Immunogenicity and Safety of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children
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ClinicalTrials.gov Identifier: NCT00621764 |
Recruitment Status :
Completed
First Posted : February 22, 2008
Results First Posted : September 25, 2014
Last Update Posted : October 2, 2014
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Safety:
To describe the safety profiles following vaccination.
Immunogenicity:
To describe the immune response after a single dose of vaccine.
Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
Actual Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (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 |
Study Start Date : | March 2008 |
Actual Primary Completion Date : | December 2009 |
Actual Study Completion Date : | May 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: 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)
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Biological: 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)
Other Name: ChimeriVax™-JE |
Experimental: 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)
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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: 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)
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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: 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)
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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 |
- Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as First Injection [ Time Frame: Day 0 up to Day 14 post-vaccination ]
12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, >39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, >3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable.
2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, >39˚C; Headache, Malaise, and Myalgia, Prevents activities.
- Number of Participants With Solicited Injection Site and Systemic Reactions After Injection With Either JE-CV or Hepatitis A Vaccine as Second Injection [ Time Frame: Day 0 up to Day 14 post-vaccination ]
12 to 24 months - Injection site: Tenderness, Erythema, and Swelling; Systemic reactions: Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥5 cm; Fever, >39.5˚C; Vomiting, ≥ 6 times/day; Abnormal crying, >3 hours; Drowsiness, Sleeping often; Appetite lost, Refuses ≥3 feeds/meals; Irritability, Inconsolable.
2 to 5 years - Injection site: Pain, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating; Erythema and Swelling, ≥5 cm; Fever, >39˚C; Headache, Malaise, and Myalgia, Prevents activities.
- Percentage of Participants With Seroconversion to JE-CV Vaccine Antigens Following Administration of JE-CV Vaccination [ Time Frame: Day 0 (pre-vaccination) and Day 28 after final vaccination ]JE virus neutralizing antibody measurement was assessed by plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer < 10 (1/dil) and post-vaccination titer ≥ 10 (1/dil), or participants with pre-vaccination titer ≥ 10 (1/dil) and 4-fold increase from pre- to post-vaccination.
- Summary of Geometric Mean Titers Against JE Antibodies Before and After JE-CV Vaccination [ Time Frame: Day 0 (pre-vaccination) and Day 28 after final vaccination ]JE virus neutralizing antibody measurement was assessed by the PRNT50 assay.
- Summary of Persistence of Seroprotection to JE-CV Antigens Up To Five Years Following Vaccination [ Time Frame: Day 0 (pre-vaccination) up to 5 years after final vaccination ]Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay.
- Summary of Geometric Mean Titer Against JE Antibodies Up To Five Years Following Vaccination With JE-CV Vaccine [ Time Frame: Day 0 (pre-vaccination) up to 5 years after final vaccination ]Japanese Encephalitis virus neutralizing antibody measurement was assessed by the PRNT50 assay.

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Ages Eligible for Study: | 12 Months to 5 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00621764
Thailand | |
Bangkok, Thailand, 10330 | |
Bangkok, Thailand, 10400 | |
Bangkok, Thailand, 10700 |
Study Director: | Medical Director | Sanofi Pasteur SA |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sanofi Pasteur, a Sanofi Company |
ClinicalTrials.gov Identifier: | NCT00621764 |
Other Study ID Numbers: |
JEC01 |
First Posted: | February 22, 2008 Key Record Dates |
Results First Posted: | September 25, 2014 |
Last Update Posted: | October 2, 2014 |
Last Verified: | September 2014 |
Japanese encephalitis (JE) Hepatitis A Inactivated Mouse-Brain |
Hepatitis A Encephalitis, Japanese Hepatitis Encephalitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Encephalitis, Arbovirus Encephalitis, Viral Central Nervous System Viral Diseases Central Nervous System Infections Infectious Encephalitis Arbovirus Infections Vector Borne Diseases Flavivirus Infections Flaviviridae Infections Vaccines Immunologic Factors Physiological Effects of Drugs |