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

Completed · Not applicable

Conditions studied: Fever, Wheezing

In brief

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.

Key facts

Study ID

NCT02295007

Run by

Columbia University

People needed

266

Starts

2014-12-01

Expected to finish

2016-05-01

Last updated by the study team

2016-05-12

Who can join

Age: 2 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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