Status:
COMPLETED
FeverText: Assessing Fever Rates After Vaccination During the 2011-12 Influenza Season Using Text Messaging
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Centers for Disease Control and Prevention
Conditions:
Fever
Eligibility:
All Genders
6-23 years
Brief 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 inactiva...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
530 Patients enrolled
Trial Details
Trial ID
NCT01467934
Start Date
November 1 2011
End Date
June 1 2012
Last Update
July 21 2014
Active Locations (2)
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1
Centers for Disease Control and Prevention
Atlanta, Georgia, United States, 30333
2
Columbia University
New York, New York, United States, 10032