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

Phase 4

• Conditions: Chickenpox
• Interventions: Biological: Live Attenuated Varicella Vaccine

• Registration Number: NCT01982409
• Lead Sponsor: Changchun Changsheng Life Science and Technology Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-10-24
• Study First Submitted QC: 2013-11-06
• Study First Posted: 2013-11-13
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-25
• Last Update Posted: 2014-03-27
• Primary Completion: 2018-01
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Live Attenuated Varicella Vaccine	Live Attenuated Varicella Vaccine	use the arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection

Primary Outcome Measures

Name	Time	Method
Immune protective effect and persistence after inoculated with live attenuated varicella vaccine	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 Outcome Measures

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

Trial Locations

Locations (1)

Maoming Center for Disease Control and Prevention; 🇨🇳 Maoming, Guangdong, China