Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00735644
First received: August 14, 2008
Last updated: October 23, 2009
Last verified: October 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Lot-to-lot Consistency, Bridging, and Safety Trial of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines

Resource links provided by NLM:


Further study details as provided by Sanofi:

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 ]

Enrollment: 1199
Study Start Date: August 2008
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Vaccine Lot 1
Biological: Japanese encephalitis vaccine
0.5 mL, Subcutaneous
Other Name: ChimeriVax™-JE
Experimental: 2
Vaccine Lot 2
Biological: Japanese encephalitis vaccine
0.5 mL, Subcutaneous
Other Name: ChimeriVax™-JE
Experimental: 3
Vaccine Lot 3
Biological: Japanese encephalitis vaccine
0.5 mL, Subcutaneous
Other Name: ChimeriVax™-JE
Active Comparator: 4 Biological: Japanese encephalitis vaccine (Acambis)
0.5 mL, Subcutaneous
Sham Comparator: 5 Biological: Hepatitis A vaccine
0.5 mL, Intramuscular
Other Name: Avaxim® 80U Pediatric

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
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: NCT00735644

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

Additional Information:
No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical Monitor, Sanofi Pasteur Inc.
ClinicalTrials.gov Identifier: NCT00735644     History of Changes
Other Study ID Numbers: JEC02
Study First Received: August 14, 2008
Last Updated: October 23, 2009
Health Authority: Philippines: Department of Health
Thailand: Food and Drug Administration

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

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
Encephalitis, Arbovirus
Encephalitis, Viral
Hepatitis
Hepatitis A
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Arbovirus Infections
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections

ClinicalTrials.gov processed this record on August 01, 2014