Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects

Completed · Phase 3

Conditions studied: Influenza, Human, Virus Diseases

In brief

This phase 3 clinical study is a randomized, observer-blind, comparator-controlled, multicenter study of QIVc versus a US-licensed comparator QIV in children 6 months through 47 months of age. The purpose of this study is to demonstrate that vaccination with QIVc elicits an immune response that is noninferior to that of a US-licensed comparator QIV containing the same virus strains, in children 6 months through 47 months of age.

Key facts

Study ID

NCT04074928

Run by

Seqirus

People needed

2414

Starts

2019-09-06

Expected to finish

2020-09-03

Last updated by the study team

2022-01-12

Who can join

Age: 1 and older, up to 4. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Individuals of 6 through 47 months of age on the day of informed consent.
• Individuals whose parent(s)/Legally Acceptable Representative (LAR) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
• Individuals who can comply with study procedures including follow-up
• Individual is in generally good health as per the Investigator's medical judgement

You may not qualify if…

• Acute (severe) febrile illness
• History of any anaphylaxis, serious vaccine reactions or hypersensitivity, including allergic reactions, to any component of vaccine or medical equipment whose use is foreseen in this study
• A known history of Guillain-Barre Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis
• Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study
• Received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent.

Where it is running

• 84035 CCR Research — Mobile, Alabama, United States
• 84040 Southland Clnical Research Center — Anaheim, California, United States
• 84044 Premier Health Research Center — Downey, California, United States
• 84028 Orange County Research Institute — Ontario, California, United States
• 84029 Center for Clinical Trials — Paramount, California, United States
• 84012 Benchmark Research — Sacramento, California, United States
• 84006 California Research Foundation — San Diego, California, United States
• 84001 Acevedo Clincal Research Associates — Miami, Florida, United States
• 84005 Sunshine Research Center — Opa-locka, Florida, United States
• 84052 Tekton Research — Chamblee, Georgia, United States
• 84036 Advanced Clinical Research — Meridian, Idaho, United States
• 84027 Heartland Research Associates — El Dorado, Kansas, United States
• 84020 Heartland Research Associates — Newton, Kansas, United States
• 84014 Heartland Research Associates — Wichita, Kansas, United States
• 84026 Heartland Research Associates — Wichita, Kansas, United States
• 84041 Kentucky Pediatric/ Adult Research — Bardstown, Kentucky, United States
• 84009 Bluegrass Clinical Research Inc. — Louisville, Kentucky, United States
• 84008 Meridian Clinical Research — Baton Rouge, Louisiana, United States
• 84046 ACC Pediatric Research — Haughton, Louisiana, United States
• 84004 Benchmark Research — Metairie, Louisiana, United States
• 84022 Med Pharmics — Metairie, Louisiana, United States
• 84053 MedPharmics — Gulfport, Mississippi, United States
• 84051 Office of Craig A. Spiegel — Bridgeton, Missouri, United States
• 84016 Center for Pharmaceutical Research — Kansas City, Missouri, United States
• 84037 Meridian Clinical Research — Norfolk, Nebraska, United States

Full record on ClinicalTrials.gov

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