Immunogenicity and Safety of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2013-05-31

Brief Summary

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Safety:

To describe the safety profiles following vaccination.

Immunogenicity:

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

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Detailed Description

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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.

Conditions

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Japanese Encephalitis Hepatitis A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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JE-CV/Hepatitis A (Group 1)

Participants aged 2 to 5 years at enrollment; to receive Japanese encephalitis vaccine (Day 0) and Hepatitis A vaccine (Day 28)

Group Type EXPERIMENTAL

Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)

Intervention Type BIOLOGICAL

≥4.0 Log10 Plaque forming units (PFU), Subcutaneous (SC; Day 0); 0.5 mL intramuscular (IM; Day 28)

Hepatitis A/JE-CV (Group 2)

Participants aged 2 to 5 years at enrollment; to receive Hepatitis A vaccine (Day 0) and Japanese encephalitis vaccine (Day 28)

Group Type EXPERIMENTAL

Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)

Intervention Type BIOLOGICAL

0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)

JE-CV/Hepatitis A (Group 3)

Participants aged 12 to 24 months at enrollment; to receive Japanese encephalitis vaccine (Day 0) and Hepatitis A vaccine (Day 28)

Group Type EXPERIMENTAL

Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)

Intervention Type BIOLOGICAL

≥4.0 Log10 PFU SC (Day 0); 0.5 mL IM (Day 28)

Hepatitis A/JE-CV (Group 4)

Participants aged 12 to 24 months at enrollment; to receive Hepatitis A vaccine (Day 0) and Japanese encephalitis vaccine (Day 28)

Group Type EXPERIMENTAL

Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)

Intervention Type BIOLOGICAL

0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)

Interventions

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Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)

≥4.0 Log10 Plaque forming units (PFU), Subcutaneous (SC; Day 0); 0.5 mL intramuscular (IM; Day 28)

Intervention Type BIOLOGICAL

Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)

0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)

Intervention Type BIOLOGICAL

Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28)

≥4.0 Log10 PFU SC (Day 0); 0.5 mL IM (Day 28)

Intervention Type BIOLOGICAL

Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)

0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)

Intervention Type BIOLOGICAL

Other Intervention Names

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ChimeriVax™-JE ChimeriVax™-JE ChimeriVax™-JE ChimeriVax™-JE

Eligibility Criteria

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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.

Minimum Eligible Age

12 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes