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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01997450
Recruitment Status : Suspended (Study recruitment has been suspended.)
First Posted : November 28, 2013
Last Update Posted : January 15, 2018
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Influenza Vaccine Effectiveness

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 Design

Study Type : Observational
Estimated Enrollment : 8760 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : December 2, 2013
Estimated Primary Completion Date : April 13, 2018
Estimated Study Completion Date : April 13, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Groups and Cohorts

FluMist Quadrivalent
Inactivated Influenza Vaccine
Inactivated Influenza Vaccine

Outcome Measures

Primary Outcome Measures :
  1. 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.

Biospecimen Retention:   Samples With DNA
A nasal swab specimen will be collected and tested for influenza and other viral pathogens.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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.

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997450

United States, Florida
Research Site
Gainesville, Florida, United States, 32608
United States, Minnesota
Research Site
Bloomington, Minnesota, United States, 55440
United States, North Carolina
Research Site
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Research Site
Akron, Ohio, United States, 44308-1063
United States, Oregon
Research Site
Portland, Oregon, United States, 97227
United States, Tennessee
Research Site
Nashville, Tennessee, United States, 37212
United States, Texas
Research Site
Temple, Texas, United States, 76508
United States, Wisconsin
Research Site
Marshfield, Wisconsin, United States, 54449
United Kingdom
Research Site
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
Sponsors and Collaborators
MedImmune LLC
Study Director: Herve Caspard, MD MedImmune LLC
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01997450     History of Changes
Other Study ID Numbers: MA-VA-MEDI3250-1116
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: January 15, 2018
Last Verified: January 2018

Keywords provided by MedImmune LLC:
Q/LAIV/FluMist® Quadrivalent Vaccine, Inactivated Influenza Vaccine (IIV), Effectiveness, Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs