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

August 14, 2008
October 23, 2009
August 2008
September 2009   (final data collection date for primary outcome measure)
Immunogenicity: To provide information concerning the immunogenicity of ChimeriVax™-Japanese Encephalitis Vaccine. [ Time Frame: 28 days post vaccination ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00735644 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines
Lot-to-lot Consistency, Bridging, and Safety Trial of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines

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

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Japanese Encephalitis
  • Hepatitis A
  • Biological: Japanese encephalitis vaccine
    0.5 mL, Subcutaneous
    Other Name: ChimeriVax™-JE
  • Biological: Japanese encephalitis vaccine (Acambis)
    0.5 mL, Subcutaneous
  • Biological: Hepatitis A vaccine
    0.5 mL, Intramuscular
    Other Name: Avaxim® 80U Pediatric
  • Experimental: 1
    Vaccine Lot 1
    Intervention: Biological: Japanese encephalitis vaccine
  • Experimental: 2
    Vaccine Lot 2
    Intervention: Biological: Japanese encephalitis vaccine
  • Experimental: 3
    Vaccine Lot 3
    Intervention: Biological: Japanese encephalitis vaccine
  • Active Comparator: 4
    Intervention: Biological: Japanese encephalitis vaccine (Acambis)
  • Sham Comparator: 5
    Intervention: Biological: Hepatitis A vaccine
Feroldi E, Pancharoen C, Kosalaraksa P, Watanaveeradej V, Phirangkul K, Capeding MR, Boaz M, Gailhardou S, Bouckenooghe A. Single-dose, live-attenuated Japanese encephalitis vaccine in children aged 12-18 months: randomized, controlled phase 3 immunogenicity and safety trial. Hum Vaccin Immunother. 2012 Jul;8(7):929-37. doi: 10.4161/hv.20071. Epub 2012 Jul 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1199
October 2009
September 2009   (final data collection date for primary outcome measure)

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.
Both
12 Months to 18 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Philippines,   Thailand
 
NCT00735644
JEC02
Yes
Medical Monitor, Sanofi Pasteur Inc.
Sanofi
Not Provided
Study Director: Medical Monitor Sanofi Pasteur Inc.
Sanofi
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP