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    Clinical Trial Results:
    Vaccine immunogenicity in Dutch frail versus non-frail older individuals (participating in the Doetinchem Cohort study)

    Summary
    EudraCT number
    		 2020-003620-16
    Trial protocol
    		 NL  
    Global end of trial date
    10 Feb 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Feb 2024
    First version publication date
    21 Feb 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IIV-465
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 ABR number : 74843.041.20, NTR-new: NL8812
    Sponsors
    Sponsor organisation name
    RIVM
    Sponsor organisation address
    PO box 1, Bilthoven, Netherlands, 3720BA
    Public contact
    VIVO studieteam, National Institute of Health and the Environment (RIVM), VIVO@rivm.nl
    Scientific contact
    VIVO studieteam, National Institute of Health and the Environment (RIVM), 0031 886897576, VIVO@rivm.nl
    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
    Interim
    Date of interim/final analysis
    05 Feb 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Feb 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Feb 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Assess the relation of frailty in 73-79 years old male and female persons with antibody responses to both vaccine pneumococcal polysaccharide serotypes and the Influenza virus vaccine strains by measuring HI titers pre and 4-6 weeks post vaccination.
    Protection of trial subjects
    QIV and PPV23 are licensed products and SARS-COV-2 vaccines have been granted a conditional marketing authorization. The products are routinely used in several countries in the same age groups and considered safe. It is therefore unlikely that serious side effects will occur that can lead to premature termination of the study. These vaccines are given by the participants’ own GP or the GGD as part of the routine immunization program for this age group, not as part of this study. Furthermore, the burden and risk of blood and saliva sampling is considered low. Blood collection could result in a small bruise at the location of injection, which will disappear within a few days. Collection of finger prick blood is regarded an adequate and safe alternative for full venous blood puncture. The applied lancet is easy to use, sterile and with a pricking needle which is designed to prevent exposure and re-use. Risk of infecting someone via the lancet is therefore very unlikely
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Sep 2020
    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
    Netherlands: 190
    Worldwide total number of subjects
    190
    EEA total number of subjects
    190
    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)
    0
    From 65 to 84 years
    190
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Persons of 73-79 years of age (year 1941-1947) participating in the DCS who have participated in round 6 of the DCS and having a GP in Doetinchem and Gaanderen (n=523) were invited for participation in the study. Recruitment was done by a personal letter inviting the subjects to participate. First inclusion: 12-09-2020, last inclusion: 04-11-2020

    Pre-assignment
    Screening details
    		 Inclusion and exclusion was checked by a researchnurse at the first visit: Inclusion -intention to get pneumococcal vaccination Exclusion -previous pneumococcal vaccination, allergy to the vaccine, receival of corticosteroids, receipt of organ- bon marrow transplant, anatomical or functional asplenia, coagulation disorder, HIV/HVC/HBV positive

    Period 1
    Period 1 title
    QIV and PPV23 immunization (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    No blinding

    Arms
    Arm title
    		 QIV and PPV23 immunization
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pneumovax 23
    Investigational medicinal product code
    Other name
    PPV23
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Each dose of 0,5 ml vaccine contains 25 microgram of each of the following 23 pneumococcalpolysacharide-serotypes: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F Each dose contains less than 1 mmol (23 mg) sodium. The primary dose of 0,5 ml is given to people above the age of 2 years old, booster vaccination is another dose of 0,5 ml. It is not recommended to apply booster vaccination within 3 years after primary vaccination.

    Investigational medicinal product name
    Vaxigrip tetra
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Influenzavirus (inactivated, split-up) of the following strains*: - A/Brisbane/02/2018 (H1N1)pdm09-like strain (A/Brisbane/02/2018, IVR-190) - 15 microgram HA** - A/Kansas/14/2017 (H3N2) - like strain (A/Kansas/14/2017, NYMC X-327) - 15 microgram HA** - B/Colorado/06/2017 - like strain (B/Maryland/15/2016, NYMC BX-69A) - 15 microgram HA** - B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, wild type) - 15 microgram HA** Per dose of 0,5 mL * cultured in fertalized chicken eggs of healthy chickens ** hemagglutinin

    Number of subjects in period 1
    		QIV and PPV23 immunization
    Started
    190
    Pre QIV and PPV23 immunization
    190
    4-6 weeks post QIV and PPV23 immunizatio
    189
    10-13 months post QIV and PPV23 immuniza
    184
    23-27 months post PPV23 immunization
    157
    Completed
    157
    Not completed
    33
         Deceased
    6
         Physician decision
    1
         Participant stopped
    14
         unknown
    1
         Lost to follow-up
    11

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    QIV and PPV23 immunization
    Reporting group description
    		 -

    Reporting group values
    		 QIV and PPV23 immunization Total
    Number of subjects
    		 190 190
    Age categorical
    Units: Subjects
        From 65-84 years
    		 190 190
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 75.3 (73 to 79) -
    Gender categorical
    Units: Subjects
        Female
    		 71 71
        Male
    		 119 119

    End points

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    End points reporting groups
    Reporting group title
    QIV and PPV23 immunization
    Reporting group description
    		 -

    Subject analysis set title
    pre QIV and PPV23 immunization
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Pneumococcal serotype-specific serum IgG, IgM and IgA antibody concentrations (GMCs) pre immunization, measured by bead-based multiplex immune assay. Influenza vaccine strain-specific serum antibody titers (GMTs) pre immunization, measured by hemagglutinin inhibition assay.

    Subject analysis set title
    4-6 weeks post QIV and PPV23 immunization
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Pneumococcal serotype-specific serum IgG, IgM and IgA antibody concentrations (GMCs) pre immunization, measured by bead-based multiplex immune assay. Influenza vaccine strain-specific serum antibody titers (GMTs) 4-6 weeks post immunization, measured by hemagglutinin inhibition assay.

    Subject analysis set title
    10-13 months post PPV23 immunization
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Pneumococcal serotype-specific serum IgG, IgM and IgA antibody concentrations (GMCs) 10-13 months post immunization, measured by bead-based multiplex immune assay.

    Subject analysis set title
    23-27 months post PPV23 immunization
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Pneumococcal serotype-specific serum IgG, IgM and IgA antibody concentrations (GMCs) 23-27 months post immunization, measured by bead-based multiplex immune assay.

    Primary: Anti pneumococcal serum IgG antibody levels

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    End point title
    		 Anti pneumococcal serum IgG antibody levels
    End point description
    Pneumococcal serotype-specific serum IgG antibody concentrations (GMCs), measured by bead-based multiplex immune assay.
    End point type
    Primary
    End point timeframe
    Pre PPV23 immunization 4-6 weeks post PPV23 immunization (21-49 days) 10-13 months post PPV23 immunization (300-410 days) 23-27 months post PPV23 immunization (690-835 days)
    End point values
    		 pre QIV and PPV23 immunization 4-6 weeks post QIV and PPV23 immunization 10-13 months post PPV23 immunization 23-27 months post PPV23 immunization
    Number of subjects analysed
    188 [1]
    186 [2]
    176 [3]
    151 [4]
    Units: µg/ml
    geometric mean (confidence interval 95%)
        Ps1
    0.19 (0.15 to 0.24)
    3.47 (2.56 to 4.71)
    1.89 (1.39 to 2.57)
    1.41 (1.01 to 1.97)
        Ps10A
    0.3 (0.23 to 0.39)
    3.72 (2.67 to 5.18)
    1.97 (1.42 to 2.75)
    1.91 (1.33 to 2.74)
        Ps11A
    0.3 (0.24 to 0.39)
    1.76 (1.36 to 2.27)
    1.13 (0.87 to 1.48)
    0.95 (0.71 to 1.26)
        Ps12F
    0.03 (0.03 to 0.04)
    0.39 (0.28 to 0.55)
    0.24 (0.17 to 0.35)
    0.24 (0.17 to 0.33)
        Ps14
    0.49 (0.36 to 0.65)
    3.55 (2.48 to 5.06)
    2.53 (1.78 to 3.60)
    2.32 (1.58 to 3.42)
        Ps15B
    0.58 (0.43 to 0.77)
    6.83 (5.04 to 9.25)
    4.33 (3.19 to 5.87)
    4.04 (2.92 to 5.60)
        Ps17F
    0.17 (0.13 to 0.23)
    2.65 (1.94 to 3.61)
    1.54 (1.13 to 2.10)
    1.33 (0.95 to 1.87)
        Ps18C
    0.56 (0.44 to 0.72)
    5.65 (4.23 to 7.53)
    3.36 (2.51 to 4.51)
    3.18 (2.29 to 4.41)
        Ps19A
    0.70 (0.55 to 0.89)
    4.51 (3.36 to 6.05)
    3.08 (2.33 to 4.05)
    2.49 (1.81 to 3.42)
        Ps19F
    0.50 (0.40 to 0.62)
    3.61 (2.75 to 4.75)
    2.16 (1.66 to 2.80)
    1.85 (1.40 to 2.44)
        Ps2
    0.47 (0.37 to 0.60)
    6.65 (5.28 to 8.37)
    4.37 (3.47 to 5.51)
    2.80 (2.15 to 3.65)
        Ps20
    0.63 (0.52 to 0.77)
    4.50 (3.57 to 5.69)
    2.98 (2.37 to 3.75)
    2.33 (1.77 to 3.06)
        Ps22F
    0.10 (0.07 to 0.13)
    1.31 (0.99 to 1.74)
    0.71 (0.53 to 0.96)
    0.58 (0.42 to 0.79)
        Ps23F
    0.24 (0.19 to 0.31)
    1.65 (1.23 to 2.20)
    0.96 (0.71 to 1.29)
    0.82 (0.59 to 1.13)
        Ps3
    0.21 (0.17 to 0.25)
    1.36 (1.09 to 1.71)
    0.67 (0.54 to 0.84)
    0.50 (0.39 to 0.64)
        Ps33F
    0.76 (0.59 to 0.97)
    8.31 (6.30 to 10.94)
    5.41 (4.10 to 7.14)
    3.50 (2.52 to 4.87)
        Ps4
    0.05 (0.04 to 0.06)
    0.42 (0.32 to 0.55)
    0.25 (0.20 to 0.33)
    0.20 (0.15 to 0.26)
        Ps5
    0.62 (0.51 to 0.76)
    7.33 (5.64 to 9.54)
    4.11 (3.16 to 5.34)
    3.24 (2.45 to 4.31)
        Ps6B
    0.18 (0.14 to 0.24)
    1.70 (1.21 to 2.40)
    1.04 (0.74 to 1.44)
    0.80 (0.55 to 1.15)
        Ps7F
    0.40 (0.31 to 0.51)
    6.06 (4.49 to 8.16)
    3.33 (2.48 to 4.47)
    2.25 (1.62 to 3.14)
        Ps8
    0.22 (0.18 to 0.28)
    3.21 (2.57 to 4.00)
    1.89 (1.53 to 2.34)
    1.44 (1.13 to 1.83)
        Ps9N
    0.18 (0.14 to 0.24)
    3.17 (2.37 to 4.23)
    1.95 (1.45 to 2.62)
    1.52 (1.11 to 2.07)
        Ps9V
    0.23 (0.18 to 0.28)
    2.70 (2.07 to 3.52)
    1.67 (1.29 to 2.15)
    1.26 (0.94 to 1.68)
    Notes
    [1] - 1 subject had too low amount of serum 1 subject was not included because its only timepoint was T0
    [2] - 2 subjects had their sample out of window 1 subject was not included in analysis for other reason
    [3] - 4 missing samples 3 samples out of window 1 sample not included for other reason
    [4] - 2 missing samples 2 not enough serum in the sample 2 samples out of window
    Statistical analysis title
    		 Pneumococcal IgG
    Comparison groups
    4-6 weeks post QIV and PPV23 immunization v 10-13 months post PPV23 immunization v pre QIV and PPV23 immunization v 23-27 months post PPV23 immunization
    Number of subjects included in analysis
    701
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Kruskal-wallis
    Confidence interval

    Primary: Anti pneumococcal serum IgA antibody levels

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    End point title
    		 Anti pneumococcal serum IgA antibody levels
    End point description
    Pneumococcal serotype-specific serum IgA antibody concentrations (GMCs), measured by bead-based multiplex immune assay.
    End point type
    Primary
    End point timeframe
    Pre PPV23 immunization 4-6 weeks post PPV23 immunization (21-49 days) 10-13 months post PPV23 immunization (300-410 days)
    End point values
    		 pre QIV and PPV23 immunization 4-6 weeks post QIV and PPV23 immunization 10-13 months post PPV23 immunization
    Number of subjects analysed
    188 [5]
    186 [6]
    176 [7]
    Units: µg/ml
    geometric mean (confidence interval 95%)
        Ps1
    0.02 (0.02 to 0.03)
    0.47 (0.37 to 0.59)
    0.24 (0.19 to 0.30)
        Ps10A
    0.02 (0.02 to 0.02)
    0.20 (0.16 to 0.25)
    0.10 (0.08 to 0.13)
        Ps11A
    0.06 (0.05 to 0.07)
    0.31 (0.26 to 0.38)
    0.17 (0.14 to 0.21)
        Ps12F
    0.01 (0.00 to 0.01)
    0.17 (0.13 to 0.21)
    0.08 (0.06 to 0.11)
        Ps14
    0.06 (0.05 to 0.07)
    0.24 (0.19 to 0.30)
    0.15 (0.12 to 0.19)
        Ps15B
    0.02 (0.01 to 0.02)
    0.19 (0.16 to 0.24)
    0.11 (0.09 to 0.13)
        Ps17F
    0.01 (0.01 to 0.01)
    0.15 (0.12 to 0.19)
    0.08 (0.06 to 0.09)
        Ps18C
    0.02 (0.02 to 0.03)
    0.15 (0.12 to 0.19)
    0.08 (0.07 to 0.10)
        Ps19A
    0.04 (0.04 to 0.05)
    0.23 (0.17 to 0.30)
    0.14 (0.11 to 0.18)
        Ps19F
    0.06 (0.05 to 0.06)
    0.29 (0.24 to 0.35)
    0.18 (0.15 to 0.21)
        Ps2
    0.01 (0.01 to 0.01)
    0.21 (0.17 to 0.26)
    0.09 (0.07 to 0.11)
        Ps20
    0.02 (0.02 to 0.02)
    0.23 (0.19 to 0.28)
    0.12 (0.10 to 0.15)
        Ps22F
    0.01 (0.01 to 0.02)
    0.18 (0.15 to 0.23)
    0.08 (0.07 to 0.11)
        Ps23F
    0.02 (0.02 to 0.03)
    0.10 (0.08 to 0.12)
    0.06 (0.05 to 0.07)
        Ps3
    0.12 (0.10 to 0.14)
    0.77 (0.64 to 0.92)
    0.35 (0.29 to 0.42)
        Ps33F
    0.02 (0.02 to 0.02)
    0.24 (0.20 to 0.30)
    0.13 (0.10 to 0.15)
        Ps4
    0.02 (0.02 to 0.03)
    0.26 (0.22 to 0.32)
    0.13 (0.11 to 0.16)
        Ps5
    0.03 (0.02 to 0.03)
    0.31 (0.26 to 0.38)
    0.17 (0.14 to 0.20)
        Ps6B
    0.03 (0.03 to 0.04)
    0.21 (0.16 to 0.26)
    0.12 (0.10 to 0.16)
        Ps7F
    0.02 (0.02 to 0.02)
    0.20 (0.16 to 0.24)
    0.10 (0.08 to 0.12)
        Ps8
    0.02 (0.01 to 0.02)
    0.23 (0.19 to 0.27)
    0.11 (0.09 to 0.13)
        Ps9N
    0.01 (0.01 to 0.02)
    0.21 (0.17 to 0.26)
    0.10 (0.08 to 0.13)
        Ps9V
    0.04 (0.03 to 0.04)
    0.36 (0.30 to 0.44)
    0.20 (0.16 to 0.25)
    Notes
    [5] - 1 subject had a to low amount of serum 1 subject was not included because T0 was its only timepoint
    [6] - 2 sample were out of window 1 sample not included for other reason
    [7] - 4 missing samples 3 samples were out window 1 sample not included for other reason
    Statistical analysis title
    		 Pneumococcal IgA
    Comparison groups
    pre QIV and PPV23 immunization v 4-6 weeks post QIV and PPV23 immunization v 10-13 months post PPV23 immunization
    Number of subjects included in analysis
    550
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Kruskal-wallis
    Confidence interval

    Primary: Anti pneumococcal serum IgM antibody levels

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    End point title
    		 Anti pneumococcal serum IgM antibody levels
    End point description
    Pneumococcal serotype-specific serum IgM antibody concentrations (GMCs), measured by bead-based multiplex immune assay.
    End point type
    Primary
    End point timeframe
    Pre PPV23 immunization 4-6 weeks post PPV23 immunization (21-49 days) 10-13 months post PPV23 immunization (300-410 days) 23-27 months post PPV23 immunization (690-835 days)
    End point values
    		 pre QIV and PPV23 immunization 4-6 weeks post QIV and PPV23 immunization 10-13 months post PPV23 immunization 23-27 months post PPV23 immunization
    Number of subjects analysed
    187 [8]
    183 [9]
    174 [10]
    145 [11]
    Units: µg/ml
    geometric mean (confidence interval 95%)
        Ps1
    0.14 (0.12 to 0.16)
    0.72 (0.58 to 0.88)
    0.31 (0.25 to 0.38)
    0.27 (0.21 to 0.33)
        Ps10A
    0.21 (0.17 to 0.24)
    0.60 (0.47 to 0.75)
    0.31 (0.25 to 0.39)
    0.29 (0.22 to 0.37)
        Ps11A
    0.17 (0.15 to 0.20)
    0.43 (0.36 to 0.50)
    0.24 (0.20 to 0.28)
    0.25 (0.20 to 0.29)
        Ps12F
    0.09 (0.08 to 0.11)
    0.74 (0.57 to 0.96)
    0.31 (0.24 to 0.40)
    0.29 (0.23 to 0.37)
        Ps14
    0.40 (0.35 to 0.46)
    0.56 (0.48 to 0.65)
    0.43 (0.37 to 0.51)
    0.51 (0.43 to 0.62)
        Ps15B
    0.07 (0.06 to 0.09)
    0.36 (0.29 to 0.45)
    0.17 (0.14 to 0.21)
    0.15 (0.12 to 0.19)
        Ps17F
    0.11 (0.09 to 0.12)
    0.34 (0.28 to 0.42)
    0.18 (0.15 to 0.21)
    0.17 (0.14 to 0.20)
        Ps18C
    0.16 (0.14 to 0.18)
    0.31 (0.26 to 0.36)
    0.29 (0.24 to 0.35)
    0.21 (0.17 to 0.26)
        Ps19A
    0.62 (0.56 to 0.70)
    0.95 (0.82 to 1.11)
    1.05 (0.90 to 1.22)
    0.74 (0.64 to 0.85)
        Ps19F
    0.60 (0.52 to 0.70)
    1.39 (1.16 to 1.66)
    0.77 (0.64 to 0.92)
    0.85 (0.72 to 1.02)
        Ps2
    0.83 (0.74 to 0.93)
    1.86 (1.62 to 2.14)
    0.93 (0.81 to 1.06)
    1.07 (0.92 to 1.25)
        Ps20
    0.28 (0.24 to 0.33)
    0.92 (0.76 to 1.12)
    0.45 (0.37 to 0.55)
    0.43 (0.35 to 0.53)
        Ps22F
    0.18 (0.16 to 0.21)
    0.92 (0.75 to 1.12)
    0.44 (0.36 to 0.52)
    0.39 (0.32 to 0.47)
        Ps23F
    0.09 (0.08 to 0.10)
    0.15 (0.13 to 0.17)
    0.09 (0.08 to 0.11)
    0.10 (0.09 to 0.12)
        Ps3
    0.25 (0.23 to 0.29)
    0.66 (0.57 to 0.76)
    0.26 (0.22 to 0.30)
    0.27 (0.23 to 0.32)
        Ps33F
    0.42 (0.36 to 0.49)
    2.38 (1.88 to 3.01)
    0.96 (0.79 to 1.18)
    1.01 (0.81 to 1.26)
        Ps4
    0.13 (0.11 to 0.14)
    0.27 (0.23 to 0.32)
    0.14 (0.12 to 0.17)
    0.15 (0.12 to 0.17)
        Ps5
    0.77 (0.69 to 0.86)
    1.49 (1.28 to 1.74)
    0.97 (0.84 to 1.12)
    1.07 (0.93 to 1.23)
        Ps6B
    0.21 (0.19 to 0.25)
    0.44 (0.37 to 0.53)
    0.30 (0.25 to 0.36)
    0.31 (0.26 to 0.37)
        Ps7F
    0.26 (0.22 to 0.30)
    0.79 (0.65 to 0.96)
    0.41 (0.34 to 0.49)
    0.43 (0.35 to 0.52)
        Ps8
    0.20 (0.17 to 0.23)
    1.09 (0.91 to 1.30)
    0.43 (0.36 to 0.52)
    0.42 (0.35 to 0.50)
        Ps9N
    0.17 (0.14 to 0.19)
    0.67 (0.55 to 0.82)
    0.34 (0.28 to 0.41)
    0.33 (0.27 to 0.39)
        Ps9V
    0.23 (0.20 to 0.26)
    0.73 (0.60 to 0.88)
    0.45 (0.38 to 0.54)
    0.47 (0.40 to 0.55)
    Notes
    [8] - 2 subjects with to low amount of serum 1 subject not included because its only sample was T0
    [9] - 2 sample out of window 3 samples not enough serum 1 sample not included for other reason
    [10] - 4 missing samples 3 samples out of window 2 samples no serum 1 sample not included other reason
    [11] - 2 missing samples 2 samples out of window 8 samples with not enough serum
    Statistical analysis title
    		 Pneumococcal IgM
    Comparison groups
    pre QIV and PPV23 immunization v 4-6 weeks post QIV and PPV23 immunization v 10-13 months post PPV23 immunization v 23-27 months post PPV23 immunization
    Number of subjects included in analysis
    689
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.05
    Method
    		 Kruskal-wallis
    Confidence interval

    Secondary: Number of immune cell subsets

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    End point title
    		 Number of immune cell subsets
    End point description
    Absolute numbers of immune cell subsets i.e. B- and T-lymphocytes, granulocytes and monocytes, in whole blood.
    End point type
    Secondary
    End point timeframe
    Pre QIV and PPV23 immunization 4-6 weeks post QIV and PPV23 immunization (21-49 days) 10-13 months post QIV and PPV23 immunization (300-410 days) 23-27 months post PPV23 immunization (690-835 days)
    End point values
    		 pre QIV and PPV23 immunization
    Number of subjects analysed
    183 [12]
    Units: Number of cells/µl whole blood
    geometric mean (confidence interval 95%)
        B cells
    149 (138 to 161)
        T cells
    1172 (1113 to 1235)
        Monocytes
    442 (423 to 462)
    Notes
    [12] - 1 subject not enough blood 1 subject not included other reason 5 subjects excluded too much B cell
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Any adverse event spontaneously reported by the subject related to and occurring within one week after swab collection or blood sampling
    Adverse event reporting additional description
    There were no SAEs and SUSARs. Elective hospital admissions were excluded from SAE reporting.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26
    Reporting groups
    Reporting group title
    QIV and PPV23 immunization
    Reporting group description
    		 -

    Serious adverse events
    		 QIV and PPV23 immunization
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 190 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 QIV and PPV23 immunization
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 190 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The only adverse events required to report were adverse events related to and occurring within one week after swab collection or blood sampling spontaneously reported by the subject. Swab collection and blood sampling are very non-invasive actions. Therefore it is not remarkable that no adverse events occurred or were reported.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Mar 2021
    Addition of the evaluation of immune response after SARS-COV-2 vaccination.
    25 May 2021
    The study is changed to clinical drug trial
    19 Aug 2021
    To broaden the window of time point from 10-11 months to 10-13 months post QIV and PPV23 immunization
    29 Oct 2021
    Addition of the evaluation of immune response after SARS-COV-2 booster vaccination
    09 Mar 2022
    Addition of the evaluation of immune response after additional SARS-COV-2 booster vaccinations
    25 Oct 2022
    Redefinition of the end of the trial and the windows of the final timepoint
    10 Feb 2023
    Addition of new participant documents and changes made in old documents (actual date of amendment was 23-05-2023, but EudraCT does not allow an amendment date after study completion, therefore the date of study completion is used)

    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.
    The secondary endpoint 'Inflammatory profiles by measuring frailty markers, such as CRP creatinine and cystatin C in plasma' has not yet been measured, but will be in the future.
    For support, Contact us.
    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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