A Study of Immune Persistence After Inoculated With One-dose Freeze-dried Live Attenuated Varicella Vaccine in Children Aged 1-6 Years

Changchun Changsheng Life Science and Technology Co., Ltd.1 site in 1 country350 target enrollmentJune 2013

ConditionsChickenpox

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Chickenpox
Sponsor: Changchun Changsheng Life Science and Technology Co., Ltd.
Enrollment: 350
Locations: 1
Primary Endpoint: Immune protective effect and persistence after inoculated with live attenuated varicella vaccine
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2013

End Date

December 2018

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Changchun Changsheng Life Science and Technology Co., Ltd.

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

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 Outcomes

Breakthrough rate, duration and severity of varicella in vaccinated children(5 years period)
Occurrence of adverse events(Up to 4 weeks after vaccination)