Study of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With JE-CV

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01190228
First received: August 25, 2010
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

The aim of the study is to investigate the memory immune response and the yearly persistence of the immunity against Japanese Encephalitis (JE) after vaccination with a new Japanese Encephalitis Chimeric Virus (JE-CV) in participants previously vaccinated with JE-CV.

Objectives:

  • To describe JE immune status before, and after a JE-CV booster dose in subjects previously vaccinated with JE-CV
  • To describe the immune status before, and immune response following JE-CV vaccination in JE-naïve control subjects.
  • To describe the safety (in terms of solicited and unsolicited adverse events) of a single dose of JE-CV up to 6 months after the last vaccination.
  • To describe all related serious adverse events (SAEs) and related deaths from 6 months to 5 years after vaccination in JE-CV-primed subjects.

Condition Intervention Phase
Japanese Encephalitis
Varicella
Biological: Japanese encephalitis chimeric virus
Biological: Varicella vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Assessment of the Memory Immune Response, Safety of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With a Single Dose of JE-CV and Long-Term Follow-Up

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Information concerning the immunogenicity of Japanese encephalitis chimeric virus vaccine [ Time Frame: 28 days post-vaccination ] [ Designated as safety issue: No ]
    Note: Immunogenicity data on Japanese encephalitis chimeric vaccination will also be assessed on Day 7 post-vaccination for all participants and yearly for up to 5 years post-vaccination in Group 1 participants.


Secondary Outcome Measures:
  • Information concerning the safety in terms of solicited and unsolicited adverse events of the vaccination in JE CV recipients and varicella recipients, respectively. [ Time Frame: Day 0 to 6 months post-vaccination ] [ Designated as safety issue: No ]
    Note: In Group 1 participants, solicited and unsolicited adverse events of the vaccination will also be reported yearly for up to 5 years post-vaccination.


Estimated Enrollment: 505
Study Start Date: August 2010
Estimated Study Completion Date: June 2016
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: JE-CV Vaccine
Participants previously vaccinated with JE-CV vaccine, will receive JE-CV vaccine
Biological: Japanese encephalitis chimeric virus
0.5 mL (single dose), Subcutaneous
Experimental: Group 2: JE-CV Vaccine
JE-CV vaccine naive participants, will receive JE-CV vaccine
Biological: Japanese encephalitis chimeric virus
0.5 mL (single dose), Subcutaneous
Active Comparator: Group 3: Varicella vaccine
JE-CV vaccine naive participants, will receive varicella vaccine
Biological: Varicella vaccine
0.5 mL (single dose), Subcutaneous
Other Name: OKAVAX®

Detailed Description:

Study participants who are previously immunized with Japanese Encephalitis Chimeric Virus (JE-CV) vaccine will receive a single dose of the new JE-CV and will be followed up for 5 years for immunogenicity.

The control (JE-CV naive) participants will receive either one dose of JE-CV or one dose of varicella vaccine.

All participants will be monitored for safety for 6 month post vaccination.

  Eligibility

Ages Eligible for Study:   36 Months to 42 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

All Participants

  • Aged 36 to 42 months on the day of inclusion
  • Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative.
  • Subject and parent/legally acceptable representative or guardian able to attend all scheduled visits and to comply with all trial procedures
  • In good general health, based on medical history and physical examination

For Japanese Encephalitis Chimeric Virus (JE-CV) vaccine primed group only

  • Subject who was vaccinated with JE-CV in JEC02 trial (NCT00735644)
  • History of central nervous system disorder or disease, including seizures and febrile seizures
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
  • Chronic illness or any underlying illness (such as cardiovascular, kidney, liver or hematological disease or development abnormalities) that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion

For Japanese Encephalitis Chimeric Virus (JE-CV) primed participants only

  • Receipt of any Japanese Encephalitis (JE) vaccine other than JE-CV during JEC02 trial (NCT00735644) and since the end of JEC02 trial

For JE-CV naive participants only

  • Previous vaccination against flavivirus disease including JE
  • History of flavivirus infection either based on clinical suspicion or laboratory proven
  • Previous vaccination against varicella
  • Previous vaccination with JE-CV in JEC02 study
  • History of varicella, confirmed either clinically, serologically, or microbiologically
  • Known systemic hypersensitivity or anaphylactic/anaphylactoid reaction to neomycin.
  • Known history of thrombocytopenia or idiopathic thrombocytopenic purpura.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190228

Locations
Philippines
Muntinlupa City, Philippines, 1781
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur SA
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01190228     History of Changes
Other Study ID Numbers: JEC15, UTN: U1111-1113-3629
Study First Received: August 25, 2010
Last Updated: April 1, 2014
Health Authority: Philippines: Department of Health

Keywords provided by Sanofi:
Japanese Encephalitis
Japanese encephalitis chimeric virus vaccine
Varicella
Varicella vaccine

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
Encephalitis, Arbovirus
Encephalitis, Viral
Chickenpox
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Central Nervous System Viral Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Arbovirus Infections
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on July 28, 2014