Clinical trial NCT02295007: Fever and Wheezing Events in Children After US Influenza Vaccines Using Text Messaging
Official title: Pilot Study to Assess Fever and Wheezing Events in Children After US Influenza Vaccines Using Text Messaging (2014-2015 Season)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fever
Wheezing
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Boston Medical Center
First posted: 2014-11-19
Enrollment: 266
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: feasibility reporting respiratory symptom
timeFrame: days 0-42 days post-vaccination
Secondary outcomes:
measure: feasibility reporting fever
timeFrame: days 0-7 days post-vaccination
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Centers for Disease Control and Prevention
state: Georgia
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Melissa Stockwell, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Philip LaRussa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.