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.

Study Overview

• Status: Completed
• Conditions: Fever

• Study Type: Observational
• Enrollment (Actual): 530

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30333
      • Centers for Disease Control and Prevention
  • New York
    • New York, New York, United States, 10032
      • Columbia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

6-23 months old visiting study sites

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fever >= 100.4	8 days

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Philip LaRussa, MD, Columbia University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: November 7, 2011
• First Submitted That Met QC Criteria: November 8, 2011
• First Posted (Estimate): November 9, 2011

Study Record Updates

• Last Update Posted (Estimate): July 21, 2014
• Last Update Submitted That Met QC Criteria: July 19, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes; Fever
• Other Study ID Numbers: AAAJ0504