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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Melissa Stockwell, MD, MPH, Columbia University
ClinicalTrials.gov Identifier:
NCT01467934
First received: November 7, 2011
Last updated: July 19, 2014
Last verified: July 2014

November 7, 2011
July 19, 2014
November 2011
April 2012   (final data collection date for primary outcome measure)
Fever >= 100.4 [ Time Frame: 8 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01467934 on ClinicalTrials.gov Archive Site
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FeverText: Assessing Fever Rates After Vaccination During the 2011-12 Influenza Season Using Text Messaging
FeverText: Assessing Fever Rates After Influenza and Pneumococcal Vaccination During the 2011-12 Influenza Season Using Text Messaging

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.

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Observational
Time Perspective: Prospective
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Non-Probability Sample

6-23 months old visiting study sites

Fever
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  • 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
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.
 
Completed
530
June 2012
April 2012   (final data collection date for primary outcome measure)

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)

Both
6 Months to 23 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01467934
AAAJ0504
No
Melissa Stockwell, MD, MPH, Columbia University
Columbia University
Centers for Disease Control and Prevention
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
Columbia University
July 2014

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