Fever and Wheezing Events in Children After US Influenza Vaccines Using Text Messaging

Fever Clinical Trial

Official title:

Pilot Study to Assess Fever and Wheezing Events in Children After US Influenza Vaccines Using Text Messaging (2014-2015 Season)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02295007
• Other study ID #: AAAO5253
• Status: Recruiting
• Phase: N/A
• First received: November 17, 2014
• Last updated: December 22, 2015
• Start date: December 2014
• Est. completion date: June 2016

Study information

• Verified date: December 2015
• Source: Columbia University
• Contact: Kathleen Jakob, RN
• Phone: 212-305-8198
• Email: kj60[@]columbia.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Children 2-11 years of age who are given the influenza vaccine (inactivated influenza (IIV) or live attenuated influenza vaccine (LAIV)) as part of their routine care can enroll in this study if their parent has the ability to receive and send text messages. Children enrolled in this study will be observed daily for an eight-day period starting on the day of vaccine administration, and then continuing over the next 7 days, and then weekly for 42 days. On the day of enrollment and nightly for the next seven days, the parent will report via text message what their child's highest temperature is. If fever is present, they will then be prompted for additional information including other symptoms, antipyretic use and medical care sought. On day 3 as well as weekly from day 7 through day 42 post-vaccination, parents will be asked via text message about breathing problems, specifically cough, wheezing and chest tightness. They will also be asked about medications taken and care sought. The purpose of this study is to assess the feasibility of collecting this data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 275
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 11 Years

Eligibility

Inclusion Criteria:

1. are 2 through 11years of age,

2. have a visit at a study site anytime during the study period,

3. receive first dose or second dose of LAIV4 or IIV in the season,

4. the parent has a cell phone with text messaging capabilities, and

5. the parent and child > 7 years of age speaks English or Spanish at the Columbia sites or English at the Boston site.

Exclusion criteria:

1. presence of fever =100.4 at time of vaccination,

2. administration of any antipyretic in the 6-hour period prior to vaccination,

3. stated intent, at time of vaccination, to use prophylactic antipyretics before the development of a fever,

4. parent only speaks a language other than English or Spanish at the Columbia sites or English at the Boston site.

5. enrollee is a child >7 years of age who only speaks a language other than English or Spanish at the Columbia sites or English at the Boston site.

6. parent's inability to read and send text messages,

7. sibling already enrolled this season (OR cell phone # already used for another child)

8. chronic medical condition considered by ACIP to be a precaution or contraindication for LAIV1 (except for asthma),

9. current asthma exacerbation, or exacerbation in the last 2 weeks

10. use of oral or other systemic steroid within the last 2 weeks

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Fever
• Wheezing

Intervention

Behavioral:
• text message

Locations

Country	Name	City	State
United States	Centers for Disease Control and Prevention	Atlanta	Georgia
United States	Boston Medical Center	Boston	Massachusetts
United States	Columbia University	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	Boston Medical Center, Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility reporting respiratory symptom	Response rates to text messages regarding wheezing, cough or chest tightness symptoms	days 0-42 days post-vaccination	No
Secondary	feasibility reporting fever	Response rates to text messages regarding temperature	days 0-7 days post-vaccination	No