Explore Active Surveillance Mode of the Community's Adverse Event Following Immunization(AEFI)
Sponsor
Beijing Center for Disease Control and Prevention (Other)
Overall Status
Unknown status
CT.gov ID
NCT01830257
Collaborator
(none)
1,000
1
14
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
The investigators will compare the rate between active and inactive surveillance of AEFI
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
1000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Phase 4 Study of MR and APDT Vaccine
Study Start Date
:
Apr 1, 2013
Anticipated Primary Completion Date
:
Dec 1, 2013
Anticipated Study Completion Date
:
Jun 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: sending message The investigators would send the tip to the children's guardian |
Other: sending message
Sending the suggestive short message
|
Outcome Measures
Primary Outcome Measures
- Incidence about AEFI [1.5years]
Incidence about AEFI comes from the rate between number of adverse event and the all quantity for immunization about MR and APDT
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Beijing Center for Disease Control and Prevention
Investigators
- Principal Investigator: Zhaoyun Wang, Doctor, Beijing Chaoyang District Centers for Disease Control and Prevention
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Beijing Center for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01830257
Other Study ID Numbers:
- BJCDPC-7
First Posted:
Apr 12, 2013
Last Update Posted:
Apr 12, 2013
Last Verified:
Apr 1, 2013
Additional relevant MeSH terms: