Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Live Attenuated JE Vaccine

Study Overview
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Brief Summary
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The purpose of this study is to observe the occurrence of adverse events and seroconversion rate, geometric mean titres (GMTs) of live attenuated varicella vaccine，live attenuated JE vaccine and live attenuated varicella vaccine combined with live attenuated JE vaccine, respectively.

Official Title
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A Study to Evaluate the Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Live Attenuated JE Vaccine

Conditions
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Japanese Encephalitis, Chickenpox

Intervention / Treatment
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* Biological: Live Attenuated Varicella Vaccine + Live Attenuated JE Vaccine
* Biological: Live Attenuated Varicella Vaccine
* Biological: live attenuated JE vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent Participant is aged ≥ 1 year to ≤ 3 years Participant without previous history of chickenpox, zoster and epidemic encephalitis B Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures Body temperature ≤ 37.5℃ Exclusion Criteria: Known allergy to any constituent of the vaccine Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction Failed to the Expanded Programme on Immunization(EPI) Receipt of any vaccine in the 4 weeks preceding the trial vaccination Plan to receive any vaccine in the 4 weeks following the trial vaccination Known bleeding disorder Receipt of whole blood, blood plasma or immunoglobulin in the 5 months preceding the trial vaccination Reported the history of acute illness had need systemic antibiotics or anti-viral treatment of infections in the 7 days preceding the trial vaccination An acute illness with or without fever (temperature ≥ 38.0℃) in the 3 days preceding enrollment in the trial Participation in any other interventional clinical trial Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Live Attenuated Varicella Vaccine + Live Attenuated JE Vaccine<br>use the left arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection | Biological: Live Attenuated Varicella Vaccine + Live Attenuated JE Vaccine<br> <br> |
| Experimental: Live Attenuated Varicella Vaccine<br>use the right arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection | Biological: Live Attenuated Varicella Vaccine<br> <br> |
| Experimental: Live Attenuated JE Vaccine<br>use the right arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection | Biological: live attenuated JE vaccine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rate and GMTs for live attenuated varicella vaccine, live attenuated JE vaccine and live attenuated varicella vaccine combined with live attenuated JE vaccine, respectively. |  | 35-42 days after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events. |  | within 30 days after each vaccination |