NCT02983656

Brief Summary

The purpose of this study is to observe the occurrence of adverse events of live attenuated varicella vaccine.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
394

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

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

November 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

January 11, 2018

Status Verified

January 1, 2018

Enrollment Period

10 months

First QC Date

December 1, 2016

Last Update Submit

January 10, 2018

Conditions

Varicocele

Keywords

Vaccine Safety

Outcome Measures

Primary Outcomes (1)

  • incidence of adverse reactions

    1 year after the first and second doses

Interventions

live attenuated varicella vaccineBIOLOGICAL

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Participant preventive inoculation of varicella vaccine in 2014-2015

You may qualify if:

  • The registered permanent residence or resident place are local (reside more than 3 months);
  • Participant preventive inoculation of varicella vaccine in 2014-2015;
  • Adverse reactions occurred and should be reported in the AEFI monitoring system.

You may not qualify if:

  • Subjects with a known allergy to any ingredient of the vaccine, and with any allergy history to any vaccine;
  • Subjects with any acute diseases, severe chronic diseases, acute bout of chronic diseases, and catching cold and fever;
  • Subjects with uncontrolled seizures and other progressive neurological diseases, with a history of Guillain-Barré syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Varicocele

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Qian Li, Bachelor

    Zhejiang Provincial Center for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy chief physician

Study Record Dates

First Submitted

December 1, 2016

First Posted

December 6, 2016

Study Start

November 1, 2016

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

January 11, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share