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

Completed

Conditions studied: Fever

In brief

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.

Key facts

Study ID

NCT01467934

Run by

Columbia University

People needed

530

Starts

2011-11-01

Expected to finish

2012-06-01

Last updated by the study team

2014-07-21

Who can join

Age: 1 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• are 6 through 23 month olds,
• have a visit at a study site during the study period of Nov. 1, 2011 through March 31, 2012,
• 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.

You may not qualify if…

• presence of fever >=100.4 at time of vaccination;
• administration of any antipyretic in the 6-hour period prior to vaccination
• stated intent to use prophylactic antipyretics at time of vaccination before the development of a fever;
• stated intention to move away from the NYC area <6 month;
• parent only speaks a language other than English or Spanish;
• inability to read text messages;
• children who received live attenuated influenza vaccine (LAIV) this visit;
• 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)

Where it is running

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

Full record on ClinicalTrials.gov

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