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

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

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.

Study Overview

• Status: Completed
• Conditions: Fever; Wheezing
• Intervention / Treatment: Behavioral: text message

• Study Type: Interventional
• Enrollment (Actual): 266
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30333
      • Centers for Disease Control and Prevention
  • Massachusetts
    • Boston, Massachusetts, United States
      • Boston Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: text message; all families will receive text messages to which they can respond to report symptoms	Behavioral: text message

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
feasibility reporting respiratory symptom	Response rates to text messages regarding wheezing, cough or chest tightness symptoms	days 0-42 days post-vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
feasibility reporting fever	Response rates to text messages regarding temperature	days 0-7 days post-vaccination

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Boston Medical Center; Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Philip LaRussa, MD, Columbia University

Publications and helpful links

General Publications

• Stockwell MS, Marchant CD, Wodi AP, Barnett ED, Broder KR, Jakob K, Lewis P, Kattan M, Rezendes AM, Barrett A, Sharma D, Fernandez N, LaRussa P. A multi-site feasibility study to assess fever and wheezing in children after influenza vaccines using text messaging. Vaccine. 2017 Dec 15;35(50):6941-6948. doi: 10.1016/j.vaccine.2017.10.073. Epub 2017 Oct 28.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: November 17, 2014
• First Submitted That Met QC Criteria: November 17, 2014
• First Posted (Estimate): November 19, 2014

Study Record Updates

• Last Update Posted (Estimate): May 12, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Body Temperature Changes; Fever; Respiratory Sounds
• Other Study ID Numbers: AAAO5253