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

NCT ID: NCT01764269

Last Updated: 2014-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 656 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-05-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

inactivated influenza vaccine (IIV)

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

Group Type: OTHER

text message surveillance for fever

Intervention Type: OTHER

Live attenuated influenza vaccine (LAIV)

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

Group Type: OTHER

text message surveillance for fever

Intervention Type: OTHER

Interventions

text message surveillance for fever

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 24 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Melissa Stockwell, MD, MPH

Assistant Professor of Pediatrics and Population and Family Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melissa Stockwell, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Philip LaRussa, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Centers for Disease Control and Prevention

Atlanta, Georgia, United States

Columbia University

New York, New York, United States

Countries

United States

Other Identifiers

AAAK8100

Identifier Type: -

Identifier Source: org_study_id