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

Study Overview
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Brief Summary
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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.

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

Conditions
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Fever

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion criteria: 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)

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 23 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Trivalent inactivated influenza vaccine<br>Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1 | |
| TIV and PCV13 together<br>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<br>13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fever >= 100.4 |  | 8 days |