Analysis on AEFI Surveillance Data for Live Attenuated Va... | NCT02983656

Studies
Analysis on AEFI Surveillance Data for Live Attenuated Varicella Vaccine

NCT02983656

Sponsor

Zhejiang Provincial Center for Disease Control and Prevention

Status

Completed

Last Update Posted

Jan 11, 2018Actual

Enrollment

394Actual

Phase

Not provided

Conditions

Varicocele

Interventions

live attenuated varicella vaccine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Aug 31, 2017Actual

Completion Date

Aug 31, 2017Actual

First Submitted Date

Dec 1, 2016

First Submission Date that Met QC Criteria

Dec 1, 2016

First Posted Date

Dec 6, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2018

Last Update Posted Date

Jan 11, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Qian Li, Deputy chief physician, Zhejiang Provincial Center for Disease Control and PreventionPrincipal Investigator

Lead Sponsor

Zhejiang Provincial Center for Disease Control and PreventionOTHER_GOV

Collaborators

Name	Class
Changchun Keygen Biological Products Co., Ltd.	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

394Actual

Name	Type	Description	Arm Group Labels	Other Names
live attenuated varicella vaccine	Biological

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of adverse reactions		1 year after the first and second doses

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

15 Years

Standard Ages

Child

Study Population

Participant preventive inoculation of varicella vaccine in 2014-2015

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Qian Li, Bachelor	Zhejiang Provincial Center for Disease Control and Prevention	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014646	Varicocele

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided