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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.
First Received: February 12, 2008   Last Updated: August 4, 2008   History of Changes
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

No publications provided

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     History of Changes
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
Japanese Encephalitis
Picornaviridae Infections
Encephalitis, Japanese
Central Nervous System Diseases
Hepatitis, Viral, Human
Brain Diseases
Encephalitis
Hepatitis
Virus Diseases
Digestive System Diseases
Central Nervous System Infections
Hepatitis A
Arbovirus Infections
Enterovirus Infections

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

ClinicalTrials.gov processed this record on May 06, 2009