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FeverText: Assessing Fever Rates After Vaccination During the 2011-12 Influenza Season Using Text Messaging

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ClinicalTrials.gov Identifier: NCT01467934
Recruitment Status : Completed
First Posted : November 9, 2011
Results First Posted : July 21, 2014
Last Update Posted : July 21, 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 November 7, 2011
First Posted Date November 9, 2011
Results First Submitted Date June 22, 2014
Results First Posted Date July 21, 2014
Last Update Posted Date July 21, 2014
Study Start Date November 2011
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 8, 2011)
Fever >= 100.4 [ Time Frame: 8 days ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title FeverText: Assessing Fever Rates After Vaccination During the 2011-12 Influenza Season Using Text Messaging
Official Title FeverText: Assessing Fever Rates After Influenza and Pneumococcal Vaccination During the 2011-12 Influenza Season Using Text Messaging
Brief Summary In this study, the investigators will prospectively assess fever rates and other associated vaccine adverse events in 6-23 month old patients during days 0-7 after administration of trivalent inactivated influenza vaccine (TIV) and 13-valent pneumococcal conjugate vaccine (PCV13) concomitantly compared to those who receive trivalent inactivated influenza vaccine (TIV) or 13-valent pneumococcal conjugate vaccine (PCV13) administered non-concomitantly. The investigators hypothesize that fever rates will be significantly higher during the 0-1 days after vaccination when inactivated influenza vaccine (TIV) and 13-valent pneumococcal conjugate vaccine (PCV13) are given concomitantly than when TIV or PCV13 is administered non-concomitantly.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 6-23 months old visiting study sites
Condition Fever
Intervention Not Provided
Study Groups/Cohorts
  • Trivalent inactivated influenza vaccine
    Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1
  • TIV and PCV13 together
    Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
  • 13-valent pneumococcal conjugate vaccine
    13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
Publications * Stockwell MS, Broder K, LaRussa P, Lewis P, Fernandez N, Sharma D, Barrett A, Sosa J, Vellozzi C. Risk of fever after pediatric trivalent inactivated influenza vaccine and 13-valent pneumococcal conjugate vaccine. JAMA Pediatr. 2014 Mar;168(3):211-9. doi: 10.1001/jamapediatrics.2013.4469.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 19, 2014)
530
Original Estimated Enrollment
 (submitted: November 8, 2011)
960
Actual Study Completion Date June 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. are 6 through 23 month olds,
  2. have a visit at a study site during the study period of Nov. 1, 2011 through March 31, 2012,
  3. receive trivalent inactivated influenza vaccine (TIV)/13-valent pneumococcal conjugate vaccine (PCV13)concomitantly, trivalent inactivated influenza vaccine (TIV)/without 13-valent pneumococcal conjugate vaccine (PCV13) or 13-valent pneumococcal conjugate vaccine (PCV13) without trivalent inactivated influenza vaccine (TIV)/(4) parent has a cell phone with text messaging capabilities; and

(5) parent speaks English or Spanish.

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 to use prophylactic antipyretics at time of vaccination before the development of a fever;
  4. stated intention to move away from the NYC area <6 month;
  5. parent only speaks a language other than English or Spanish;
  6. inability to read text messages;
  7. children who received live attenuated influenza vaccine (LAIV) this visit;
  8. children who received trivalent inactivated influenza vaccine (TIV) or 13-valent pneumococcal conjugate vaccine (PCV13) in the seven days prior to enrollment date

Note: Patient may receive other vaccines in addition to trivalent inactivated influenza vaccine (TIV)/13-valent pneumococcal conjugate vaccine (PCV13)

Sex/Gender
Sexes Eligible for Study: All
Ages 6 Months to 23 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01467934
Other Study ID Numbers AAAJ0504
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Melissa Stockwell, MD, MPH, Columbia University
Study Sponsor Columbia University
Collaborators Centers for Disease Control and Prevention
Investigators
Principal Investigator: Melissa Stockwell, MD MPH Columbia University
Principal Investigator: Philip LaRussa, MD Columbia University
Principal Investigator: Karen Broder, MD Centers for Disease Control and Prevention
PRS Account Columbia University
Verification Date July 2014