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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

Primary Purpose

Fever

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
text message surveillance for fever
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Fever

Eligibility Criteria

24 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centers for Disease Control and Prevention
  • Columbia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

inactivated influenza vaccine (IIV)

Live attenuated influenza vaccine (LAIV)

Arm Description

Patients whose provider chooses to administer to them inactivated influenza vaccine (IIV)

Patients whose provider chooses to administer to them Live attenuated influenza vaccine (LAIV)

Outcomes

Primary Outcome Measures

fever
day of vaccination plus 10 more days

Secondary Outcome Measures

Full Information

First Posted
January 7, 2013
Last Updated
June 22, 2014
Sponsor
Columbia University
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01764269
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
656 (Actual)

8. Arms, Groups, and Interventions

Arm Title
inactivated influenza vaccine (IIV)
Arm Type
Other
Arm Description
Patients whose provider chooses to administer to them inactivated influenza vaccine (IIV)
Arm Title
Live attenuated influenza vaccine (LAIV)
Arm Type
Other
Arm Description
Patients whose provider chooses to administer to them Live attenuated influenza vaccine (LAIV)
Intervention Type
Other
Intervention Name(s)
text message surveillance for fever
Primary Outcome Measure Information:
Title
fever
Description
day of vaccination plus 10 more days
Time Frame
11 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: are 24 through 59 months of age, have a visit at a study site anytime during the study period, receive first dose LAIV or IIV in the season, the parent has a cell phone with text messaging capabilities, and the parent speaks English or Spanish. Exclusion criteria: 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), currently on oral or other systemic steroids or used in the past month, currently on inhaled steroids or used in the past 2 weeks, 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, parent's inability to read text messages, child receiving the second dose of influenza vaccine in the current season.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Stockwell, MD MPH
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philip LaRussa, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centers for Disease Control and Prevention
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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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

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