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Immunogenicity and Safety of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children
This study is ongoing, but not recruiting participants.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00621764
  Purpose

Safety:

To describe the safety profiles following vaccination.

Immunogenicity:

To describe the immune response after a single dose of vaccine.


Condition Intervention Phase
Japanese Encephalitis
Hepatitis A
Biological: Japanese encephalitis vaccine (D0) Hepatitis A vaccine (D28)
Biological: Hepatitis A vaccine (D0) Japanese encephalitis vaccine (D28)
Phase II

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, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title: A Controlled Study of the Safety and Immunogenicity of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Safety: - To provide information concerning the safety and occurrence of out-of-normal-range biological test after each injection. [ Time Frame: 4/28 Days and 6 months post-vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To provide information concerning the antibody levels against flavivirus infection at screening [ Time Frame: At Screening ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: March 2008
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Biological: Japanese encephalitis vaccine (D0) Hepatitis A vaccine (D28)
≥4.0 Log10 PFU, SC (Day 0); 0.5 mL IM (Day 28)
2: Experimental Biological: Hepatitis A vaccine (D0) Japanese encephalitis vaccine (D28)
0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)
3: Experimental Biological: Japanese encephalitis vaccine (D0) Hepatitis A vaccine (D28)
≥4.0 Log10 PFU SC (Day 0); 0.5 mL IM (Day 28)
4: Experimental Biological: Hepatitis A vaccine (D0) Japanese encephalitis vaccine (D28)
0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)

Detailed Description:

This is a randomized, cross-over, open, active controlled, multi-center trial in toddlers and children in Thailand. Stepwise enrollment of children in 2 age cohorts.

  Eligibility

Ages Eligible for Study:   12 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provision of consent form signed by at least one parent or another legally acceptable representative, and by at least one independent witness.
  • Completion of vaccinations according to the national immunization schedule
  • Subject and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
  • Previous receipt of two doses of a mouse-brain-derived JE vaccine at 12 to 15 months of age according to the national immunization schedule and aged 2 to 5 years on the day of inclusion.
  • Aged 12 to 24 months on the day of inclusion and have not received any JE vaccine.

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.
  • 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 the trial vaccine or 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.
  • Receipt of hepatitis A vaccine.
  • History of flavivirus infection (confirmed either clinically, serologically or microbiologically).
  • Administration of any anti-viral within 2 months preceding the screening visit.
  • History of central nervous system disorder or disease.
  • Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
  • Planned participation in another clinical trial during the present trial period.
  • 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, hepatitis B or hepatitis C seropositivity in the blood sample taken at screening.
  • Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination.
  • Previous vaccination against flavivirus disease at any time before the trial other than a mouse-brain-derived JE vaccine given in a two-dose regimen at 12 to 15 months of age in accordance with the national immunization schedule.
  • Febrile illness or any acute illness/infection on the day of vaccination, according to investigator judgment
  • History of seizures.
  • Previous vaccination against flavivirus disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00621764

Locations
Thailand
Bangkok, Thailand, 10700
Bangkok, Thailand, 10400
Bangkok, Thailand, 10330
Sponsors and Collaborators
Sanofi-Aventis
  More Information

Responsible Party: Sanofi Pasteur, Inc ( Medical Monitor )
Study ID Numbers: JEC01
Study First Received: February 12, 2008
Last Updated: August 4, 2008
ClinicalTrials.gov Identifier: NCT00621764  
Health Authority: Thailand: Food and Drug Administration

Keywords provided by Sanofi-Aventis:
Japanese encephalitis (JE)
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:
Encephalitis, Viral
RNA Virus Infections
Flaviviridae Infections
Flavivirus Infections
Nervous System Diseases
Central Nervous System Viral Diseases
Encephalitis, Arbovirus

ClinicalTrials.gov processed this record on January 16, 2009