This trial is active, not recruiting.

Condition chickenpox
Treatment live attenuated varicella vaccine
Phase phase 4
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
use the arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
live attenuated varicella vaccine

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

Secondary Outcomes

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

Eligibility Criteria

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

Additional Information

Official title A Study of Immune Persistence After Inoculated With One-dose Freeze-dried Live Attenuated Varicella Vaccine in Children Aged 1-6 Years
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Changchun Changsheng Life Science and Technology Co., Ltd..