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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by MedImmune LLC
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01997450
First received: November 6, 2013
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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 Phase
Influenza Vaccine Effectiveness
Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 5200
Study Start Date: December 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Q/LAIV
FluMist Quadrivalent
Inactivated Influenza Vaccine
Inactivated Influenza Vaccine

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.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01997450

Contacts
Contact: Naomi Veney 301-398-0000 ClinicalTrialEnquiries@Medimmune.com

Locations
United States, North Carolina
Wake Forrest School of Medicine Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
United States, Texas
Scott and White Memorial Hospital Recruiting
Temple, Texas, United States, 76508
United States, Wisconsin
Marshfield Clinical Research Foundation Not yet recruiting
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
MedImmune LLC
AstraZeneca
Investigators
Study Director: Herve Caspard, MD MedImmune LLC
  More Information

No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01997450     History of Changes
Other Study ID Numbers: MA-VA-MEDI3250-1116
Study First Received: November 6, 2013
Last Updated: June 26, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 22, 2014