Study of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With JE-CV

An individual had to fulfill all of the following criteria in order to be eligible for trial enrollment:

All Participants

• Aged 36 to 42 months on the day of inclusion

• Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative

• Participant and parent/legally acceptable representative or guardian able to attend all scheduled visits and to comply with all trial procedures

• In good general health, based on medical history and physical examination

For JE-CV vaccine primed group only

• Participant who was vaccinated with JE-CV in JEC02 trial (NCT00735644)

An individual fulfilling any of the following criteria was excluded from trial enrollment:

All Participants

• Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination

• Planned participation in another clinical trial during the Day 0 - Month 6 period and for Group 1 up to 5 years for any flavivirus vaccine trial

• Receipt of any vaccine* in the 4 weeks preceding the trial vaccination, except for pandemic influenza vaccination, which may be received at least 2 weeks before study vaccines

• Planned receipt of any vaccine* in the 4 weeks following the trial vaccination, except for pandemic influenza vaccine. In the event of local or national immunization program with a pandemic influenza vaccine, participants who receive a pandemic influenza vaccine at any time during the trial will not be withdrawn from the trial.

• Planned receipt of any JE vaccine during the course of the trial

• Administration of any anti-viral within 2 months preceding the trial vaccination and up to 4 weeks following the trial vaccination

• Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response

• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

• Seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, as reported by the parent/legally acceptable representative

• History of central nervous system disorder or disease, including seizures and febrile seizures

• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances

• Chronic illness or any underlying illness (such as cardiovascular, kidney, liver or hematological disease or development abnormalities) that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion

• Except in case of national immunization days with oral polio vaccine

For JE-CV primed participants only

• Receipt of any JE vaccine other than JE-CV during JEC02 trial(NCT00735644) and since the end of JEC02 trial

For JE-CV naïve participants only

• Previous vaccination against flavivirus disease including JE

• History of flavivirus infection either based on clinical suspicion or laboratory proven

• Previous vaccination against varicella

• Previous vaccination with JE-CV in JEC02 study

• History of varicella, confirmed either clinically, serologically, or microbiologically

• Known systemic hypersensitivity or anaphylactic/anaphylactoid reaction to neomycin.

• Known history of thrombocytopenia or idiopathic thrombocytopenic purpura

Temporary Contraindications:

A prospective participant was not to be included in the study until the following conditions and/or symptoms had resolved:

1. Receipt of oral or injected antibiotic therapy within 72 hours prior to the first blood draw (for Groups 1 and 2)

2. Febrile illness (temperature ≥38.0°C [≥100.4°F]) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination (for all participants)

for Group 1 up to 5 years for any flavivirus vaccine trial
 

• Receipt of any vaccine* in the 4 weeks preceding the trial vaccination, except for
 pandemic influenza vaccination, which may be received at least 2 weeks before study
 vaccines
 
• Planned receipt of any vaccine* in the 4 weeks following the trial vaccination, except
 for pandemic influenza vaccine. In the event of local or national immunization program
 with a pandemic influenza vaccine, participants who receive a pandemic influenza
 vaccine at any time during the trial will not be withdrawn from the trial.
 
• Planned receipt of any JE vaccine during the course of the trial
 
• Administration of any anti-viral within 2 months preceding the trial vaccination and
 up to 4 weeks following the trial vaccination
 
• Receipt of blood or blood-derived products in the past 3 months, which might interfere
 with assessment of the immune response
 
• Known or suspected congenital or acquired immunodeficiency; or receipt of
 immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within
 the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or
 equivalent for more than 2 consecutive weeks within the past 3 months)
 
• Seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, as
 reported by the parent/legally acceptable representative
 
• History of central nervous system disorder or disease, including seizures and febrile
 seizures
 
• Known systemic hypersensitivity to any of the vaccine components, or history of a
 life-threatening reaction to the vaccine used in the trial or to a vaccine containing
 any of the same substances
 
• Chronic illness or any underlying illness (such as cardiovascular, kidney, liver or
 hematological disease or development abnormalities) that, in the opinion of the
 investigator, is at a stage where it might interfere with trial conduct or completion
 
• Except in case of national immunization days with oral polio vaccine
 
 For JE-CV primed participants only
 
• Receipt of any JE vaccine other than JE-CV during JEC02 trial(NCT00735644) and since
 the end of JEC02 trial
 
 For JE-CV naïve participants only
 
• Previous vaccination against flavivirus disease including JE
 
• History of flavivirus infection either based on clinical suspicion or laboratory
 proven
 
• Previous vaccination against varicella
 
• Previous vaccination with JE-CV in JEC02 study
 
• History of varicella, confirmed either clinically, serologically, or microbiologically
 
• Known systemic hypersensitivity or anaphylactic/anaphylactoid reaction to neomycin.
 
• Known history of thrombocytopenia or idiopathic thrombocytopenic purpura
 
 Temporary Contraindications:
 
 A prospective participant was not to be included in the study until the following
 conditions and/or symptoms had resolved:
 

1. Receipt of oral or injected antibiotic therapy within 72 hours prior to the first
 blood draw (for Groups 1 and 2)
 
2. Febrile illness (temperature ≥38.0°C [≥100.4°F]) or moderate or severe acute
 illness/infection (according to investigator judgment) on the day of vaccination (for
 all participants)
 
 The Investigator was to postpone vaccination until the situation/condition resolved. Vaccination could be postponed within the timeframe for vaccination indicated in the protocol trial flowchart.