A Case Control Study of the Effectiveness of Q/LAIV Versus Inactivated Influenza Vaccine and No Vaccine in Subjects 2-17 Years of Age (ICICLE)

MedImmune

Status: Terminated

Conditions: Influenza Vaccine Effectiveness

Study type: Observational

Funder types: Industry

Identifiers

NCT01997450

MA-VA-MEDI3250-1116

Details and patient eligibility

About

This is a post-marketing case-controlled study of the effectiveness of a quadrivalent live attenuated influenza vaccine (Q/LAIV/FluMist® Quadrivalent) versus Inactivated Influenza Vaccine (IIV) and No Vaccine in subjects 2-17 years of age.

Full description

This post-marketing study will enroll approximately 5,200 subjects 2-17 years of age who are seeking care in an outpatient setting for febrile acute respiratory illness. This study will begin in the fall of 2013 and will be completed after 4 influenza seasons (i.e.after the 2016-2017 influenza season). No investigational product will be administered in this study. A nasal swab will be obtained and tested for the presence of influenza virus and other viral pathogens. This study will be conducted at 4 sites in the United States of America. The duration of study participation for each subject is one day.

Enrollment: 4,121 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Community-dwelling children and adolescents 2 to 17 years of age.
• Written Informed Consent or Assent.
• Acute respiratory illness documented at study visit or at home with fever (oral temperature ≥ 100.0° Fahrenheit at study visit, or history of fever reported by parents, or use of antipyretic prior to study visit)
• Symptom onset less than 5 days prior to study visit.
• Subject and/or subject's legal representative is able to understand and comply with the requirements of the protocol as judged by the investigator.

Exclusion criteria

• Treatment with an antiviral drug for influenza (oseltamivir or Tamiflu®, zanamivir or Relenza®) during the 14 days before enrollment
• Any condition that, in the opinion of the investigator, would interfere with interpretation of subject safety or study results
• Concurrent enrollment in another clinical study

Patient already enrolled during this influenza season

• Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.

Trial design

4,121 participants in 2 patient groups

Q/LAIV

Description:

FluMist Quadrivalent

Inactivated Influenza Vaccine

Description:

Inactivated Influenza Vaccine