NCT01815073

Brief Summary

The purpose of this study is to observe the occurrence of adverse events and seroconversion rate, geometric mean titres (GMTs) of live attenuated varicella vaccine，live attenuated JE vaccine and live attenuated varicella vaccine combined with live attenuated JE vaccine, respectively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
497

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

February 24, 2014

Status Verified

February 1, 2014

Enrollment Period

4 months

First QC Date

March 18, 2013

Last Update Submit

February 20, 2014

Conditions

Japanese EncephalitisChickenpox

Outcome Measures

Primary Outcomes (1)

  • Seroconversion rate and GMTs for live attenuated varicella vaccine, live attenuated JE vaccine and live attenuated varicella vaccine combined with live attenuated JE vaccine, respectively.

    35-42 days after vaccination

Secondary Outcomes (1)

  • Occurrence of adverse events.

    within 30 days after each vaccination

Study Arms (3)

Live Attenuated Varicella Vaccine + Live Attenuated JE Vaccine

EXPERIMENTAL

use the left arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection

Biological: Live Attenuated Varicella Vaccine + Live Attenuated JE Vaccine

Live Attenuated Varicella Vaccine

EXPERIMENTAL

use the right arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection

Biological: Live Attenuated Varicella Vaccine

Live Attenuated JE Vaccine

EXPERIMENTAL

use the right arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection

Biological: live attenuated JE vaccine

Interventions

Live Attenuated Varicella Vaccine + Live Attenuated JE VaccineBIOLOGICAL
Live Attenuated Varicella Vaccine + Live Attenuated JE Vaccine
Live Attenuated Varicella VaccineBIOLOGICAL
Live Attenuated Varicella Vaccine
live attenuated JE vaccineBIOLOGICAL
Live Attenuated JE Vaccine

Eligibility Criteria

Age1 Year - 3 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent
  • Participant is aged ≥ 1 year to ≤ 3 years
  • Participant without previous history of chickenpox, zoster and epidemic encephalitis B
  • Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures
  • Body temperature ≤ 37.5℃

You may not qualify if:

  • Known allergy to any constituent of the vaccine
  • Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever
  • Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
  • Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
  • Failed to the Expanded Programme on Immunization(EPI)
  • Receipt of any vaccine in the 4 weeks preceding the trial vaccination
  • Plan to receive any vaccine in the 4 weeks following the trial vaccination
  • Known bleeding disorder
  • Receipt of whole blood, blood plasma or immunoglobulin in the 5 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
  • An acute illness with or without fever (temperature ≥ 38.0℃) in the 3 days preceding enrollment in the trial
  • Participation in any other interventional clinical trial
  • Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Haizhu District Center for Disease Control and Prevention

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Encephalitis, JapaneseChickenpox

Condition Hierarchy (Ancestors)

Encephalitis, ArbovirusEncephalitis, ViralCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsInfectious EncephalitisArbovirus InfectionsVector Borne DiseasesMosquito-Borne DiseasesVirus DiseasesRNA Virus InfectionsFlavivirus InfectionsFlaviviridae InfectionsEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory DiseasesVaricella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus Infections

Study Officials

  • Zheng Huizhen, Master

    Guangdong Center for Disease Prevention and Control

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2013

First Posted

March 20, 2013

Study Start

March 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

February 24, 2014

Record last verified: 2014-02

Locations

CN(1)