Study Stopped
FDA did not require the fourth season of recruitment as planned originally. Study closed.
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
1 other identifier
observational
4,121
2 countries
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2013
Typical duration for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2013
CompletedFirst Posted
Study publicly available on registry
November 28, 2013
CompletedStudy Start
First participant enrolled
December 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2016
CompletedMarch 10, 2025
February 1, 2025
2.4 years
November 6, 2013
March 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Q/LAIV
FluMist Quadrivalent
Inactivated Influenza Vaccine
Inactivated Influenza Vaccine
Eligibility Criteria
Subjects 2 to 17 years of age who are seeking care in an outpatient setting for febrile acute respiratory illness.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
- AstraZenecacollaborator
Study Sites (12)
Research Site
Gainesville, Florida, 32608, United States
Research Site
Bloomington, Minnesota, 55440, United States
Research Site
Winston-Salem, North Carolina, 27157, United States
Research Site
Akron, Ohio, 44308-1063, United States
Research Site
Portland, Oregon, 97227, United States
Research Site
Nashville, Tennessee, 37212, United States
Research Site
Temple, Texas, 76508, United States
Research Site
Marshfield, Wisconsin, 54449, United States
Research Site
Bristol, BS2 8AE, United Kingdom
Research Site
Oxford, OX3 7EJ, United Kingdom
Research Site
Southampton, SO16 6YD, United Kingdom
Research Site
Tooting, SW17 0QT, United Kingdom
Related Publications (3)
Poehling KA, Caspard H, Peters TR, Belongia EA, Congeni B, Gaglani M, Griffin MR, Irving SA, Kavathekar PK, McLean HQ, Naleway AL, Ryan K, Talbot HK, Ambrose CS. 2015-2016 Vaccine Effectiveness of Live Attenuated and Inactivated Influenza Vaccines in Children in the United States. Clin Infect Dis. 2018 Feb 10;66(5):665-672. doi: 10.1093/cid/cix869.
PMID: 29029064DERIVEDMcLean HQ, Caspard H, Griffin MR, Poehling KA, Gaglani M, Belongia EA, Talbot HK, Peters TR, Murthy K, Ambrose CS. Effectiveness of live attenuated influenza vaccine and inactivated influenza vaccine in children during the 2014-2015 season. Vaccine. 2017 May 9;35(20):2685-2693. doi: 10.1016/j.vaccine.2017.03.085. Epub 2017 Apr 10.
PMID: 28408121DERIVEDCaspard H, Coelingh KL, Mallory RM, Ambrose CS. Association of vaccine handling conditions with effectiveness of live attenuated influenza vaccine against H1N1pdm09 viruses in the United States. Vaccine. 2016 Sep 30;34(42):5066-5072. doi: 10.1016/j.vaccine.2016.08.079. Epub 2016 Sep 6.
PMID: 27613072DERIVED
Related Links
Biospecimen
A nasal swab specimen will be collected and tested for influenza and other viral pathogens.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Herve Caspard, MD
MedImmune LLC
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2013
First Posted
November 28, 2013
Study Start
December 2, 2013
Primary Completion
April 15, 2016
Study Completion
April 15, 2016
Last Updated
March 10, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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
- 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.
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.