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Concomitant Administration of the Novavax Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Adults Aged ≥60 Years (NVX_PCV20)

Primary Purpose

COVID-19, Pneumococcal Infections

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
NVX
PCV20
Placebo
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age: 60 years or older Males and females Able and willing (in the investigator's opinion) to comply with all study requirements. Participants, who already received three Covid-19 vaccines, of which the third was a mRNA vaccine (BNT162b2 or mRNA-1273) and at least 16 weeks ago Only applicable for women: last menstrual bleeding more than one year ago Exclusion Criteria: Use of immunosuppressants Congenital or acquired immunodeficiency (eg, history of HIV infection, hematological disease, current malignancy, or others) Chronic condition that may significantly interfere with the immune response in the opinion of the investigator History of Covid-19 within 16 weeks before study vaccination Previous pneumococcal vaccination Contraindication against any ingredient of the NVX or the PCV20 vaccine

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Experimental

    Placebo Comparator

    Arm Label

    NVX arm

    PCV20 arm

    Combination arm

    Placebo arm

    Arm Description

    NVX plus placebo

    PCV20 (Apexxnar®) plus placebo

    NVX plus PCV20

    Placebo (normal saline) plus placebo

    Outcomes

    Primary Outcome Measures

    Immunogenicity
    Antibody levels

    Secondary Outcome Measures

    Full Information

    First Posted
    March 2, 2023
    Last Updated
    March 13, 2023
    Sponsor
    Medical University of Vienna
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05767606
    Brief Title
    Concomitant Administration of the Novavax Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Adults Aged ≥60 Years
    Acronym
    NVX_PCV20
    Official Title
    Safety and Immunogenicity of Concomitant Administration of the Novavax Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Adults Aged ≥60 Years: a Four-arm, Double-blind, Non-inferiority Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2023 (Anticipated)
    Primary Completion Date
    July 2023 (Anticipated)
    Study Completion Date
    August 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of Vienna

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Vaccination is a key strategy for preventing respiratory illnesses. Pneumococcal vaccination is recommended for all adults aged over 60 or 65 years (depending local guidelines) who have never received a pneumococcal vaccine or whose previous vaccination history is unknown. Given their wide application, co-administration of pneumococcal and Covid-19 vaccines may support broad population-wide coverage. However, it is unclear whether the co-administration of the Novavax (NVX) vaccine and a 20-valent pneumococcal conjugate vaccine (PCV20) results in lower immunogenicity than the administration of either alone. The investigators will thus conduct a 4-four arm study with the following treatments: NVX plus placebo (NVX arm), PCV20 plus placebo group (PCV20 arm), NVX plus PCV20 (Combination arm), and placebo plus placebo group (Placebo arm). Vaccines and/or placebo will be administered as single doses, given as intramuscular injections on Day 1 (one in each shoulder). Subjects will be randomly assigned to one of the four arms. The outcome will be the antibody levels after 28 days.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19, Pneumococcal Infections

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    256 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    NVX arm
    Arm Type
    Active Comparator
    Arm Description
    NVX plus placebo
    Arm Title
    PCV20 arm
    Arm Type
    Active Comparator
    Arm Description
    PCV20 (Apexxnar®) plus placebo
    Arm Title
    Combination arm
    Arm Type
    Experimental
    Arm Description
    NVX plus PCV20
    Arm Title
    Placebo arm
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo (normal saline) plus placebo
    Intervention Type
    Biological
    Intervention Name(s)
    NVX
    Intervention Description
    Administration of NVX
    Intervention Type
    Biological
    Intervention Name(s)
    PCV20
    Intervention Description
    Administration of PCV20
    Intervention Type
    Biological
    Intervention Name(s)
    Placebo
    Intervention Description
    No intervention
    Primary Outcome Measure Information:
    Title
    Immunogenicity
    Description
    Antibody levels
    Time Frame
    Day 28

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age: 60 years or older Males and females Able and willing (in the investigator's opinion) to comply with all study requirements. Participants, who already received three Covid-19 vaccines, of which the third was a mRNA vaccine (BNT162b2 or mRNA-1273) and at least 16 weeks ago Only applicable for women: last menstrual bleeding more than one year ago Exclusion Criteria: Use of immunosuppressants Congenital or acquired immunodeficiency (eg, history of HIV infection, hematological disease, current malignancy, or others) Chronic condition that may significantly interfere with the immune response in the opinion of the investigator History of Covid-19 within 16 weeks before study vaccination Previous pneumococcal vaccination Contraindication against any ingredient of the NVX or the PCV20 vaccine

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Concomitant Administration of the Novavax Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Adults Aged ≥60 Years

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