Clinical trial NCT04074928: Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
Official title: A Phase 3, Randomized, Observer-Blind, Multicenter, Noninferiority Study to Evaluate Safety and Immunogenicity of a Cell-Based Quadrivalent Subunit Influenza Virus Vaccine (QIVc) and a United States Licensed Quadrivalent Influenza Virus Vaccine (QIV) in Healthy Subjects 6 Months Through 47 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Human
Virus Diseases
Keywords: Influenza
RNA Virus
WHO Strains
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2019-08-30
Enrollment: 2414
Sex: ALL
Minimum age (years): 6
Maximum age (years): 47
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HAI) Assay Using Cell-derived Target Viruses
timeFrame: Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects
measure: Immunogenicity Endpoint: Seroconversion Rates (SCR) and Differences in SCR Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Cell-derived Target Viruses
timeFrame: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
measure: Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by Microneutralization (MN) Assay Using Cell-derived Target Viruses
timeFrame: Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects
measure: Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived Target Viruses
timeFrame: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Secondary outcomes:
measure: Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Egg-derived Target Viruses
timeFrame: Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects
measure: Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H1N1, B/Victoria and B/ Yamagata Vaccine Strains by HAI Assay Using Egg-derived Target Viruses
timeFrame: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
measure: Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses
timeFrame: Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects
measure: Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses
timeFrame: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
measure: Immunogenicity Endpoint: Geometric Mean Ratio (GMR) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Cell-derived and Egg-derived Target Viruses
timeFrame: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
measure: Immunogenicity Endpoint: GMR Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived and Egg-derived Target Viruses
timeFrame: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
measure: Immunogenicity Endpoint: GMR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived and Egg-derived Target Viruses
timeFrame: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
measure: Safety Endpoint: Percentage of Subjects With Solicited Adverse Events (AEs)
timeFrame: Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects)
measure: Safety Endpoint: Percentage of Subjects With Any Unsolicited AEs
timeFrame: Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
measure: Safety Endpoint: Percentage of Subjects With Any Serious Adverse Events (SAEs), New Onset of Chronic Disease (NOCD) or AEs Leading to Withdrawal During the Entire Study Period
timeFrame: Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects
Other outcomes:
Locations:
city: Mobile
country: United States
facility: 84035 CCR Research
state: Alabama
city: Anaheim
country: United States
facility: 84040 Southland Clnical Research Center
state: California
city: Downey
country: United States
facility: 84044 Premier Health Research Center
state: California
city: Ontario
country: United States
facility: 84028 Orange County Research Institute
state: California
city: Paramount
country: United States
facility: 84029 Center for Clinical Trials
state: California
city: Sacramento
country: United States
facility: 84012 Benchmark Research
state: California
city: San Diego
country: United States
facility: 84006 California Research Foundation
state: California
city: Miami
country: United States
facility: 84001 Acevedo Clincal Research Associates
state: Florida
city: Opa-locka
country: United States
facility: 84005 Sunshine Research Center
state: Florida
city: Chamblee
country: United States
facility: 84052 Tekton Research
state: Georgia
city: Meridian
country: United States
facility: 84036 Advanced Clinical Research
state: Idaho
city: El Dorado
country: United States
facility: 84027 Heartland Research Associates
state: Kansas
city: Newton
country: United States
facility: 84020 Heartland Research Associates
state: Kansas
city: Wichita
country: United States
facility: 84014 Heartland Research Associates
state: Kansas
city: Wichita
country: United States
facility: 84026 Heartland Research Associates
state: Kansas
city: Bardstown
country: United States
facility: 84041 Kentucky Pediatric/ Adult Research
state: Kentucky
city: Louisville
country: United States
facility: 84009 Bluegrass Clinical Research Inc.
state: Kentucky
city: Baton Rouge
country: United States
facility: 84008 Meridian Clinical Research
state: Louisiana
city: Haughton
country: United States
facility: 84046 ACC Pediatric Research
state: Louisiana
city: Metairie
country: United States
facility: 84004 Benchmark Research
state: Louisiana
city: Metairie
country: United States
facility: 84022 Med Pharmics
state: Louisiana
city: Gulfport
country: United States
facility: 84053 MedPharmics
state: Mississippi
city: Bridgeton
country: United States
facility: 84051 Office of Craig A. Spiegel
state: Missouri
city: Kansas City
country: United States
facility: 84016 Center for Pharmaceutical Research
state: Missouri
city: Norfolk
country: United States
facility: 84037 Meridian Clinical Research
state: Nebraska
city: Omaha
country: United States
facility: 84017 Meridian Clinical Research
state: Nebraska
city: Albuquerque
country: United States
facility: 84033 Med Pharmics
state: New Mexico
city: Binghamton
country: United States
facility: 84013 Regional Clinical Research
state: New York
city: Dayton
country: United States
facility: 84045 Dayton Clinical
state: Ohio
city: Dayton
country: United States
facility: 84003 PriMed Clinical Research
state: Ohio
city: Dakota Dunes
country: United States
facility: 84015 Meridian Clinical Research
state: South Dakota
city: Nashville
country: United States
facility: 84032 Clinical Research Associates
state: Tennessee
city: Austin
country: United States
facility: 84007 Benchmark Research
state: Texas
city: Fort Worth
country: United States
facility: 84023 Ventavia Research Group
state: Texas
city: Fort Worth
country: United States
facility: 84042 Universtiy of North Texas Health Science Center
state: Texas
city: Fort Worth
country: United States
facility: 84043 Benchmark Research
state: Texas
city: Houston
country: United States
facility: 84047 Ventavia Research Group
state: Texas
city: Houston
country: United States
facility: 84011 West Houston Clinical Research
state: Texas
city: Keller
country: United States
facility: 84019 Ventavia Research Group
state: Texas
city: San Angelo
country: United States
facility: 84021 Benchmark Research
state: Texas
city: San Antonio
country: United States
facility: 84002 Tekton Research
state: Texas
city: Tomball
country: United States
facility: 84025 Pediatric Healthcare of NW Houston
state: Texas
city: Layton
country: United States
facility: 84018 Tanner Clinic
state: Utah
city: Salt Lake City
country: United States
facility: 84050 JBR Clinical Research Group
state: Utah
city: Salt Lake City
country: United States
facility: 84048 J. Lewis Research/Foothill Family Clinic South
state: Utah
city: West Jordan
country: United States
facility: 84031 Advanced Clinical Research
state: Utah
city: Charlottesville
country: United States
facility: 84039 Pediatric Research of Charlottesville
state: Virginia
Study officials:
affiliation: Seqirus
name: Clinical Program Director
role: STUDY_DIRECTOR
References:
citation: Essink BJ, Heeringa M, Jeanfreau RJ, Finn D, Matassa V, Edelman J, Hohenboken M, Molrine D. Safety and Immunogenicity of Cell-Based Quadrivalent Influenza Vaccine: A Randomized Trial. Pediatrics. 2022 Nov 1;150(5):e2022057509. doi: 10.1542/peds.2022-057509.