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
  Purpose

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.


Condition
Fever

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: FeverText: Assessing Fever Rates After Influenza and Pneumococcal Vaccination During the 2011-12 Influenza Season Using Text Messaging

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Fever >= 100.4 [ Time Frame: 8 days ] [ Designated as safety issue: No ]

Enrollment: 530
Study Start Date: November 2011
Study Completion Date: June 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   6 Months to 23 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

6-23 months old visiting study sites

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)

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467934

Locations
United States, Georgia
Centers for Disease Control and Prevention
Atlanta, Georgia, United States, 30333
United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
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
  More Information

No publications provided by Columbia University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Melissa Stockwell, MD, MPH, Assistant Professor of Pediatrics and Population and Family Health, Columbia University
ClinicalTrials.gov Identifier: NCT01467934     History of Changes
Other Study ID Numbers: AAAJ0504
Study First Received: November 7, 2011
Results First Received: June 22, 2014
Last Updated: July 19, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fever
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014