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    Clinical Trial Results:
    Exploratory study into age-related immunological differences related to immunogenicity in influenza vaccination and herpes zoster vaccination (INFLUENZA-SHINGRIX)

    Summary
    EudraCT number
    		 2020-005682-13
    Trial protocol
    		 NL  
    Global end of trial date
    17 May 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jun 2024
    First version publication date
    01 Jun 2024
    Other versions
    Summary report(s)
    		 Summary of the study and results

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    76061
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05082688
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 PaNaMa: 111350
    Sponsors
    Sponsor organisation name
    Radboudumc
    Sponsor organisation address
    Geert Grooteplein Zuid 8, Nijmegen, Netherlands, 6525GA
    Public contact
    Gizem Kilic, Radboudumc, gizem.kilic@radboudumc.nl
    Scientific contact
    Gizem Kilic, Radboudumc, gizem.kilic@radboudumc.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
    Final
    Date of interim/final analysis
    16 May 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 May 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    17 May 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To explore immunological features between young and older adults after administration of an adjuvanted herpes zoster (Shingrix) or unadjuvanted influenza (Fluarix) vaccine that could explain differences in vaccine immunogenicity.
    Protection of trial subjects
    Blood drawing and vaccination were performed by trained and experienced nurses and medical doctors. Subjects are monitored after intervention. The study team was easily reachable for adverse events and questions etc. For the privacy, unique sample codes were used for the participants. Moreover, the documents with participant identification data were kept with a password in the hospital server, with designated people being able to open.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Sep 2021
    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: 147
    Worldwide total number of subjects
    147
    EEA total number of subjects
    147
    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)
    101
    From 65 to 84 years
    46
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Posters and flyers of the study were distributed around the Radboudumc and Radboud University. A news item about the clinical trial was published in the research newsletter of Radboudumc. Furthermore, the study was announced in a local newspaper Gelderlander and a local magazine de Brug.

    Pre-assignment
    Screening details
    		 After signing the informed consent, the participants were randomized and screened for their suitability to participate. Then, the first study was planned on another date depending on the experimental group.

    Period 1
    Period 1 title
    D0 Visit
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: HZV Young
    Arm description
    		 Young adults between 18-35 years of age received the adjuvanted herpes zoster vaccine (Shingrix) on D0 and D60.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Shingrix powder and suspension for injection
    Investigational medicinal product code
    Other name
    Herpes zoster vaccine (recombinant, adjuvanted)
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    On Day 0 and Day 60, 0.5 ml solution was injected intramuscularly into the deltoid muscle of the arm.

    Arm title
    		 Group 2: HZV Old
    Arm description
    		 Older adults (≥60 years of age) received the adjuvanted herpes zoster vaccine (Shingrix) on D0 and D60.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Shingrix powder and suspension for injection
    Investigational medicinal product code
    Other name
    Herpes zoster vaccine (recombinant, adjuvanted)
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    On Day 0 and Day 60, 0.5 ml solution was injected intramuscularly into the deltoid muscle of the arm.

    Arm title
    		 Group 3: QIV Young
    Arm description
    		 Young adults between 18-35 years of age received the quadrivalent inactivated influenza vaccine (Fluarix) on D0.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fluarix Tetra
    Investigational medicinal product code
    Other name
    Fluarix Quadrivalent
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    0.5 ml solution was injected intramuscularly into the deltoid muscle of the arm.

    Arm title
    		 Group 4: QIV Old
    Arm description
    		 Older adults (≥60 years of age) received the quadrivalent inactivated influenza vaccine (Fluarix) on D0.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fluarix Tetra
    Investigational medicinal product code
    Other name
    Fluarix Quadrivalent
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    0.5 ml solution was injected intramuscularly into the deltoid muscle of the arm.

    Arm title
    		 Group 5: HZV-Associated Placebo
    Arm description
    		 Young adults between 18-35 years of age received a placebo on D0 and D60.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Natrium Chloride Inj Vlst 0.9%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intramuscular use, Injection
    Dosage and administration details
    On Day 0 and Day 60, 0.5 ml solution was injected intramuscularly into the deltoid muscle of the arm.

    Arm title
    		 Group 6: QIV-Associated Placebo
    Arm description
    		 Young adults between 18-35 years of age received a placebo on D0.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Natrium Chloride Inj Vlst 0.9%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    On Day 0, 0.5 ml solution was injected intramuscularly into the deltoid muscle of the arm.

    Number of subjects in period 1
    		Group 1: HZV Young Group 2: HZV Old Group 3: QIV Young Group 4: QIV Old Group 5: HZV-Associated Placebo Group 6: QIV-Associated Placebo
    Started
    29
    33
    33
    30
    11
    11
    Completed
    22
    31
    30
    27
    11
    11
    Not completed
    7
    2
    3
    3
    0
    0
         Consent withdrawn by subject
    1
    2
    2
    3
    -
    -
         Lost to follow-up
    6
    -
    1
    -
    -
    -
    Period 2
    Period 2 title
    Day 1 post vaccination (D1)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: HZV Young D1
    Arm description
    		 Blood was drawn.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 2: HZV Old D1
    Arm description
    		 Blood was drawn.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 3: QIV Young D1
    Arm description
    		 Blood was drawn.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 4: QIV Old D1
    Arm description
    		 Blood was drawn.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 5: HZV-Associated Placebo
    Arm description
    		 This group did not have a follow-up visit on day 1.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 6: QIV-Associated Placebo
    Arm description
    		 This group did not have a follow-up visit on day 1.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Group 1: HZV Young D1 Group 2: HZV Old D1 Group 3: QIV Young D1 Group 4: QIV Old D1 Group 5: HZV-Associated Placebo Group 6: QIV-Associated Placebo
    Started
    22
    31
    30
    27
    11
    11
    Completed
    22
    31
    30
    27
    11
    11
    Period 3
    Period 3 title
    D7 post vaccination (D7)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: HZV Young D7
    Arm description
    		 Blood was drawn.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 2: HZV Old D7
    Arm description
    		 Blood was drawn.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 3: QIV Young D7
    Arm description
    		 Blood was drawn.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 4: QIV Old D7
    Arm description
    		 Blood was drawn.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 5: HZV-Associated Placebo
    Arm description
    		 This group did not have a follow-up visit on day 7.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 6: QIV-Associated Placebo
    Arm description
    		 This group did not have a follow-up visit on day 7.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3
    		Group 1: HZV Young D7 Group 2: HZV Old D7 Group 3: QIV Young D7 Group 4: QIV Old D7 Group 5: HZV-Associated Placebo Group 6: QIV-Associated Placebo
    Started
    22
    31
    30
    27
    11
    11
    Completed
    22
    31
    30
    27
    11
    11
    Period 4
    Period 4 title
    D60 Visit (D60)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: HZV Young D60
    Arm description
    		 Young adults between 18-35 years of age received the adjuvanted herpes zoster vaccine (Shingrix) on D0 and D60.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Shingrix powder and suspension for injection
    Investigational medicinal product code
    Other name
    Herpes zoster vaccine (recombinant, adjuvanted)
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use, Injection
    Dosage and administration details
    On Day 0 and Day 60, 0.5 ml solution was injected intramuscularly into the deltoid muscle of the arm.

    Arm title
    		 Group 2: HZV Old D60
    Arm description
    		 Older adults (≥60 years of age) received the adjuvanted herpes zoster vaccine (Shingrix) on D0 and D60.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Shingrix powder and suspension for injection
    Investigational medicinal product code
    Other name
    Herpes zoster vaccine (recombinant, adjuvanted)
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Injection , Intramuscular use
    Dosage and administration details
    On Day 0 and Day 60, 0.5 ml solution was injected intramuscularly into the deltoid muscle of the arm.

    Arm title
    		 Group 3: QIV Young D60
    Arm description
    		 Blood was drawn.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 4: QIV Old D60
    Arm description
    		 Blood was drawn.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 5: HZV-Associated Placebo D60
    Arm description
    		 Young adults between 18-35 years of age received a placebo on D0 and D60.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Natrium Chloride Inj Vlst 0.9%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intramuscular use, Injection
    Dosage and administration details
    On Day 0 and Day 60, 0.5 ml solution was injected intramuscularly into the deltoid muscle of the arm.

    Arm title
    		 Group 6: QIV-Associated Placebo D60
    Arm description
    		 Blood was drawn.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 4
    		Group 1: HZV Young D60 Group 2: HZV Old D60 Group 3: QIV Young D60 Group 4: QIV Old D60 Group 5: HZV-Associated Placebo D60 Group 6: QIV-Associated Placebo D60
    Started
    22
    31
    30
    27
    11
    11
    Completed
    21
    31
    29
    27
    11
    11
    Not completed
    1
    0
    1
    0
    0
    0
         Consent withdrawn by subject
    1
    -
    -
    -
    -
    -
         Exclusion due to receiving another vaccine
    -
    -
    1
    -
    -
    -
    Period 5
    Period 5 title
    D1 post booster vaccination (D61)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: HZV Young D61
    Arm description
    		 Blood was drawn.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 2: HZV Old D61
    Arm description
    		 Blood was drawn.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 5: HZV-Associated Placebo
    Arm description
    		 This group did not have a follow-up visit on day 61.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 6: QIV-Associated Placebo
    Arm description
    		 This group did not have a follow-up visit on day 61.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 5 [1]
    		Group 1: HZV Young D61 Group 2: HZV Old D61 Group 5: HZV-Associated Placebo Group 6: QIV-Associated Placebo
    Started
    21
    31
    11
    11
    Completed
    21
    31
    11
    11
    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: D61 visits are only for Groups 1 and 2, while D60 visits are for all groups.
    Period 6
    Period 6 title
    D7 post booster vaccination (D67)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: HZV Young D67
    Arm description
    		 Blood was drawn.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 2: HZV Old D67
    Arm description
    		 Blood was drawn.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 5: HZV-Associated Placebo
    Arm description
    		 This group did not have a follow-up visit on day 67.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 6: QIV-Associated Placebo
    Arm description
    		 This group did not have a follow-up visit on day 67.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 6
    		Group 1: HZV Young D67 Group 2: HZV Old D67 Group 5: HZV-Associated Placebo Group 6: QIV-Associated Placebo
    Started
    21
    31
    11
    11
    Completed
    21
    31
    11
    11
    Period 7
    Period 7 title
    D60 post booster vaccination (D120)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: HZV Young D120
    Arm description
    		 Blood was drawn.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 2: HZV Old D120
    Arm description
    		 Blood was drawn.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 5: HZV-Associated Placebo D120
    Arm description
    		 Blood was drawn.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 6: QIV-Associated Placebo
    Arm description
    		 This group did not have a follow-up visit on day 120.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 7
    		Group 1: HZV Young D120 Group 2: HZV Old D120 Group 5: HZV-Associated Placebo D120 Group 6: QIV-Associated Placebo
    Started
    21
    31
    11
    11
    Completed
    21
    30
    11
    11
    Not completed
    0
    1
    0
    0
         Adverse event, serious fatal
    -
    1
    -
    -
    Period 8
    Period 8 title
    Last visit (D180 post Fluarix Tetra)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 3: QIV Young D180
    Arm description
    		 Blood was drawn.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 4: QIV Old D180
    Arm description
    		 Blood was drawn.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 6: QIV-Associated Placebo D180
    Arm description
    		 Blood was drawn.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 8 [2]
    		Group 3: QIV Young D180 Group 4: QIV Old D180 Group 6: QIV-Associated Placebo D180
    Started
    29
    27
    11
    Completed
    28
    27
    11
    Not completed
    1
    0
    0
         Lost to follow-up
    1
    -
    -
    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: D120 visits are for the Groups 1, 2, and 5, while D180 visits are for the Groups 3, 4, and 6.
    Period 9
    Period 9 title
    Last visit (D240 post Shingrix)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: HZV Young D240
    Arm description
    		 Blood was drawn.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 2: HZV Old D240
    Arm description
    		 Blood was drawn.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 5: HZV-Associated Placebo D240
    Arm description
    		 Blood was drawn.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 9 [3]
    		Group 1: HZV Young D240 Group 2: HZV Old D240 Group 5: HZV-Associated Placebo D240
    Started
    21
    30
    11
    Completed
    20
    30
    11
    Not completed
    1
    0
    0
         Lost to follow-up
    1
    -
    -
    Notes
    [3] - 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: D240 visits are for the Groups 1, 2, and 5, while D180 visits are for the Groups 3, 4, and 6.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: HZV Young
    Reporting group description
    		 Young adults between 18-35 years of age received the adjuvanted herpes zoster vaccine (Shingrix) on D0 and D60.

    Reporting group title
    Group 2: HZV Old
    Reporting group description
    		 Older adults (≥60 years of age) received the adjuvanted herpes zoster vaccine (Shingrix) on D0 and D60.

    Reporting group title
    Group 3: QIV Young
    Reporting group description
    		 Young adults between 18-35 years of age received the quadrivalent inactivated influenza vaccine (Fluarix) on D0.

    Reporting group title
    Group 4: QIV Old
    Reporting group description
    		 Older adults (≥60 years of age) received the quadrivalent inactivated influenza vaccine (Fluarix) on D0.

    Reporting group title
    Group 5: HZV-Associated Placebo
    Reporting group description
    		 Young adults between 18-35 years of age received a placebo on D0 and D60.

    Reporting group title
    Group 6: QIV-Associated Placebo
    Reporting group description
    		 Young adults between 18-35 years of age received a placebo on D0.

    Reporting group values
    		 Group 1: HZV Young Group 2: HZV Old Group 3: QIV Young Group 4: QIV Old Group 5: HZV-Associated Placebo Group 6: QIV-Associated Placebo Total
    Number of subjects
    		 29 33 33 30 11 11 147
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0 0
        Adults (18-64 years)
    		 29 8 33 4 11 11 96
        From 65-84 years
    		 0 25 0 26 0 0 51
        85 years and over
    		 0 0 0 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 19 9 24 16 8 8 84
        Male
    		 10 24 9 14 3 3 63

    End points

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    End points reporting groups
    Reporting group title
    Group 1: HZV Young
    Reporting group description
    		 Young adults between 18-35 years of age received the adjuvanted herpes zoster vaccine (Shingrix) on D0 and D60.

    Reporting group title
    Group 2: HZV Old
    Reporting group description
    		 Older adults (≥60 years of age) received the adjuvanted herpes zoster vaccine (Shingrix) on D0 and D60.

    Reporting group title
    Group 3: QIV Young
    Reporting group description
    		 Young adults between 18-35 years of age received the quadrivalent inactivated influenza vaccine (Fluarix) on D0.

    Reporting group title
    Group 4: QIV Old
    Reporting group description
    		 Older adults (≥60 years of age) received the quadrivalent inactivated influenza vaccine (Fluarix) on D0.

    Reporting group title
    Group 5: HZV-Associated Placebo
    Reporting group description
    		 Young adults between 18-35 years of age received a placebo on D0 and D60.

    Reporting group title
    Group 6: QIV-Associated Placebo
    Reporting group description
    		 Young adults between 18-35 years of age received a placebo on D0.
    Reporting group title
    Group 1: HZV Young D1
    Reporting group description
    		 Blood was drawn.

    Reporting group title
    Group 2: HZV Old D1
    Reporting group description
    		 Blood was drawn.

    Reporting group title
    Group 3: QIV Young D1
    Reporting group description
    		 Blood was drawn.

    Reporting group title
    Group 4: QIV Old D1
    Reporting group description
    		 Blood was drawn.

    Reporting group title
    Group 5: HZV-Associated Placebo
    Reporting group description
    		 This group did not have a follow-up visit on day 1.

    Reporting group title
    Group 6: QIV-Associated Placebo
    Reporting group description
    		 This group did not have a follow-up visit on day 1.
    Reporting group title
    Group 1: HZV Young D7
    Reporting group description
    		 Blood was drawn.

    Reporting group title
    Group 2: HZV Old D7
    Reporting group description
    		 Blood was drawn.

    Reporting group title
    Group 3: QIV Young D7
    Reporting group description
    		 Blood was drawn.

    Reporting group title
    Group 4: QIV Old D7
    Reporting group description
    		 Blood was drawn.

    Reporting group title
    Group 5: HZV-Associated Placebo
    Reporting group description
    		 This group did not have a follow-up visit on day 7.

    Reporting group title
    Group 6: QIV-Associated Placebo
    Reporting group description
    		 This group did not have a follow-up visit on day 7.
    Reporting group title
    Group 1: HZV Young D60
    Reporting group description
    		 Young adults between 18-35 years of age received the adjuvanted herpes zoster vaccine (Shingrix) on D0 and D60.

    Reporting group title
    Group 2: HZV Old D60
    Reporting group description
    		 Older adults (≥60 years of age) received the adjuvanted herpes zoster vaccine (Shingrix) on D0 and D60.

    Reporting group title
    Group 3: QIV Young D60
    Reporting group description
    		 Blood was drawn.

    Reporting group title
    Group 4: QIV Old D60
    Reporting group description
    		 Blood was drawn.

    Reporting group title
    Group 5: HZV-Associated Placebo D60
    Reporting group description
    		 Young adults between 18-35 years of age received a placebo on D0 and D60.

    Reporting group title
    Group 6: QIV-Associated Placebo D60
    Reporting group description
    		 Blood was drawn.
    Reporting group title
    Group 1: HZV Young D61
    Reporting group description
    		 Blood was drawn.

    Reporting group title
    Group 2: HZV Old D61
    Reporting group description
    		 Blood was drawn.

    Reporting group title
    Group 5: HZV-Associated Placebo
    Reporting group description
    		 This group did not have a follow-up visit on day 61.

    Reporting group title
    Group 6: QIV-Associated Placebo
    Reporting group description
    		 This group did not have a follow-up visit on day 61.
    Reporting group title
    Group 1: HZV Young D67
    Reporting group description
    		 Blood was drawn.

    Reporting group title
    Group 2: HZV Old D67
    Reporting group description
    		 Blood was drawn.

    Reporting group title
    Group 5: HZV-Associated Placebo
    Reporting group description
    		 This group did not have a follow-up visit on day 67.

    Reporting group title
    Group 6: QIV-Associated Placebo
    Reporting group description
    		 This group did not have a follow-up visit on day 67.
    Reporting group title
    Group 1: HZV Young D120
    Reporting group description
    		 Blood was drawn.

    Reporting group title
    Group 2: HZV Old D120
    Reporting group description
    		 Blood was drawn.

    Reporting group title
    Group 5: HZV-Associated Placebo D120
    Reporting group description
    		 Blood was drawn.

    Reporting group title
    Group 6: QIV-Associated Placebo
    Reporting group description
    		 This group did not have a follow-up visit on day 120.
    Reporting group title
    Group 3: QIV Young D180
    Reporting group description
    		 Blood was drawn.

    Reporting group title
    Group 4: QIV Old D180
    Reporting group description
    		 Blood was drawn.

    Reporting group title
    Group 6: QIV-Associated Placebo D180
    Reporting group description
    		 Blood was drawn.
    Reporting group title
    Group 1: HZV Young D240
    Reporting group description
    		 Blood was drawn.

    Reporting group title
    Group 2: HZV Old D240
    Reporting group description
    		 Blood was drawn.

    Reporting group title
    Group 5: HZV-Associated Placebo D240
    Reporting group description
    		 Blood was drawn.

    Primary: Neutrophil Counts 7 Days After Vaccination

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    End point title
    		 Neutrophil Counts 7 Days After Vaccination [1] [2]
    End point description
    Neutrophil cell counts were measured.
    End point type
    Primary
    End point timeframe
    Before vaccination, 1-day and 7-days after vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Time points were compared using one way ANOVA followed by the Dunn’s multiple comparisons test
    [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: Secondary end point reports all groups in the baseline period.
    End point values
    		 Group 1: HZV Young Group 2: HZV Old Group 3: QIV Young Group 4: QIV Old Group 1: HZV Young D1 Group 2: HZV Old D1 Group 3: QIV Young D1 Group 4: QIV Old D1 Group 1: HZV Young D7 Group 2: HZV Old D7 Group 3: QIV Young D7 Group 4: QIV Old D7 Group 1: HZV Young D60 Group 2: HZV Old D60 Group 1: HZV Young D61 Group 2: HZV Old D61 Group 1: HZV Young D67 Group 2: HZV Old D67
    Number of subjects analysed
    20
    31
    29
    27
    21
    31
    24
    22
    21
    31
    29
    20
    21
    30
    19
    28
    20
    31
    Units: million/ml
        median (standard deviation)
    3.13 ( 1.70 )
    3.34 ( 0.85 )
    3.39 ( 1.27 )
    3.41 ( 1.18 )
    5.85 ( 1.58 )
    5.76 ( 1.32 )
    3.66 ( 1.28 )
    4.01 ( 1.17 )
    3.76 ( 1.32 )
    3.82 ( 1.25 )
    3.73 ( 1.63 )
    3.97 ( 0.90 )
    2.97 ( 1.91 )
    3.17 ( 0.94 )
    5.19 ( 1.62 )
    5.25 ( 0.96 )
    3.15 ( 1.69 )
    3.53 ( 1.27 )
    Attachments
    		 Neutrophil Counts
    No statistical analyses for this end point

    Primary: Lymphocyte Counts 7 Days After Vaccination

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    End point title
    		 Lymphocyte Counts 7 Days After Vaccination [3] [4]
    End point description
    End point type
    Primary
    End point timeframe
    Lymphocyte counts were measured before vaccination. 1-day and 7-days after vaccination.
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Time points were compared using one way ANOVA followed by the Dunn’s multiple comparisons test
    [4] - 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: Secondary end point reports all groups in the baseline period.
    End point values
    		 Group 1: HZV Young Group 2: HZV Old Group 3: QIV Young Group 4: QIV Old Group 1: HZV Young D1 Group 2: HZV Old D1 Group 3: QIV Young D1 Group 4: QIV Old D1 Group 1: HZV Young D7 Group 2: HZV Old D7 Group 3: QIV Young D7 Group 4: QIV Old D7 Group 1: HZV Young D60 Group 2: HZV Old D60 Group 1: HZV Young D61 Group 2: HZV Old D61 Group 1: HZV Young D67 Group 2: HZV Old D67
    Number of subjects analysed
    21
    31
    29
    27
    22
    31
    24
    22
    22
    31
    29
    20
    21
    30
    19
    28
    20
    31
    Units: million cells/ml
        median (standard deviation)
    1.67 ( 0.52 )
    1.69 ( 0.70 )
    1.63 ( 0.49 )
    1.62 ( 0.49 )
    1.38 ( 0.46 )
    1.7 ( 0.57 )
    1.50 ( 0.46 )
    1.50 ( 0.63 )
    2.22 ( 0.53 )
    1.87 ( 0.57 )
    1.93 ( 0.49 )
    1.86 ( 0.53 )
    1.58 ( 0.43 )
    1.61 ( 0.52 )
    1.31 ( 0.32 )
    1.21 ( 0.57 )
    1.96 ( 0.55 )
    1.71 ( 0.63 )
    Attachments
    		 Lymphocyte Counts
    No statistical analyses for this end point

    Primary: Monocyte Counts 7 Days After Vaccination

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    End point title
    		 Monocyte Counts 7 Days After Vaccination [5] [6]
    End point description
    End point type
    Primary
    End point timeframe
    Monocyte counts were measured before vaccination, 1 day and 7 days after vaccination.
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Time points were compared using one way ANOVA followed by the Dunn’s multiple comparisons test
    [6] - 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: Secondary end point reports all groups in the baseline period.
    End point values
    		 Group 1: HZV Young Group 2: HZV Old Group 3: QIV Young Group 4: QIV Old Group 1: HZV Young D1 Group 2: HZV Old D1 Group 3: QIV Young D1 Group 4: QIV Old D1 Group 1: HZV Young D7 Group 2: HZV Old D7 Group 3: QIV Young D7 Group 4: QIV Old D7 Group 1: HZV Young D60 Group 2: HZV Old D60 Group 1: HZV Young D61 Group 2: HZV Old D61 Group 1: HZV Young D67 Group 2: HZV Old D67
    Number of subjects analysed
    21
    31
    29
    27
    22
    31
    24
    22
    22
    31
    29
    20
    21
    30
    19
    28
    20
    31
    Units: million/ml
        median (standard deviation)
    0.5 ( 0.19 )
    0.51 ( 0.24 )
    0.44 ( 0.15 )
    0.47 ( 0.22 )
    0.89 ( 0.22 )
    0.7 ( 0.26 )
    0.64 ( 0.14 )
    0.59 ( 0.18 )
    0.54 ( 0.19 )
    0.54 ( 0.20 )
    0.5 ( 0.2 )
    0.52 ( 0.12 )
    0.49 ( 0.16 )
    0.48 ( 0.12 )
    0.79 ( 0.15 )
    0.64 ( 0.17 )
    0.52 ( 0.15 )
    0.53 ( 0.17 )
    Attachments
    		 Monocyte Counts
    No statistical analyses for this end point

    Secondary: Neutrophil Counts Long-Term

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    End point title
    		 Neutrophil Counts Long-Term
    End point description
    End point type
    Secondary
    End point timeframe
    Neutrophil counts were measured at day 0, 60, 120, and 240 for HZV-related groups, and at day 0, 60 and 180 for QIV-related groups.
    End point values
    		 Group 1: HZV Young Group 2: HZV Old Group 3: QIV Young Group 4: QIV Old Group 5: HZV-Associated Placebo Group 6: QIV-Associated Placebo Group 1: HZV Young D60 Group 2: HZV Old D60 Group 3: QIV Young D60 Group 4: QIV Old D60 Group 5: HZV-Associated Placebo D60 Group 6: QIV-Associated Placebo D60 Group 1: HZV Young D120 Group 2: HZV Old D120 Group 5: HZV-Associated Placebo D120 Group 3: QIV Young D180 Group 4: QIV Old D180 Group 6: QIV-Associated Placebo D180 Group 1: HZV Young D240 Group 2: HZV Old D240 Group 5: HZV-Associated Placebo D240
    Number of subjects analysed
    21
    31
    29
    27
    11
    9
    21
    30
    27
    26
    11
    9
    21
    30
    10
    28
    27
    11
    20
    30
    11
    Units: million/ml
        median (standard deviation)
    3.13 ( 1.70 )
    3.34 ( 0.85 )
    3.39 ( 1.27 )
    3.41 ( 1.80 )
    5.06 ( 1.52 )
    4.57 ( 1.57 )
    2.97 ( 1.92 )
    3.17 ( 0.94 )
    3.66 ( 1.76 )
    3.66 ( 1.05 )
    3.45 ( 1.28 )
    3.48 ( 1.32 )
    3.03 ( 1.05 )
    3.41 ( 1.14 )
    3.64 ( 0.77 )
    3.84 ( 1.73 )
    3.39 ( 0.75 )
    4.13 ( 2.23 )
    2.58 ( 1.00 )
    3.33 ( 1.33 )
    3.03 ( 1.01 )
    Attachments
    		 Neutrophil Counts
    No statistical analyses for this end point

    Secondary: Lymphocyte Counts Long-Term

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    End point title
    		 Lymphocyte Counts Long-Term
    End point description
    End point type
    Secondary
    End point timeframe
    Neutrophil counts were measured at day 0, 60, 120, and 240 for HZV-related groups, and at day 0, 60 and 180 for QIV-related groups.
    End point values
    		 Group 1: HZV Young Group 2: HZV Old Group 3: QIV Young Group 4: QIV Old Group 5: HZV-Associated Placebo Group 6: QIV-Associated Placebo Group 1: HZV Young D60 Group 2: HZV Old D60 Group 3: QIV Young D60 Group 4: QIV Old D60 Group 5: HZV-Associated Placebo D60 Group 6: QIV-Associated Placebo D60 Group 1: HZV Young D120 Group 2: HZV Old D120 Group 5: HZV-Associated Placebo D120 Group 3: QIV Young D180 Group 4: QIV Old D180 Group 6: QIV-Associated Placebo D180 Group 1: HZV Young D240 Group 2: HZV Old D240 Group 5: HZV-Associated Placebo D240
    Number of subjects analysed
    21
    31
    29
    27
    11
    9
    21
    30
    27
    26
    11
    9
    21
    30
    10
    28
    27
    11
    20
    30
    11
    Units: million/ml
        median (standard deviation)
    1.67 ( 0.53 )
    1.69 ( 0.70 )
    1.63 ( 0.49 )
    1.62 ( 0.49 )
    2.12 ( 1.32 )
    1.96 ( 0.63 )
    1.58 ( 0.43 )
    1.62 ( 0.52 )
    1.79 ( 0.50 )
    1.58 ( 0.53 )
    2.12 ( 0.72 )
    1.97 ( 0.60 )
    1.89 ( 0.56 )
    1.78 ( 0.51 )
    1.98 ( 0.41 )
    1.83 ( 0.60 )
    1.63 ( 0.45 )
    2.1 ( 0.59 )
    1.58 ( 0.43 )
    1.57 ( 0.43 )
    1.92 ( 0.42 )
    Attachments
    		 Lymphocyte Counts
    No statistical analyses for this end point

    Secondary: Monocyte Counts Long-Term

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    End point title
    		 Monocyte Counts Long-Term
    End point description
    End point type
    Secondary
    End point timeframe
    Neutrophil counts were measured at day 0, 60, 120, and 240 for HZV-related groups, and at day 0, 60 and 180 for QIV-related groups.
    End point values
    		 Group 1: HZV Young Group 2: HZV Old Group 3: QIV Young Group 4: QIV Old Group 5: HZV-Associated Placebo Group 6: QIV-Associated Placebo Group 1: HZV Young D60 Group 2: HZV Old D60 Group 3: QIV Young D60 Group 4: QIV Old D60 Group 5: HZV-Associated Placebo D60 Group 6: QIV-Associated Placebo D60 Group 1: HZV Young D120 Group 2: HZV Old D120 Group 5: HZV-Associated Placebo D120 Group 3: QIV Young D180 Group 4: QIV Old D180 Group 6: QIV-Associated Placebo D180 Group 1: HZV Young D240 Group 2: HZV Old D240 Group 5: HZV-Associated Placebo D240
    Number of subjects analysed
    21
    31
    29
    27
    11
    9
    21
    30
    27
    26
    11
    9
    21
    30
    10
    28
    27
    11
    20
    30
    11
    Units: million/ml
        median (standard deviation)
    0.5 ( 0.19 )
    0.51 ( 0.24 )
    0.44 ( 0.15 )
    0.47 ( 0.22 )
    0.58 ( 0.31 )
    0.55 ( 0.21 )
    0.49 ( 0.16 )
    0.48 ( 0.12 )
    0.44 ( 0.16 )
    0.57 ( 0.12 )
    0.49 ( 0.10 )
    0.49 ( 0.17 )
    0.52 ( 0.13 )
    0.5 ( 0.16 )
    0.57 ( 0.14 )
    0.51 ( 0.17 )
    0.52 ( 0.13 )
    0.55 ( 0.14 )
    0.45 ( 0.10 )
    0.51 ( 0.16 )
    0.51 ( 0.11 )
    Attachments
    		 Monocyte Counts
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected through the course of the study.
    Adverse event reporting additional description
    The follow-up period was 6 months for the Fluarix Tetra and associated placebo groups (groups 3, 4, and 6) and 8 months for the Shingrix and associated placebo groups (groups 1, 2, and 5).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Group 1: HZV Young
    Reporting group description
    		 Young adults between 18-35 years of age received the adjuvanted herpes zoster vaccine (Shingrix) on D0 and D60. The adverse events were collected within 7 days after the first dose of Shingrix vaccination.

    Reporting group title
    Group 2: HZV Old
    Reporting group description
    		 Older adults (≥60 years of age) received the adjuvanted herpes zoster vaccine (Shingrix) on D0 and D60. The adverse events were collected within 7 days after the first dose of Shingrix vaccination.

    Reporting group title
    Group 3: QIV Young
    Reporting group description
    		 Young adults between 18-35 years of age received the quadrivalent inactivated influenza vaccine (Fluarix) on D0. The adverse events were collected within 7 days after Fluarix vaccination.

    Reporting group title
    Group 4: QIV Old
    Reporting group description
    		 Older adults (≥60 years of age) received the quadrivalent inactivated influenza vaccine (Fluarix) on D0. The adverse events were collected within 7 days after Fluarix vaccination.

    Reporting group title
    Group 5: HZV-Associated Placebo
    Reporting group description
    		 Young adults between 18-35 years of age received a placebo on D0 and D60. The adverse events were collected within 7 days after the first dose of placebo vaccination.

    Reporting group title
    Group 6: QIV-Associated Placebo
    Reporting group description
    		 Young adults between 18-35 years of age received a placebo on D0. The adverse events were collected within 7 days after placebo vaccination.

    Reporting group title
    Group 1: HZV Young Booster
    Reporting group description
    		 Adverse events were reported within 7 days after the booster Shingrix vaccination.

    Reporting group title
    Group 2: HZV Old Booster
    Reporting group description
    		 Adverse events were reported within 7 days after the booster Shingrix vaccination.

    Reporting group title
    Group 5: HZV-Associated Placebo Booster
    Reporting group description
    		 Adverse events were reported within 7 days after the booster placebo vaccination.

    Reporting group title
    Group 1: HZV Young Long-Term
    Reporting group description
    		 Adverse events reported throughout the study, except within 7-days after vaccination.

    Reporting group title
    Group 2: HZV Old Long-Term
    Reporting group description
    		 Adverse events reported throughout the study, except within 7-days after vaccination.

    Reporting group title
    Group 3: QIV Young Long-Term
    Reporting group description
    		 Adverse events reported throughout the study, except within 7-days after vaccination.

    Reporting group title
    Group 4: QIV Old Long-Term
    Reporting group description
    		 Adverse events reported throughout the study, except within 7-days after vaccination.

    Reporting group title
    Group 5: HZV-Associated Placebo Long-Term
    Reporting group description
    		 Adverse events reported throughout the study, except within 7-days after vaccination.

    Reporting group title
    Group 6: QIV-Associated Placebo Long-Term
    Reporting group description
    		 Adverse events reported throughout the study, except within 7-days after vaccination.

    Serious adverse events
    		 Group 1: HZV Young Group 2: HZV Old Group 3: QIV Young Group 4: QIV Old Group 5: HZV-Associated Placebo Group 6: QIV-Associated Placebo Group 1: HZV Young Booster Group 2: HZV Old Booster Group 5: HZV-Associated Placebo Booster Group 1: HZV Young Long-Term Group 2: HZV Old Long-Term Group 3: QIV Young Long-Term Group 4: QIV Old Long-Term Group 5: HZV-Associated Placebo Long-Term Group 6: QIV-Associated Placebo Long-Term
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    1 / 22 (4.55%)
    2 / 31 (6.45%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Road traffic accident
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    1 / 22 (4.55%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Heart failure with reduced ejection fraction
    Additional description: Acute heart failure is the correct cause.
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.5%
    Non-serious adverse events
    		 Group 1: HZV Young Group 2: HZV Old Group 3: QIV Young Group 4: QIV Old Group 5: HZV-Associated Placebo Group 6: QIV-Associated Placebo Group 1: HZV Young Booster Group 2: HZV Old Booster Group 5: HZV-Associated Placebo Booster Group 1: HZV Young Long-Term Group 2: HZV Old Long-Term Group 3: QIV Young Long-Term Group 4: QIV Old Long-Term Group 5: HZV-Associated Placebo Long-Term Group 6: QIV-Associated Placebo Long-Term
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 22 (100.00%)
    29 / 31 (93.55%)
    29 / 31 (93.55%)
    20 / 27 (74.07%)
    6 / 11 (54.55%)
    8 / 11 (72.73%)
    21 / 21 (100.00%)
    26 / 31 (83.87%)
    4 / 10 (40.00%)
    11 / 22 (50.00%)
    11 / 31 (35.48%)
    17 / 31 (54.84%)
    5 / 27 (18.52%)
    3 / 11 (27.27%)
    5 / 11 (45.45%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Eyelid cyst
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    1 / 22 (4.55%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Febrile infection
    Additional description: The option "fever" does not exist, however, the correct AE is fever.
         subjects affected / exposed
    5 / 22 (22.73%)
    2 / 31 (6.45%)
    0 / 31 (0.00%)
    1 / 27 (3.70%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    10 / 21 (47.62%)
    6 / 31 (19.35%)
    0 / 10 (0.00%)
    1 / 22 (4.55%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    5
    2
    0
    1
    0
    0
    10
    6
    0
    1
    0
    0
    0
    0
    0
    Fatigue
         subjects affected / exposed
    15 / 22 (68.18%)
    11 / 31 (35.48%)
    12 / 31 (38.71%)
    7 / 27 (25.93%)
    3 / 11 (27.27%)
    4 / 11 (36.36%)
    15 / 21 (71.43%)
    11 / 31 (35.48%)
    2 / 10 (20.00%)
    0 / 22 (0.00%)
    3 / 31 (9.68%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    15
    11
    12
    7
    3
    4
    15
    11
    2
    0
    3
    0
    0
    0
    0
    Malaise
    Additional description: General malaise
         subjects affected / exposed
    10 / 22 (45.45%)
    9 / 31 (29.03%)
    6 / 31 (19.35%)
    6 / 27 (22.22%)
    1 / 11 (9.09%)
    2 / 11 (18.18%)
    13 / 21 (61.90%)
    9 / 31 (29.03%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    10
    9
    6
    6
    1
    2
    13
    9
    0
    0
    0
    0
    0
    0
    0
    Lymph node palpable
    Additional description: Swollen lymph node at the side of injection
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 21 (4.76%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    Menstruation irregular
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    2 / 31 (6.45%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Pain
    Additional description: Pain at the injection site
         subjects affected / exposed
    22 / 22 (100.00%)
    28 / 31 (90.32%)
    24 / 31 (77.42%)
    15 / 27 (55.56%)
    2 / 11 (18.18%)
    4 / 11 (36.36%)
    19 / 21 (90.48%)
    24 / 31 (77.42%)
    2 / 10 (20.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    22
    28
    24
    15
    2
    4
    19
    24
    2
    0
    0
    0
    0
    0
    0
    Swelling
    Additional description: Swelling at the injection site
         subjects affected / exposed
    4 / 22 (18.18%)
    7 / 31 (22.58%)
    3 / 31 (9.68%)
    2 / 27 (7.41%)
    1 / 11 (9.09%)
    1 / 11 (9.09%)
    7 / 21 (33.33%)
    4 / 31 (12.90%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    4
    7
    3
    2
    1
    1
    7
    4
    0
    0
    0
    0
    0
    0
    0
    Accident
    Additional description: Bike accident
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 21 (4.76%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    Nose deformity
    Additional description: Broken nose
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Cardiac disorders
    Chest pain
         subjects affected / exposed
    0 / 22 (0.00%)
    11 / 31 (35.48%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    11
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 22 (45.45%)
    8 / 31 (25.81%)
    9 / 31 (29.03%)
    4 / 27 (14.81%)
    2 / 11 (18.18%)
    1 / 11 (9.09%)
    16 / 21 (76.19%)
    7 / 31 (22.58%)
    2 / 10 (20.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    10
    8
    9
    4
    2
    1
    16
    7
    2
    0
    0
    0
    0
    0
    0
    Dizziness
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Sensitive skin
    Additional description: Tingling of mouth and tongue
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nerve compression
    Additional description: Nerve pain
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Erythema
    Additional description: Redness on the back or abdomen
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    2 / 31 (6.45%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Iron deficiency
    Additional description: Decreased ferritine levels
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    1 / 31 (3.23%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Ear infection
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Hearing disability
    Additional description: Age-related hearing loss
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Eye disorders
    Corneal infection
    Additional description: Inflammation
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    1 / 22 (4.55%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Sight disability
    Additional description: Loss of sight
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    5 / 22 (22.73%)
    3 / 31 (9.68%)
    4 / 31 (12.90%)
    3 / 27 (11.11%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    6 / 21 (28.57%)
    5 / 31 (16.13%)
    1 / 10 (10.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    5
    3
    4
    3
    0
    1
    6
    5
    1
    0
    0
    0
    0
    0
    0
    Abdominal discomfort
    Additional description: Abdominal cramps
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 27 (3.70%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Infection
    Additional description: Viral gastroenteritis, stomach flu
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    2 / 22 (9.09%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    1
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    1 / 22 (4.55%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    Flatulence
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    1 / 22 (4.55%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Defaecation disorder
    Additional description: Change in defaecation pattern
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Erythema
    Additional description: Redness at the injection site
         subjects affected / exposed
    4 / 22 (18.18%)
    7 / 31 (22.58%)
    3 / 31 (9.68%)
    2 / 27 (7.41%)
    1 / 11 (9.09%)
    1 / 11 (9.09%)
    8 / 21 (38.10%)
    8 / 31 (25.81%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    4
    7
    3
    2
    1
    1
    8
    8
    0
    0
    0
    0
    0
    0
    0
    Rash
    Additional description: Skin rash
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Eczema
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Herpes simplex
    Additional description: Cold sores
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 27 (3.70%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Urticaria
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    1 / 22 (4.55%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Itching scar
    Additional description: Itch on skin
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    1 / 27 (3.70%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    1
    0
    Lipoma excision
    Additional description: Lipoma excision in spine
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 27 (3.70%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    15 / 22 (68.18%)
    9 / 31 (29.03%)
    15 / 31 (48.39%)
    7 / 27 (25.93%)
    2 / 11 (18.18%)
    2 / 11 (18.18%)
    17 / 21 (80.95%)
    8 / 31 (25.81%)
    2 / 10 (20.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    15
    9
    15
    7
    2
    2
    17
    8
    2
    0
    0
    0
    0
    0
    0
    Joint stiffness
    Additional description: Joint pain/stiffness
         subjects affected / exposed
    2 / 22 (9.09%)
    5 / 31 (16.13%)
    2 / 31 (6.45%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    2 / 21 (9.52%)
    5 / 31 (16.13%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    2
    5
    2
    0
    0
    0
    2
    5
    0
    0
    1
    0
    0
    0
    0
    Back pain
         subjects affected / exposed
    1 / 22 (4.55%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 27 (3.70%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Pain in extremity
    Additional description: Pain in hand
         subjects affected / exposed
    0 / 22 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pain in jaw
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    1 / 31 (3.23%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Trigger finger
    Additional description: Trigger finger operation
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 27 (3.70%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Infections and infestations
    Chills
         subjects affected / exposed
    6 / 22 (27.27%)
    7 / 31 (22.58%)
    4 / 31 (12.90%)
    3 / 27 (11.11%)
    1 / 11 (9.09%)
    1 / 11 (9.09%)
    10 / 21 (47.62%)
    3 / 31 (9.68%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    6
    7
    4
    3
    1
    1
    10
    3
    0
    0
    0
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 22 (0.00%)
    2 / 31 (6.45%)
    2 / 31 (6.45%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 21 (4.76%)
    1 / 31 (3.23%)
    0 / 10 (0.00%)
    1 / 22 (4.55%)
    1 / 31 (3.23%)
    3 / 31 (9.68%)
    1 / 27 (3.70%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    2
    2
    0
    0
    0
    1
    1
    0
    1
    1
    3
    1
    0
    1
    Throat irritation
    Additional description: Irritation/ache
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 27 (3.70%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    COVID-19
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    4 / 22 (18.18%)
    1 / 31 (3.23%)
    7 / 31 (22.58%)
    2 / 27 (7.41%)
    1 / 11 (9.09%)
    3 / 11 (27.27%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    1
    7
    2
    1
    3
    Urinary tract infection
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Mumps
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Cough
         subjects affected / exposed
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 21 (0.00%)
    0 / 31 (0.00%)
    0 / 10 (0.00%)
    0 / 22 (0.00%)
    0 / 31 (0.00%)
    2 / 31 (6.45%)
    0 / 27 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Sep 2021
    Clarification of the participant inclusion and addition of the “pre-visit”. Pre-visits will be planned with the interested volunteers to discuss the study in detail and allow them to ask their questions. If they would like to participate, an informed consent form will be signed and they will be randomized into one of the study groups. Then the D0 visit (baseline) will be planned later.
    12 Nov 2021
    Change of the inclusion/exclusion criteria. The lower limit for inclusion for the older adults groups was decreased from 65 to 60. Medication use (except for immunomodulatory drugs) was allowed. Furthermore, having a recent (during 2021/2022 season) influenza vaccination was added as an exclusion factor.
    24 Dec 2021
    As the older participant recruitments went very slow, the exclusion criterium of having vaccinated with an influenza vaccine was removed. The recruited participants were scheduled to get an influenza vaccine in the next flu season.

    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
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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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