Clinical trial NCT01467934: FeverText: Assessing Fever Rates After Vaccination During the 2011-12 Influenza Season Using Text Messaging
Official title: FeverText: Assessing Fever Rates After Influenza and Pneumococcal Vaccination During the 2011-12 Influenza Season Using Text Messaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fever
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2011-11-09
Enrollment: 530
Sex: ALL
Minimum age (years): 6
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 6-23 months old visiting study sites

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 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:

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)

Primary outcomes:
measure: Fever >= 100.4
timeFrame: 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Centers for Disease Control and Prevention
state: Georgia
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Melissa Stockwell, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Philip LaRussa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Disease Control and Prevention
name: Karen Broder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stockwell MS, Broder K, LaRussa P, Lewis P, Fernandez N, Sharma D, Barrett A, Sosa J, Vellozzi C. Risk of fever after pediatric trivalent inactivated influenza vaccine and 13-valent pneumococcal conjugate vaccine. JAMA Pediatr. 2014 Mar;168(3):211-9. doi: 10.1001/jamapediatrics.2013.4469.