Immune Persistence After Inoculated With One-dose Freeze-Dried Live Attenuated Varicella Vaccine in Children Vaccine in Children
This trial is active, not recruiting.
|Treatment||live attenuated varicella vaccine|
|Sponsor||Changchun Changsheng Life Science and Technology Co., Ltd.|
|Collaborator||Guangdong Provincial Institute of Biological Products And Materia Medica|
|Start date||June 2013|
|End date||January 2018|
|Trial size||350 participants|
|Trial identifier||NCT01982409, NCT02038508|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
use the arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
Immune protective effect and persistence after inoculated with live attenuated varicella vaccine
time frame: Before vaccination, six weeks and every year in 5 years study period after inoculation of the live varicella vaccine
Breakthrough rate, duration and severity of varicella in vaccinated children
time frame: 5 years period
Occurrence of adverse events
time frame: Up to 4 weeks after vaccination
Male or female participants from 1 year up to 6 years old.
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
|Official title||A Study of Immune Persistence After Inoculated With One-dose Freeze-dried Live Attenuated Varicella Vaccine in Children Aged 1-6 Years|
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