Immunogenicity Study of the Japanese Encephalitis Vaccine IC51

March 20, 2024 updated by: Valneva Austria GmbH

Observer Blinded, Randomized Phase 3 Study to Investigate the Non-Inferiority of IC51 vs. JE-VAX as Vaccines for Japanese Encephalitis in Healthy Subjects

The objective is to demonstrate the non-inferiority of the Japanese Encephalitis vaccine IC51 compared to JE-VAX in healthy subjects aged > or = 18 years

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

867

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

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
Experimental: IC51
6 mcg (microgram) i.m. (intramuscular) on Day0, 14 and 28
Biological: IC51
IC51 (JE-PIV), 6 mcg, i.m. injection, 2 vaccinations, days 0 and 28
Other Names:
  • Japanese Encephalitis purified inactivated vaccine
Active Comparator: JE-VAX
given s.c. on Day 0, 7 and 28
Biological: JE-VAX
JE-VAX, 1mL s.c. injection, 3 vaccinations, days 0, 7 and 28

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SCR (Seroconversion Rate)of IC51 Compared to JE-VAX at Day 56
Time Frame: Day 56
SCR: anti-JEV neutralizing antibody titer ≥1:10
Day 56
GMT (Geometric Mean Titer) of IC51 Compared to JE-VAX at Day 56
Time Frame: Day 56
GMT: geometric mean of PRNT50
Day 56

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and Adverse Events
Time Frame: until Day 56
until Day 56
Immunogenicity at Day 28
Time Frame: Day 28
Day 28
Immunogenicity at Day 56 for North America vs. Europe
Time Frame: Day 56
Day 56
Immunogenicity at Day 56 for Subjects Older vs. Younger Than 50 Years of Age
Time Frame: Day 56
Day 56

Collaborators and Investigators

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

Sponsor

Valneva Austria GmbH

Investigators

  • Study Director: Astrid Kaltenboeck, Ph.D., 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)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

January 4, 2008

First Submitted That Met QC Criteria

January 16, 2008

First Posted (Estimated)

January 30, 2008

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC51-301

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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