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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Guangdong Provincial Institute of Biological Products And Materia Medica
Information provided by (Responsible Party):
Changchun Changsheng Life Science and Technology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01982409
First received: October 24, 2013
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Chickenpox
Biological: Live Attenuated Varicella Vaccine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Study of Immune Persistence After Inoculated With One-dose Freeze-dried Live Attenuated Varicella Vaccine in Children Aged 1-6 Years

Resource links provided by NLM:


Further study details as provided by Changchun Changsheng Life Science and Technology Co., Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Breakthrough rate, duration and severity of varicella in vaccinated children [ Time Frame: 5 years period ] [ Designated as safety issue: No ]
  • Occurrence of adverse events [ Time Frame: Up to 4 weeks after vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 350
Study Start Date: June 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   1 Year to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01982409

Locations
China, Guangdong
Maoming Center for Disease Control and Prevention
Maoming, Guangdong, China
Sponsors and Collaborators
Changchun Changsheng Life Science and Technology Co., Ltd.
Guangdong Provincial Institute of Biological Products And Materia Medica
  More Information

No publications provided

Responsible Party: Changchun Changsheng Life Science and Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT01982409     History of Changes
Other Study ID Numbers: NCT02038508
Study First Received: October 24, 2013
Last Updated: March 25, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Chickenpox
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on July 23, 2014