Clinical trial NCT00735644: Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines
Official title: Lot-to-lot Consistency, Bridging, and Safety Trial of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Japanese Encephalitis
Hepatitis A
Keywords: Japanese encephalitis, Hepatitis A, Inactivated Mouse-Brain
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-08-15
Enrollment: 1200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

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

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Seroconversion to Vaccine Antigens Following Vaccination With JE-CV by GPO MBP Lots
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Secondary outcomes:
measure: Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or Walter Reed Army Institute of Research (WRAIR) JE-CV
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: Number of Participants With Seroprotection to Japanese Encephalitis Chimeric Virus Antigens Before and Following Vaccination With a JE-CV by GPO MBP Lot or WRAIR JE-CV
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: Geometric Mean Titers Ratios Against the Japanese Encephalitis Chimeric Virus (JE-CV) Antigen Following Vaccination With One of the JE-CV by GPO MBP Lots or WRAIR JE-CV Vaccine
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
measure: Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE- CV) by GPO MBP Lot or WRAIR JE-CV, or Hepatitis A Vaccine.
timeFrame: Day 0 up to Day 14 post-vaccination
Other outcomes:
measure: Serological Status of Flavivirus Infection at Baseline (Before) Vaccination With a Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) or Hepatitis A Vaccine.
timeFrame: Day 0 (pre-vaccination)
Locations:
city: Alabang
country: Philippines
city: Bayanan
country: Philippines
city: Buli
country: Philippines
city: Cupang
country: Philippines
city: Sucat
country: Philippines
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Khon Kaen
country: Thailand
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Bonaparte M, Dweik B, Feroldi E, Meric C, Bouckenooghe A, Hildreth S, Hu B, Yoksan S, Boaz M. Immune response to live-attenuated Japanese encephalitis vaccine (JE-CV) neutralizes Japanese encephalitis virus isolates from south-east Asia and India. BMC Infect Dis. 2014 Mar 21;14:156. doi: 10.1186/1471-2334-14-156.