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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

530 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Assessing Fever Rates in Children Ages 24 to 59 Months After Live Attenuated Influenza Vaccine (LAIV) or Inactivated Influenza Vaccines (IIV) Using Text Messaging for U.S. Influenza Vaccines in 2012-2013 & 2013-2014

NCT01764269

Fever

COMPLETED NA

Fever and Wheezing Events in Children After US Influenza Vaccines Using Text Messaging

NCT02295007

Fever Wheezing

COMPLETED NA

PregText: Feasibility of Monitoring Influenza Vaccine Safety in Pregnant Women Using Text Messaging

NCT01974050

Pregnancy

COMPLETED NA

Pilot Text Message for Influenza Vaccination

NCT01761734

Influenza

COMPLETED NA

TextFluenza: Using Technology To Promote Flu Vaccination In Underserved Maternal And Child Populations

NCT01146912

Influenza

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fever

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Trivalent inactivated influenza vaccine

Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1

No interventions assigned to this group

TIV and PCV13 together

Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1

No interventions assigned to this group

13-valent pneumococcal conjugate vaccine

13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

6 Months

Maximum Eligible Age

23 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No