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

Fever Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764269
• Other study ID #: AAAK8100
• Status: Completed
• Phase: N/A
• First received: January 7, 2013
• Last updated: June 22, 2014
• Start date: January 2013
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 656
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Months to 59 Months

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Fever

Intervention

Other:
• text message surveillance for fever

Locations

Country	Name	City	State
United States	Centers for Disease Control and Prevention	Atlanta	Georgia
United States	Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fever	day of vaccination plus 10 more days	11 days	No