NCT02173899

Brief Summary

The purpose of this study is to observe the occurrence of adverse events, seroconversion rate and geometric mean titres(GMTs) of 2 doses of live attenuated varicella vaccine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
716

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2014

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

June 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

September 1, 2014

Status Verified

August 1, 2014

Enrollment Period

2 months

First QC Date

June 24, 2014

Last Update Submit

August 28, 2014

Conditions

Varicella

Outcome Measures

Primary Outcomes (1)

  • Seroconversion rate and GMTs for live attenuated varicella vaccine

    35-42 days after the second dose

Secondary Outcomes (1)

  • Occurrence of adverse events

    within 30 days after the second dose

Study Arms (3)

varicella-1

EXPERIMENTAL

The second varicella vaccine and 1 year of the interval time between 2 doses

Biological: varicella-1

varicella-3

EXPERIMENTAL

The second varicella vaccine and 3 years of the interval time between 2 doses

Biological: varicella-3

varicella-5

EXPERIMENTAL

The second varicella vaccine and 5 years of the interval time between 2 doses

Biological: varicella-5

Interventions

varicella-1BIOLOGICAL

Give the second varicella vaccine (a single 0.5 ml) and get blood samples at 0, 35-42 day

varicella-1
varicella-3BIOLOGICAL

Give the second varicella vaccine (a single 0.5 ml) and get blood samples at 0, 35-42 day

varicella-3
varicella-5BIOLOGICAL

Give the second varicella vaccine (a single 0.5 ml) and get blood samples at 0, 35-42 day

varicella-5

Eligibility Criteria

Age1 Year - 7 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 ≤ 7 years
  • Participant without preventive inoculation of varicella vaccine and previous history of chickenpox and zoster
  • 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 antiviral 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)

Shenzhen Luohu District Center for Disease Control and Prevention

Shenzhen, Guangdong, China

Location

MeSH Terms

Conditions

Chickenpox

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Huizhen Zheng, 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

June 24, 2014

First Posted

June 25, 2014

Study Start

June 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 1, 2014

Record last verified: 2014-08

Locations

CN(1)