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 | Completed

• 1 other identifier: AAAK8100
• Study Type: interventional
• Target: 656
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Fever

Outcome Measures

Primary Outcomes (1)

• fever

  day of vaccination plus 10 more days

  11 days

Study Arms (2)

inactivated influenza vaccine (IIV)

OTHER

Patients whose provider chooses to administer to them inactivated influenza vaccine (IIV)

Other: text message surveillance for fever

Live attenuated influenza vaccine (LAIV)

OTHER

Patients whose provider chooses to administer to them Live attenuated influenza vaccine (LAIV)

Other: text message surveillance for fever

Interventions

text message surveillance for fever OTHER

Live attenuated influenza vaccine (LAIV); inactivated influenza vaccine (IIV)

Eligibility Criteria

• Age: 24 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (2)

Centers for Disease Control and Prevention

Atlanta, Georgia, United States

Location

Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Fever

Interventions

Diathermy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Study Officials

• Melissa Stockwell, MD MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

• Philip LaRussa, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics and Population and Family Health

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: January 9, 2013
• Study Start: January 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 24, 2014

Record last verified: 2014-06

Locations

US (2)