Seasonal Influenza Vaccination Reminders for Children With High-risk Conditions

Seasonal Influenza Vaccination Clinical Trial

Official title:

Seasonal Influenza Vaccination Reminders for Children With High-risk Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01431183
• Other study ID #: 5U01IP000132
• Status: Completed
• Phase: N/A
• First received: September 6, 2011
• Last updated: September 7, 2011
• Start date: October 2008
• Est. completion date: December 2010

Study information

• Verified date: September 2011
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The objective of this study was to assess the feasibility and effectiveness of using a statewide immunization information system (IIS) to send seasonal influenza vaccine reminders from Local Health Departments (LHDs), targeting children with high-risk conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3618
• Est. completion date: December 2010
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Months to 60 Months

Eligibility

Inclusion Criteria:

• children, 24-60 months

• current or previous enrollment in Medicaid (Michigan)

• presence of at least 1 chronic condition, as indicated by the Michigan Care Improvement Registry (MCIR)

• resident of Kalamazoo, Ottawa, or Kent counties (Michigan)

Exclusion Criteria:

• receipt of influenza prior to notification date

• ineligible for reminder/recall notification in the Michigan Care Improvement Registry (MCIR)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Influenza, Human
• Seasonal Influenza Vaccination

Intervention

Behavioral:
• Mailed influenza vaccination reminder notice
Influenza vaccination reminder sent by postal mail

Locations

Country	Name	City	State
United States	University of Michigan, Child Health Evaluation and Research Unit	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	seasonal influenza vaccination	Receipt of 1 or more dose of seasonal influenza vaccine, either trivalent inactivated influenza vaccine (TIV) or live attenuated influenza vaccine (LAIV)	up to 4 months following reminder notification	No
Secondary	invalid mailing address	Postal mailing address determined to be invalid for mail delivery, either by physical return of mailed reminder notification, or through the United States Postal Service's National Change of Address (NCOA) process	up to 4 months following reminder notification	No