Immune Persistence After Inoculated With One-dose Freeze-Dried Live Attenuated Varicella Vaccine in Children Vaccine in Children

Changchun Changsheng Life Science and Technology

Status and phase

Unknown

Phase 4

Conditions

Chickenpox

Treatments

Biological: Live Attenuated Varicella Vaccine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01982409

NCT02038508

Details and patient eligibility

About

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.

Enrollment

350 patients

Sex

All

Ages

1 to 6 years old

Volunteers

Accepts Healthy Volunteers

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