Status:
COMPLETED
Fever and Wheezing Events in Children After US Influenza Vaccines Using Text Messaging
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Centers for Disease Control and Prevention
Boston Medical Center
Conditions:
Fever
Wheezing
Eligibility:
All Genders
2-11 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
266 Patients enrolled
Trial Details
Trial ID
NCT02295007
Start Date
December 1 2014
End Date
May 1 2016
Last Update
May 12 2016
Active Locations (3)
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1
Centers for Disease Control and Prevention
Atlanta, Georgia, United States, 30333
2
Boston Medical Center
Boston, Massachusetts, United States
3
Columbia University
New York, New York, United States, 10032