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Trial record 3 of 4 for:    seqirus | QIVc

Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04074928
Recruitment Status : Completed
First Posted : August 30, 2019
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
Seqirus

Brief Summary:
This phase 3 clinical study is a randomized, observer-blind, comparator controlled, multicenter study of QIVc versus a 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 Comparator QIV containing the same virus strains, in children 6 months through 47 months of age.

Condition or disease Intervention/treatment Phase
Influenza Human Virus Diseases Biological: QIVc Biological: Comparator QIV Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
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
Actual Study Start Date : September 6, 2019
Actual Primary Completion Date : September 3, 2020
Actual Study Completion Date : September 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: QIVc
Cell-derived Quadrivalent Influenza Vaccine
Biological: QIVc
Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains.
Other Name: Flucelvax Quadrivalent

Active Comparator: Comparator QIV
Comparator Quadrivalent Influenza Vaccine
Biological: Comparator QIV
Comparator Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains.




Primary Outcome Measures :
  1. Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT ratio against A/H1N1, B/Victoria and B/Yamagata vaccine strains by HAI assay using cell-derived target virus [ Time Frame: Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for subjects not previously vaccinated ]
    HAI = hemagglutination inhibition

  2. Immunogenicity Endpoint: Seroconversion rates (SCR) and differences in SCR against A/H1N1, B/Victoria and B/Yamagata vaccine strains by HAI assay using cell-derived target virus [ Time Frame: Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for subjects not previously vaccinated ]
    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 post vaccination HAI titer.

  3. Immunogenicity Endpoint: GMT and GMT ratio against A/H3N2 vaccine strains by microneutralization (MN) assay using cell-derived target virus [ Time Frame: Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for subjects not previously vaccinated ]
  4. Immunogenicity Endpoint: Seroconversion rates (SCR) and differences in SCR against A/H3N2 vaccine strains by MN assay using cell-derived target virus [ Time Frame: Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for subjects not previously vaccinated ]

    The SCR is defined as the percentage of subjects with either a prevaccination MN titer <1:10 (Lower Limit Of Quantification [LLOQ]) and a postvaccination MN titer

    ≥1:40 (4*LLOQ), or a prevaccination MN titer ≥1:10 (LLOQ) and a ≥4-fold increase in postvaccination MN titer.



Secondary Outcome Measures :
  1. Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT ratio against A/H1N1, B/Victoria and B/Yamagata vaccine strains by HAI assay using egg-derived target virus [ Time Frame: Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for subjects not previously vaccinated ]
  2. Immunogenicity Endpoint: Seroconversion rates (SCR) and differences in SCR against A/H1N1, B/Victoria and B/Yamagata vaccine strains by HAI assay using egg-derived target virus [ Time Frame: Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for subjects not previously vaccinated ]
  3. Immunogenicity Endpoint: GMT and GMT ratio against A/H3N2 vaccine strains by MN assay using egg-derived target virus [ Time Frame: Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for subjects not previously vaccinated ]
  4. Immunogenicity Endpoint: Seroconversion rates (SCR) and differences in SCR against A/H3N2 vaccine strains by MN assay using cell-derived and egg-derived target virus [ Time Frame: Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for subjects not previously vaccinated ]
  5. Immunogenicity Endpoint: Geometric Mean Ratio (GMR) against A/H1N1, B/Victoria and B/Yamagata vaccine strains by HAI assay using cell-derived and egg-derived target virus [ Time Frame: Day 1 to Day 29 in previously vaccinated subjects; Day 1 to Day 57 in subjects not previously vaccinated ]
    GMR is defined as the folder increase in serum HAI GMT postvaccination (Day 29/57) compared to prevaccination (Day 1)

  6. Immunogenicity Endpoint: Geometric Mean Ratio (GMR) against A/H1N1, B/Victoria and B/Yamagata vaccine strains by MN assay using cell-derived and egg-derived target virus [ Time Frame: Day 1 to Day 29 in previously vaccinated subjects; Day 1 to Day 57 in subjects not previously vaccinated ]
    GMR is defined as the folder increase in serum MN GMT postvaccination (Day 29/57) compared to prevaccination (Day 1)

  7. Immunogenicity Endpoint: Geometric Mean Ratio (GMR) against A/H3N2 vaccine strains by MN assay using cell-derived and egg-derived target virus [ Time Frame: Day 1 to Day 29 in previously vaccinated subjects; Day 1 to Day 57 in subjects not previously vaccinated ]
    GMR is defined as the folder increase in serum MN GMT postvaccination (Day 29/57) compared to prevaccination (Day 1)

  8. Safety Endpoint: Percentage of subjects with solicited adverse events (AE) [ Time Frame: 7 days after each vaccination ]
  9. Safety Endpoint: Percentage of subjects with any unsolicited AEs [ Time Frame: Day 1 to Day 29 in previously vaccinated subjects; Day 1 to Day 57 in subjects not previously vaccinated ]
  10. Safety Endpoint: Percentage of subjects with any SAEs, NOCDs, AEs leading to withdrawal during the entire study period [ Time Frame: Day 1 to Day 181 in previously vaccinated subjects; Day 1 to Day 209 in subjects not previously vaccinated ]
    SAE = serious adverse event; NOCD = new onset of chronic disease



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 47 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Additional eligibility criteria may be discussed by contacting the site.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04074928


Locations
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Sponsors and Collaborators
Seqirus
Investigators
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Study Director: Clinical Program Director Seqirus
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Responsible Party: Seqirus
ClinicalTrials.gov Identifier: NCT04074928    
Other Study ID Numbers: V130_10
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seqirus:
Influenza
RNA Virus
WHO Strains
Additional relevant MeSH terms:
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Influenza, Human
Virus Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases