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

NCT ID: NCT02295007

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-05-31

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.

Conditions

Fever; Wheezing

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

text message

all families will receive text messages to which they can respond to report symptoms

Group Type: OTHER

text message

Intervention Type: BEHAVIORAL

Interventions

text message

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Melissa Stockwell

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

Boston Medical Center

Boston, Massachusetts, United States

Columbia University

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29089191 (View on PubMed)

Other Identifiers

AAAO5253

Identifier Type: -

Identifier Source: org_study_id