N/A N=530

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

Fever

Bottom Line

View on ClinicalTrials.gov: NCT01467934 ↗

Enrolled (actual)

530

Serious AEs

0.0%

Results posted

Jul 2014

Primary outcome: Primary: Fever >= 100.4 — 7.5; 37.6; 9.5 percentage of participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Columbia University
Primary completion: Apr 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Fever >= 100.4	7.5; 37.6; 9.5	—

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01467934). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.