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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Beijing Center for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01830257
First received: March 31, 2013
Last updated: April 11, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Adverse Reaction to Drug
Other: sending message
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase 4 Study of MR and APDT Vaccine

Further study details as provided by Beijing Center for Disease Control and Prevention:

Primary Outcome Measures:
  • Incidence about AEFI [ Time Frame: 1.5years ] [ Designated as safety issue: Yes ]
    Incidence about AEFI comes from the rate between number of adverse event and the all quantity for immunization about MR and APDT


Estimated Enrollment: 1000
Study Start Date: April 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sending message
The investigators would send the tip to the children's guardian
Other: sending message
Sending the suggestive short message

Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01830257

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
  More Information

No publications provided

Responsible Party: Beijing Center for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01830257     History of Changes
Other Study ID Numbers: BJCDPC-7
Study First Received: March 31, 2013
Last Updated: April 11, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on October 20, 2014