Chickenpox
Conditions
Brief summary
The purpose of this study is to observe the persistence of protection, duration of protection, safety and breakthrough infection rates afforded by live attenuated varicella vaccine in children over a 5-year period.
Interventions
BIOLOGICALLive Attenuated Varicella Vaccine
Sponsors
Guangdong Provincial Institute of Biological Products And Materia Medica
Changchun Changsheng Life Science and Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant are healthy children aged 1-6 years, who has inquired for medical history and physical examination, and met the requirement of the vaccine trial * Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent * Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures * Body temperature ≤37℃
Exclusion criteria
* Participant with previous history of chickenpox or zoster * Receipt of varicella vaccine * Reported the family history of allergies, convulsions, epilepsy and mental illness * Known allergy to any constituent of the vaccine * Known serve illness, in a fever, acute infection and chronic disease activity * Receipt of steroid * Reported the history of thrombocytopenia or other coagulation disorders, which may cause * Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth * Known congenital malformation, developmental disorders and severe chronic disease (e.g. Down's syndrome, diabetes, sickle cell anemia and neurologic disorders) * Known dermatopathy with allergy, herpes, fester, and fungal infection * Receipt of whole blood, blood plasma or immunoglobulin in the 3 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 * Participant with fever(temperature≥ 38℃) in the days * Any condition, which, in the opinion of the investigator, would pose a health risk to the subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune protective effect and persistence after inoculated with live attenuated varicella vaccine | Before vaccination, six weeks and every year in 5 years study period after inoculation of the live varicella vaccine | Clinical subjects are drawn 3ml's vein blood，respectively before vaccination, six weeks and every year in 5 years study period after inoculation of the live varicella vaccine. FAMA methods are used to test antibody rate of pox virus. |
Secondary
| Measure | Time frame |
|---|---|
| Breakthrough rate, duration and severity of varicella in vaccinated children | 5 years period |
| Occurrence of adverse events | Up to 4 weeks after vaccination |
Countries
China
Outcome results
None listed