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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    		 2022-004118-12
    Trial protocol
    		 AT  
    Global end of trial date
    03 Jun 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Apr 2026
    First version publication date
    11 Apr 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NVX_PCV20
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria, 1090
    Public contact
    Department of Clinical Pharmacology, Medical University of Vienna, +43 14040029810, klin-pharmakologie@meduniwien.ac.at
    Scientific contact
    Department of Clinical Pharmacology, Medical University of Vienna, +43 14040029810, klin-pharmakologie@meduniwien.ac.at
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Oct 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Jun 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jun 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate whether the combined administration of NVX XBB.1.5 with a PCV20 is non-inferior to the administration of the NVX vaccine alone in terms of immunogenicity, as determined by anti-RBD antibody levels at day 28.
    Protection of trial subjects
    All subjects were under continous supervison of a physician or an experienced study nurse.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 2024
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 256
    Worldwide total number of subjects
    256
    EEA total number of subjects
    256
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    126
    From 65 to 84 years
    130
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study pobulation included female and male subjects aged 60 years or older without clinically relevant comorbidities and concomitant medication that might interfere with the immunogenicity or their eligibility for vaccination.

    Pre-assignment
    Screening details
    		 • Males and females • Able and willing (in the investigator's opinion) to comply with all study requirements. • Participants, who already received at least two Covid-19 vaccines, of which the last was an mRNA vaccine (BNT162b2 or mRNA-1273) and at least 12 weeks ago • Only applicable for women: last menstrual bleeding more than one year ago

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    In this double-blind trial, all participants will receive two injections on Day 1 (one in each shoulder). All participants and physicians, who are responsible for IMP administration and outcomeassessment, will be blinded. A separate, unblinded team will independently prepare the syringesfor injection. Each syringe will be labeled with the following information: unique participant identifier, unique IMP identifier, and side (left or right).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 NVX arm
    Arm description
    		 NVX XBB 1.5 plus placebo
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nuvaxovid XBB.1.5
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    administered as single dose, given as intramuscular injections on Day 1

    Arm title
    		 PCV20arm
    Arm description
    		 PCV20 (Apexxnar®) plus placebo group
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Apexxnar
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    single dose administration on Day one (in shoulder)

    Arm title
    		 Combination arm
    Arm description
    		 NVX XBB.1.5 plus PCV20
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Nuvaxovid XBB.1.5
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    administered as single dose, given as intramuscular injections on Day 1

    Investigational medicinal product name
    Apexxnar
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    single dose administration on Day one (in shoulder)

    Arm title
    		 Placebo
    Arm description
    		 Placebo (normal saline) plus placebo group
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    saline solution, single dose on Day 1

    Number of subjects in period 1
    		NVX arm PCV20arm Combination arm Placebo
    Started
    65
    64
    64
    63
    Completed
    65
    64
    64
    63

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    NVX arm
    Reporting group description
    		 NVX XBB 1.5 plus placebo

    Reporting group title
    PCV20arm
    Reporting group description
    		 PCV20 (Apexxnar®) plus placebo group

    Reporting group title
    Combination arm
    Reporting group description
    		 NVX XBB.1.5 plus PCV20

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (normal saline) plus placebo group

    Reporting group values
    		 NVX arm PCV20arm Combination arm Placebo Total
    Number of subjects
    		 65 64 64 63 256
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 32 31 31 31 125
        From 65-84 years
    		 33 33 33 32 131
        85 years and over
    		 0 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 34 36 45 36 151
        Male
    		 31 28 19 27 105

    End points

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    End points reporting groups
    Reporting group title
    NVX arm
    Reporting group description
    		 NVX XBB 1.5 plus placebo

    Reporting group title
    PCV20arm
    Reporting group description
    		 PCV20 (Apexxnar®) plus placebo group

    Reporting group title
    Combination arm
    Reporting group description
    		 NVX XBB.1.5 plus PCV20

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (normal saline) plus placebo group

    Primary: Omicron-specific anti-spike IgG ELISA units

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    End point title
    		 Omicron-specific anti-spike IgG ELISA units
    End point description
    Anti-receptor-binding domain (RBD) antibody levels at Day 28 (BAU/mL)
    End point type
    Primary
    End point timeframe
    28 Days
    End point values
    		 NVX arm PCV20arm Combination arm Placebo
    Number of subjects analysed
    65
    64
    64
    63
    Units: BAU/ml
        geometric mean (confidence interval 95%)
    556 (460 to 672)
    309 (242 to 395)
    534 (432 to 660)
    347 (269 to 449)
    Statistical analysis title
    		 Statistical analysis
    Statistical analysis description
    Non-inferiority comparison between 28-day titer values between the combination arm vs the NVX-only arm. Non-inferiority margin: 0.67 for the lower limit of the 95% confidence interval of the geoemtric mean titer ratio.
    Comparison groups
    NVX arm v PCV20arm v Combination arm v Placebo
    Number of subjects included in analysis
    256
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05 [1]
    Method
    		 t-test, 2-sided
    Confidence interval
    Notes
    [1] - Primary analysis is based on 95% confidence interval for the non-inferiority analysis.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 0 (Day of vaccination) until day 28 (EoS)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    NVX-CoV2601 plus PCV20
    Reporting group description
    		 -

    Reporting group title
    NVX-CoV2601 plus Placebo
    Reporting group description
    		 -

    Reporting group title
    PCV20 plus Placebo
    Reporting group description
    		 -

    Reporting group title
    Placebo plus Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 NVX-CoV2601 plus PCV20 NVX-CoV2601 plus Placebo PCV20 plus Placebo Placebo plus Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 65 (0.00%)
    0 / 64 (0.00%)
    0 / 63 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 NVX-CoV2601 plus PCV20 NVX-CoV2601 plus Placebo PCV20 plus Placebo Placebo plus Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    54 / 64 (84.38%)
    41 / 65 (63.08%)
    54 / 64 (84.38%)
    29 / 63 (46.03%)
    Immune system disorders
    Systemic immune activation
    Additional description: chills, fever, nausea, vomitting, diarrhea, arthralgia, fatigue, headache
         subjects affected / exposed
    54 / 64 (84.38%)
    33 / 65 (50.77%)
    26 / 64 (40.63%)
    29 / 63 (46.03%)
         occurrences all number
    54
    33
    26
    29
    Skin and subcutaneous tissue disorders
    Any local solicited adverse event
    Additional description: Itch, pain, redness, swelling, tenderness, warmth
         subjects affected / exposed
    54 / 64 (84.38%)
    41 / 65 (63.08%)
    54 / 64 (84.38%)
    11 / 63 (17.46%)
         occurrences all number
    54
    41
    54
    11

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/39756693
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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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