Study of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) Compared to CD.JEVAX™ in Toddlers

March 24, 2014 updated by: Sanofi Pasteur, a Sanofi Company

Immunogenicity and Safety of a Single Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) in Comparison With a Single Dose of SA14-14-2 Vaccine (CD.JEVAX™, Chengdu Institute of Biological Products, China) Administered in Healthy Toddlers in South-Korea

The purpose of this study is to compare Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV™) with Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine [CD.JEVAX™]) after a single dose vaccination to support product registration.

Primary Objective:

  • To demonstrate the non-inferiority of the antibody response 28 days after administration of one dose of IMOJEV™ compared to the antibody response 28 days after administration of one dose of the CD.JEVAX™ control vaccine.

Secondary Objectives:

  • To describe the immune response to Japanese encephalitis (JE) in both vaccine groups using 50% plaque reduction neutralization assay (PRNT50) assays before and after a single dose of IMOJEV™ vaccine or a single dose of CD.JEVAX™ vaccine.
  • To describe the safety of vaccination in all subjects up to 28 days and all serious adverse events up to 6-month after vaccination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All participants will receive a single dose of their assigned vaccination at Visit 1 (Day 0) and undergo immunogenicity assessment at Day 28 post-vaccination. Safety will be assessed from day of vaccination and up to 6 months post-vaccination.

Study Type

Interventional

Enrollment (Actual)

274

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Goyang, Korea, Republic of
      • Incheon, Korea, Republic of
      • Seongnam, Korea, Republic of
      • Seoul, Korea, Republic of
      • Suwon, Korea, Republic of
      • Wonju, Korea, Republic of

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

4 months to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 12 to 24 months on the day of inclusion
  • In good general health, without significant medical history.
  • Provision of informed consent form signed by at least one parent or other legally acceptable representative.
  • Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures.

Exclusion Criteria:

  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
  • Known systemic hypersensitivity to any of IMOJEV™ components or history of a life-threatening reaction to a vaccine containing any of the same substances and vaccination,known systemic hypersensitivity to CD.JEVAX® main components and the other components (including Gelatin, kanamycin, and gentamicin).
  • Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
  • Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response.
  • Previous vaccination against flavivirus disease, including Japanese encephalitis (JE).
  • Administration of any anti-viral within 2 months preceding Visit 01 and up to the 4 weeks following the trial vaccination.
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for pandemic influenza vaccination, which may be received at least two weeks before the study vaccines.
  • Planned receipt of any vaccine from the inclusion up to the 4 weeks following the trial vaccination.
  • History of central nervous system disorder or disease, including seizures.
  • Planned receipt of any JE vaccine during the course of the study.
  • History of flavivirus infection (confirmed either clinically, serologically or virologically).
  • Administration of systemic corticosteroids for more than two consecutive weeks within the 4 weeks preceding vaccination.
  • Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection 3 days before vaccination as well as the day of vaccination, according to Investigator judgment.
  • Thrombocytopenia or bleeding disorder contraindicated for vaccination with same administration route, or receipt of anticoagulants in the 3 weeks preceding inclusion.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMOJEV™ Vaccine Group
Participants will receive a single dose of the Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV™) on Day 0.
Biological: Live attenuated Japanese encephalitis chimeric virus vaccine
0.5 mL, Subcutaneous
Other Names:
  • IMOJEV™
Active Comparator: CD.JEVAX ™ Vaccine Group
Participants will receive a single dose of the Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine), CD.JEVAX™ on Day 0
Biological: Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine)
0.5 mL, Subcutaneous
Other Names:
  • CD.JEVAX™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Seroconversion to Japanese Encephalitis Chimeric Virus Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine
Time Frame: Day 28 post-vaccination
Immunogenicity assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50). Seroconversion was defined as the percentage of participants who developed neutralizing antibody titers above 10 (1/dil) when seronegative at baseline (<1/10) or who presented a ≥4-fold rise in their neutralizing antibody titers when seropositive (≥1/10) at baseline.
Day 28 post-vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine
Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination

Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50).

JE-CV PRNT50 antibody titer >10 (1/dil, Day 0)
Day 0 (pre-vaccination) and Day 28 post-vaccination
Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine
Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Immunogenicity was assessed using a Japanese encephalitis chimeric virus (JE-CV) PRNT50 assay. Seroprotection was defined as the percentage of participants with a titer ≥10 (1/dil) at pre-vaccination and at Day 28 post-vaccination.
Day 0 (pre-vaccination) and Day 28 post-vaccination
Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine
Time Frame: Day 0 up to Day 14 post-vaccination
Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling longest diameter ≥50 mm. Grade 3 systemic reactions: Fever >39.5°C; Vomiting ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - >3 hours; Drowsiness - sleeping most of the time or difficult to wake; Appetite Loss - refuses ≥3 feeds or most feeds; Irritability - inconsolable.
Day 0 up to Day 14 post-vaccination

Collaborators and Investigators

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

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

July 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

July 14, 2011

First Submitted That Met QC Criteria

July 15, 2011

First Posted (Estimate)

July 18, 2011

Study Record Updates

Last Update Posted (Estimate)

April 25, 2014

Last Update Submitted That Met QC Criteria

March 24, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JEC12
  • U1111-1117-7378 (Other Identifier: WHO)

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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