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

NCT02295007 | Completed

• 1 other identifier: AAAO5253
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 3

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.

Conditions

Fever; Wheezing

Outcome Measures

Primary Outcomes (1)

• feasibility reporting respiratory symptom

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

  days 0-42 days post-vaccination

Secondary Outcomes (1)

• feasibility reporting fever

  days 0-7 days post-vaccination

Study Arms (1)

text message

OTHER

all families will receive text messages to which they can respond to report symptoms

Behavioral: text message

Interventions

text message BEHAVIORAL

text message

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Columbia University: lead
• Centers for Disease Control and Prevention: collaborator
• Boston Medical Center: collaborator

Study Sites (3)

Centers for Disease Control and Prevention

Atlanta, Georgia, 30333, United States

Location

Boston Medical Center

Boston, Massachusetts, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 29089191 DERIVED

MeSH Terms

Conditions

Fever; Respiratory Sounds

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory

Study Officials

• Melissa Stockwell, MD MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

• Philip LaRussa, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics and Population and Family Health

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: November 19, 2014
• Study Start: December 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

US (3)