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

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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

Tracking Information
First Submitted Date  ICMJE November 17, 2014
First Posted Date  ICMJE November 19, 2014
Last Update Posted Date May 12, 2016
Study Start Date  ICMJE December 2014
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2014)
feasibility reporting respiratory symptom [ Time Frame: days 0-42 days post-vaccination ]
Response rates to text messages regarding wheezing, cough or chest tightness symptoms
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2014)
feasibility reporting fever [ Time Frame: days 0-7 days post-vaccination ]
Response rates to text messages regarding temperature
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fever and Wheezing Events in Children After US Influenza Vaccines Using Text Messaging
Official Title  ICMJE Pilot Study to Assess Fever and Wheezing Events in Children After US Influenza Vaccines Using Text Messaging (2014-2015 Season)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Fever
  • Wheezing
Intervention  ICMJE Behavioral: text message
Study Arms  ICMJE text message
all families will receive text messages to which they can respond to report symptoms
Intervention: Behavioral: text message
Publications * Stockwell MS, Marchant CD, Wodi AP, Barnett ED, Broder KR, Jakob K, Lewis P, Kattan M, Rezendes AM, Barrett A, Sharma D, Fernandez N, LaRussa P. A multi-site feasibility study to assess fever and wheezing in children after influenza vaccines using text messaging. Vaccine. 2017 Dec 15;35(50):6941-6948. doi: 10.1016/j.vaccine.2017.10.073. Epub 2017 Oct 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2016)
266
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2014)
150
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02295007
Other Study ID Numbers  ICMJE AAAO5253
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Melissa Stockwell, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE
  • Centers for Disease Control and Prevention
  • Boston Medical Center
Investigators  ICMJE
Principal Investigator: Melissa Stockwell, MD MPH Columbia University
Principal Investigator: Philip LaRussa, MD Columbia University
PRS Account Columbia University
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP