Fever
Conditions
Brief summary
In this study, the investigators will prospectively assess fever rates in 24-59 month old patients during days 0-10 after administration of inactivated influenza vaccine (IIV) or live attenuated influenza vaccine (LAIV). Children in one of three study sites who receive these vaccines 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 for an eleven day period starting on the day of vaccine administration via a series text messages to their parents.
Interventions
OTHERtext message surveillance for fever
Sponsors
Centers for Disease Control and Prevention
Columbia University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Months to 59 Months
Healthy volunteers
No
Inclusion criteria
1. are 24 through 59 months of age, 2. have a visit at a study site anytime during the study period, 3. receive first dose LAIV or IIV in the season, 4. the parent has a cell phone with text messaging capabilities, and 5. the parent speaks English or Spanish.
Exclusion criteria
1. any chronic medical condition in the child that precludes receipt of LAIV (except for history of asthma or a wheezing episode within the past 12 months noted in the medical record), 2. currently on oral or other systemic steroids or used in the past month, 3. currently on inhaled steroids or used in the past 2 weeks, 4. presence of fever \>=100.4 at time of vaccination, 5. administration of any antipyretic in the 6-hour period prior to vaccination, 6. stated intent, at time of vaccination, to use prophylactic antipyretics before the development of a fever, 7. parent only speaks a language other than English or Spanish, 8. parent's inability to read text messages, 9. child receiving the second dose of influenza vaccine in the current season.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| fever | 11 days | day of vaccination plus 10 more days |
Countries
United States
Outcome results
None listed