Title

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

    Phase 4
  • Study Type

    Interventional
  • Status

    Unknown status
  • Study Participants

    350
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.
Study Started
Jun 30
2013
Primary Completion
Jan 31
2018
Anticipated
Study Completion
Dec 31
2018
Anticipated
Last Update
Mar 27
2014
Estimate

Biological Live Attenuated Varicella Vaccine

Live Attenuated Varicella Vaccine Experimental

use the arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection

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
No Results Posted