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

Status:	Recruiting
Conditions:	Infectious Disease
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	2 - 11
Updated:	4/21/2016
Start Date:	December 2014
End Date:	June 2016
Contact:	Kathleen Jakob, RN
Email:	kj60@columbia.edu
Phone:	212-305-8198

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

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.

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

We found this trial at

sites

Columbia University

116th St and Broadway
New York, New York 10027

(212) 854-1754