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

NCT ID: NCT01982409

Last Updated: 2014-03-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2018-12-31

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.

Conditions

Chickenpox

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Live Attenuated Varicella Vaccine

Intervention Type: BIOLOGICAL

Interventions

Live Attenuated Varicella Vaccine

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangdong Provincial Institute of Biological Products And Materia Medica

OTHER

Sponsor Role: collaborator

Changchun Changsheng Life Science and Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Maoming Center for Disease Control and Prevention

Maoming, Guangdong, China

Countries

China

Other Identifiers

NCT02038508

Identifier Type: -

Identifier Source: org_study_id