Assessing Fever Rates in Children Ages 24 to 59 Months After Live Attenuated Influenza Vaccine (LAIV) or Inactivated Influenza Vaccines (IIV) Using Text Messaging for U.S. Influenza Vaccines in 2012-2013 & 2013-2014

Not Applicable

Completed

• Conditions: Fever
• Interventions: Other: text message surveillance for fever

• Registration Number: NCT01764269
• Lead Sponsor: Columbia University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-07
• Study First Submitted QC: 2013-01-07
• Study First Posted: 2013-01-09
• Primary Completion: 2014-04
• Study Completion: 2014-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-22
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 656

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
inactivated influenza vaccine (IIV)	text message surveillance for fever	Patients whose provider chooses to administer to them inactivated influenza vaccine (IIV)
Live attenuated influenza vaccine (LAIV)	text message surveillance for fever	Patients whose provider chooses to administer to them Live attenuated influenza vaccine (LAIV)

Primary Outcome Measures

Name	Time	Method
fever	11 days	day of vaccination plus 10 more days

Trial Locations

Locations (2)

Columbia University; 🇺🇸 New York, New York, United States

Centers for Disease Control and Prevention; 🇺🇸 Atlanta, Georgia, United States