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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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ClinicalTrials.gov Identifier: NCT01764269
Recruitment Status : Completed
First Posted : January 9, 2013
Last Update Posted : June 24, 2014
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Melissa Stockwell, MD, MPH, Columbia University

Tracking Information
First Submitted Date  ICMJE January 7, 2013
First Posted Date  ICMJE January 9, 2013
Last Update Posted Date June 24, 2014
Study Start Date  ICMJE January 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2013)
fever [ Time Frame: 11 days ]
day of vaccination plus 10 more days
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Fever
Intervention  ICMJE Other: text message surveillance for fever
Study Arms  ICMJE
  • inactivated influenza vaccine (IIV)
    Patients whose provider chooses to administer to them inactivated influenza vaccine (IIV)
    Intervention: Other: text message surveillance for fever
  • Live attenuated influenza vaccine (LAIV)
    Patients whose provider chooses to administer to them Live attenuated influenza vaccine (LAIV)
    Intervention: Other: text message surveillance for fever
Publications * Not Provided

*   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: June 22, 2014)
656
Original Estimated Enrollment  ICMJE
 (submitted: January 7, 2013)
3300
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 24 Months to 59 Months   (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 NCT01764269
Other Study ID Numbers  ICMJE AAAK8100
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Melissa Stockwell, MD, MPH, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE Centers for Disease Control and Prevention
Investigators  ICMJE
Principal Investigator: Melissa Stockwell, MD MPH Columbia University
Principal Investigator: Philip LaRussa, MD Columbia University
PRS Account Columbia University
Verification Date June 2014

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