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Fever and Wheezing Events in Children After US Influenza Vaccines Using Text Messaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02295007
Recruitment Status : Completed
First Posted : November 19, 2014
Last Update Posted : May 12, 2016
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Boston Medical Center
Information provided by (Responsible Party):
Melissa Stockwell, Columbia University

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 parent has the ability to receive and send text messages. Children enrolled in this study will be observed daily for an eight-day period starting on the day of vaccine administration, and then continuing over the next 7 days, and then weekly for 42 days. On the day of enrollment and nightly for the next seven days, the parent will report via text message what their child's highest temperature is. If fever is present, they will then be prompted for additional information including other symptoms, antipyretic use and medical care sought. On day 3 as well as weekly from day 7 through day 42 post-vaccination, parents will be asked via text message about breathing problems, specifically cough, wheezing and chest tightness. They will also be asked about medications taken and care sought. The purpose of this study is to assess the feasibility of collecting this data.

Condition or disease Intervention/treatment Phase
Fever Wheezing Behavioral: text message Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 266 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Pilot Study to Assess Fever and Wheezing Events in Children After US Influenza Vaccines Using Text Messaging (2014-2015 Season)
Study Start Date : December 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Flu Shot

Arm Intervention/treatment
text message
all families will receive text messages to which they can respond to report symptoms
Behavioral: text message



Primary Outcome Measures :
  1. feasibility reporting respiratory symptom [ Time Frame: days 0-42 days post-vaccination ]
    Response rates to text messages regarding wheezing, cough or chest tightness symptoms


Secondary Outcome Measures :
  1. feasibility reporting fever [ Time Frame: days 0-7 days post-vaccination ]
    Response rates to text messages regarding temperature



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. are 2 through 11years of age,
  2. have a visit at a study site anytime during the study period,
  3. receive first dose or second dose of LAIV4 or IIV in the season,
  4. the parent has a cell phone with text messaging capabilities, and
  5. the parent and child > 7 years of age speaks English or Spanish at the Columbia sites or English at the Boston site.

Exclusion criteria:

  1. presence of fever ≥100.4 at time of vaccination,
  2. administration of any antipyretic in the 6-hour period prior to vaccination,
  3. stated intent, at time of vaccination, to use prophylactic antipyretics before the development of a fever,
  4. parent only speaks a language other than English or Spanish at the Columbia sites or English at the Boston site.
  5. 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.
  6. parent's inability to read and send text messages,
  7. sibling already enrolled this season (OR cell phone # already used for another child)
  8. chronic medical condition considered by ACIP to be a precaution or contraindication for LAIV1 (except for asthma),
  9. current asthma exacerbation, or exacerbation in the last 2 weeks
  10. use of oral or other systemic steroid within the last 2 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295007


Locations
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United States, Georgia
Centers for Disease Control and Prevention
Atlanta, Georgia, United States, 30333
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States
United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Centers for Disease Control and Prevention
Boston Medical Center
Investigators
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Principal Investigator: Melissa Stockwell, MD MPH Columbia University
Principal Investigator: Philip LaRussa, MD Columbia University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Melissa Stockwell, Assistant Professor of Pediatrics and Population and Family Health, Columbia University
ClinicalTrials.gov Identifier: NCT02295007    
Other Study ID Numbers: AAAO5253
First Posted: November 19, 2014    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Fever
Respiratory Sounds
Body Temperature Changes
Signs and Symptoms
Signs and Symptoms, Respiratory