Trial record 12 of 256 for:
Encephalitis
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:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01190228
First received: August 25, 2010
Last updated: March 28, 2013
Last verified: March 2013
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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: | May 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 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: | March 28, 2013 |
| 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 June 18, 2013