A Case Control Study of the Effectiveness of Q/LAIV Versus Inactivated Influenza Vaccine and No Vaccine in Subjects 2-17 Years of Age
NCT ID: NCT01997450
Last Updated: 2025-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
4121 participants
OBSERVATIONAL
2013-12-02
2016-04-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Quadrivalent Influenza Vaccine Among Children
NCT01240746
Study With Quadrivalent Recombinant Influenza Vaccine (RIV4) Compared With Egg-Based Quadrivalent Influenza Vaccine (IIV4) in Participants Aged 3 to 8 Years
NCT05513391
A Study to Evaluate the Immunogenicity of Quadrivalent Live Attenuated Influenza Vaccine (LAIV) in Children
NCT01091246
A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age
NCT02545543
A Study of Influenza Virus Vaccines in Children and Adults
NCT00988143
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Q/LAIV
FluMist Quadrivalent
No interventions assigned to this group
Inactivated Influenza Vaccine
Inactivated Influenza Vaccine
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
2 Years
17 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
MedImmune LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Herve Caspard, MD
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Gainesville, Florida, United States
Research Site
Bloomington, Minnesota, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Akron, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Nashville, Tennessee, United States
Research Site
Temple, Texas, United States
Research Site
Marshfield, Wisconsin, United States
Research Site
Bristol, , United Kingdom
Research Site
Oxford, , United Kingdom
Research Site
Southampton, , United Kingdom
Research Site
Tooting, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
McLean 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.
Caspard 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.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MA-VA-MEDI3250-1116
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.