NCT01982409

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 27, 2014

Status Verified

March 1, 2014

Enrollment Period

4.6 years

First QC Date

October 24, 2013

Last Update Submit

March 25, 2014

Conditions

Chickenpox

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Breakthrough rate, duration and severity of varicella in vaccinated children

    5 years period

  • Occurrence of adverse events

    Up to 4 weeks after vaccination

Study Arms (1)

Live Attenuated Varicella Vaccine

EXPERIMENTAL

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

Interventions

Live Attenuated Varicella VaccineBIOLOGICAL
Live Attenuated Varicella Vaccine

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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℃

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maoming Center for Disease Control and Prevention

Maoming, Guangdong, China

Location

MeSH Terms

Conditions

Chickenpox

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2013

First Posted

November 13, 2013

Study Start

June 1, 2013

Primary Completion

January 1, 2018

Study Completion

December 1, 2018

Last Updated

March 27, 2014

Record last verified: 2014-03

Locations

CN(1)