Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects

NCT04074928 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: V130_102020-002785-13
• Study Type: interventional
• Target: 2,414
• Locations: 1 country
• Sites: 47

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.

Conditions

Influenza; Human; Virus Diseases

Keywords

Influenza; RNA Virus; WHO Strains

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (10)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

QIVc

EXPERIMENTAL

Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains

Biological: QIVc

Comparator QIV

ACTIVE COMPARATOR

Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains

Biological: Comparator QIV

Interventions

QIVc BIOLOGICAL

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.

Also known as: Flucelvax Quadrivalent

QIVc

Comparator QIV BIOLOGICAL

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.

Also known as: Afluria Quadrivalent

Comparator QIV

Eligibility Criteria

• Age: 6 Months - 47 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Seqirus: lead

Study Sites (47)

84035 CCR Research

Mobile, Alabama, 36608, United States

Location

84040 Southland Clnical Research Center

Anaheim, California, 92804, United States

Location

84044 Premier Health Research Center

Downey, California, 90240, United States

Location

84028 Orange County Research Institute

Ontario, California, 91763, United States

Location

84029 Center for Clinical Trials

Paramount, California, 90723, United States

Location

84012 Benchmark Research

Sacramento, California, 95864, United States

Location

84006 California Research Foundation

San Diego, California, 92123-1881, United States

Location

84001 Acevedo Clincal Research Associates

Miami, Florida, 33142, United States

Location

84005 Sunshine Research Center

Opa-locka, Florida, 33054, United States

Location

84052 Tekton Research

Chamblee, Georgia, 30341, United States

Location

84036 Advanced Clinical Research

Meridian, Idaho, 83642, United States

Location

84027 Heartland Research Associates

El Dorado, Kansas, 67042, United States

Location

84020 Heartland Research Associates

Newton, Kansas, 67114, United States

Location

84014 Heartland Research Associates

Wichita, Kansas, 67205, United States

Location

84026 Heartland Research Associates

Wichita, Kansas, 67207, United States

Location

84041 Kentucky Pediatric/ Adult Research

Bardstown, Kentucky, 40004, United States

Location

84009 Bluegrass Clinical Research Inc.

Louisville, Kentucky, 40291, United States

Location

84008 Meridian Clinical Research

Baton Rouge, Louisiana, 70806, United States

Location

84046 ACC Pediatric Research

Haughton, Louisiana, 71037, United States

Location

84004 Benchmark Research

Metairie, Louisiana, 70006, United States

Location

84022 Med Pharmics

Metairie, Louisiana, 70006, United States

Location

84053 MedPharmics

Gulfport, Mississippi, 39503, United States

Location

84051 Office of Craig A. Spiegel

Bridgeton, Missouri, 63044, United States

Location

84016 Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

84037 Meridian Clinical Research

Norfolk, Nebraska, 68701, United States

Location

84017 Meridian Clinical Research

Omaha, Nebraska, 68116, United States

Location

84033 Med Pharmics

Albuquerque, New Mexico, 87102, United States

Location

84013 Regional Clinical Research

Binghamton, New York, 13901, United States

Location

84045 Dayton Clinical

Dayton, Ohio, 45406, United States

Location

84003 PriMed Clinical Research

Dayton, Ohio, 45419, United States

Location

84015 Meridian Clinical Research

Dakota Dunes, South Dakota, 57049, United States

Location

84032 Clinical Research Associates

Nashville, Tennessee, 37203, United States

Location

84007 Benchmark Research

Austin, Texas, 78705, United States

Location

84023 Ventavia Research Group

Fort Worth, Texas, 76104, United States

Location

84042 Universtiy of North Texas Health Science Center

Fort Worth, Texas, 76107, United States

Location

84043 Benchmark Research

Fort Worth, Texas, 76135, United States

Location

84047 Ventavia Research Group

Houston, Texas, 77008, United States

Location

84011 West Houston Clinical Research

Houston, Texas, 77055, United States

Location

84019 Ventavia Research Group

Keller, Texas, 76248, United States

Location

84021 Benchmark Research

San Angelo, Texas, 76904, United States

Location

84002 Tekton Research

San Antonio, Texas, 78240, United States

Location

84025 Pediatric Healthcare of NW Houston

Tomball, Texas, 77375, United States

Location

84018 Tanner Clinic

Layton, Utah, 84041, United States

Location

84050 JBR Clinical Research Group

Salt Lake City, Utah, 84107, United States

Location

84048 J. Lewis Research/Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States

Location

84031 Advanced Clinical Research

West Jordan, Utah, 84088, United States

Location

84039 Pediatric Research of Charlottesville

Charlottesville, Virginia, 22902, United States

Location

Related Publications (1)

• 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.

  PMID: 36214072 DERIVED

MeSH Terms

Conditions

Influenza, Human; Virus Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Diseases

Results Point of Contact

• Title: Seqirus Clinical Trial Manager
• Organization: Seqirus

seqirus.clinicaltrials@Seqirus.com

1-855-358-8966

Study Officials

• Clinical Program Director

  Seqirus

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The trial is designed as an observer-blind study. During the treatment period of the study designated unblinded nurse(s), physician(s), or other qualified health care professional will be responsible for administering the study vaccine to the subjects.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: August 30, 2019
• Study Start: September 6, 2019
• Primary Completion: September 3, 2020
• Study Completion: September 3, 2020
• Last Updated: January 12, 2022
• Results First Posted: January 12, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (47)