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

This study is currently recruiting participants.
Verified August 2013 by Columbia University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Melissa Stockwell, MD, MPH, Columbia University
ClinicalTrials.gov Identifier:
NCT01764269
First received: January 7, 2013
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Fever
Other: text message surveillance for fever

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • fever [ Time Frame: 11 days ] [ Designated as safety issue: No ]
    day of vaccination plus 10 more days


Estimated Enrollment: 3300
Study Start Date: January 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
inactivated influenza vaccine (IIV)
Patients whose provider chooses to administer to them inactivated influenza vaccine (IIV)
Other: text message surveillance for fever
Live attenuated influenza vaccine (LAIV)
Patients whose provider chooses to administer to them Live attenuated influenza vaccine (LAIV)
Other: text message surveillance for fever

  Eligibility

Ages Eligible for Study:   24 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion criteria:

  1. 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),
  2. currently on oral or other systemic steroids or used in the past month,
  3. currently on inhaled steroids or used in the past 2 weeks,
  4. presence of fever >=100.4 at time of vaccination,
  5. administration of any antipyretic in the 6-hour period prior to vaccination,
  6. stated intent, at time of vaccination, to use prophylactic antipyretics before the development of a fever,
  7. parent only speaks a language other than English or Spanish,
  8. parent's inability to read text messages,
  9. child receiving the second dose of influenza vaccine in the current season.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764269

Contacts
Contact: Melissa Stockwell, MD MPH 212-342-5732 mss2112@columbia.edu
Contact: Philip LaRussa, MD 212-305-0898 plarussa@columbia.edu

Locations
United States, Georgia
Centers for Disease Control and Prevention Not yet recruiting
Atlanta, Georgia, United States
Contact: Karen Broder, MD       krb2@cdc.gov   
Principal Investigator: Karen Broder, MD         
Sub-Investigator: Claudia Vellozzi, MD MPH         
Sub-Investigator: Devindra Sharma, MSN, MPH         
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Melissa Stockwell, MD MPH    212-342-5732    mss2112@columbia.edu   
Principal Investigator: Melissa Stockwell, MD MPH         
Principal Investigator: Phil LaRussa, MD         
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Melissa Stockwell, MD MPH Columbia University
Principal Investigator: Philip LaRussa, MD Columbia University
  More Information

No publications provided

Responsible Party: Melissa Stockwell, MD, MPH, Assistant Professor of Pediatrics and Population and Family Health, Columbia University
ClinicalTrials.gov Identifier: NCT01764269     History of Changes
Other Study ID Numbers: AAAK8100
Study First Received: January 7, 2013
Last Updated: August 1, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fever
Influenza, Human
Body Temperature Changes
Signs and Symptoms
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014