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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Fever, Wheezing

Intervention / Treatment
-----------------
* Behavioral: text message


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: are 2 through 11years of age, have a visit at a study site anytime during the study period, receive first dose or second dose of LAIV4 or IIV in the season, the parent has a cell phone with text messaging capabilities, and the parent and child > 7 years of age speaks English or Spanish at the Columbia sites or English at the Boston site. Exclusion criteria: presence of fever ≥100.4 at time of vaccination, administration of any antipyretic in the 6-hour period prior to vaccination, stated intent, at time of vaccination, to use prophylactic antipyretics before the development of a fever, parent only speaks a language other than English or Spanish at the Columbia sites or English at the Boston site. 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. parent's inability to read and send text messages, sibling already enrolled this season (OR cell phone # already used for another child) chronic medical condition considered by ACIP to be a precaution or contraindication for LAIV1 (except for asthma), current asthma exacerbation, or exacerbation in the last 2 weeks use of oral or other systemic steroid within the last 2 weeks

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 11 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: text message<br>all families will receive text messages to which they can respond to report symptoms | Behavioral: text message<br> <br> |

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 |