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    Clinical Trial Results:
    Imovax® Rabies and VERORAB® Immunogenicity and Safety after One Week 2-sites Intradermal or 1-site Intramuscular Pre- Exposure Prophylaxis Regimens, Followed by a Simulated Intradermal or Intramuscular Post-Exposure Prophylaxis Regimen at One Year

    Summary
    EudraCT number
    		 2020-001223-14
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    08 Apr 2020

    Results information
    Results version number
    		 v1
    This version publication date
    14 Apr 2021
    First version publication date
    14 Apr 2021
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    VAJ00001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03700242
    WHO universal trial number (UTN)
    		 U1111-1183-5743
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur
    Sponsor organisation address
    14, Espace Henry Vallée, Lyon, France, 69007
    Public contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Jan 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Apr 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that a short intramuscular (IM) pre-exposure prophylaxis (PrEP) regimen is non-inferior to the reference IM PrEP regimen in terms of seroconversion rate 14 days (D) after the last PrEP vaccination (Vacc.) with human diploid cell vaccine (HDCV) (Group 1 versus Group 2).
    Protection of trial subjects
    Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment were also available on site in case of any immediate allergic reactions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Sep 2018
    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
    Philippines: 570
    Worldwide total number of subjects
    570
    EEA total number of subjects
    0
    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)
    165
    Adolescents (12-17 years)
    91
    Adults (18-64 years)
    314
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted at 2 centres in the Philippines. A total of 570 subjects were enrolled between 26 September 2018 and 19 February 2019.

    Pre-assignment
    Screening details
    		 A total of 570 subjects were enrolled and randomised in the study.

    Period 1
    Period 1 title
    PrEP vaccination phase: up to 6.5 Months
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: Short HDCV IM PrEP Regimen
    Arm description
    		 Subjects received a single IM dose of HDCV on Day 0 and Day 7 and were followed up to 1 year post last PrEP vaccination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Human Diploid Cell Vaccine
    Investigational medicinal product code
    Other name
    Imovax® Rabies
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 millitre (mL), single IM injection on the deltoid area of the arm.

    Arm title
    		 Group 2: Reference HDCV IM PrEP Regimen
    Arm description
    		 Subjects received a single IM dose of HDCV on Day 0, Day 7, and Day 21 and were followed up to 1 year post last PrEP vaccination.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Human Diploid Cell Vaccine
    Investigational medicinal product code
    Other name
    Imovax® Rabies
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 mL, single IM injection on the deltoid area of the arm.

    Arm title
    		 Group 3: Short HDCV Intradermal (ID) PrEP regimen
    Arm description
    		 Subjects received two ID doses of HDCV on Day 0 and Day 7 and were followed up to 1 year post last PrEP vaccination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Human Diploid Cell Vaccine
    Investigational medicinal product code
    Other name
    Imovax® Rabies
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    0.1 mL, two injections on deltoid area of both the arm.

    Arm title
    		 Group 4: Short PVRV IM PrEP regimen
    Arm description
    		 Subjects received a single IM dose of purified Vero cell rabies vaccine (PVRV) on Day 0 and Day 7 and were followed up to 1 year post last PrEP vaccination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Purified Vero cell Rabies Vaccine
    Investigational medicinal product code
    Other name
    Verorab®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, single IM injection on the deltoid area of the arm.

    Arm title
    		 Group 5: Short PVRV ID PrEP regimen
    Arm description
    		 Subjects received two ID doses of PVRV on Day 0 and Day 7 and were followed up to 1 year post last PrEP vaccination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Purified Vero cell Rabies Vaccine
    Investigational medicinal product code
    Other name
    Verorab®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    0.1 mL, two ID injections on deltoid area of both the arms.

    Number of subjects in period 1
    		Group 1: Short HDCV IM PrEP Regimen Group 2: Reference HDCV IM PrEP Regimen Group 3: Short HDCV Intradermal (ID) PrEP regimen Group 4: Short PVRV IM PrEP regimen Group 5: Short PVRV ID PrEP regimen
    Started
    228
    115
    77
    75
    75
    Completed
    227
    115
    77
    75
    74
    Not completed
    1
    0
    0
    0
    1
         Voluntary withdrawal not due to an adverse event
    1
    -
    -
    -
    1
    Period 2
    Period 2 title
    PEP Vaccination Phase: up to 5.8 Months
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: Short HDCV IM Post-exposure Prophylaxis (PEP) Regimen
    Arm description
    		 Pre-immunised subjects received a single IM dose of HDCV on Year 1 and Year 1 + 3 days, post last PrEP vaccination and were followed up for 31 days post last PEP vaccination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Human Diploid Cell Vaccine
    Investigational medicinal product code
    Other name
    Imovax® Rabies
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 mL, single IM injection on the deltoid area of the arm.

    Arm title
    		 Group 2: Reference HDCV IM PEP Regimen
    Arm description
    		 Pre-immunised subjects received a single IM dose of HDCV on Year 1 and Year 1 + 3 days, post last PrEP vaccination and were followed up for 31 days post last PEP vaccination.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Human Diploid Cell Vaccine
    Investigational medicinal product code
    Other name
    Imovax® Rabies
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 mL, single IM injection on the deltoid area of the arm.

    Arm title
    		 Group 3: Short HDCV ID PEP regimen
    Arm description
    		 Pre-immunised subjects received a single ID dose of HDCV on Year 1 and Year 1 + 3 days, post last PrEP vaccination and were followed up for 31 days post last PEP vaccination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Human Diploid Cell Vaccine
    Investigational medicinal product code
    Other name
    Imovax® Rabies
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    0.1 mL, single ID injection on deltoid area of both the arm.

    Arm title
    		 Group 4: Short PVRV IM PEP regimen
    Arm description
    		 Pre-immunised subjects received a single IM dose of PVRV on Year 1 and on Year 1 + 3 days, post last PrEP vaccination and were followed up for 31 days post last PEP vaccination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Purified Vero cell Rabies Vaccine
    Investigational medicinal product code
    Other name
    Verorab®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, single IM injection on the deltoid area of the arm.

    Arm title
    		 Group 5: Short PVRV ID PEP regimen
    Arm description
    		 Pre-immunised subjects received a single ID dose of PVRV on Year 1 and Year 1 + 3 days, post last PrEP vaccination and were followed up for 31 days post last PEP vaccination.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Purified Vero cell Rabies Vaccine
    Investigational medicinal product code
    Other name
    Verorab®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    0.1 mL, single ID injection on deltoid area of both the arms.

    Number of subjects in period 2 [1]
    		Group 1: Short HDCV IM Post-exposure Prophylaxis (PEP) Regimen Group 2: Reference HDCV IM PEP Regimen Group 3: Short HDCV ID PEP regimen Group 4: Short PVRV IM PEP regimen Group 5: Short PVRV ID PEP regimen
    Started
    200
    107
    68
    68
    71
    Completed
    199
    107
    68
    68
    71
    Not completed
    1
    0
    0
    0
    0
         Voluntary withdrawal not due to an adverse event
    1
    -
    -
    -
    -
    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: Post PrEP phase, only pre-immunised subjects were vaccinated with a simulated PEP regimen.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Group 1: Short HDCV IM PrEP Regimen
    Reporting group description
    		 Subjects received a single IM dose of HDCV on Day 0 and Day 7 and were followed up to 1 year post last PrEP vaccination.

    Reporting group title
    Group 2: Reference HDCV IM PrEP Regimen
    Reporting group description
    		 Subjects received a single IM dose of HDCV on Day 0, Day 7, and Day 21 and were followed up to 1 year post last PrEP vaccination.

    Reporting group title
    Group 3: Short HDCV Intradermal (ID) PrEP regimen
    Reporting group description
    		 Subjects received two ID doses of HDCV on Day 0 and Day 7 and were followed up to 1 year post last PrEP vaccination.

    Reporting group title
    Group 4: Short PVRV IM PrEP regimen
    Reporting group description
    		 Subjects received a single IM dose of purified Vero cell rabies vaccine (PVRV) on Day 0 and Day 7 and were followed up to 1 year post last PrEP vaccination.

    Reporting group title
    Group 5: Short PVRV ID PrEP regimen
    Reporting group description
    		 Subjects received two ID doses of PVRV on Day 0 and Day 7 and were followed up to 1 year post last PrEP vaccination.

    Reporting group values
    		 Group 1: Short HDCV IM PrEP Regimen Group 2: Reference HDCV IM PrEP Regimen Group 3: Short HDCV Intradermal (ID) PrEP regimen Group 4: Short PVRV IM PrEP regimen Group 5: Short PVRV ID PrEP regimen Total
    Number of subjects
    		 228 115 77 75 75 570
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 22.5 ± 13.63 24.1 ± 14.74 19.2 ± 12.98 22.6 ± 14.19 23.8 ± 15.33 -
    Gender categorical
    Units: Subjects
        Female
    		 113 67 41 41 39 301
        Male
    		 115 48 36 34 36 269

    End points

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    End points reporting groups
    Reporting group title
    Group 1: Short HDCV IM PrEP Regimen
    Reporting group description
    		 Subjects received a single IM dose of HDCV on Day 0 and Day 7 and were followed up to 1 year post last PrEP vaccination.

    Reporting group title
    Group 2: Reference HDCV IM PrEP Regimen
    Reporting group description
    		 Subjects received a single IM dose of HDCV on Day 0, Day 7, and Day 21 and were followed up to 1 year post last PrEP vaccination.

    Reporting group title
    Group 3: Short HDCV Intradermal (ID) PrEP regimen
    Reporting group description
    		 Subjects received two ID doses of HDCV on Day 0 and Day 7 and were followed up to 1 year post last PrEP vaccination.

    Reporting group title
    Group 4: Short PVRV IM PrEP regimen
    Reporting group description
    		 Subjects received a single IM dose of purified Vero cell rabies vaccine (PVRV) on Day 0 and Day 7 and were followed up to 1 year post last PrEP vaccination.

    Reporting group title
    Group 5: Short PVRV ID PrEP regimen
    Reporting group description
    		 Subjects received two ID doses of PVRV on Day 0 and Day 7 and were followed up to 1 year post last PrEP vaccination.
    Reporting group title
    Group 1: Short HDCV IM Post-exposure Prophylaxis (PEP) Regimen
    Reporting group description
    		 Pre-immunised subjects received a single IM dose of HDCV on Year 1 and Year 1 + 3 days, post last PrEP vaccination and were followed up for 31 days post last PEP vaccination.

    Reporting group title
    Group 2: Reference HDCV IM PEP Regimen
    Reporting group description
    		 Pre-immunised subjects received a single IM dose of HDCV on Year 1 and Year 1 + 3 days, post last PrEP vaccination and were followed up for 31 days post last PEP vaccination.

    Reporting group title
    Group 3: Short HDCV ID PEP regimen
    Reporting group description
    		 Pre-immunised subjects received a single ID dose of HDCV on Year 1 and Year 1 + 3 days, post last PrEP vaccination and were followed up for 31 days post last PEP vaccination.

    Reporting group title
    Group 4: Short PVRV IM PEP regimen
    Reporting group description
    		 Pre-immunised subjects received a single IM dose of PVRV on Year 1 and on Year 1 + 3 days, post last PrEP vaccination and were followed up for 31 days post last PEP vaccination.

    Reporting group title
    Group 5: Short PVRV ID PEP regimen
    Reporting group description
    		 Pre-immunised subjects received a single ID dose of PVRV on Year 1 and Year 1 + 3 days, post last PrEP vaccination and were followed up for 31 days post last PEP vaccination.

    Primary: Percentage of Subjects With Rabies Virus Neutralising Antibodies (RVNA) Titer Greater Than or Equal to (>=) 0.5 International Units Per Millilitre (IU/mL) After Last PrEP Vaccination with HDCV: Group 1 and Group 2

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    End point title
    		 Percentage of Subjects With Rabies Virus Neutralising Antibodies (RVNA) Titer Greater Than or Equal to (>=) 0.5 International Units Per Millilitre (IU/mL) After Last PrEP Vaccination with HDCV: Group 1 and Group 2 [1]
    End point description
    RVNA titer was assessed using the rapid fluorescent focus inhibition test (RFFIT) assay method. Analysis was performed on the PrEP Per-Protocol Analysis Set (PPAS) that included all randomised subjects who received at least one dose of the study vaccines during the PrEP period and had no relevant protocol deviations.
    End point type
    Primary
    End point timeframe
    14 days after last PrEP vaccination (i.e. Day 21 for Group 1; Day 35 for Group 2)
    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: Data for this endpoint was not planned to be collected and analysed for Group 3, 4 and 5, as pre-specified in protocol.
    End point values
    		 Group 1: Short HDCV IM PrEP Regimen Group 2: Reference HDCV IM PrEP Regimen
    Number of subjects analysed
    209
    109
    Units: percentage of subjects
        number (confidence interval 95%)
    96.7 (93.2 to 98.6)
    100.0 (96.7 to 100.0)
    Statistical analysis title
    		 Group 1 versus Group 2
    Comparison groups
    Group 1: Short HDCV IM PrEP Regimen v Group 2: Reference HDCV IM PrEP Regimen
    Number of subjects included in analysis
    318
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -3.349
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.751
         upper limit
    		 0.464
    Notes
    [2] - Non-inferiority was demonstrated if the lower limit of the 95% confidence interval of the difference of the 2 percentages (Group1-Group2) was greater than (>) -5%.

    Secondary: Percentage of Subjects With RVNA Titer >= 0.5 IU/mL at Day 0 (pre-vaccination) and 14 Days After Last PrEP Vaccination with HDCV or PVRV

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    End point title
    		 Percentage of Subjects With RVNA Titer >= 0.5 IU/mL at Day 0 (pre-vaccination) and 14 Days After Last PrEP Vaccination with HDCV or PVRV
    End point description
    RVNA titer was assessed using the RFFIT assay method. Analysis was performed on the PrEP Full Analysis Set (FAS) that included all randomised subjects who received at least 1 dose of the study vaccines during the PrEP period. Here, ‘n’= subjects with available data for each specified category. Here, '99999' was used as space fillers and signifies that the subjects of the respective groups did not receive any vaccination at the specified time-point and therefore were not evaluable.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and 14 days after last PrEP vaccination (i.e. Day 21 for Groups 1, 3, 4 and 5; Day 35 for Group 2)
    End point values
    		 Group 1: Short HDCV IM PrEP Regimen Group 2: Reference HDCV IM PrEP Regimen Group 3: Short HDCV Intradermal (ID) PrEP regimen Group 4: Short PVRV IM PrEP regimen Group 5: Short PVRV ID PrEP regimen
    Number of subjects analysed
    228
    115
    77
    75
    75
    Units: percentage of subjects
    number (confidence interval 95%)
        Day 0 (n=226, 115, 76, 74, 73)
    0.4 (0.0 to 2.4)
    2.6 (0.5 to 7.4)
    1.3 (0.0 to 7.1)
    1.4 (0.0 to 7.3)
    1.4 (0.0 to 7.4)
        Day 21 (n=214, 0, 74, 70, 71)
    96.7 (93.4 to 98.7)
    99999 (99999 to 99999)
    98.6 (92.7 to 100.0)
    98.6 (92.3 to 100.0)
    97.2 (90.2 to 99.7)
        Day 35 (n= 0, 112, 0, 0, 0)
    99999 (99999 to 99999)
    100.0 (96.8 to 100.0)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With RVNA Titer >= 0.2 IU/mL at Day 0 (pre-vaccination) and 14 Days After Last PrEP Vaccination with HDCV or PVRV

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    End point title
    		 Percentage of Subjects With RVNA Titer >= 0.2 IU/mL at Day 0 (pre-vaccination) and 14 Days After Last PrEP Vaccination with HDCV or PVRV
    End point description
    RVNA titer was assessed using the RFFIT assay method. Analysis was performed on the PrEP FAS population. Here, ‘n’= subjects with available data for each specified category. Here, '99999' was used as space fillers and signifies that the subjects of the respective groups did not receive any vaccination at the specified time-point and therefore were not evaluable.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and 14 days after last PrEP vaccination (i.e. Day 21 for Groups 1, 3, 4 and 5; Day 35 for Group 2)
    End point values
    		 Group 1: Short HDCV IM PrEP Regimen Group 2: Reference HDCV IM PrEP Regimen Group 3: Short HDCV Intradermal (ID) PrEP regimen Group 4: Short PVRV IM PrEP regimen Group 5: Short PVRV ID PrEP regimen
    Number of subjects analysed
    228
    115
    77
    75
    75
    Units: percentage of subjects
    number (confidence interval 95%)
        Day 0 (n=226, 115, 76, 74, 73)
    1.3 (0.3 to 3.8)
    2.6 (0.5 to 7.4)
    1.3 (0.0 to 7.1)
    4.1 (0.8 to 11.4)
    1.4 (0.0 to 7.4)
        Day 21 (n=214, 0, 74, 70, 71)
    99.5 (97.4 to 100.0)
    99999 (99999 to 99999)
    100.0 (95.1 to 100.0)
    100.0 (94.9 to 100.0)
    98.6 (92.4 to 100.0)
        Day 35 (n=0, 112, 0, 0, 0)
    99999 (99999 to 99999)
    100.0 (96.8 to 100.0)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of RVNA at Day 0 (pre-vaccination) and 14 Days After Last PrEP Vaccination with HDCV or PVRV

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    End point title
    		 Geometric Mean Titers (GMTs) of RVNA at Day 0 (pre-vaccination) and 14 Days After Last PrEP Vaccination with HDCV or PVRV
    End point description
    RVNA titers was assessed using the RFFIT assay method and expressed in terms of IU/mL. Analysis was performed on the PrEP FAS population. Here, ‘n’= subjects with available data for each specified category. Here, '99999' was used as space fillers and signifies that the subjects of the respective groups did not receive any vaccination at the specified time-point and therefore were not evaluable.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and 14 days after last PrEP vaccination (i.e. Day 21 for Groups 1, 3, 4 and 5; Day 35 for Group 2)
    End point values
    		 Group 1: Short HDCV IM PrEP Regimen Group 2: Reference HDCV IM PrEP Regimen Group 3: Short HDCV Intradermal (ID) PrEP regimen Group 4: Short PVRV IM PrEP regimen Group 5: Short PVRV ID PrEP regimen
    Number of subjects analysed
    228
    115
    77
    75
    75
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Day 0 (n=226, 115, 76, 74, 73)
    0.102 (0.100 to 0.105)
    0.109 (0.099 to 0.121)
    0.102 (0.098 to 0.107)
    0.110 (0.098 to 0.123)
    0.108 (0.094 to 0.124)
        Day 21 (n=214, 0, 74, 70, 71)
    3.18 (2.76 to 3.67)
    99999 (99999 to 99999)
    3.30 (2.55 to 4.28)
    5.06 (3.94 to 6.50)
    6.38 (4.64 to 8.77)
        Day 35 (n=0, 112, 0, 0, 0)
    99999 (99999 to 99999)
    12.6 (10.8 to 14.7)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer Ratio (GMTR) of RVNA Following PrEP Vaccination with HDCV or PVRV

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    End point title
    		 Geometric Mean Titer Ratio (GMTR) of RVNA Following PrEP Vaccination with HDCV or PVRV
    End point description
    RVNA titer was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs of 14 days after last PrEP vaccination and GMTs of pre-vaccination. Analysis was performed on the PrEP FAS population. Here, ‘n’= subjects with available data for each specified category. Here, '99999' was used as space fillers and signifies that the subjects of the respective groups did not receive any vaccination at the specified time-point and therefore were not evaluable.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and 14 days after last PrEP vaccination (i.e. Day 21 for Groups 1, 3, 4 and 5; Day 35 for Group 2)
    End point values
    		 Group 1: Short HDCV IM PrEP Regimen Group 2: Reference HDCV IM PrEP Regimen Group 3: Short HDCV Intradermal (ID) PrEP regimen Group 4: Short PVRV IM PrEP regimen Group 5: Short PVRV ID PrEP regimen
    Number of subjects analysed
    228
    115
    77
    75
    75
    Units: ratio
    geometric mean (confidence interval 95%)
        Day 21/Day 0 (n=212, 0, 73, 69, 70)
    30.7 (26.7 to 35.2)
    99999 (99999 to 99999)
    31.1 (24.6 to 39.3)
    44.9 (35.9 to 56.2)
    59.2 (42.8 to 81.9)
        Day 35/Day 0 (n=0, 112, 0, 0, 0)
    99999 (99999 to 99999)
    115 (98.2 to 134)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With RVNA Titer >= 0.5 IU/mL at 6 Months and 1 Year After Last PrEP Vaccination with HDCV or PVRV

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    End point title
    		 Percentage of Subjects With RVNA Titer >= 0.5 IU/mL at 6 Months and 1 Year After Last PrEP Vaccination with HDCV or PVRV
    End point description
    RVNA titer was assessed using the RFFIT assay method. Analysis was performed on the PrEP FAS population. Here, ‘n’= subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    6 months (i.e. Day 180) and 1 year (i.e. Year 1) after last PrEP vaccination
    End point values
    		 Group 1: Short HDCV IM PrEP Regimen Group 2: Reference HDCV IM PrEP Regimen Group 3: Short HDCV Intradermal (ID) PrEP regimen Group 4: Short PVRV IM PrEP regimen Group 5: Short PVRV ID PrEP regimen
    Number of subjects analysed
    228
    115
    77
    75
    75
    Units: percentage of subjects
    number (confidence interval 95%)
        Day 180 (n=216, 105, 73, 70, 69)
    45.8 (39.1 to 52.7)
    55.2 (45.2 to 65.0)
    45.2 (33.5 to 57.3)
    58.6 (46.2 to 70.2)
    65.2 (52.8 to 76.3)
        Year 1 (n=211,110,73,71,72)
    57.8 (50.8 to 64.6)
    62.7 (53.0 to 71.8)
    58.9 (46.8 to 70.3)
    64.8 (52.5 to 75.8)
    77.8 (66.4 to 86.7)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With RVNA Titer >= 0.2 IU/mL at 6 Months and 1 Year After Last PrEP Vaccination with HDCV or PVRV

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    End point title
    		 Percentage of Subjects With RVNA Titer >= 0.2 IU/mL at 6 Months and 1 Year After Last PrEP Vaccination with HDCV or PVRV
    End point description
    RVNA titer was assessed using the RFFIT assay method. Analysis was performed on the PrEP FAS population. Here, ‘n’= subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    6 months (i.e. Day 180) and 1 year (i.e. Year 1) after last PrEP vaccination
    End point values
    		 Group 1: Short HDCV IM PrEP Regimen Group 2: Reference HDCV IM PrEP Regimen Group 3: Short HDCV Intradermal (ID) PrEP regimen Group 4: Short PVRV IM PrEP regimen Group 5: Short PVRV ID PrEP regimen
    Number of subjects analysed
    228
    115
    77
    75
    75
    Units: percentage of subjects
    number (confidence interval 95%)
        Day 180 (n=216, 105, 73, 70, 69)
    71.8 (65.3 to 77.7)
    88.6 (80.9 to 94.0)
    75.3 (63.9 to 84.7)
    85.7 (75.3 to 92.9)
    88.4 (78.4 to 94.9)
        Year 1 (n=211,110,73,71,72)
    78.7 (72.5 to 84.0)
    86.4 (78.5 to 92.2)
    89.0 (79.5 to 95.1)
    87.3 (77.3 to 94.0)
    87.5 (77.6 to 94.1)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of RVNA at 6 Months and 1 Year After Last PrEP Vaccination with HDCV or PVRV

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    End point title
    		 Geometric Mean Titers of RVNA at 6 Months and 1 Year After Last PrEP Vaccination with HDCV or PVRV
    End point description
    RVNA titer was assessed using the RFFIT assay method and expressed in terms of IU/mL. Analysis was performed on the PrEP FAS population. Here, ‘n’= subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    6 months (i.e. Day 180) and 1 year (i.e. Year 1) after last PrEP vaccination
    End point values
    		 Group 1: Short HDCV IM PrEP Regimen Group 2: Reference HDCV IM PrEP Regimen Group 3: Short HDCV Intradermal (ID) PrEP regimen Group 4: Short PVRV IM PrEP regimen Group 5: Short PVRV ID PrEP regimen
    Number of subjects analysed
    228
    115
    77
    75
    75
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Day 180 (n=216, 105, 73, 70, 69)
    0.443 (0.380 to 0.516)
    0.695 (0.550 to 0.880)
    0.453 (0.349 to 0.588)
    0.639 (0.487 to 0.838)
    0.808 (0.593 to 1.10)
        Year 1 (n=211,110,73,71,72)
    0.607 (0.510 to 0.723)
    0.769 (0.605 to 0.979)
    0.710 (0.530 to 0.950)
    0.819 (0.613 to 1.09)
    0.934 (0.712 to 1.23)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer Ratio (GMTR) of RVNA at 6 Months After Last PrEP Vaccination with HDCV or PVRV

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    End point title
    		 Geometric Mean Titer Ratio (GMTR) of RVNA at 6 Months After Last PrEP Vaccination with HDCV or PVRV
    End point description
    RVNA titer was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs of 6 months after last PrEP vaccination and GMTs of 14 days after last PrEP vaccination. Analysis was performed on the PrEP FAS population. Here, ‘n’= subjects with available data for each specified category. Here, '99999' was used as space fillers and signifies that the subjects of the respective groups did not receive any vaccination at the specified time-point and therefore were not evaluable.
    End point type
    Secondary
    End point timeframe
    14 days (i.e. Day 21 for Groups 1, 3, 4 and 5; Day 35 for Group 2) and 6 months (i.e. Day 180) after last PrEP vaccination
    End point values
    		 Group 1: Short HDCV IM PrEP Regimen Group 2: Reference HDCV IM PrEP Regimen Group 3: Short HDCV Intradermal (ID) PrEP regimen Group 4: Short PVRV IM PrEP regimen Group 5: Short PVRV ID PrEP regimen
    Number of subjects analysed
    228
    115
    70
    75
    75
    Units: ratio
    geometric mean (confidence interval 95%)
        Day 180/Day 21 (n=203, 0, 70, 65, 65)
    0.145 (0.127 to 0.165)
    99999 (99999 to 99999)
    0.144 (0.118 to 0.177)
    0.137 (0.113 to 0.165)
    0.130 (0.103 to 0.163)
        Day 180/Day 35 (n=0, 102, 0, 0, 0)
    99999 (99999 to 99999)
    0.057 (0.048 to 0.068)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer Ratio (GMTR) of RVNA at 1 Year After Last PrEP Vaccination with HDCV or PVRV

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    End point title
    		 Geometric Mean Titer Ratio (GMTR) of RVNA at 1 Year After Last PrEP Vaccination with HDCV or PVRV
    End point description
    RVNA titer was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs of 1 year after last PrEP vaccination and GMTs of 14 days after last PrEP vaccination. Analysis was performed on the PrEP FAS population. Here, ‘n’= subjects with available data for each specified category. Here, '99999' was used as space fillers and signifies that the subjects of the respective groups did not receive any vaccination at the specified time-point and therefore were not evaluable.
    End point type
    Secondary
    End point timeframe
    14 days (i.e. Day 21 for Groups 1, 3, 4 and 5; Day 35 for Group 2) and 1 year (i.e. Year 1) after last PrEP vaccination
    End point values
    		 Group 1: Short HDCV IM PrEP Regimen Group 2: Reference HDCV IM PrEP Regimen Group 3: Short HDCV Intradermal (ID) PrEP regimen Group 4: Short PVRV IM PrEP regimen Group 5: Short PVRV ID PrEP regimen
    Number of subjects analysed
    228
    115
    77
    75
    75
    Units: ratio
    geometric mean (confidence interval 95%)
        Year 1/Day 21 (n= 198, 0, 70, 66, 69)
    0.186 (0.160 to 0.218)
    99999 (99999 to 99999)
    0.211 (0.164 to 0.272)
    0.174 (0.138 to 0.219)
    0.162 (0.130 to 0.201)
        Year 1/Day 35 (n=0, 107, 0, 0, 0)
    99999 (99999 to 99999)
    0.061 (0.050 to 0.076)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With RVNA Titer >=0.5 IU/mL at 7 Days and 14 Days After First Simulated PEP Vaccination With HDCV or PVRV

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    End point title
    		 Percentage of Subjects With RVNA Titer >=0.5 IU/mL at 7 Days and 14 Days After First Simulated PEP Vaccination With HDCV or PVRV
    End point description
    RVNA titer was assessed using the RFFIT assay method. Analysis was performed on the PEP FAS population that included subjects who received at least 1 dose of the study vaccines during the simulated PEP period. Here, ‘n’= subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    7 days (i.e. Year 1 + 7 days) and 14 days (i.e. Year 1 + 14 days) after first simulated PEP vaccination
    End point values
    		 Group 1: Short HDCV IM Post-exposure Prophylaxis (PEP) Regimen Group 2: Reference HDCV IM PEP Regimen Group 3: Short HDCV ID PEP regimen Group 4: Short PVRV IM PEP regimen Group 5: Short PVRV ID PEP regimen
    Number of subjects analysed
    200
    107
    68
    68
    71
    Units: percentage of subjects
    number (confidence interval 95%)
        Year 1 + 7 days (n=198,106,68,68,71)
    100.0 (98.2 to 100.0)
    100.0 (96.6 to 100.0)
    100.0 (94.7 to 100.0)
    100.0 (94.7 to 100.0)
    98.6 (92.4 to 100.0)
        Year 1 + 14 days (n=193,101,66,63,70)
    100.0 (98.1 to 100.0)
    100.0 (96.4 to 100.0)
    100.0 (94.6 to 100.0)
    100.0 (94.3 to 100.0)
    98.6 (92.3 to 100.0)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With RVNA Titer >=0.2 IU/mL at 7 Days and 14 Days After First Simulated PEP Vaccination With HDCV or PVRV

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    End point title
    		 Percentage of Subjects With RVNA Titer >=0.2 IU/mL at 7 Days and 14 Days After First Simulated PEP Vaccination With HDCV or PVRV
    End point description
    RVNA titer was assessed using the RFFIT assay method. Analysis was performed on the PEP FAS population. Here, ‘n’= subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    7 days (i.e. Year 1 + 7 days) and 14 days (i.e. Year 1 + 14 days) after first simulated PEP vaccination
    End point values
    		 Group 1: Short HDCV IM Post-exposure Prophylaxis (PEP) Regimen Group 2: Reference HDCV IM PEP Regimen Group 3: Short HDCV ID PEP regimen Group 4: Short PVRV IM PEP regimen Group 5: Short PVRV ID PEP regimen
    Number of subjects analysed
    200
    107
    68
    68
    71
    Units: percentage of subjects
    number (confidence interval 95%)
        Year 1 + 7 days (n=198,106,68,68,71)
    100.0 (98.2 to 100.0)
    100.0 (96.6 to 100.0)
    100.0 (94.7 to 100.0)
    100.0 (94.7 to 100.0)
    98.6 (92.4 to 100.0)
        Year 1 + 14 days (n=193,101,66,63,70)
    100.0 (98.1 to 100.0)
    100.0 (96.4 to 100.0)
    100.0 (94.6 to 100.0)
    100.0 (94.3 to 100.0)
    98.6 (92.3 to 100.0)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of RVNA at 7 Days and 14 Days After First Simulated PEP Vaccination With HDCV or PVRV

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    End point title
    		 Geometric Mean Titers of RVNA at 7 Days and 14 Days After First Simulated PEP Vaccination With HDCV or PVRV
    End point description
    RVNA titer was assessed using the RFFIT assay method and expressed in terms of IU/mL. Analysis was performed on the PEP FAS population. Here, ‘n’= subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    7 days (i.e. Year 1 + 7 days) and 14 days (i.e. Year 1 + 14 days) after first simulated PEP vaccination
    End point values
    		 Group 1: Short HDCV IM Post-exposure Prophylaxis (PEP) Regimen Group 2: Reference HDCV IM PEP Regimen Group 3: Short HDCV ID PEP regimen Group 4: Short PVRV IM PEP regimen Group 5: Short PVRV ID PEP regimen
    Number of subjects analysed
    200
    107
    68
    68
    71
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Year 1 + 7 days (n=198,106,68,68,71)
    32.4 (27.4 to 38.3)
    25.3 (20.9 to 30.6)
    13.6 (10.7 to 17.3)
    44.8 (35.1 to 57.1)
    18.5 (14.0 to 24.4)
        Year 1 + 14 days (n=193,101,66,63,70)
    71.6 (61.2 to 83.6)
    51.3 (43.5 to 60.6)
    35.8 (27.8 to 46.2)
    98.3 (75.0 to 129)
    61.8 (45.5 to 84.1)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer Ratio (GMTR) of RVNA After First Simulated PEP vaccination With HDCV or PVRV

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    End point title
    		 Geometric Mean Titer Ratio (GMTR) of RVNA After First Simulated PEP vaccination With HDCV or PVRV
    End point description
    RVNA titer was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs of 7 and 14 days after first simulated PEP vaccination and GMTs of 1 year after the last PrEP vaccination. Analysis was performed on the PEP FAS population. Here, ‘n’= subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    7 days (i.e. Year 1 + 7 days) and 14 days (i.e. Year 1 + 14 days) after first simulated PEP vaccination and 1 Year after last PrEP vaccination
    End point values
    		 Group 1: Short HDCV IM Post-exposure Prophylaxis (PEP) Regimen Group 2: Reference HDCV IM PEP Regimen Group 3: Short HDCV ID PEP regimen Group 4: Short PVRV IM PEP regimen Group 5: Short PVRV ID PEP regimen
    Number of subjects analysed
    200
    107
    68
    68
    71
    Units: ratio
    geometric mean (confidence interval 95%)
        Year 1 + 7 days/Year 1 (n=193,106,68,68,70)
    60.7 (50.8 to 72.6)
    34.4 (27.2 to 43.5)
    20.6 (14.8 to 28.5)
    58.2 (42.7 to 79.2)
    19.9 (14.5 to 27.3)
        Year 1 + 14 days/Year 1 (n=188,101,66,63,69)
    138 (116 to 164)
    71.9 (54.1 to 95.6)
    56.4 (39.4 to 80.8)
    133 (95.3 to 185)
    70.0 (48.0 to 102)
    No statistical analyses for this end point

    Secondary: Number of Subjects With Immediate Unsolicited Systemic Adverse Events (AEs) Following PrEP Vaccination with HDCV or PVRV

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    End point title
    		 Number of Subjects With Immediate Unsolicited Systemic Adverse Events (AEs) Following PrEP Vaccination with HDCV or PVRV
    End point description
    An AE was any untoward medical occurrence in a subject who received study vaccines and did not necessarily had to have causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the electronic case report form (eCRF) in terms of diagnosis and/or onset post-vaccination. Systemic AEs were all AEs that were not injection or administration site reactions. All subjects were observed for 30 minutes after any vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited systemic AEs in the eCRF. Analysis was performed on the PrEP safety analysis set (SafAS) population that included subjects who had received at least 1 dose of the study vaccine during the PrEP period and were analysed according to the actual vaccine they received.
    End point type
    Secondary
    End point timeframe
    Within 30 minutes after any PrEP vaccination
    End point values
    		 Group 1: Short HDCV IM PrEP Regimen Group 2: Reference HDCV IM PrEP Regimen Group 3: Short HDCV Intradermal (ID) PrEP regimen Group 4: Short PVRV IM PrEP regimen Group 5: Short PVRV ID PrEP regimen
    Number of subjects analysed
    228
    115
    77
    75
    75
    Units: subjects
        number (not applicable)
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Immediate Unsolicited Systemic Adverse Events Following PEP Vaccination with HDCV or PVRV

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    End point title
    		 Number of Subjects With Immediate Unsolicited Systemic Adverse Events Following PEP Vaccination with HDCV or PVRV
    End point description
    An AE was any untoward medical occurrence in a subject who received study vaccines and did not necessarily had to have causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the eCRF in terms of diagnosis and/or onset post-vaccination. Systemic AEs were all AEs that were not injection or administration site reactions. All subjects were observed for 30 minutes after any vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited systemic AEs in the eCRF. Analysis was performed on the simulated PEP SafAS population that include subjects who had received at least 1 dose of the study vaccine during the simulated PEP period and were analysed according to the actual vaccine they received.
    End point type
    Secondary
    End point timeframe
    Within 30 minutes after any simulated PEP vaccination
    End point values
    		 Group 1: Short HDCV IM Post-exposure Prophylaxis (PEP) Regimen Group 2: Reference HDCV IM PEP Regimen Group 3: Short HDCV ID PEP regimen Group 4: Short PVRV IM PEP regimen Group 5: Short PVRV ID PEP regimen
    Number of subjects analysed
    200
    107
    68
    68
    71
    Units: subjects
        number (not applicable)
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Solicited Injection Site Reactions Following PrEP Vaccination with HDCV or PVRV

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    End point title
    		 Number of Subjects With Solicited Injection Site Reactions Following PrEP Vaccination with HDCV or PVRV
    End point description
    A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited injection site reactions included pain, erythema and swelling. Analysis was performed on the PrEP SafAS population. Here, ‘n’= subjects with available data for each specified category and '99999' was used as space fillers and signifies that the subjects of Groups 1, 3, 4 and 5 did not receive any vaccination at Day 21 and therefore were not evaluable. Here, "vacc" in the categories below denotes "vaccination".
    End point type
    Secondary
    End point timeframe
    Within 7 days after any and each PrEP vaccination
    End point values
    		 Group 1: Short HDCV IM PrEP Regimen Group 2: Reference HDCV IM PrEP Regimen Group 3: Short HDCV Intradermal (ID) PrEP regimen Group 4: Short PVRV IM PrEP regimen Group 5: Short PVRV ID PrEP regimen
    Number of subjects analysed
    228
    115
    77
    75
    75
    Units: subjects
    number (not applicable)
        Pain post-any vacc (n=228, 115, 77, 75, 75)
    71
    41
    23
    18
    15
        Pain Post-vacc: Day 0 (n=228,115, 77, 75, 75)
    55
    27
    18
    12
    13
        Pain Post-vacc: Day 7 (n=227,115, 77, 75, 75)
    40
    19
    14
    13
    6
        Pain Post-vacc: Day 21 (n = 0, 115, 0, 0, 0)
    99999
    16
    99999
    99999
    99999
        Erythema post-any vacc (n=228,115,77,75, 75)
    1
    3
    9
    0
    1
        Erythema post-vacc: Day 0 (n=228,115,77,75,75)
    1
    1
    3
    0
    1
        Erythema post-vacc: Day 7 (n=227,115,77,75,75)
    0
    0
    8
    0
    1
        Erythema post-vacc: Day 21 (n=0,115, 0, 0,0)
    99999
    2
    99999
    99999
    99999
        Swelling Post-any vacc (n=228,115,77,75,75)
    2
    4
    5
    0
    1
        Swelling Post-vacc: Day 0 (n=228,115,77,75,75)
    2
    3
    3
    0
    1
        Swelling Post-vacc: Day 7 (n=227,115,77,75,75)
    0
    0
    4
    0
    1
        Swelling Post-vacc: Day 21 (n=0, 115, 0, 0,0)
    99999
    1
    99999
    99999
    99999
    No statistical analyses for this end point

    Secondary: Number of Subjects With Solicited Systemic Reactions Following PrEP Vaccination with HDCV or PVRV

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    End point title
    		 Number of Subjects With Solicited Systemic Reactions Following PrEP Vaccination with HDCV or PVRV
    End point description
    A SR was an AR observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited systemic reactions included fever, headache, malaise and myalgia. Analysis was performed on the PrEP SafAS population. Here, ‘n’= subjects with available data for each specified category and '99999' was used as space fillers and signifies that the subjects of Groups 1, 3, 4 and 5 did not receive any vaccination at Day 21 and therefore were not evaluable. Here, "vacc" in the categories below denotes "vaccination".
    End point type
    Secondary
    End point timeframe
    Within 7 days after any and each PrEP vaccination
    End point values
    		 Group 1: Short HDCV IM PrEP Regimen Group 2: Reference HDCV IM PrEP Regimen Group 3: Short HDCV Intradermal (ID) PrEP regimen Group 4: Short PVRV IM PrEP regimen Group 5: Short PVRV ID PrEP regimen
    Number of subjects analysed
    228
    115
    77
    75
    75
    Units: subjects
    number (not applicable)
        Fever Post-any vacc (n= 228,115,77,75,75)
    10
    13
    5
    3
    4
        Fever Post-vacc: Day 0 (n= 228,115,77,75,75)
    2
    7
    1
    1
    2
        Fever Post-vacc: Day 7 (n= 227,115,77,75,75)
    8
    7
    4
    2
    2
        Fever Post-vacc: Day 21 (n = 0, 115, 0, 0,0)
    99999
    1
    99999
    99999
    99999
        Headache Post-any vacc (n=228,115,77,75,75)
    41
    28
    21
    17
    11
        Headache Post-vacc: Day 0 (n=228,115,77,75,75)
    27
    15
    12
    13
    6
        Headache Post-vacc: Day 7 (n=227,115,77,75,75)
    24
    12
    11
    11
    6
        Headache Post-vacc: Day 21 (n= 0, 115,0,0,0)
    99999
    8
    99999
    99999
    99999
        Malaise Post-any vacc (n=228,115,77,75,75)
    43
    24
    19
    14
    10
        Malaise Post-vacc: Day 0 (n=228,115,77,75,75)
    27
    13
    14
    7
    5
        Malaise Post-vacc: Day 7 (n=227,115,77,75,75)
    25
    9
    9
    9
    6
        Malaise Post-vacc: Day 21 (n=0, 115, 0, 0, 0)
    99999
    7
    99999
    99999
    99999
        Myalgia Post-any vacc (n=228,115,77,75,75)
    35
    18
    15
    12
    5
        Myalgia Post-vacc: Day 0 (n=228,115,77,75,75)
    24
    10
    10
    6
    2
        Myalgia Post-vacc: Day 7 (n=227,115,77,75,75)
    20
    5
    7
    9
    3
        Myalgia Post-vacc: Day 21 (n= 0, 115, 0,0,0)
    99999
    7
    99999
    99999
    99999
    No statistical analyses for this end point

    Secondary: Number of Subjects With Unsolicited Non-Serious Adverse Events Following PrEP Vaccination with HDCV or PVRV

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    End point title
    		 Number of Subjects With Unsolicited Non-Serious Adverse Events Following PrEP Vaccination with HDCV or PVRV
    End point description
    An AE was any untoward medical occurrence in a subject who received study vaccines and did not necessarily had to have causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the eCRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on the PrEP SafAS population. Here, ‘n’= subjects with available data for each specified category and '99999' was used as space fillers and signifies that the subjects of Groups 1, 3, 4 and 5 did not receive any vaccination at Day 21 and therefore were not evaluable. Here, "vacc" in the categories below denotes "vaccination".
    End point type
    Secondary
    End point timeframe
    Up to 28 days after any and each PrEP vaccination
    End point values
    		 Group 1: Short HDCV IM PrEP Regimen Group 2: Reference HDCV IM PrEP Regimen Group 3: Short HDCV Intradermal (ID) PrEP regimen Group 4: Short PVRV IM PrEP regimen Group 5: Short PVRV ID PrEP regimen
    Number of subjects analysed
    228
    115
    77
    75
    75
    Units: subjects
    number (not applicable)
        Post-any vacc (n=228, 115, 77, 75, 75)
    29
    22
    15
    7
    10
        Post-vacc: Day 0 (n=228, 115, 77, 75, 75)
    10
    5
    5
    2
    2
        Post-vacc: Day 7 (n=227, 115, 77, 75, 75)
    21
    10
    10
    5
    8
        Post-vacc: Day 21 (n=0, 115, 0, 0, 0)
    99999
    9
    99999
    99999
    99999
    No statistical analyses for this end point

    Secondary: Number of Subjects With Serious Adverse Events (SAEs) Following PrEP Vaccination with HDCV or PVRV

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    End point title
    		 Number of Subjects With Serious Adverse Events (SAEs) Following PrEP Vaccination with HDCV or PVRV
    End point description
    An SAE was any untoward medical occurrence that at any dose resulted in death; life-threatening; initial or prolonged inpatient hospitalisation; persistent or significant disability/incapacity; congenital anomaly/birth defect or a medically important event. Analysis was performed on the PrEP SafAS population.
    End point type
    Secondary
    End point timeframe
    From Day 0 (pre-vaccination) up to 28 days after last PrEP vaccination
    End point values
    		 Group 1: Short HDCV IM PrEP Regimen Group 2: Reference HDCV IM PrEP Regimen Group 3: Short HDCV Intradermal (ID) PrEP regimen Group 4: Short PVRV IM PrEP regimen Group 5: Short PVRV ID PrEP regimen
    Number of subjects analysed
    228
    115
    77
    75
    75
    Units: subjects
        number (not applicable)
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Solicited Injection Site Reactions Following PEP Vaccination with HDCV or PVRV

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    End point title
    		 Number of Subjects With Solicited Injection Site Reactions Following PEP Vaccination with HDCV or PVRV
    End point description
    A SR was an AR observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited injection site reactions included pain, erythema and swelling. Analysis was performed on the PEP SafAS population. Here, ‘n’= subjects with available data for each specified category. Here, "vacc" in the categories below denotes "vaccination" and “D” denotes “Days”.
    End point type
    Secondary
    End point timeframe
    Within 7 days after any and each simulated PEP vaccination
    End point values
    		 Group 1: Short HDCV IM Post-exposure Prophylaxis (PEP) Regimen Group 2: Reference HDCV IM PEP Regimen Group 3: Short HDCV ID PEP regimen Group 4: Short PVRV IM PEP regimen Group 5: Short PVRV ID PEP regimen
    Number of subjects analysed
    200
    107
    68
    68
    71
    Units: subjects
    number (not applicable)
        Pain Post-any vacc (n=200, 107, 68, 68, 71)
    38
    21
    11
    14
    12
        Pain Post-vacc: Year 1 (n=200, 107, 68, 68, 71)
    34
    18
    8
    12
    12
        Pain Post-vacc: Year 1+3 D (n=200,106,68,68,70)
    17
    10
    4
    10
    5
        Erythema Post-any vacc (n=200, 107, 68, 68, 71)
    1
    0
    3
    0
    3
        Erythema Post-vacc: Year 1 (n=200, 107,68,68,71)
    1
    0
    3
    0
    3
        Erythema Post-vacc: Year 1+3D (n=200,106,68,68,70)
    0
    0
    0
    0
    0
        Swelling Post-any vacc (n=200, 107, 68, 68, 71)
    2
    2
    3
    0
    2
        Swelling Post-vacc: Year 1 (n=200, 107,68,68,71)
    1
    0
    3
    0
    2
        Swelling Post-vacc: Year 1+3D (n=200,106,68,68,70)
    1
    2
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Solicited Systemic Reactions Following PEP Vaccination with HDCV or PVRV

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    End point title
    		 Number of Subjects With Solicited Systemic Reactions Following PEP Vaccination with HDCV or PVRV
    End point description
    A SR was an AR observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited systemic reactions included fever, headache, malaise and myalgia. Analysis was performed on the PEP SafAS population. Here, ‘n’= subjects with available data for each specified category. Here, "vacc" in the categories below denotes "vaccination" and "D" denotes "Days".
    End point type
    Secondary
    End point timeframe
    Within 7 days after any and each simulated PEP Vaccination
    End point values
    		 Group 1: Short HDCV IM Post-exposure Prophylaxis (PEP) Regimen Group 2: Reference HDCV IM PEP Regimen Group 3: Short HDCV ID PEP regimen Group 4: Short PVRV IM PEP regimen Group 5: Short PVRV ID PEP regimen
    Number of subjects analysed
    200
    107
    68
    68
    71
    Units: subjects
    number (not applicable)
        Fever Post-any vacc (n=200,107,68,68,71)
    2
    1
    2
    0
    0
        Fever Post-vacc: Year 1 (n=200, 107,68,68,71)
    0
    0
    1
    0
    0
        Fever Post-vacc: Year 1+3D (n=200,106,68,68,70)
    2
    1
    1
    0
    0
        Headache Post-any vacc (n=200,107,68,68,71)
    17
    8
    13
    5
    5
        Headache Post-vacc: Year 1(n=200,107,68,68,71)
    15
    7
    8
    4
    4
        Headache Post-vacc: Year 1+3D(n=200,106,68,68,70)
    4
    4
    7
    3
    1
        Malaise Post-any vacc (n=200, 107,68,68,71)
    13
    7
    12
    3
    3
        Malaise Post-vacc: Year 1(n=200, 107,68,68,71)
    10
    6
    9
    2
    1
        Malaise Post-vacc: Year 1+3D(n=200, 106,68,68,70)
    5
    3
    6
    3
    2
        Myalgia Post-any vacc (n=200, 107,68,68,71)
    22
    8
    12
    7
    9
        Myalgia Post-vacc: Year 1 (n=200, 107, 68,68,71)
    19
    8
    8
    5
    7
        Myalgia Post-vacc: Year 1+3D(n=200,106,68,68,70)
    6
    3
    6
    3
    4
    No statistical analyses for this end point

    Secondary: Number of Subjects With Unsolicited Non-Serious Adverse Events Following Simulated PEP Vaccination with HDCV or PVRV

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    End point title
    		 Number of Subjects With Unsolicited Non-Serious Adverse Events Following Simulated PEP Vaccination with HDCV or PVRV
    End point description
    An AE was any untoward medical occurrence in a subject who received study vaccines and did not necessarily had to have causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the eCRF in terms of diagnosis and/or onset post-vaccination. Analysis was performed on the PEP SafAS population. Here, ‘n’= subjects with available data for each specified category. Here, "vacc" in the categories below denotes "vaccination".
    End point type
    Secondary
    End point timeframe
    Up to 28 days after any and each simulated PEP vaccination
    End point values
    		 Group 1: Short HDCV IM Post-exposure Prophylaxis (PEP) Regimen Group 2: Reference HDCV IM PEP Regimen Group 3: Short HDCV ID PEP regimen Group 4: Short PVRV IM PEP regimen Group 5: Short PVRV ID PEP regimen
    Number of subjects analysed
    200
    107
    68
    68
    71
    Units: subjects
    number (not applicable)
        Post-any vacc (n=200, 107, 68, 68, 71)
    3
    1
    3
    3
    2
        Post-vacc: Year 1 (n=200, 107, 68, 68, 71)
    1
    0
    0
    1
    1
        Post-vacc: Year 1+3Days (n=200, 106, 68, 68, 70)
    2
    1
    3
    2
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects With Serious Adverse Events Following PEP Vaccination with HDCV or PVRV

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    End point title
    		 Number of Subjects With Serious Adverse Events Following PEP Vaccination with HDCV or PVRV
    End point description
    An SAE was any untoward medical occurrence that at any dose resulted in death; life-threatening; initial or prolonged inpatient hospitalisation; persistent or significant disability/incapacity; congenital anomaly/birth defect or a medically important event. Analysis was performed on the PEP SafAS population.
    End point type
    Secondary
    End point timeframe
    From 1 year after last PrEP vaccination up to 31 days after last simulated PEP vaccination
    End point values
    		 Group 1: Short HDCV IM Post-exposure Prophylaxis (PEP) Regimen Group 2: Reference HDCV IM PEP Regimen Group 3: Short HDCV ID PEP regimen Group 4: Short PVRV IM PEP regimen Group 5: Short PVRV ID PEP regimen
    Number of subjects analysed
    200
    107
    68
    68
    71
    Units: subjects
        number (not applicable)
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Related SAEs, Unrelated Deaths, and Life-threatening SAEs at Time Period Between PrEP and PEP Phase

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    End point title
    		 Number of Subjects With Related SAEs, Unrelated Deaths, and Life-threatening SAEs at Time Period Between PrEP and PEP Phase
    End point description
    An SAE was any untoward medical occurrence that at any dose resulted in death; life-threatening; initial or prolonged inpatient hospitalisation; persistent or significant disability/incapacity; congenital anomaly/birth defect or a medically important event. All related SAEs, unrelated deaths, and life-threatening SAEs were collected between the end of the PrEP phase and the beginning of the PEP phase. Analysis was performed on PrEP SafAS population.
    End point type
    Secondary
    End point timeframe
    From 28 days after last PrEP vaccination up to 1 year after last PrEP vaccination
    End point values
    		 Group 1: Short HDCV IM PrEP Regimen Group 2: Reference HDCV IM PrEP Regimen Group 3: Short HDCV Intradermal (ID) PrEP regimen Group 4: Short PVRV IM PrEP regimen Group 5: Short PVRV ID PrEP regimen
    Number of subjects analysed
    228
    115
    77
    75
    75
    Units: subjects
    number (not applicable)
        Related SAEs
    0
    0
    0
    0
    0
        Unrelated Deaths
    1
    0
    0
    0
    0
        Life-threatening SAEs
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Female Subjects Who Were Pregnant During PrEP Phase

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    End point title
    		 Number of Female Subjects Who Were Pregnant During PrEP Phase
    End point description
    Number of female subjects who got pregnant during PrEP phase was collected and reported. Analysis was performed on PrEP SafAS population. Number of subjects analysed = female subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    From Day 0 (pre-vaccination) up to 28 days after last PrEP vaccination
    End point values
    		 Group 1: Short HDCV IM PrEP Regimen Group 2: Reference HDCV IM PrEP Regimen Group 3: Short HDCV Intradermal (ID) PrEP regimen Group 4: Short PVRV IM PrEP regimen Group 5: Short PVRV ID PrEP regimen
    Number of subjects analysed
    113
    67
    41
    41
    39
    Units: subjects
        number (not applicable)
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Female Subjects Who Were Pregnant Between PrEP and PEP Phase

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    End point title
    		 Number of Female Subjects Who Were Pregnant Between PrEP and PEP Phase
    End point description
    Number of female subjects who got pregnant between the end of the PrEP phase and the beginning of the PEP phase was collected and reported in this endpoint. Analysis was performed on PrEP SafAS population. Number of subjects analysed = female subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    From 28 days after last PrEP vaccination up to 1 year after last PrEP vaccination
    End point values
    		 Group 1: Short HDCV IM PrEP Regimen Group 2: Reference HDCV IM PrEP Regimen Group 3: Short HDCV Intradermal (ID) PrEP regimen Group 4: Short PVRV IM PrEP regimen Group 5: Short PVRV ID PrEP regimen
    Number of subjects analysed
    113
    67
    41
    41
    39
    Units: subjects
        number (not applicable)
    6
    3
    4
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AE data: from Day 0 (pre-vaccination) up to 28 days post any vaccination. SR data: collected within 7 days post any vaccination. SAE data: collected throughout study (i.e. up to 28 and 31 days after last PrEP and simulated PEP vaccination, respectively).
    Adverse event reporting additional description
    A SR was an AE that was pre-listed (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Group 1: Short HDCV IM PrEP + PEP Regimen
    Reporting group description
    		 In PrEP regimen, subjects received a single IM dose of HDCV on Day 0 and Day 7 and were followed up to 1 year post last PrEP vaccination. In simulated PEP regimen, pre-immunised subjects received a single dose of HDCV at Year 1 and Year 1 + 3 days, post last PrEP vaccination and were followed up for 31 days post last PEP vaccination.

    Reporting group title
    Group 2: Reference HDCV IM PrEP + PEP Regimen
    Reporting group description
    		 In PrEP regimen, subjects received a single IM dose of HDCV on Day 0, Day 7, and Day 21 and were followed up to 1 year post last PrEP vaccination. In simulated PEP regimen, pre-immunised subjects received a single dose of HDCV on Year 1 and Year 1 + 3 days, post last PrEP vaccination and were followed up for 31 days post last PEP vaccination.

    Reporting group title
    Group 3: Short HDCV ID PrEP + PEP regimen
    Reporting group description
    		 In PrEP regimen, subjects received two ID doses of HDCV on Day 0 and Day 7 and were followed up to 1 year post last PrEP vaccination. In simulated PEP regimen, pre-immunised subjects received a single dose of HDCV on Year 1 and Year 1 + 3 days, post last PrEP vaccination and were followed up for 31 days post last PEP vaccination.

    Reporting group title
    Group 4: Short PVRV IM PrEP + PEP regimen
    Reporting group description
    		 In PrEP regimen, subjects received a single IM dose of purified Vero cell rabies vaccine (PVRV) on Day 0 and Day 7 and were followed up to 1 year post last PrEP vaccination. In simulated PEP regimen, pre-immunised subjects received a single dose of PVRV on Year 1 and on Year 1 + 3 days, post last PrEP vaccination and were followed up for 31 days post last PEP vaccination.

    Reporting group title
    Group 5: Short PVRV ID PrEP + PEP regimen
    Reporting group description
    		 In PrEP regimen, subjects received two ID doses of PVRV on Day 0 and Day 7 and were followed up to 1 year post last PrEP vaccination. In simulated PEP regimen, Pre-immunised subjects received a single dose of PVRV on Year 1 and Year 1 + 3 days, post last PrEP vaccination and were followed up for 31 days post last PEP vaccination.

    Serious adverse events
    		 Group 1: Short HDCV IM PrEP + PEP Regimen Group 2: Reference HDCV IM PrEP + PEP Regimen Group 3: Short HDCV ID PrEP + PEP regimen Group 4: Short PVRV IM PrEP + PEP regimen Group 5: Short PVRV ID PrEP + PEP regimen
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 228 (0.44%)
    2 / 115 (1.74%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 75 (0.00%)
         number of deaths (all causes)
    1
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Pregnancy, puerperium and perinatal conditions
    Abortion Spontaneous
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 115 (0.87%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foetal Death
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 115 (0.87%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 115 (0.00%)
    0 / 77 (0.00%)
    0 / 75 (0.00%)
    0 / 75 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group 1: Short HDCV IM PrEP + PEP Regimen Group 2: Reference HDCV IM PrEP + PEP Regimen Group 3: Short HDCV ID PrEP + PEP regimen Group 4: Short PVRV IM PrEP + PEP regimen Group 5: Short PVRV ID PrEP + PEP regimen
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    115 / 228 (50.44%)
    64 / 115 (55.65%)
    47 / 77 (61.04%)
    36 / 75 (48.00%)
    32 / 75 (42.67%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    51 / 228 (22.37%)
    34 / 115 (29.57%)
    27 / 77 (35.06%)
    19 / 75 (25.33%)
    14 / 75 (18.67%)
         occurrences all number
    126
    76
    76
    45
    25
    General disorders and administration site conditions
    Injection Site Erythema
         subjects affected / exposed
    1 / 228 (0.44%)
    3 / 115 (2.61%)
    11 / 77 (14.29%)
    0 / 75 (0.00%)
    4 / 75 (5.33%)
         occurrences all number
    4
    4
    39
    0
    9
    Injection Site Pain
         subjects affected / exposed
    86 / 228 (37.72%)
    47 / 115 (40.87%)
    27 / 77 (35.06%)
    26 / 75 (34.67%)
    22 / 75 (29.33%)
         occurrences all number
    237
    146
    124
    65
    70
    Injection Site Swelling
         subjects affected / exposed
    3 / 228 (1.32%)
    5 / 115 (4.35%)
    7 / 77 (9.09%)
    0 / 75 (0.00%)
    3 / 75 (4.00%)
         occurrences all number
    7
    9
    26
    0
    7
    Malaise
         subjects affected / exposed
    50 / 228 (21.93%)
    28 / 115 (24.35%)
    27 / 77 (35.06%)
    15 / 75 (20.00%)
    11 / 75 (14.67%)
         occurrences all number
    117
    66
    81
    38
    21
    Pyrexia
    Additional description: Pyrexia events that occurred after 7 days post-vaccination were considered as unsolicited AE.
         subjects affected / exposed
    14 / 228 (6.14%)
    13 / 115 (11.30%)
    7 / 77 (9.09%)
    3 / 75 (4.00%)
    4 / 75 (5.33%)
         occurrences all number
    22
    27
    20
    5
    10
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    47 / 228 (20.61%)
    22 / 115 (19.13%)
    21 / 77 (27.27%)
    17 / 75 (22.67%)
    12 / 75 (16.00%)
         occurrences all number
    109
    51
    60
    32
    30
    Infections and infestations
    Upper Respiratory Tract Infection
         subjects affected / exposed
    16 / 228 (7.02%)
    10 / 115 (8.70%)
    10 / 77 (12.99%)
    5 / 75 (6.67%)
    6 / 75 (8.00%)
         occurrences all number
    16
    11
    10
    5
    6

    More information

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

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

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