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

June 22, 2014 updated by: Melissa Stockwell, MD, MPH, Columbia University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

656

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States
        • Centers for Disease Control and Prevention
    • New York
      • New York, New York, United States, 10032
        • Columbia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: inactivated influenza vaccine (IIV)
Patients whose provider chooses to administer to them inactivated influenza vaccine (IIV)
Other: text message surveillance for fever
Other: Live attenuated influenza vaccine (LAIV)
Patients whose provider chooses to administer to them Live attenuated influenza vaccine (LAIV)
Other: text message surveillance for fever

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fever
Time Frame: 11 days
day of vaccination plus 10 more days
11 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Philip LaRussa, MD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

January 7, 2013

First Submitted That Met QC Criteria

January 7, 2013

First Posted (Estimate)

January 9, 2013

Study Record Updates

Last Update Posted (Estimate)

June 24, 2014

Last Update Submitted That Met QC Criteria

June 22, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAK8100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fever

Clinical Trials on text message surveillance for fever

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe