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

Not Applicable

Completed

• Conditions: Wheezing; Fever
• Interventions: Behavioral: text message

• Registration Number: NCT02295007
• Lead Sponsor: Columbia University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-17
• Study First Submitted QC: 2014-11-17
• Study First Posted: 2014-11-19
• Study Start: 2014-12
• Primary Completion: 2016-04
• Status Verified: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 266

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
text message	text message	all families will receive text messages to which they can respond to report symptoms

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
feasibility reporting fever	days 0-7 days post-vaccination	Response rates to text messages regarding temperature

Trial Locations

Locations (3)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

Columbia University; 🇺🇸 New York, New York, United States

Centers for Disease Control and Prevention; 🇺🇸 Atlanta, Georgia, United States