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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

Tracking Information
First Submitted Date  ICMJE August 27, 2019
First Posted Date  ICMJE August 30, 2019
Last Update Posted Date September 30, 2020
Actual Study Start Date  ICMJE September 6, 2019
Actual Primary Completion Date September 3, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2019)
  • 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
  • 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.
  • 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 ]
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2019)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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)
  • 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)
  • 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)
  • Safety Endpoint: Percentage of subjects with solicited adverse events (AE) [ Time Frame: 7 days after each vaccination ]
  • 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 ]
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Influenza
  • Human
  • Virus Diseases
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Experimental: QIVc
    Cell-derived Quadrivalent Influenza Vaccine
    Intervention: Biological: QIVc
  • Active Comparator: Comparator QIV
    Comparator Quadrivalent Influenza Vaccine
    Intervention: Biological: Comparator QIV
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2020)
2414
Original Estimated Enrollment  ICMJE
 (submitted: August 27, 2019)
2502
Actual Study Completion Date  ICMJE September 3, 2020
Actual Primary Completion Date September 3, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 47 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04074928
Other Study ID Numbers  ICMJE V130_10
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Seqirus
Study Sponsor  ICMJE Seqirus
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Program Director Seqirus
PRS Account Seqirus
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP