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    Summary
    EudraCT Number:2025-000541-19
    Sponsor's Protocol Code Number:VBV23344
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2026-07-08
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2025-000541-19
    A.3Full title of the trial
    A Phase 3 Open-Label, Single-Arm Study to Evaluate the Safety and Immunogenicity of an Omicron JN.1 Subvariant SARS-CoV-2 rS Vaccine Adjuvanted with Matrix-M
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Immunogenicity of NVX-CoV2705
    A.3.2Name or abbreviated title of the trial where available
    Safety and Immunogenicity of NVX-CoV2705
    A.4.1Sponsor's protocol code numberVBV23344
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT07079670
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSanofi Vaccines US Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSanofi Vaccines US Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Vaccines US Inc.
    B.5.2Functional name of contact pointTrial Transparency Team
    B.5.3 Address:
    B.5.3.1Street Address1 Discovery Drive
    B.5.3.2Town/ citySwiftwater
    B.5.3.3Post code18370
    B.5.3.4CountryUnited States
    B.5.6E-mailcontact-us@sanofi.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name NUVAXOVID™
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Vaccines US Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNUVAXOVID™
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOmicron JN.1
    D.3.9.2Current sponsor codeNVX-CoV2705
    D.3.9.3Other descriptive nameSARS-CoV-2, variant Omicron JN.1, spike protein, recombinant, expressed in Sf9 cells derived from Spodoptera frugiperda
    D.3.9.4EV Substance CodeSUB396895
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe acute respiratory syndrome coronavirus 2
    E.1.1.1Medical condition in easily understood language
    Coronavirus
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine if the NVX-CoV2705 vaccine induces superior neutralizing antibody responses against the Omicron LP.8.1 subvariant compared to baseline.
    E.2.2Secondary objectives of the trial
    To describe neutralizing antibody responses induced by NVX-CoV2705 against the Omicron LP.8.1 subvariant.
    To describe the overall safety of a single dose of NVX-CoV2705.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participants ≥ 65 years of age and participants 12 through 64 years who have at least one underlying condition that puts them at high risk of severe outcomes from COVID-19 at time of study vaccination. In each instance, the investigator’s judgment may be exercised and other eligibility criteria must be respected.
    2. Previously vaccinated with a COVID-19 vaccine with the last dose administered ≥ 90 days prior to study vaccination (written or verbal confirmation by participant).
    3. Participant and parent(s)/caregiver(s) or legally acceptable representative willing and able to give informed consent and assent prior to study enrollment and to comply with study procedures.
    4. Female participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea ≥ 12 consecutive months]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study OR agree to consistently use a
    medically acceptable method of contraception listed below from ≥ 28 days prior to enrollment and through the end of the study.
    a. Condoms (male or female) with spermicide (if acceptable in country)
    b. Diaphragm with spermicide
    c. Cervical cap with spermicide
    d. Intrauterine device
    e. Oral or patch contraceptives
    f. Norplant®, Depo-Provera®, or other in country regulatory approved contraceptive method that is designed to protect against pregnancy
    g. Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle
    NOTE: Periodic abstinence (eg, calendar, ovulation, sympto-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
    5. Is medically stable, as determined by the investigator (based on review of health status, vital signs [to include body temperature], medical history, and physical examination). Vital signs must be within medically acceptable ranges prior to study vaccination. If the individual has a diagnosis of hypertension, it must be stable and controlled with necessary medication.
    6. Agrees not to participate in any research involving receipt of investigational products (drug/biologic/device), including other SARS-CoV-2 prevention or treatment trials, for the duration of the study.
    E.4Principal exclusion criteria
    1. Current participation in research involving receipt of investigational products (drug/biologic/device).
    2. Received any other vaccine (except for a licensed seasonal influenza vaccine or rabies vaccine [if medically indicated]) within 28 days prior to study vaccination. For the influenza vaccine, a participant is eligible as long as the vaccine was administered
    ≥ 14 days prior to study vaccination.
    3. Any known history of allergies to products contained in the investigational product in the participant’s lifetime.
    4. Any known history of anaphylaxis to any prior vaccine in the participant’s lifetime.
    5. Known history of myocarditis or pericarditis in the participant’s lifetime.
    6. Suspected or known history of alcohol abuse or drug addiction within 2 years prior to study vaccination that, in the opinion of the investigator, might interfere with protocol compliance.
    7. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) that requires the use of immune modulators.
    NOTE: Stable endocrine disorders (eg, thyroiditis, pancreatitis), including stable diabetes mellitus with no history of diabetic ketoacidosis, are NOT excluded.
    8. Chronic administration (defined as > 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to study vaccination (Day 0).
    NOTE: An immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical, inhaled or intranasal glucocorticoids is permitted. Topical tacrolimus and ocular cyclosporin are permitted.
    9. Received any prohibited medication (see Section 7.3), immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to study vaccination (Day 0).
    10. Active cancer (malignancy) on chemotherapy within 3 years prior to study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator).
    11. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study.
    12. Any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the study vaccine or interpretation of study results (including neurologic or psychiatric conditions likely to impair the quality of safety reporting).
    13. Study team member or immediate family member of any study team member (inclusive of Sponsor, clinical research organization [CRO], and study site personnel involved in the
    conduct or planning of the study).
    14. Temperature of > 38°C/≥ 100.4°F (oral measurement) or respiratory symptoms in the past 3 days (ie, cough, sore throat, difficulty breathing) leading up to Day 0.
    15. SARS-CoV-2 infection or COVID-19 vaccination within 90 days prior to study vaccination.
    E.5 End points
    E.5.1Primary end point(s)
    Pseudovirus neutralization (inhibitory dilution at a concentration of 50% [ID50]) geometric mean fold rise (GMFR) for the Omicron LP.8.1 subvariant at Day 28 following study vaccination.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary immunogenicity endpoint will be analyzed using the Per-Protocol Analysis (PP Analysis Set) separately for each age cohort (12 through 64 years of age and ≥ 65 years of age) and will be analyzed from baseline to Day 28.
    E.5.2Secondary end point(s)
    • Pseudovirus neutralization (inhibitory dilution at a concentration of 50% [ID50]) geometric mean titers (GMTs) for the Omicron LP.8.1 subvariant at Day 28 following study vaccination.
    • Seroresponse rates (SRRs) in ID50 titers for the Omicron LP.8.1 subvariant assessed at Day 28 following study vaccination.
    • SRR is defined as percentage of participants with either:
    a. Baseline assay result ≥ lower limit of quantitation (LLOQ) who achieve ≥ 4-fold rise in antibody response from baseline, or
    b. Baseline assay result < LLOQ who achieve a post-baseline antibody response ≥ 4 × LLOQ.
    • Incidence, duration, and severity of solicited local and systemic AEs for 7 days following vaccination.
    • Incidence, severity, and relationship of any unsolicited AEs and medically attended adverse events (MAAEs) through 28 days after vaccination.
    • Incidence and severity of treatment-related MAAEs, adverse events of special interest (AESIs) (predefined list, including potential immune-mediated medical conditions [PIMMCs] and myocarditis and/or pericarditis), and serious adverse events (SAEs) through Day 180 (end of study [EoS]).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary immunogenicity endpoints will be analyzed descriptively using the PP Analysis and Safety Analysis Set, including the period when participants receive the dose of study vaccine and up to 28 days after study vaccination. SAEs are captured through completion of the End of Study (EoS) visit.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Day 180: End of study (EoS) visit for all participants. EoS procedures will be conducted via telephone.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 165
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 165
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 165
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 330
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Participant and parent(s)/caregiver(s) or legally acceptable representative willing and able to give informed consent and assent prior to study enrollment and to comply with study procedures.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 660
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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