ClinicalTrials.gov

History of Changes for Study: NCT01092507
A Study of Japanese Encephalitis Chimeric Virus Vaccine Compared With SA14-14-2 Vaccine in Infants and Toddlers
Latest version (submitted November 30, 2013) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 March 24, 2010 None (earliest Version on record)
2 June 22, 2010 Recruitment Status, Study Status, Contacts/Locations and Study Description
3 July 21, 2011 Study Status
4 October 10, 2011 Recruitment Status, Study Status, Sponsor/Collaborators and Study Design
5 September 30, 2013 Outcome Measures, Study Status, Arms and Interventions, Sponsor/Collaborators, Study Identification, Results, References and Eligibility
6 November 30, 2013 Adverse Events, Study Status, Outcome Measures and Baseline Characteristics
Comparison Format:

Scroll up to access the controls

Study NCT01092507
Submitted Date:  March 24, 2010 (v1)

Open or close this module Study Identification
Unique Protocol ID: JEC07
Brief Title: A Study of Japanese Encephalitis Chimeric Virus Vaccine Compared With SA14-14-2 Vaccine in Infants and Toddlers
Official Title: A Controlled Study of the Immunogenicity and Safety of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Comparison With SA14-14-2 Vaccine in Infants and Toddlers in Thailand - Primary Vaccination and Long-term Follow-up to 5 Years Post-vaccination
Secondary IDs: UTN: U1111-1112-2269 [WHO]
Open or close this module Study Status
Record Verification: March 2010
Overall Status: Recruiting
Study Start: March 2010
Primary Completion: March 2015 [Anticipated]
Study Completion: October 2015 [Anticipated]
First Submitted: March 23, 2010
First Submitted that
Met QC Criteria:
March 24, 2010
First Posted: March 25, 2010 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 24, 2010
Last Update Posted: March 25, 2010 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Sanofi
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary:

The purpose of this study is to compare a single dose of Japanese encephalitis (JE) chimeric virus vaccine (JE-CV) with two doses of SA14-14-2 live vaccine as primary vaccination in infants and toddlers.

Primary Objective:

  • To demonstrate the non-inferiority of the antibody response 28 days after vaccine administration of one dose of JE CV (administered on Day 0) compared to the antibody response after one dose of the SA14-14-2 control vaccine (administered on Day 0).

Secondary Objectives:

  • To describe the immune response to JE in both vaccine groups in JE-CV virus and SA14-14-2 virus before and after a single dose of JE CV or a single dose of SA14-14-2 vaccine
  • To describe the safety profile in all vaccinated subjects up to 28 days and all serious adverse events (SAEs) up to 6 months after vaccination.
  • To describe only related SAEs and all death from 6 month to 12-month follow-up.
Detailed Description: All participants will receive one injection of their randomized vaccine on Day 0. Follow-up will continue for 12 months after vaccination.
Open or close this module Conditions
Conditions: Encephalitis
Japanese Encephalitis
Keywords: Encephalitis
Japanese Encephalitis
Japanese Encephalitis Vaccines
Infant
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 300 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: JE-CV Group
Participants will receive one dose of Japanese encephalitis chimeric virus vaccine (JE-CV)
Biological: Japanese encephalitis chimeric virus vaccine (JE CV)
0.5 mL, Subcutaneous
Active Comparator: SA14-14-2 vaccine Group
Participants will receive one dose of Japanese encephalitis live vaccine, SA14-14-2 vaccine. (CD.JEVAX®)
Biological: Japanese encephalitis live vaccine (SA14-14-2 vaccine) (CD.JEVAX®)
0.5 mL, Subcutaneous
Other Names:
  • CD.JEVAX®
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Immunogenicity in terms of seroconversion post-vaccination with Japanese encephalitis chimeric virus vaccine.
[ Time Frame: 28 days post-vaccination ]

Secondary Outcome Measures:
1. Safety in terms of solicited injection site and systemic events, and serious adverse events (SAEs) after primary administration of Japanese encephalitis chimeric virus vaccine.
[ Time Frame: 0-14 days and up to 12 months post-vaccination ]

Open or close this module Eligibility
Minimum Age: 9 Months
Maximum Age: 18 Months
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria :

  • Aged 9 to 18 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, and by at least one independent witness if required by local regulations
  • Subject and parent/legally acceptable representatives able to attend all scheduled visits and comply with all trial procedures
  • Completion of vaccinations according to the national immunization schedule.

Exclusion Criteria :

  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy
  • Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing any of the same substances
  • 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 first vaccination and up to the 4 weeks following the last trial vaccination at Month 3
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
  • Planned receipt of any vaccine from the inclusion up to the 4 weeks following the last trial vaccination at Month 3
  • Planned receipt of any Japanese encephalitis vaccine during the course of the study (up to Year 5)
  • History of central nervous system disorder or disease, including seizures
  • History of flavivirus infection (confirmed either clinically, serologically or microbiologically)
  • Febrile illness (temperature ≥ 38°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.
Open or close this module Contacts/Locations
Central Contact Person: Public Registry Sanofi Pasteur
Email: RegistryContactUs@sanofipasteur.com
Study Officials: Medical Director
Study Director
Sanofi Pasteur Inc.
Locations: Thailand
[Recruiting]
Bangkok, Thailand, 10330
[Recruiting]
Bangkok, Thailand, 10700
[Recruiting]
Khon Kaen, Thailand, 40002
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links: Description: Related Info
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services