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    Clinical Trial Results:
    Population-based prospective, clinical study on efficacy and safety of a booster COVID-19 vaccination

    Summary
    EudraCT number
    		 2021-005094-28
    Trial protocol
    		 AT  
    Global end of trial date
    11 Jul 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Apr 2023
    First version publication date
    06 Apr 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    VAC3_COVID-19_antibody_study_V1
    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
    Clinical Trials Office, Medical University of Vienna, 0043 014040067300, daniela.sieghart@meduniwien.ac.at
    Scientific contact
    Clinical Trials Office, Medical University of Vienna, 0043 014040043010, daniela.sieghart@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
    Interim
    Date of interim/final analysis
    01 Dec 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Jul 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jul 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evidence of efficacy and safety of a third vaccination in real-live setting is still missing. The aim of this study is to provide scientific support to the vaccination campaign of the City of Vienna by performing a population-based study to generate evidence on efficacy and safety of a third vaccination against SARS-CoV-2 in a real world setting. The expected magnitude and broad range of this epidemiological study would enable us to take into account various factors associated with immune response as well as safety.
    Protection of trial subjects
    Healthy participants were recruited after receiving the Covid-19 booster vaccination. The study was limited to questionaires and blood draws (3 times) at different time points. Blood draw was reduced to the minimal amount needed for analysis (max. 8ml) per visit. Blood was drawn by qualified nurses and doctors in a comfortable environment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Oct 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 4955
    Worldwide total number of subjects
    4955
    EEA total number of subjects
    4955
    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)
    4507
    From 65 to 84 years
    443
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment start was on the 28th of October 2021 and recruitment end was on the 21st of January 2022. 4954 peolpe were recruited for trial participation at Austria's largest vaccination site, the Austria Center Vienna (n=4117) and at the AKH Vienna/the Medical University of Vienna (n=837).

    Pre-assignment
    Screening details
    		 In total, 4997 people were screened for potential participation in the clincial trial. The most frequent cause for screening failure was the violoation of protocol regarding standard vaccination (vaccines used, time between vaccinations, ...).

    Period 1
    Period 1 title
    Baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    no blinding

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BioNTech/Pfizer BI
    Arm description
    		 Participants received BioNTech/Pfizer as their basic immunisation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Comirnaty consentrate for dispersion for injection
    Investigational medicinal product code
    BNT162B2
    Other name
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 µg dispersion for intramuscular use

    Arm title
    		 Moderna BI
    Arm description
    		 Participants received Moderna as their basic immunisation
    Arm type
    		 Experimental

    Investigational medicinal product name
    Covid-19 vaccine Moderna dispersion for injection
    Investigational medicinal product code
    CX-024414
    Other name
    mRNA-1273
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    50 µg (half dose) for booster vaccination; intramuscular use

    Arm title
    		 Influenza combined
    Arm description
    		 247 participants were vaccinated with influenza and SARS-CoV-2 in combination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Comirnaty concentrate for dispersion for injection
    Investigational medicinal product code
    BNT162B2
    Other name
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 µg, intramuscular use

    Investigational medicinal product name
    Influvac Tetra
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    60 µg in total (15 µg each strain) for intramuscular use

    Arm title
    		 Influenza only
    Arm description
    		 Participants received only an Influenza vaccination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Influvac Tetra
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    60 µg in total (15 µg each strain) for intramuscular use

    Arm title
    		 AstraZeneca and mRNA BI
    Arm description
    		 Subjects who received AstraZeneca Vaxzevria as their first vaccine, but mRNA (Moderna or BioNTech/Pfizer) as their second vaccine.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vaxzevria
    Investigational medicinal product code
    ChAdOx1-S
    Other name
    Covid-19 Vaccine AstraZeneca
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0,5 mL dispersion for intramuscular use.

    Investigational medicinal product name
    Comirnaty consentrate for dispersion for injection
    Investigational medicinal product code
    BNT162B2
    Other name
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 µg dispersion for intramuscular use

    Investigational medicinal product name
    Covid-19 vaccine Moderna dispersion for injection
    Investigational medicinal product code
    CX-024414
    Other name
    mRNA-1273
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    50 µg (half dose) for booster vaccination; intramuscular use

    Arm title
    		 AstraZeneca Vaxzevria BI
    Arm description
    		 Subjects received two doses of Vaxzevria as their basic immunisation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vaxzevria
    Investigational medicinal product code
    ChAdOx1-S
    Other name
    Covid-19 Vaccine AstraZeneca
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0,5 mL dispersion for intramuscular use.

    Arm title
    		 COVID-19 Vaccine Janssen BI
    Arm description
    		 Subjects received COVID-19 Vaccine Janssen for their basic immunisation
    Arm type
    		 Experimental

    Investigational medicinal product name
    COVID-19 Vaccine Janssen suspension for injection
    Investigational medicinal product code
    Ad26.COV2-S.02
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0,5 mL dispersion for intramuscular use.

    Arm title
    		 other
    Arm description
    		 Subjects who received only one vaccine as their base immunization but were infected befor were also included in this study. Also some subjects received BioNTech and Moderna as their base immunization. On some subject data concerning the first two vaccination is missing.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Comirnaty consentrate for dispersion for injection
    Investigational medicinal product code
    BNT162B2
    Other name
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 µg dispersion for intramuscular use

    Investigational medicinal product name
    Covid-19 vaccine Moderna dispersion for injection
    Investigational medicinal product code
    CX-024414
    Other name
    mRNA-1273
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    50 µg (half dose) for booster vaccination; intramuscular use

    Investigational medicinal product name
    Vaxzevria
    Investigational medicinal product code
    ChAdOx1-S
    Other name
    Covid-19 Vaccine AstraZeneca
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0,5 mL dispersion for intramuscular use.

    Number of subjects in period 1
    		BioNTech/Pfizer BI Moderna BI Influenza combined Influenza only AstraZeneca and mRNA BI AstraZeneca Vaxzevria BI COVID-19 Vaccine Janssen BI other
    Started
    2779
    385
    247
    33
    85
    1246
    94
    86
    Completed
    2779
    385
    247
    33
    85
    1246
    94
    86
    Period 2
    Period 2 title
    4 weeks
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BioNTech/Pfizer Booster
    Arm description
    		 Participants received a booster vaccination with BioNTech/Pfizer
    Arm type
    		 Experimental

    Investigational medicinal product name
    Comirnaty consentrate for dispersion for injection
    Investigational medicinal product code
    BNT162B2
    Other name
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 µg dispersion for intramuscular use

    Arm title
    		 Moderna Booster
    Arm description
    		 Participants received a booster vaccination with Moderna
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Covid-19 vaccine Moderna dispersion for injection
    Investigational medicinal product code
    CX-024414
    Other name
    mRNA-1273
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    50 µg (half dose) for booster vaccination; intramuscular use

    Arm title
    		 Influenza combined
    Arm description
    		 247 participants were vaccinated with influenza and SARS-CoV-2 in combination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Comirnaty concentrate for dispersion for injection
    Investigational medicinal product code
    BNT162B2
    Other name
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 µg, intramuscular use

    Investigational medicinal product name
    Influvac Tetra
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    60 µg in total (15 µg each strain) for intramuscular use

    Arm title
    		 Influenza only
    Arm description
    		 Participants received only an Influenza vaccination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Influvac Tetra
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    60 µg in total (15 µg each strain) for intramuscular use

    Arm title
    		 other Booster
    Arm description
    		 Subjects boosted with other vaccine e. g. Astra Zeneca or Johnson&Johnson
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vaxzevria
    Investigational medicinal product code
    ChAdOx1-S
    Other name
    Covid-19 Vaccine AstraZeneca
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0,5 mL dispersion for intramuscular use.

    Investigational medicinal product name
    COVID-19 Vaccine Janssen suspension for injection
    Investigational medicinal product code
    Ad26.COV2-S.02
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0,5 mL dispersion for intramuscular use.

    Number of subjects in period 2 [1]
    		BioNTech/Pfizer Booster Moderna Booster Influenza combined Influenza only other Booster
    Started
    3940
    598
    229
    31
    10
    Completed
    3940
    598
    229
    31
    10
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Probands were lost to follow up in between Periods.
    Period 3
    Period 3 title
    month 6
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BioNTech/Pfizer Booster
    Arm description
    		 Participants received a booster vaccination with BioNTech/Pfizer
    Arm type
    		 Experimental

    Investigational medicinal product name
    Comirnaty consentrate for dispersion for injection
    Investigational medicinal product code
    BNT162B2
    Other name
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 µg dispersion for intramuscular use

    Arm title
    		 Moderna Booster
    Arm description
    		 Participants received a booster vaccination with Moderna
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Covid-19 vaccine Moderna dispersion for injection
    Investigational medicinal product code
    CX-024414
    Other name
    mRNA-1273
    Pharmaceutical forms
    Dispersion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    50 µg (half dose) for booster vaccination; intramuscular use

    Arm title
    		 other Booster
    Arm description
    		 Subjects boosted with other vaccine e. g. Astra Zeneca or Johnson&Johnson
    Arm type
    		 Experimental

    Investigational medicinal product name
    COVID-19 Vaccine Janssen suspension for injection
    Investigational medicinal product code
    Ad26.COV2-S.02
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0,5 mL dispersion for intramuscular use.

    Investigational medicinal product name
    Vaxzevria
    Investigational medicinal product code
    ChAdOx1-S
    Other name
    Covid-19 Vaccine AstraZeneca
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0,5 mL dispersion for intramuscular use.

    Number of subjects in period 3 [2] [3]
    		BioNTech/Pfizer Booster Moderna Booster other Booster
    Started
    3155
    525
    10
    Completed
    3348
    525
    10
    Joined
    193
    0
    0
         Transferred in from other group/arm
    193
    -
    -
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Probands were lost to follow up in between Periods.
    [3] - The number of subjects transferring in and out of the arms in the period are not the same. It is expected the net number of transfers in and out of the arms in a period, will be zero.
    Justification: Probands from the influenza combined arm (which ended in period 2) were transferred to the BnT arm for further analysis.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BioNTech/Pfizer BI
    Reporting group description
    		 Participants received BioNTech/Pfizer as their basic immunisation.

    Reporting group title
    Moderna BI
    Reporting group description
    		 Participants received Moderna as their basic immunisation

    Reporting group title
    Influenza combined
    Reporting group description
    		 247 participants were vaccinated with influenza and SARS-CoV-2 in combination.

    Reporting group title
    Influenza only
    Reporting group description
    		 Participants received only an Influenza vaccination.

    Reporting group title
    AstraZeneca and mRNA BI
    Reporting group description
    		 Subjects who received AstraZeneca Vaxzevria as their first vaccine, but mRNA (Moderna or BioNTech/Pfizer) as their second vaccine.

    Reporting group title
    AstraZeneca Vaxzevria BI
    Reporting group description
    		 Subjects received two doses of Vaxzevria as their basic immunisation.

    Reporting group title
    COVID-19 Vaccine Janssen BI
    Reporting group description
    		 Subjects received COVID-19 Vaccine Janssen for their basic immunisation

    Reporting group title
    other
    Reporting group description
    		 Subjects who received only one vaccine as their base immunization but were infected befor were also included in this study. Also some subjects received BioNTech and Moderna as their base immunization. On some subject data concerning the first two vaccination is missing.

    Reporting group values
    		 BioNTech/Pfizer BI Moderna BI Influenza combined Influenza only AstraZeneca and mRNA BI AstraZeneca Vaxzevria BI COVID-19 Vaccine Janssen BI other Total
    Number of subjects
    		 2779 385 247 33 85 1246 94 86 4955
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 2521 332 246 32 81 1126 93 76 4507
        From 65-84 years
    		 255 52 1 1 4 120 1 9 443
        85 years and over
    		 3 1 0 0 0 0 0 1 5
    Gender categorical
    Units: Subjects
        Female
    		 1605 228 141 19 31 737 44 53 2858
        Male
    		 1174 156 106 14 54 509 50 33 2096
        unknown
    		 0 1 0 0 0 0 0 0 1
    Subject analysis sets

    Subject analysis set title
    Infected
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants with recorded Covid-19 breakthrough infection between week 4 and month 6.

    Subject analysis set title
    Non-infected
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Control group; participants without a recorded breakthrough infection between week 4 and month 6 (and negative for nucleocapsid antibodies; markers for infection).

    Subject analysis set title
    Homologous vaccination
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Patients who received a homologous vaccination schema (3x BNT162B2 or 3x mRNA-1273)

    Subject analysis set title
    Heterologous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants receiving a heterologous vaccination schema (2x vector vaccination and 1x mRNA).

    Subject analysis set title
    Influenza only
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received only Influenza vaccine. Screening took place at baseline and week 4.

    Subject analysis set title
    Influenza combined
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Probands receiving Covid 19 booster at the same time as the influenza vaccine.

    Subject analysis sets values
    		 Infected Non-infected Homologous vaccination Heterologous Influenza only Influenza combined
    Number of subjects
    1372
    2386
    2437
    1213
    33
    247
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
    0
    0
        Adults (18-64 years)
    1270
    2102
    2171
    1101
    32
    246
        From 65-84 years
    102
    280
    263
    112
    1
    1
        85 years and over
    0
    4
    3
    0
    0
    0
    Age continuous
    Units: years
        
    ±
    ±
    ±
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    805
    1445
    1463
    727
    19
    141
        Male
    567
    941
    974
    486
    14
    106
        unknown
    0
    0
    0
    0
    0
    0

    End points

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    End points reporting groups
    Reporting group title
    BioNTech/Pfizer BI
    Reporting group description
    		 Participants received BioNTech/Pfizer as their basic immunisation.

    Reporting group title
    Moderna BI
    Reporting group description
    		 Participants received Moderna as their basic immunisation

    Reporting group title
    Influenza combined
    Reporting group description
    		 247 participants were vaccinated with influenza and SARS-CoV-2 in combination.

    Reporting group title
    Influenza only
    Reporting group description
    		 Participants received only an Influenza vaccination.

    Reporting group title
    AstraZeneca and mRNA BI
    Reporting group description
    		 Subjects who received AstraZeneca Vaxzevria as their first vaccine, but mRNA (Moderna or BioNTech/Pfizer) as their second vaccine.

    Reporting group title
    AstraZeneca Vaxzevria BI
    Reporting group description
    		 Subjects received two doses of Vaxzevria as their basic immunisation.

    Reporting group title
    COVID-19 Vaccine Janssen BI
    Reporting group description
    		 Subjects received COVID-19 Vaccine Janssen for their basic immunisation

    Reporting group title
    other
    Reporting group description
    		 Subjects who received only one vaccine as their base immunization but were infected befor were also included in this study. Also some subjects received BioNTech and Moderna as their base immunization. On some subject data concerning the first two vaccination is missing.
    Reporting group title
    BioNTech/Pfizer Booster
    Reporting group description
    		 Participants received a booster vaccination with BioNTech/Pfizer

    Reporting group title
    Moderna Booster
    Reporting group description
    		 Participants received a booster vaccination with Moderna

    Reporting group title
    Influenza combined
    Reporting group description
    		 247 participants were vaccinated with influenza and SARS-CoV-2 in combination.

    Reporting group title
    Influenza only
    Reporting group description
    		 Participants received only an Influenza vaccination.

    Reporting group title
    other Booster
    Reporting group description
    		 Subjects boosted with other vaccine e. g. Astra Zeneca or Johnson&Johnson
    Reporting group title
    BioNTech/Pfizer Booster
    Reporting group description
    		 Participants received a booster vaccination with BioNTech/Pfizer

    Reporting group title
    Moderna Booster
    Reporting group description
    		 Participants received a booster vaccination with Moderna

    Reporting group title
    other Booster
    Reporting group description
    		 Subjects boosted with other vaccine e. g. Astra Zeneca or Johnson&Johnson

    Subject analysis set title
    Infected
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants with recorded Covid-19 breakthrough infection between week 4 and month 6.

    Subject analysis set title
    Non-infected
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Control group; participants without a recorded breakthrough infection between week 4 and month 6 (and negative for nucleocapsid antibodies; markers for infection).

    Subject analysis set title
    Homologous vaccination
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Patients who received a homologous vaccination schema (3x BNT162B2 or 3x mRNA-1273)

    Subject analysis set title
    Heterologous
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants receiving a heterologous vaccination schema (2x vector vaccination and 1x mRNA).

    Subject analysis set title
    Influenza only
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects received only Influenza vaccine. Screening took place at baseline and week 4.

    Subject analysis set title
    Influenza combined
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Probands receiving Covid 19 booster at the same time as the influenza vaccine.

    Primary: 6 months post booster vaccine

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    End point title
    		 6 months post booster vaccine
    End point description
    End point type
    Primary
    End point timeframe
    Due to feasibilty the final visits were scheduled in a time range of 6 months (± 25 days) after receiving the booster vaccine.
    End point values
    		 Infected Non-infected Homologous vaccination Heterologous
    Number of subjects analysed
    1362
    2276
    1075
    2267
    Units: Weeks
    1362
    2276
    1075
    2267
    Statistical analysis title
    		 Association antibodies and break through infection
    Statistical analysis description
    The association of anti-RBD-antibodies with incident break-through infections was modelled with Cox proportional hazards regression. Due to missing data, not all subject were included into the statistical analysis.
    Comparison groups
    Non-infected v Infected
    Number of subjects included in analysis
    3638
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 ≤ 0.05
    Method
    		 Regression, Cox
    Parameter type
    		 Cox proportional hazard
    Confidence interval
    Statistical analysis title
    		 Infection after hetero-/homologous immunisation
    Statistical analysis description
    Infections in subjects with heterologous and homologous immunisation strategies were compared to each other. Due to missing data, not all subject were included into the statistical analysis.
    Comparison groups
    Homologous vaccination v Heterologous
    Number of subjects included in analysis
    3342
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 ≤ 0.05
    Method
    		 Regression, Cox
    Parameter type
    		 Cox proportional hazard
    Confidence interval

    Primary: 4 weeks post influenza vaccine

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    End point title
    		 4 weeks post influenza vaccine [1]
    End point description
    End point type
    Primary
    End point timeframe
    For Influenza only arm 2 visits took place. Due to feasibility visits were scheduled within 28 ± 7 days.
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint only applies to two of the arms.
    End point values
    		 Influenza combined Influenza only Influenza only Influenza combined
    Number of subjects analysed
    229
    32
    32
    229
    Units: Weeks
    229
    32
    32
    229
    Statistical analysis title
    		 Influenza only vs. Influenza Covid combined
    Statistical analysis description
    This analysis compared the effectiveness of different vaccination strategies. Subjects from the influenza only and influenza combined arms as well as 558 matched subjects from the boosster arm were included. The number of antibodies produced and adverse events were assessed.
    Comparison groups
    Influenza combined v Influenza only
    Number of subjects included in analysis
    261
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 ≤ 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Baseline

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    End point title
    		 Baseline [2]
    End point description
    At the baseline visit blood samples were drawn and antibody titers were measured. Antibodylevels were correlated with the vaccination strategy to find differences between those strategies.
    End point type
    Primary
    End point timeframe
    Baseline visits took place from October 28th to January 21st.
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Due to small sample sizes, not all arms were included in the statistic analysis.
    End point values
    		 BioNTech/Pfizer BI Moderna BI AstraZeneca Vaxzevria BI
    Number of subjects analysed
    2271
    251
    1246
    Units: visits
    2271
    251
    1246
    Statistical analysis title
    		 Antibody level comparison vector vs. mRNA
    Statistical analysis description
    Due to small sample sizes of Janssen and AstraZeneca+mRNA, no analysis of these groups were conducted. Due to missing data, not all subjects were analysed.
    Comparison groups
    BioNTech/Pfizer BI v Moderna BI v AstraZeneca Vaxzevria BI
    Number of subjects included in analysis
    3768
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [3]
    P-value
    		 ≤ 0.001
    Method
    		 Regression, Linear
    Confidence interval
    Notes
    [3] - Antibody levels from subjects vaccinated with vector vaccine (Vaxzevria) were compared to subjects who received mRNA vaccines (Moderna or BioNTech/Pfizer)

    Primary: 4 weeks post booster vaccine

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    End point title
    		 4 weeks post booster vaccine
    End point description
    End point type
    Primary
    End point timeframe
    Due to feasibility visits were scheduled within 28 ± 7 days.
    End point values
    		 BioNTech/Pfizer Booster Moderna Booster Homologous vaccination Heterologous
    Number of subjects analysed
    3288
    550
    2924
    1171
    Units: Weeks
    3288
    550
    2924
    1171
    Statistical analysis title
    		 homologous vs. heterologous vaccination
    Statistical analysis description
    Due to missing data, not all subject were included into the statistical analysis.
    Comparison groups
    Homologous vaccination v Heterologous
    Number of subjects included in analysis
    4095
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 ≤ 0.001
    Method
    		 Regression, Linear
    Confidence interval
    Statistical analysis title
    		 Moderna vs. BioNTech
    Statistical analysis description
    Due to missing data, not all subject were included into the statistical analysis.
    Comparison groups
    Moderna Booster v BioNTech/Pfizer Booster
    Number of subjects included in analysis
    3838
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 ≤ 0.001
    Method
    		 Regression, Linear
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected during the baseline visit until first follow-up visit 4 weeks after the booster vaccintion by questionnaire and interview. Severe adverse events (SAEs) were reported during the complete study period of 6 months.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICH E2A
    Dictionary version
    1
    Reporting groups
    Reporting group title
    BioNTech Pfizer
    Reporting group description
    		 -

    Reporting group title
    Moderna
    Reporting group description
    		 -

    Reporting group title
    Influenza combined
    Reporting group description
    		 -

    Reporting group title
    Influenza only
    Reporting group description
    		 -

    Reporting group title
    other
    Reporting group description
    		 -

    Serious adverse events
    		 BioNTech Pfizer Moderna Influenza combined Influenza only other
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 3996 (0.18%)
    2 / 653 (0.31%)
    0 / 247 (0.00%)
    0 / 40 (0.00%)
    0 / 13 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Vascular disorders
    Intracranial haematoma
    Additional description: intracranial bleeding and subarachnoidal bleeding
         subjects affected / exposed
    1 / 3996 (0.03%)
    0 / 653 (0.00%)
    0 / 247 (0.00%)
    0 / 40 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocarditis
    Additional description: Shortness of breath and heart burn three weeks after immunization. Diganosis: Myocarditis/Takotsubo Additional dysesthesia of left body - might be related to cardiac event.
         subjects affected / exposed
    1 / 3996 (0.03%)
    0 / 653 (0.00%)
    0 / 247 (0.00%)
    0 / 40 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Anaphylactic reaction
    Additional description: Symptoms: hypertension, headache, nausea, chills, perioral numbness
         subjects affected / exposed
    1 / 3996 (0.03%)
    0 / 653 (0.00%)
    0 / 247 (0.00%)
    0 / 40 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
    Additional description: Acute onset of vertigo and emesis, diagnosed with vertigo due to vestibular paroxysmia.
         subjects affected / exposed
    1 / 3996 (0.03%)
    0 / 653 (0.00%)
    0 / 247 (0.00%)
    0 / 40 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Visual impairment
    Additional description: Acute loss of vision in right eye, intermittend supraventricular Tachycarida and atherosclerosis diagnosed. Visual impairment due to macular disorder, surgery was performed.
         subjects affected / exposed
    1 / 3996 (0.03%)
    1 / 653 (0.15%)
    0 / 247 (0.00%)
    0 / 40 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diverticulitis intestinal perforated
    Additional description: Diverticulitis with acute perforation of the colon and putride peritonitis - immediate Sigmaresection was performed. Loss of blood - another acute surgery - no bleeding site found. Pain and neurological symptoms - guillian barre syndrome suspected.
         subjects affected / exposed
    0 / 3996 (0.00%)
    1 / 653 (0.15%)
    0 / 247 (0.00%)
    0 / 40 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticular bleeding
    Additional description: Intestinal diverticular bleeding and haemorrhagic anaemia, sigmaresection performed.
         subjects affected / exposed
    1 / 3996 (0.03%)
    0 / 653 (0.00%)
    0 / 247 (0.00%)
    0 / 40 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
    Additional description: Patient with known depression had to be admitted to hospital to treat flair of disease; according to treating psychiatrist the event is not suspected to be related to vaccination.
         subjects affected / exposed
    1 / 3996 (0.03%)
    0 / 653 (0.00%)
    0 / 247 (0.00%)
    0 / 40 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 BioNTech Pfizer Moderna Influenza combined Influenza only other
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2946 / 3996 (73.72%)
    523 / 653 (80.09%)
    196 / 247 (79.35%)
    15 / 40 (37.50%)
    8 / 13 (61.54%)
    General disorders and administration site conditions
    Body temperature increased
    Additional description: Fever
         subjects affected / exposed
    452 / 3996 (11.31%)
    145 / 653 (22.21%)
    39 / 247 (15.79%)
    1 / 40 (2.50%)
    1 / 13 (7.69%)
         occurrences all number
    638
    638
    638
    638
    638
    Fatigue
         subjects affected / exposed
    1770 / 3996 (44.29%)
    310 / 653 (47.47%)
    120 / 247 (48.58%)
    6 / 40 (15.00%)
    2 / 13 (15.38%)
         occurrences all number
    2208
    2208
    2208
    2208
    2208
    Headache
         subjects affected / exposed
    1164 / 3996 (29.13%)
    222 / 653 (34.00%)
    77 / 247 (31.17%)
    6 / 40 (15.00%)
    4 / 13 (30.77%)
         occurrences all number
    1477
    1477
    1477
    1477
    1477
    Chills
         subjects affected / exposed
    375 / 3996 (9.38%)
    113 / 653 (17.30%)
    26 / 247 (10.53%)
    0 / 40 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    488
    488
    488
    488
    488
    Swelling
    Additional description: Swelling around injection site
         subjects affected / exposed
    716 / 3996 (17.92%)
    165 / 653 (25.27%)
    57 / 247 (23.08%)
    5 / 40 (12.50%)
    1 / 13 (7.69%)
         occurrences all number
    944
    944
    944
    944
    944
    Redness
    Additional description: Redness around injection site
         subjects affected / exposed
    558 / 3996 (13.96%)
    141 / 653 (21.59%)
    38 / 247 (15.38%)
    2 / 40 (5.00%)
    3 / 13 (23.08%)
         occurrences all number
    742
    742
    742
    742
    742
    Pain
    Additional description: Pain around injection site
         subjects affected / exposed
    2058 / 3996 (51.50%)
    373 / 653 (57.12%)
    152 / 247 (61.54%)
    10 / 40 (25.00%)
    3 / 13 (23.08%)
         occurrences all number
    2596
    2596
    2596
    2596
    2596
    Muscle Pain
         subjects affected / exposed
    1023 / 3996 (25.60%)
    200 / 653 (30.63%)
    61 / 247 (24.70%)
    1 / 40 (2.50%)
    2 / 13 (15.38%)
         occurrences all number
    1287
    1287
    1287
    1287
    1287
    Joint pain
         subjects affected / exposed
    626 / 3996 (15.67%)
    127 / 653 (19.45%)
    40 / 247 (16.19%)
    1 / 40 (2.50%)
    0 / 13 (0.00%)
         occurrences all number
    794
    794
    794
    794
    794
    Blood and lymphatic system disorders
    Lymph node swelling
         subjects affected / exposed
    141 / 3996 (3.53%)
    13 / 653 (1.99%)
    5 / 247 (2.02%)
    0 / 40 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    161
    161
    161
    161
    161
    Ear and labyrinth disorders
    Acute hearing loss
         subjects affected / exposed
    0 / 3996 (0.00%)
    0 / 653 (0.00%)
    0 / 247 (0.00%)
    0 / 40 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    1
    1
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    172 / 3996 (4.30%)
    35 / 653 (5.36%)
    10 / 247 (4.05%)
    0 / 40 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    217
    217
    217
    217
    217

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Nov 2021
    We adapted the inclusion criteria according to the recommendation of the Austrian vaccination committee The wording of ICFs was adapted according to the recommendation of the data security manager and the legal office of the Medical University of Vienna. The submission of study results to the participants was describedin more detail.
    31 Mar 2022
    The numbers of trial subjects recruited at each site was adjusted. Information on blood group and sleeping quality/circadian rhythm will be collected during 3rd visit. We further specified the timing of study visits. Trial data will be merged with an Austrian epidemiologic database to verify information on Covid-19 infection and vaccination.

    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.
    1) It was a non-randomized study -> distribution of mRNA-1273 and BNT162b2 booster is not balanced, with more individuals boosted with BNT162b2. 2) Information gained during the study was partly self-reported by participants ; recall bias.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/36328594
    http://www.ncbi.nlm.nih.gov/pubmed/36509374
    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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