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OpenTrials
Completed

NCT Number: NCT01467934

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

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.

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Key information

Conditions

Fever Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 month–23 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Centers for Disease Control and Prevention, Atlanta, Georgia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Fever >= 100.4

    Time frame: 8 days

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 9, 2011
Registry last updated
Jul 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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