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

Fever Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01467934
• Other study ID #: AAAJ0504
• Status: Completed
• Phase: N/A
• First received: November 7, 2011
• Last updated: July 19, 2014
• Start date: November 2011
• Est. completion date: June 2012

Study information

• Verified date: July 2014
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 530
• Est. completion date: June 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 23 Months

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Fever

Locations

Country	Name	City	State
United States	Centers for Disease Control and Prevention	Atlanta	Georgia
United States	Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fever >= 100.4		8 days	No