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

Chickenpox Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01982409
• Other study ID #: NCT02038508
• Status: Active, not recruiting
• Phase: Phase 4
• First received: October 24, 2013
• Last updated: March 25, 2014
• Start date: June 2013
• Est. completion date: December 2018

Study information

• Verified date: March 2014
• Source: Changchun Changsheng Life Science and Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: December 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 6 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chickenpox

Intervention

Biological:
• Live Attenuated Varicella Vaccine

Locations

Country	Name	City	State
China	Maoming Center for Disease Control and Prevention	Maoming	Guangdong

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Breakthrough rate, duration and severity of varicella in vaccinated children		5 years period	No
Secondary	Occurrence of adverse events		Up to 4 weeks after vaccination	Yes