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

Influenza Vaccine Effectiveness Clinical Trial

— ICICLE  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01997450
• Other study ID #: MA-VA-MEDI3250-1116
• Status: Suspended
• Start date: December 2, 2013
• Est. completion date: May 23, 2025

Study information

• Verified date: January 2024
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 8760
• Est. completion date: May 23, 2025
• Est. primary completion date: May 23, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza Vaccine Effectiveness
• Influenza, Human

Locations

Country	Name	City	State
United Kingdom	Research Site	Bristol
United Kingdom	Research Site	Oxford
United Kingdom	Research Site	Southampton
United Kingdom	Research Site	Tooting
United States	Research Site	Akron	Ohio
United States	Research Site	Bloomington	Minnesota
United States	Research Site	Gainesville	Florida
United States	Research Site	Marshfield	Wisconsin
United States	Research Site	Nashville	Tennessee
United States	Research Site	Portland	Oregon
United States	Research Site	Temple	Texas
United States	Research Site	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
MedImmune LLC	AstraZeneca

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of cases positive for wild-type influenza with an end-point PCR genotyping assay.	Vaccine Effectiveness is defined as 100 x (1-odds ratio), where the odds ratio is the odds of exposures (Q/LAIV versus Inactivated Influenza Vaccine or no vaccine) among laboratory confirmed cases of flu versus controls. Effectiveness will be monitored by flu season, class of age and by influenza strain.	Up to 6 months for each individual flu season