Immunogenicity and Safety of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children
This study is ongoing, but not recruiting participants.
Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00621764
First received: February 12, 2008
Last updated: March 28, 2013
Last verified: March 2013
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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 (Day 0) Hepatitis A vaccine (Day 28) Biological: Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Controlled Study of the Safety and Immunogenicity of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- To provide information concerning the safety and occurrence of out-of-normal-range biological test after each injection. [ Time Frame: 4 Days up to 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: | October 2013 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
Participants aged 2 to 5 years at enrollment; to receive Japanese encephalitis vaccine (Day 0) and Hepatitis A vaccine (Day 28)
|
Biological: Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)
≥4.0 Log10 Plaque forming units (PFU), Sub cutaneous (SC; Day 0); 0.5 mL intramuscular (IM; Day 28)
Other Name: ChimeriVax™-JE
|
|
Experimental: Group 2
Participants aged 2 to 5 years at enrollment; to receive Hepatitis A vaccine (Day 0) and Japanese encephalitis vaccine (Day 28)
|
Biological: Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)
0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)
Other Name: ChimeriVax™-JE
|
|
Experimental: Group 3
Participants aged 12 to 24 months at enrollment; to receive Japanese encephalitis vaccine (Day 0) and Hepatitis A vaccine (Day 28)
|
Biological: Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)
≥4.0 Log10 PFU SC (Day 0); 0.5 mL IM (Day 28)
Other Name: ChimeriVax™-JE
|
|
Experimental: Group 4
Participants aged 12 to 24 months at enrollment; to receive Hepatitis A vaccine (Day 0) and Japanese encephalitis vaccine (Day 28)
|
Biological: Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)
0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)
Other Name: ChimeriVax™-JE
|
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. Subjects will be followed for 5 years.
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 More Information
Publications:
| Responsible Party: | Sanofi ( Sanofi Pasteur, a Sanofi Company ) |
| ClinicalTrials.gov Identifier: | NCT00621764 History of Changes |
| Other Study ID Numbers: | JEC01 |
| Study First Received: | February 12, 2008 |
| Last Updated: | March 28, 2013 |
| Health Authority: | Thailand: Food and Drug Administration |
Keywords provided by Sanofi:
|
Japanese encephalitis (JE) Hepatitis A Inactivated Mouse-Brain |
Additional relevant MeSH terms:
|
Encephalitis, Japanese Encephalitis Hepatitis Hepatitis A Central Nervous System Viral Diseases Virus Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Central Nervous System Infections Encephalitis, Arbovirus |
Arbovirus Infections Encephalitis, Viral 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 May 23, 2013