Fever and Wheezing Events in Children After US Influenza Vaccines Using Text Messaging

• ClinicalTrials.gov Identifier: NCT02295007
• Recruitment Status: Completed
• First Posted: November 19, 2014
• Last Update Posted: May 12, 2016
• Sponsor: Columbia University
• Collaborators: Centers for Disease Control and Prevention; Boston Medical Center
• Information provided by (Responsible Party): Melissa Stockwell, Columbia University

Study Description

Brief Summary:

Children 2-11 years of age who are given the influenza vaccine (inactivated influenza (IIV) or live attenuated influenza vaccine (LAIV)) 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 daily for an eight-day period starting on the day of vaccine administration, and then continuing over the next 7 days, and then weekly for 42 days. On the day of enrollment and nightly for the next seven days, the parent will report via text message what their child's highest temperature is. If fever is present, they will then be prompted for additional information including other symptoms, antipyretic use and medical care sought. On day 3 as well as weekly from day 7 through day 42 post-vaccination, parents will be asked via text message about breathing problems, specifically cough, wheezing and chest tightness. They will also be asked about medications taken and care sought. The purpose of this study is to assess the feasibility of collecting this data.

Condition or disease	Intervention/treatment	Phase
Fever; Wheezing	Behavioral: text message	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 266 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Pilot Study to Assess Fever and Wheezing Events in Children After US Influenza Vaccines Using Text Messaging (2014-2015 Season)
• Study Start Date: December 2014
• Actual Primary Completion Date: April 2016
• Actual Study Completion Date: May 2016

Arms and Interventions

Arm	Intervention/treatment
text message; all families will receive text messages to which they can respond to report symptoms	Behavioral: text message

Outcome Measures

Primary Outcome Measures :

1. feasibility reporting respiratory symptom [ Time Frame: days 0-42 days post-vaccination ]
   Response rates to text messages regarding wheezing, cough or chest tightness symptoms

Secondary Outcome Measures :

1. feasibility reporting fever [ Time Frame: days 0-7 days post-vaccination ]
   Response rates to text messages regarding temperature

Eligibility Criteria

• Ages Eligible for Study: 2 Years to 11 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. are 2 through 11years of age,
2. have a visit at a study site anytime during the study period,
3. receive first dose or second dose of LAIV4 or IIV in the season,
4. the parent has a cell phone with text messaging capabilities, and
5. the parent and child > 7 years of age speaks English or Spanish at the Columbia sites or English at the Boston site.

Exclusion criteria:

1. presence of fever ≥100.4 at time of vaccination,
2. administration of any antipyretic in the 6-hour period prior to vaccination,
3. stated intent, at time of vaccination, to use prophylactic antipyretics before the development of a fever,
4. parent only speaks a language other than English or Spanish at the Columbia sites or English at the Boston site.
5. enrollee is a child >7 years of age who only speaks a language other than English or Spanish at the Columbia sites or English at the Boston site.
6. parent's inability to read and send text messages,
7. sibling already enrolled this season (OR cell phone # already used for another child)
8. chronic medical condition considered by ACIP to be a precaution or contraindication for LAIV1 (except for asthma),
9. current asthma exacerbation, or exacerbation in the last 2 weeks
10. use of oral or other systemic steroid within the last 2 weeks

Contacts and Locations

Locations

United States, Georgia

Centers for Disease Control and Prevention

Atlanta, Georgia, United States, 30333

United States, Massachusetts

Boston Medical Center

Boston, Massachusetts, United States

United States, New York

Columbia University

New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

Centers for Disease Control and Prevention

Boston Medical Center

Investigators

• Principal Investigator: Melissa Stockwell, MD MPH; Columbia University
• Principal Investigator: Philip LaRussa, MD; Columbia University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Stockwell MS, Marchant CD, Wodi AP, Barnett ED, Broder KR, Jakob K, Lewis P, Kattan M, Rezendes AM, Barrett A, Sharma D, Fernandez N, LaRussa P. A multi-site feasibility study to assess fever and wheezing in children after influenza vaccines using text messaging. Vaccine. 2017 Dec 15;35(50):6941-6948. doi: 10.1016/j.vaccine.2017.10.073. Epub 2017 Oct 28.

• Responsible Party: Melissa Stockwell, Assistant Professor of Pediatrics and Population and Family Health, Columbia University
• ClinicalTrials.gov Identifier: NCT02295007
• Other Study ID Numbers: AAAO5253
• First Posted: November 19, 2014
• Last Update Posted: May 12, 2016
• Last Verified: May 2016

Additional relevant MeSH terms:

Fever; Respiratory Sounds; Body Temperature Changes; Signs and Symptoms, Respiratory