Explore Active Surveillance Mode of the Community's Adver... | NCT01830257

Studies
Explore Active Surveillance Mode of the Community's Adverse Event Following Immunization(AEFI)

NCT01830257

Sponsor

Beijing Center for Disease Control and Prevention

Status

Unknown status

Last Update Posted

Apr 12, 2013Estimated

Enrollment

1,000Estimated

Phase

Phase 4

Conditions

Adverse Reaction to Drug

Interventions

sending message

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

Apr 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Dec 2013Estimated

Completion Date

Jun 2014Estimated

First Submitted Date

Mar 31, 2013

First Submission Date that Met QC Criteria

Apr 11, 2013

First Posted Date

Apr 12, 2013Estimated

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

Apr 11, 2013

Last Update Posted Date

Apr 12, 2013Estimated

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

Description Module

Brief Summary

The investigators would remind the guardians of observation after immunization via sending short message and collect the information of AEFI by two ways, short message/telephone and website questionnaire.

Detailed Description

The investigators will compare the rate between active and inactive surveillance of AEFI

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sending message	Experimental	The investigators would send the tip to the children's guardian	Other: sending message

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sending message	Other	Sending the suggestive short message	sending message

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence about AEFI	Incidence about AEFI comes from the rate between number of adverse event and the all quantity for immunization about MR and APDT	1.5years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

According with the regular vaccination
Immunization the acellular pertussis diphtheria tetanus vaccine and Measles and rubella combined vaccine

Exclusion Criteria:

Disapproval the AEFI information

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zhaoyun Wang, Doctor	Beijing Chaoyang District Centers for Disease Control and Prevention	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D064420	Drug-Related Side Effects and Adverse Reactions

Ancestor Terms

ID	Term
D064419	Chemically-Induced Disorders

Browse Leaves

Not provided

Browse Branches

Not provided