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

Changchun Keygen Biological Products

Status and phase: Completed; Phase 4

Conditions: Japanese Encephalitis; Chickenpox

Treatments: Biological: Live Attenuated Varicella Vaccine; Biological: Live Attenuated Varicella Vaccine + Live Attenuated JE Vaccine; Biological: live attenuated JE vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01815073

NCT02049715

Details and patient eligibility

About

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.

Enrollment: 497 patients

Sex: All

Ages: 1 to 3 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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497 participants in 3 patient groups

Live Attenuated Varicella Vaccine + Live Attenuated JE Vaccine

Experimental group

Description:

use the left arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection

Treatment:

Biological: Live Attenuated Varicella Vaccine + Live Attenuated JE Vaccine

Live Attenuated Varicella Vaccine

Experimental group

Description:

use the right arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection

Treatment:

Biological: Live Attenuated Varicella Vaccine

Live Attenuated JE Vaccine

Experimental group

Description:

use the right arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection

Treatment:

Biological: live attenuated JE vaccine