Clinical trial NCT01982409: Immune Persistence After Inoculated With One-dose Freeze-Dried Live Attenuated Varicella Vaccine in Children Vaccine in Children
Official title: A Study of Immune Persistence After Inoculated With One-dose Freeze-dried Live Attenuated Varicella Vaccine in Children Aged 1-6 Years
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chickenpox
Lead sponsor: Changchun Changsheng Life Science and Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Guangdong Provincial Institute of Biological Products And Materia Medica
First posted: 2013-11-13
Enrollment: 350
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Immune protective effect and persistence after inoculated with live attenuated varicella vaccine
timeFrame: Before vaccination, six weeks and every year in 5 years study period after inoculation of the live varicella vaccine
Secondary outcomes:
measure: Breakthrough rate, duration and severity of varicella in vaccinated children
timeFrame: 5 years period
measure: Occurrence of adverse events
timeFrame: Up to 4 weeks after vaccination
Other outcomes:
Locations:
city: Maoming
country: China
facility: Maoming Center for Disease Control and Prevention
state: Guangdong
Study officials:
References: