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

Adverse Reaction to Drug Clinical Trial

— AEFI  

Official title:

Phase 4 Study of MR and APDT Vaccine

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01830257
• Other study ID #: BJCDPC-7
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: March 31, 2013
• Last updated: April 11, 2013
• Start date: April 2013
• Est. completion date: June 2014

Study information

• Verified date: April 2013
• Source: Beijing Center for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adverse Reaction to Drug
• Drug-Related Side Effects and Adverse Reactions

Intervention

Other:
• sending message
Sending the suggestive short message

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Center for Disease Control and Prevention

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes