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OpenTrials
Completed

NCT Number: NCT01764269

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

In this study, the investigators will prospectively assess fever rates in 24-59 month old patients during days 0-10 after administration of inactivated influenza vaccine (IIV) or live attenuated influenza vaccine (LAIV). Children in one of three study sites who receive these vaccines as part of their routine care can enroll in this study if their parent has the ability to receive and send text messages. Children enrolled in this study will be observed for an eleven day period starting on the day of vaccine administration via a series text messages to their parents.

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Key information

Conditions

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

Age range

24 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

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 24 through 59 months of age,
  • have a visit at a study site anytime during the study period,
  • receive first dose LAIV or IIV in the season,
  • the parent has a cell phone with text messaging capabilities, and
  • the parent speaks English or Spanish.

Exclusion criteria

  • any chronic medical condition in the child that precludes receipt of LAIV (except for history of asthma or a wheezing episode within the past 12 months noted in the medical record),
  • currently on oral or other systemic steroids or used in the past month,
  • currently on inhaled steroids or used in the past 2 weeks,
  • presence of fever >=100.4 at time of vaccination,
  • administration of any antipyretic in the 6-hour period prior to vaccination,
  • stated intent, at time of vaccination, to use prophylactic antipyretics before the development of a fever,
  • parent only speaks a language other than English or Spanish,
  • parent's inability to read text messages,
  • child receiving the second dose of influenza vaccine in the current season.

Treatment and study plan

text message surveillance for fever

Other

Primary outcomes

  1. fever

    Time frame: 11 days

    day of vaccination plus 10 more days

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 9, 2013
Registry last updated
Jun 24, 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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