Study 5 of 112 for search of: "Encephalitis"
Previous Study Return to Search Results Next Study

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines
This study is currently recruiting participants.
Verified by Sanofi-Aventis, August 2008
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00735644
  Purpose

This study is to assess the safety and immunogenicity of three consecutive lots of JE-CV in toddlers aged 12-18 months.

Primary objective:

To demonstrate the bio-equivalence of three lots of JE-CV vaccine manufactured by sanofi pasteur.

Secondary objective:

To describe the safety of vaccination in all subjects


Condition Intervention Phase
Japanese Encephalitis
Hepatitis A
Biological: Japanese encephalitis vaccine
Biological: Japanese encephalitis vaccine (Acambis)
Biological: Hepatitis A vaccine
Phase III

MedlinePlus related topics: Encephalitis Hepatitis Hepatitis A
Drug Information available for: Hepatitis A Vaccines Japanese Encephalitis Vaccines
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Lot-to-Lot Consistency, Bridging, and Safety Trial of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Immunogenicity: To provide information concerning the immunogenicity of ChimeriVax™-Japanese Encephalitis Vaccine. [ Time Frame: 28 days post vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: August 2008
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Vaccine Lot 1
Biological: Japanese encephalitis vaccine
0.5 mL, Subcutaneous
2: Experimental
Vaccine Lot 2
Biological: Japanese encephalitis vaccine
0.5 mL, Subcutaneous
3: Experimental
Vaccine Lot 3
Biological: Japanese encephalitis vaccine
0.5 mL, Subcutaneous
4: Active Comparator Biological: Japanese encephalitis vaccine (Acambis)
0.5 mL, Subcutaneous
5: Sham Comparator Biological: Hepatitis A vaccine
0.5 mL, Intramuscular

Detailed Description:

This is a Phase III trial in toddlers in Thailand and the Philippines.

  Eligibility

Ages Eligible for Study:   12 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Aged 12 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 representative 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 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 corticosteroids 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.
  • Administration of any anti-viral within 2 months preceding V01.
  • History of central nervous system disorder or disease, including seizures.
  • Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
  • Planned receipt of any vaccine in the 4 weeks following any trial vaccination.
  • Personal human immunodeficiency virus seropositivity in the blood sample taken at screening.
  • Receipt of any JE vaccine or hepatitis A vaccine.
  • Previous vaccination against flavivirus disease.
  • History of flavivirus infection (confirmed either clinically, serologically or microbiologically)
  • Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination.
  • Febrile illness (temperature >=38°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00735644

Contacts
Contact: Public Registry Sanofi Pasteur. RegistryContactUs@sanofipasteur.com

Locations
Philippines
Recruiting
Muntinlupa City, Philippines, 1781
Thailand
Recruiting
Bangkok, Thailand, 10330
Recruiting
Khon Kaen, Thailand, 40002
Recruiting
Bangkok, Thailand, 10400
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.
  More Information

Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Sanofi Pasteur Inc. ( Medical Monitor )
Study ID Numbers: JEC02
Study First Received: August 14, 2008
Last Updated: August 14, 2008
ClinicalTrials.gov Identifier: NCT00735644  
Health Authority: Philippines: Department of Health;   Thailand: Food and Drug Administration

Keywords provided by Sanofi-Aventis:
Japanese encephalitis, Hepatitis A, Inactivated Mouse-Brain

Study placed in the following topic categories:
Liver Diseases
Picornaviridae Infections
Encephalitis, Japanese
Central Nervous System Diseases
Hepatitis, Viral, Human
Brain Diseases
Encephalitis
Hepatitis
Virus Diseases
Japanese encephalitis
Digestive System Diseases
Central Nervous System Infections
Hepatitis A
Arbovirus Infections
Enterovirus Infections

Additional relevant MeSH terms:
RNA Virus Infections
Flaviviridae Infections
Flavivirus Infections
Encephalitis, Viral
Encephalitis, Arbovirus
Nervous System Diseases
Central Nervous System Viral Diseases

ClinicalTrials.gov processed this record on January 16, 2009