified inactivated vaccine
Active Comparator: IC51 1 x 6 mcg
1 x 6 mcg (microgram)
Biological: IC51
Other Names:
  • Japanese Encephalitis purified inactivated vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SCR (Seroconversion Rate) at Day 56
Time Frame: day 56
Seroconversion rate: percentage of subjects with >= 1:10 anti-JEV neutralizing antibody titer
day 56

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SCR at Day 10, 28 and 35
Time Frame: Day 10, 28 and 35
Day 10, 28 and 35
GMT at Day 10, 28, 35 and 56
Time Frame: Day 10, 28, 35 and 56
Day 10, 28, 35 and 56
Safety
Time Frame: Study duration
AEs, Local and systemic tolerability, Safety laboratory parameters
Study duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valneva Austria GmbH

Investigators

  • Study Director: Susanne Eder, Mag., Valneva Austria GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

January 4, 2008

First Submitted That Met QC Criteria

January 4, 2008

First Posted (Estimate)

January 16, 2008

Study Record Updates

Last Update Posted (Estimate)

April 29, 2014

Last Update Submitted That Met QC Criteria

April 9, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC51-304

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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