Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy Study With QIVc in 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Influenza, Human Biological: QIVc Biological: Comparator Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3830 participants
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
Official Title: 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
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : March 28, 2022
Estimated Study Completion Date : March 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Seqirus QIVc
Cell-derived Quadrivalent Influenza Vaccine
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

Active Comparator: Comparator
Non-influenza Comparator (NesiVac-C)
Biological: Comparator
Meningococcal Group C Polysaccharide Conjugate Vaccine (MenC vaccine, Neisvac-C)




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


  6. 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


  7. 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

  8. 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

  9. 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

  10. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 47 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


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): NCT03932682


Contacts
Layout table for location contacts
Contact: Seqirus Clinical Data Disclosure Manager Use Email seqirus.clinicaltrials@seqirus.com

Locations
Show Show 56 study locations
Sponsors and Collaborators
Seqirus
Investigators
Layout table for investigator information
Study Director: Clinical Program Director Seqirus
Layout table for additonal information
Responsible Party: Seqirus
ClinicalTrials.gov Identifier: NCT03932682    
Other Study ID Numbers: V130_14
2018-001857-29 ( EudraCT Number )
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Seqirus:
Influenza Vaccine
Additional relevant MeSH terms:
Layout table for MeSH terms
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases