Chickenpox
Conditions
Brief summary
The purpose of this study is to observe the occurrence of adverse events, seroconversion rate and geometric mean titres(GMTs) of 2 doses of live attenuated varicella vaccine.
Interventions
BIOLOGICALLive Attenuated Varicella Vaccine
Sponsors
Guangdong Provincial Institute of Biological Products And Materia Medica
Changchun Keygen Biological Products Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 3 Years
Healthy volunteers
Yes
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 preventive inoculation of varicella vaccine and previous history of chickenpox and zoster * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroconversion rate and GMTs for live attenuated varicella vaccine | 35-42 days after the first and second doses |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of adverse events | within 30 days after each vaccination |
Countries
China
Outcome results
None listed