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)

January 17, 2024 updated by: MedImmune LLC
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.

Study Overview

Status

Suspended

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

8760

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bristol, United Kingdom, BS2 8AE
        • Research Site
      • Oxford, United Kingdom, OX3 7EJ
        • Research Site
      • Southampton, United Kingdom, SO16 6YD
        • Research Site
      • Tooting, United Kingdom, SW17 0QT
        • Research Site
  • United States
    • Florida
      • Gainesville, Florida, United States, 32608
        • Research Site
    • Minnesota
      • Bloomington, Minnesota, United States, 55440
        • Research Site
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Research Site
    • Ohio
      • Akron, Ohio, United States, 44308-1063
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97227
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Research Site
    • Texas
      • Temple, Texas, United States, 76508
        • Research Site
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Subjects 2 to 17 years of age who are seeking care in an outpatient setting for febrile acute respiratory illness.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Q/LAIV
FluMist Quadrivalent
Inactivated Influenza Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of cases positive for wild-type influenza with an end-point PCR genotyping assay.
Time Frame: Up to 6 months for each individual flu season
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedImmune LLC

Collaborators

AstraZeneca

Investigators

  • Study Director: Herve Caspard, MD, MedImmune LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2013

Primary Completion (Estimated)

May 23, 2025

Study Completion (Estimated)

May 23, 2025

Study Registration Dates

First Submitted

November 6, 2013

First Submitted That Met QC Criteria

November 22, 2013

First Posted (Estimated)

November 28, 2013

Study Record Updates

Last Update Posted (Estimated)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA-VA-MEDI3250-1116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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