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

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 Overview

• Status: Unknown
• Conditions: Chickenpox
• Intervention / Treatment: Biological: Live Attenuated Varicella Vaccine

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Maoming, Guangdong, China
      • Maoming Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Biological: Live Attenuated Varicella Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immune protective effect and persistence after inoculated with live attenuated 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.	Before vaccination, six weeks and every year in 5 years study period after inoculation of the live varicella vaccine

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Changchun Changsheng Life Science and Technology Co., Ltd.
• Collaborators: Guangdong Provincial Institute of Biological Products And Materia Medica

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: October 24, 2013
• First Submitted That Met QC Criteria: November 6, 2013
• First Posted (Estimate): November 13, 2013

Study Record Updates

• Last Update Posted (Estimate): March 27, 2014
• Last Update Submitted That Met QC Criteria: March 25, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Varicella Zoster Virus Infection; Chickenpox
• Other Study ID Numbers: NCT02038508