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

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.

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Key information

Conditions

Fever Body Temperature Changes Pathological Conditions, Signs and Symptoms Respiratory Sounds Signs and Symptoms Signs and Symptoms, Respiratory Wheezing

Age range

2 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centers for Disease Control and Prevention, Atlanta, Georgia, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Text Message

Behavioral

Primary outcomes

feasibility reporting respiratory symptom

Time frame: days 0-42 days post-vaccination

Response rates to text messages regarding wheezing, cough or chest tightness symptoms

Secondary outcomes

feasibility reporting fever

Time frame: days 0-7 days post-vaccination

Response rates to text messages regarding temperature

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

Boston Medical Center
Centers for Disease Control and Prevention

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Nov 19, 2014
Registry last updated: May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed