Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04074928
• Other study ID #: V130_10
• Secondary ID: 2020-002785-13
• Status: Completed
• Phase: Phase 3
• Start date: September 6, 2019
• Est. completion date: September 3, 2020

Study information

• Verified date: December 2021
• Source: Seqirus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2414
• Est. completion date: September 3, 2020
• Est. primary completion date: September 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 47 Months

Eligibility

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.

Related Conditions & MeSH terms

• Human
• Influenza
• Influenza, Human
• Virus Diseases

Intervention

Biological:
• QIVc
Previously vaccinated subjects received a 0.5 mL intramuscular dose of QIVc on Day 1; not previously vaccinated subjects received a 0.5 mL intramuscular dose of QIVc on Day 1 and Day 29.
• Comparator QIV
Previously vaccinated subjects received a dose of Comparator QIV on Day 1; not previously vaccinated subjects received a dose of Comparator QIV on Day 1 and Day 29. Subjects 6 months through 35 months of age received a 0.25 mL intramuscular dose of Comparator QIV; subjects 36 months through 47 months of age received a 0.5 mL intramuscular dose of Comparator QIV.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Seqirus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects
Primary	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	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.	Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Primary	Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by Microneutralization (MN) Assay Using Cell-derived Target Viruses	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.	Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects
Primary	Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived Target Viruses	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.	Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Secondary	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	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.	Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects
Secondary	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	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.	Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Secondary	Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses	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.	Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects
Secondary	Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses	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.	Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Secondary	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	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).	Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Secondary	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	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).	Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Secondary	Immunogenicity Endpoint: GMR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived and Egg-derived Target Viruses	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).	Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Secondary	Safety Endpoint: Percentage of Subjects With Solicited Adverse Events (AEs)	The percentage of subjects with at least one solicited AE Day 1 through Day 7 after any study vaccination.	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)
Secondary	Safety Endpoint: Percentage of Subjects With Any Unsolicited AEs	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.	Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Secondary	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	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	Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects