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Efficacy Study With QIVc in Pediatric Subjects

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ClinicalTrials.gov Identifier: NCT03932682
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Seqirus

Tracking Information
First Submitted Date  ICMJE April 22, 2019
First Posted Date  ICMJE May 1, 2019
Last Update Posted Date August 25, 2020
Actual Study Start Date  ICMJE May 13, 2019
Estimated Primary Completion Date March 28, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
  • Efficacy Endpoint: First occurrence of RT-PCR confirmed influenza, due to any influenza Type A and/or B virus regardless of antigenic match [ Time Frame: Day 14 to Day 180 ]
    First occurrence of RT-PCR confirmed influenza, due to any influenza Type A and/or B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined influenza-like illness (ILI) symptoms
  • Efficacy Endpoint: First occurrence of culture confirmed influenza, due to influenza Type A and/or B virus antigenically matched by ferret antigenicity testing to the strains selected for the seasonal influenza vaccine [ Time Frame: Day 14 to Day 180 ]
    First occurrence of culture confirmed influenza, due to influenza Type A and/or B virus antigenically matched by ferret antigenicity testing to the strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
  • Efficacy Endpoint: First occurrence of culture confirmed influenza caused by influenza virus strains antigenically dissimilar to the influenza strains selected for the seasonal influenza vaccine [ Time Frame: Day 14 to Day 180 ]
    First occurrence of culture confirmed influenza caused by influenza virus strains antigenically dissimilar to the influenza strains selected for the seasonal vaccine occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms
  • Efficacy Endpoint: First occurrence of culture confirmed influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine [ Time Frame: Day 14 to Day 180 ]
    First occurrence of culture confirmed influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms
  • Efficacy Endpoint: First occurrence of RT-PCR confirmed moderate-to-severe influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine [ Time Frame: Day 14 to Day 180 ]
    First occurrence of RT-PCR confirmed moderate-to-severe influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season
  • Immunogenicity Endpoint: a) Prevaccination and postvaccination Geometric Mean Titer (GMT) [ Time Frame: Day 1 and 28 days after last vaccination ]
    The measures for immunogenicity are determined by a haemagglutination inhibition [HI] and/or a microneutralization [MN] assay prior to first vaccination and 28 days after last vaccination for all four influenza strains
  • Immunogenicity Endpoint: Seroconversion rates (SCR) [ Time Frame: Day 1 and 28 days after last vaccination ]
    The measures for immunogenicity are determined by a HI and/or a MN assay prior to first vaccination and 28 days after last vaccination for all four influenza strains SCR is defined as the percentage of subjects with either a prevaccination HI (or MN) titer < 1:10 and a postvaccination HI (or MN) titer ≥ 1:40, or a prevaccination HI (or MN) titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination HI (or MN) titer
  • Immunogenicity endpoint: Geometric Mean Ratio (GMR) [ Time Frame: Day 1 and 28 days after last vaccination ]
    The measures for immunogenicity are determined by a haemagglutination inhibition [HI] and/or a micro neutralization [MN] assay prior to first vaccination and 28 days after last vaccination for all four influenza strains GMR is the geometric mean of the fold increase of post-vaccination HI (or MN) titer over the pre-vaccination HI (or MN) titer
  • Safety Endpoint: Percentage of subjects with solicited local and systemic adverse events (AE) [ Time Frame: 7 days following each vaccination ]
    Percentage of subjects with solicited local and systemic AEs will be assessed for 7 days following each vaccination in the QIVc group and in the comparator group
  • Safety Endpoint: Percentage of subjects with unsolicited AEs [ Time Frame: 28 days following each vaccination ]
    Percentage of subjects with any unsolicited AEs will be assessed in the QIVc group and in the comparator group until 28 days after each vaccination
  • Safety Endpoint: Percentage of subjects with SAEs, NOCDs, AEs leading to withdrawal from the study or vaccination [ Time Frame: Day 1 to Day 180 ]
    Percentage of subjects with serious AEs (SAE), new onset of chronic disease (NOCD), AEs leading to withdrawal from the study or vaccination, and all medications associated with these events will be reported in the QIVc group and in the comparator group
  • Safety Endpoint: Percentage of subjects with medically-attended AEs [ Time Frame: 30 days following ILI onset ]
    Percentage of subjects with medically-attended AEs within 30 days after ILI onset will be reported in the QIVc group and in the comparator group
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 Efficacy Study With QIVc in Pediatric Subjects
Official Title  ICMJE A Phase 3, Randomized, Observer-blind, Multicenter Study to Evaluate the Efficacy, Immunogenicity and Safety of Seqirus' Cell-Based Quadrivalent Subunit Influenza Virus Vaccine (QIVc) Compared to a Non-Influenza Vaccine When Administrated in Healthy Subjects Aged 6 Months Through 47 Months
Brief Summary This phase 3 clinical study is a randomized, observer-blind, multicenter study of QIVc versus a non-influenza vaccine in subjects 6 months though 47 months of age. The purpose of this study is to evaluate efficacy of QIVc in the prevention of Reverse transcription polymerase chain reaction (RT-PCR) confirmed influenza A or B disease in children 6 through 47 months of age, compared to a non-influenza vaccine.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The trial is designed as an observer-blind study. During the treatment period of the study designated and trained unblinded personnel will be responsible for administering the study vaccines to the subjects.
Primary Purpose: Prevention
Condition  ICMJE Influenza, Human
Intervention  ICMJE
  • Biological: QIVc
    QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.
    Other Name: Flucelvax Quadrivalent
  • Biological: Comparator
    Meningococcal Group C Polysaccharide Conjugate Vaccine (MenC vaccine, Neisvac-C)
Study Arms  ICMJE
  • Experimental: Seqirus QIVc
    Cell-derived Quadrivalent Influenza Vaccine
    Intervention: Biological: QIVc
  • Active Comparator: Comparator
    Non-influenza Comparator (NesiVac-C)
    Intervention: Biological: Comparator
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 26, 2019)
3830
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 28, 2022
Estimated Primary Completion Date March 28, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

In order to participate in this study, all subjects must meet all of the inclusion criteria described.

  • 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 .
  • Individuals in generally good health as per the Investigator's medical judgement.

Prior to receipt of second study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. If subjects do not meet the criteria of the original inclusion criteria listed above, they should not receive additional vaccinations.

Exclusion Criteria:

  • Acute (severe) febrile illness. Enrollment could be considered if the fever is absent for 72 hours.
  • 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.
  • Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. These may include known bleeding disorders, or treatment with anticoagulants in the 3 weeks preceding vaccination.
  • A known history of Guillain-Barré Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis.
  • Abnormal function of the immune system resulting from a clinical condition
  • Received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent.
  • Prior vaccination to prevent Neisseria meningitides serogroup C disease or prior infection caused by this organism.

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: Seqirus Clinical Data Disclosure Manager Use Email seqirus.clinicaltrials@seqirus.com
Listed Location Countries  ICMJE Bangladesh,   Bulgaria,   Czechia,   Estonia,   Honduras,   Latvia,   Malaysia,   New Zealand,   Philippines,   Poland,   Romania,   Thailand,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03932682
Other Study ID Numbers  ICMJE V130_14
2018-001857-29 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
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 August 2020

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