Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects

Phase 3

Completed

Conditions: Influenza
Human
Virus Diseases

Interventions: Biological: QIVc
Biological: Comparator QIV

Registration Number: NCT04074928

Lead Sponsor: Seqirus

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2414

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QIVc	QIVc	Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
Comparator QIV	Comparator QIV	Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains

Primary Outcome Measures

Name	Time	Method
Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by Microneutralization (MN) Assay Using Cell-derived Target Viruses	Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects	The GMT ratio is defined as the geometric mean of the postvaccination (28 days after last vaccination) MN titer for the Comparator QIV divided by the geometric mean of the postvaccination MN titer for QIVc.
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	Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects	The GMT ratio is defined as the geometric mean of the postvaccination (28 days after last vaccination) HAI titer for the Comparator QIV divided by the geometric mean of the postvaccination HAI titer for QIVc.
Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived Target Viruses	Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects	The SCR is defined as the percentage of subjects with either a prevaccination MN titer \<1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a ≥4-fold increase in postvaccination MN titer. The SCR difference is defined as the Comparator QIV SCR minus the QIVc SCR.
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	Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects	The SCR is defined as the percentage of subjects with either a prevaccination HAI titer \<1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a ≥4-fold increase in postvaccination HAI titer. The SCR difference is defined as the Comparator QIV SCR minus the QIVc SCR.

Secondary Outcome Measures

Name	Time	Method
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	Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects	GMR is defined as the geometric mean of the (within-subject) fold increase in serum HAI GMT postvaccination (Day 29/57) compared to prevaccination (Day 1).
Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses	Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects	The SCR is defined as the percentage of subjects with either a prevaccination MN titer \<1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a ≥4-fold increase in postvaccination MN titer. The SCR difference is defined as the Comparator QIV SCR minus the QIVc SCR.
Immunogenicity Endpoint: GMR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived and Egg-derived Target Viruses	Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects	GMR is defined as the geometric mean of the (within-subject) fold increase in serum MN GMT postvaccination (Day 29/57) compared to prevaccination (Day 1).
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	Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects	The GMT ratio is defined as the geometric mean of the postvaccination (28 days after last vaccination) HAI titer for the Comparator QIV divided by the geometric mean of the postvaccination HAI titer for QIVc.
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	Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects	The SCR is defined as the percentage of subjects with either a prevaccination HAI titer \<1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a ≥4-fold increase in postvaccination HAI titer. The SCR difference is defined as the Comparator QIV SCR minus the QIVc SCR.
Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses	Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects	The GMT ratio is defined as the geometric mean of the postvaccination (28 days after last vaccination) MN titer for the Comparator QIV divided by the geometric mean of the postvaccination MN titer for QIVc.
Safety Endpoint: Percentage of Subjects With Solicited Adverse Events (AEs)	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)	The percentage of subjects with at least one solicited AE Day 1 through Day 7 after any study vaccination.
Safety Endpoint: Percentage of Subjects With Any Unsolicited AEs	Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects	The percentage of subjects with at least one unsolicited AE from Day 1 to Day 29 for previously vaccinated subjects and from Day 1 to Day 57 for not previously vaccinated subjects. Related AEs = considered at least possibly related to study vaccination by the investigator; Severity = based on the greatest severity associated with a preferred term for a reported AE.
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	Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects	The percentage of subjects with any SAE, NOCD or AE leading to withdrawal during the study period from Day 1 to Day 181 for previously vaccinated subjects or from Day 1 to Day 209 for not previously vaccinated subjects. Definitions: SAEs = AEs defined as any untoward medical occurrence that at any dose resulted in one or more of the following: 1. Death, 2. Life-threatening 3. Required/prolonged hospitalization 4. Persistent or significant disability/incapacity 5. congenital anomaly/or birth defect 6. An important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based on appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above
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	Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects	GMR is defined as the geometric mean of the (within-subject) fold increase in serum MN GMT postvaccination (Day 29/57) compared to prevaccination (Day 1).

Trial Locations

Locations (47): 84029 Center for Clinical Trials
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Paramount, California, United States
84045 Dayton Clinical
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Dayton, Ohio, United States
84007 Benchmark Research
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Austin, Texas, United States
84050 JBR Clinical Research Group
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Salt Lake City, Utah, United States
84004 Benchmark Research
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Metairie, Louisiana, United States
84021 Benchmark Research
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San Angelo, Texas, United States
84043 Benchmark Research
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Fort Worth, Texas, United States
84009 Bluegrass Clinical Research Inc.
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Louisville, Kentucky, United States
84052 Tekton Research
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Chamblee, Georgia, United States
84018 Tanner Clinic
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Layton, Utah, United States
84035 CCR Research
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Mobile, Alabama, United States
84016 Center for Pharmaceutical Research
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Kansas City, Missouri, United States
84033 Med Pharmics
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Albuquerque, New Mexico, United States
84025 Pediatric Healthcare of NW Houston
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Tomball, Texas, United States
84023 Ventavia Research Group
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Fort Worth, Texas, United States
84048 J. Lewis Research/Foothill Family Clinic South
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Salt Lake City, Utah, United States
84051 Office of Craig A. Spiegel
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Bridgeton, Missouri, United States
84047 Ventavia Research Group
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Houston, Texas, United States
84011 West Houston Clinical Research
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Houston, Texas, United States
84040 Southland Clnical Research Center
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Anaheim, California, United States
84006 California Research Foundation
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San Diego, California, United States
84012 Benchmark Research
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Sacramento, California, United States
84028 Orange County Research Institute
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Ontario, California, United States
84001 Acevedo Clincal Research Associates
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Miami, Florida, United States
84005 Sunshine Research Center
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Opa-locka, Florida, United States
84041 Kentucky Pediatric/ Adult Research
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Bardstown, Kentucky, United States
84027 Heartland Research Associates
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El Dorado, Kansas, United States
84003 PriMed Clinical Research
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Dayton, Ohio, United States
84019 Ventavia Research Group
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Keller, Texas, United States
84031 Advanced Clinical Research
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West Jordan, Utah, United States
84039 Pediatric Research of Charlottesville
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Charlottesville, Virginia, United States
84020 Heartland Research Associates
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Newton, Kansas, United States
84026 Heartland Research Associates
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Wichita, Kansas, United States
84014 Heartland Research Associates
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Wichita, Kansas, United States
84015 Meridian Clinical Research
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Dakota Dunes, South Dakota, United States
84008 Meridian Clinical Research
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Baton Rouge, Louisiana, United States
84037 Meridian Clinical Research
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Norfolk, Nebraska, United States
84036 Advanced Clinical Research
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Meridian, Idaho, United States
84046 ACC Pediatric Research
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Haughton, Louisiana, United States
84017 Meridian Clinical Research
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Omaha, Nebraska, United States
84022 Med Pharmics
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Metairie, Louisiana, United States
84053 MedPharmics
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Gulfport, Mississippi, United States
84044 Premier Health Research Center
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Downey, California, United States
84042 Universtiy of North Texas Health Science Center
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Fort Worth, Texas, United States
84002 Tekton Research
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San Antonio, Texas, United States
84013 Regional Clinical Research
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Binghamton, New York, United States
84032 Clinical Research Associates
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Nashville, Tennessee, United States