Back to resultsExplore Active Surveillance Mode of the Community's Adverse Event Following Immunization(AEFI) (AEFI)
Primary Purpose
Adverse Reaction to Drug
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
sending message
Sponsored by
About this trial
This is an interventional prevention trial for Adverse Reaction to Drug
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
sending message
Arm Description
The investigators would send the tip to the children's guardian
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01830257
First Posted
March 31, 2013
Last Updated
April 11, 2013
Sponsor
Beijing Center for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT01830257
Brief Title
Explore Active Surveillance Mode of the Community's Adverse Event Following Immunization(AEFI)
Acronym
AEFI
Official Title
Phase 4 Study of MR and APDT Vaccine
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
June 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Center for Disease Control and Prevention
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Reaction to Drug
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sending message
Arm Type
Experimental
Arm Description
The investigators would send the tip to the children's guardian
Intervention Type
Other
Intervention Name(s)
sending message
Intervention Description
Sending the suggestive short message
Primary Outcome Measure Information:
Title
Incidence about AEFI
Description
Incidence about AEFI comes from the rate between number of adverse event and the all quantity for immunization about MR and APDT
Time Frame
1.5years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaoyun Wang, Doctor
Organizational Affiliation
Beijing Chaoyang District Centers for Disease Control and Prevention
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Explore Active Surveillance Mode of the Community's Adverse Event Following Immunization(AEFI)
We'll reach out to this number within 24 hrs