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
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 Toxicity
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on April 22, 2014