NCT01830257

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2013

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 12, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

April 12, 2013

Status Verified

April 1, 2013

Enrollment Period

8 months

First QC Date

March 31, 2013

Last Update Submit

April 11, 2013

Conditions

Adverse Reaction to Drug

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

sending message

EXPERIMENTAL

The investigators would send the tip to the children's guardian

Other: sending message

Interventions

sending messageOTHER

Sending the suggestive short message

sending message

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • According with the regular vaccination
  • Immunization the acellular pertussis diphtheria tetanus vaccine and Measles and rubella combined vaccine

You may not qualify if:

  • Disapproval the AEFI information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • Zhaoyun Wang, Doctor

    Beijing Chaoyang District Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2013

First Posted

April 12, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2013

Study Completion

June 1, 2014

Last Updated

April 12, 2013

Record last verified: 2013-04