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    Clinical Trial Results:
    A Randomized, Double-blind, Phase 3 Study to Evaluate 6 Dose Levels of Ad26.COV2.S Administered As a Two-Dose Schedule in Healthy Adults

    Summary
    EudraCT number
    		 2020-005801-14
    Trial protocol
    		 DE   PL  
    Global end of trial date
    10 Jul 2023

    Results information
    Results version number
    		 v1
    This version publication date
    07 Feb 2024
    First version publication date
    07 Feb 2024
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    VAC31518COV3003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04908722
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Vaccines & Prevention B.V.
    Sponsor organisation address
    Archimedesweg 4-6, CN, Leiden, Netherlands, 2333
    Public contact
    Clinical Registry Group, Janssen Vaccines & Prevention B.V., ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Vaccines & Prevention B.V., ClinicalTrialsEU@its.jnj.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Aug 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jul 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this trial was to evaluate 6 dose levels of Ad26.COV2.S administered as a 2-dose schedule in healthy adults and demonstrate non-inferiority of each dose level comparing with the release titer.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practice and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jun 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Brazil: 811
    Country: Number of subjects enrolled
    Germany: 368
    Country: Number of subjects enrolled
    United States: 292
    Country: Number of subjects enrolled
    South Africa: 122
    Worldwide total number of subjects
    1593
    EEA total number of subjects
    368
    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)
    1593
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study involves Main study:1321 subjects were enrolled, of which 1080 completed the main study and Sub study:272 subjects were enrolled of which 231 completed the sub study. As planned, the Subject disposition, Baseline characteristics, Outcome measures data, and Adverse events data were analysed and reported combined for the Main and sub-study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1: Ad26.COV2.S 9x10^10 vp
    Arm description
    		 Subjects in the main study and sub study received intramuscular (IM) injection of Ad26.COV2.S 9x10^10 viral particles (vp) on Days 1 and 57.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ad26.COV2.S
    Investigational medicinal product code
    VAC31518
    Other name
    JNJ-78436735 Ad26COVS1
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects in the received Ad26.COV2.S 9X10^10 vp on Days 1 and 57.

    Arm title
    		 Group 2: Ad26.COV2.S 7x10^10 vp
    Arm description
    		 Subjects in the main study received IM injection of Ad26.COV2.S 7x10^10 vp on Days 1 and 57.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ad26.COV2.S
    Investigational medicinal product code
    VAC31518
    Other name
    JNJ-78436735 Ad26COVS1
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received Ad26.COV2.S 7x10^10 vp on Days 1 and 57.

    Arm title
    		 Group 3: Ad26.COV2.S 5x10^10 vp
    Arm description
    		 Subjects in the main study and sub study received IM injection of Ad26.COV2.S 5x10^10 vp on Days 1 and 57.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ad26.COV2.S
    Investigational medicinal product code
    VAC31518
    Other name
    JNJ-78436735 Ad26COVS1
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received Ad26.COV2.S 5x10^10 vp on Days 1 and 57.

    Arm title
    		 Group 4: Ad26.COV2.S 3.5x10^10 vp
    Arm description
    		 Subjects in the main study received IM injection of Ad26.COV2.S 3.5x10^10 vp on Days 1 and 57.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ad26.COV2.S
    Investigational medicinal product code
    VAC31518
    Other name
    JNJ-78436735 Ad26COVS1
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received Ad26.COV2.S 3.5x10^10 vp on Days 1 and 57.

    Arm title
    		 Group 5: Ad26.COV2.S 2.5x10^10 vp
    Arm description
    		 Subjects in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10^10 vp on Days 1 and 57.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ad26.COV2.S
    Investigational medicinal product code
    VAC31518
    Other name
    JNJ-78436735 Ad26COVS1
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received Ad26.COV2.S 2.5x10^10 vp on Days 1 and 57.

    Arm title
    		 Group 6: Ad26.COV2.S 1.25x10^10 vp
    Arm description
    		 Subjects in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10^10 vp on Days 1 and 57.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ad26.COV2.S
    Investigational medicinal product code
    VAC31518
    Other name
    JNJ-78436735 Ad26COVS1
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received Ad26.COV2.S 1.25x10^10 vp on Days 1 and 57.

    Number of subjects in period 1
    		Group 1: Ad26.COV2.S 9x10^10 vp Group 2: Ad26.COV2.S 7x10^10 vp Group 3: Ad26.COV2.S 5x10^10 vp Group 4: Ad26.COV2.S 3.5x10^10 vp Group 5: Ad26.COV2.S 2.5x10^10 vp Group 6: Ad26.COV2.S 1.25x10^10 vp
    Started
    288
    221
    291
    220
    288
    285
    Main Study
    220 [1]
    221
    222 [2]
    220
    219 [3]
    219 [4]
    Sub Study
    68 [5]
    0 [6]
    69 [7]
    0 [8]
    69 [9]
    66 [10]
    Per protocol immunogenicity (PPI) set
    276
    212
    282
    212
    277
    271
    Completed
    237
    178
    244
    179
    240
    233
    Not completed
    51
    43
    47
    41
    48
    52
         Adverse event, serious fatal
    1
    -
    -
    -
    -
    1
         Physician decision
    1
    1
    1
    2
    -
    -
         Initiated prohibited medication
    -
    -
    -
    1
    -
    1
         Protocol deviation
    1
    -
    -
    -
    -
    1
         Unspecified
    3
    1
    3
    2
    4
    1
         Lost to follow-up
    33
    33
    36
    30
    32
    34
         Withdrawal by subject
    12
    8
    7
    6
    12
    14
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Only reported subjects were included in main study.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Only reported subjects were included in sub study.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Only reported subjects were included in sub study.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Only reported subjects were included in sub study.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Only reported subjects were included in sub study.
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Only reported subjects were included in sub study.
    [7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Only reported subjects were included in main study.
    [8] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Only reported subjects were included in main study.
    [9] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Only reported subjects were included in main study.
    [10] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Only reported subjects were included in main study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: Ad26.COV2.S 9x10^10 vp
    Reporting group description
    		 Subjects in the main study and sub study received intramuscular (IM) injection of Ad26.COV2.S 9x10^10 viral particles (vp) on Days 1 and 57.

    Reporting group title
    Group 2: Ad26.COV2.S 7x10^10 vp
    Reporting group description
    		 Subjects in the main study received IM injection of Ad26.COV2.S 7x10^10 vp on Days 1 and 57.

    Reporting group title
    Group 3: Ad26.COV2.S 5x10^10 vp
    Reporting group description
    		 Subjects in the main study and sub study received IM injection of Ad26.COV2.S 5x10^10 vp on Days 1 and 57.

    Reporting group title
    Group 4: Ad26.COV2.S 3.5x10^10 vp
    Reporting group description
    		 Subjects in the main study received IM injection of Ad26.COV2.S 3.5x10^10 vp on Days 1 and 57.

    Reporting group title
    Group 5: Ad26.COV2.S 2.5x10^10 vp
    Reporting group description
    		 Subjects in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10^10 vp on Days 1 and 57.

    Reporting group title
    Group 6: Ad26.COV2.S 1.25x10^10 vp
    Reporting group description
    		 Subjects in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10^10 vp on Days 1 and 57.

    Reporting group values
    		 Group 1: Ad26.COV2.S 9x10^10 vp Group 2: Ad26.COV2.S 7x10^10 vp Group 3: Ad26.COV2.S 5x10^10 vp Group 4: Ad26.COV2.S 3.5x10^10 vp Group 5: Ad26.COV2.S 2.5x10^10 vp Group 6: Ad26.COV2.S 1.25x10^10 vp Total
    Number of subjects
    		 288 221 291 220 288 285 1593
    Title for AgeCategorical
    Units: subjects
        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)
    		 288 221 291 220 288 285 1593
        From 65 to 84 years
    		 0 0 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 35.6 ( 10.21 ) 35.2 ( 9.87 ) 34.8 ( 9.82 ) 34.7 ( 9.36 ) 34.5 ( 9.81 ) 33.4 ( 9.63 ) -
    Title for Gender
    Units: subjects
        Female
    		 117 73 119 72 106 103 590
        Male
    		 170 148 172 148 182 182 1002
        Undifferentiated
    		 1 0 0 0 0 0 1

    End points

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    End points reporting groups
    Reporting group title
    Group 1: Ad26.COV2.S 9x10^10 vp
    Reporting group description
    		 Subjects in the main study and sub study received intramuscular (IM) injection of Ad26.COV2.S 9x10^10 viral particles (vp) on Days 1 and 57.

    Reporting group title
    Group 2: Ad26.COV2.S 7x10^10 vp
    Reporting group description
    		 Subjects in the main study received IM injection of Ad26.COV2.S 7x10^10 vp on Days 1 and 57.

    Reporting group title
    Group 3: Ad26.COV2.S 5x10^10 vp
    Reporting group description
    		 Subjects in the main study and sub study received IM injection of Ad26.COV2.S 5x10^10 vp on Days 1 and 57.

    Reporting group title
    Group 4: Ad26.COV2.S 3.5x10^10 vp
    Reporting group description
    		 Subjects in the main study received IM injection of Ad26.COV2.S 3.5x10^10 vp on Days 1 and 57.

    Reporting group title
    Group 5: Ad26.COV2.S 2.5x10^10 vp
    Reporting group description
    		 Subjects in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10^10 vp on Days 1 and 57.

    Reporting group title
    Group 6: Ad26.COV2.S 1.25x10^10 vp
    Reporting group description
    		 Subjects in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10^10 vp on Days 1 and 57.

    Primary: Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After First Vaccination

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    End point title
    		 Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After First Vaccination [1]
    End point description
    Geometric mean concentration of SARS-CoV-2 S protein binding antibodies measured by ELISA were reported. As per planned analysis, the data were analysed and reported combined for the main study and sub-study. The per protocol immunogenicity set included all randomised and vaccinated subjects for whom immunogenicity data were available excluding subjects with major protocol deviations expected to impact the immunogenicity outcomes. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    28 days after first vaccination (at Day 29)
    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: Descriptive statistics was done, no inferential statistical analysis was performed.
    End point values
    		 Group 1: Ad26.COV2.S 9x10^10 vp Group 2: Ad26.COV2.S 7x10^10 vp Group 3: Ad26.COV2.S 5x10^10 vp Group 4: Ad26.COV2.S 3.5x10^10 vp Group 5: Ad26.COV2.S 2.5x10^10 vp Group 6: Ad26.COV2.S 1.25x10^10 vp
    Number of subjects analysed
    249
    191
    250
    189
    243
    251
    Units: ELISA Units per millilitre (EU/mL)
        geometric mean (confidence interval 95%)
    2351 (1849 to 2989)
    1714 (1305 to 2250)
    2189 (1726 to 2775)
    1377 (1062 to 1786)
    1626 (1255 to 2106)
    1976 (1521 to 2566)
    No statistical analyses for this end point

    Primary: Geometric Mean Ratio of Antibodies Measured by S-ELISA at 28 Days After First Vaccination

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    End point title
    		 Geometric Mean Ratio of Antibodies Measured by S-ELISA at 28 Days After First Vaccination [2] [3]
    End point description
    Geometric mean ratio of antibodies measured by S-ELISA were reported. Geometric mean ratio was calculated as ratio of 1 dose of Ad26.COV2.S 9x10^10 vp, Ad26.COV2.S 7x10^10 vp, Ad26.COV2.S 3.5x10^10, Ad26.COV2.S 2.5x10^10, and Ad26.COV2.S 1.25x10^10 vp divided by 1 dose of Ad26.COV2.S 5x10^10 vp at Day 29. As per planned analysis, the data were analysed and reported combined for the main study and sub-study. The per protocol immunogenicity set included all randomized and vaccinated subjects for whom immunogenicity data were available excluding subjects with major protocol deviations expected to impact the immunogenicity outcomes. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this end point.
    End point type
    Primary
    End point timeframe
    Day 29 (28 days post dose 1)
    Notes
    [2] - 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: Descriptive statistics was done, no inferential statistical analysis was performed.
    [3] - 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: Statistical Analysis was not planned for all the arms of Baseline period.
    End point values
    		 Group 1: Ad26.COV2.S 9x10^10 vp Group 2: Ad26.COV2.S 7x10^10 vp Group 4: Ad26.COV2.S 3.5x10^10 vp Group 5: Ad26.COV2.S 2.5x10^10 vp Group 6: Ad26.COV2.S 1.25x10^10 vp
    Number of subjects analysed
    249
    191
    189
    243
    251
    Units: Ratio
        geometric mean (confidence interval 97.5%)
    1.15 (0.926 to 1.440)
    1.07 (0.844 to 1.356)
    0.94 (0.742 to 1.193)
    0.80 (0.641 to 1.00)
    0.81 (0.648 to 1.007)
    No statistical analyses for this end point

    Primary: Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 14 Days After Second Vaccination

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    End point title
    		 Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 14 Days After Second Vaccination [4]
    End point description
    Geometric mean concentration of SARS-CoV-2 S protein binding antibodies measured by ELISA were reported. As per planned analysis, the data were analysed and reported combined for the main study and sub-study. The per protocol immunogenicity set included all randomised and vaccinated subjects for whom immunogenicity data were available excluding subjects with major protocol deviations expected to impact the immunogenicity outcomes. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    14 days after second vaccination (at Day 71)
    Notes
    [4] - 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: Descriptive statistics was done, no inferential statistical analysis was performed.
    End point values
    		 Group 1: Ad26.COV2.S 9x10^10 vp Group 2: Ad26.COV2.S 7x10^10 vp Group 3: Ad26.COV2.S 5x10^10 vp Group 4: Ad26.COV2.S 3.5x10^10 vp Group 5: Ad26.COV2.S 2.5x10^10 vp Group 6: Ad26.COV2.S 1.25x10^10 vp
    Number of subjects analysed
    171
    130
    180
    134
    172
    184
    Units: ELISA Units per millilitre (EU/mL)
        geometric mean (confidence interval 95%)
    4997 (4145 to 6023)
    3757 (3030 to 4659)
    3855 (3185 to 4666)
    3460 (2781 to 4304)
    3641 (2969 to 4465)
    3905 (3113 to 4897)
    No statistical analyses for this end point

    Primary: Geometric Mean Ratio of Antibodies Measured by S-ELISA 14 Days After Second Vaccination

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    End point title
    		 Geometric Mean Ratio of Antibodies Measured by S-ELISA 14 Days After Second Vaccination [5] [6]
    End point description
    Geometric mean ratio of antibodies measured by S-ELISA were reported. Geometric mean ratio was calculated as ratio of 2 doses on Day 71 dose of Ad26.COV2.S 9x10^10 vp, Ad26.COV2.S 7x10^10 vp, Ad26.COV2.S 3.5x10^10, Ad26.COV2.S 2.5x10^10, and Ad26.COV2.S 1.25x10^10 vp divided by 1 dose of Ad26.COV2.S 5x10^10 vp at Day 29 and values observed at post-vaccination on Day 71 of 2 doses of Ad26.COV2.S 9x10^10 vp, Ad26.COV2.S 7x10^10 vp, Ad26.COV2.S 3.5x10^10, Ad26.COV2.S 2.5x10^10, and Ad26.COV2.S 1.25x10^10 vp divided by 2 doses for Ad26.COV2.S 5x10^10 vp at Day 71. As per planned analysis, the data were analysed and reported combined for the main study and sub-study. The per protocol immunogenicity set included all randomised and vaccinated subjects for whom immunogenicity data were available excluding subjects with major protocol deviations expected to impact the immunogenicity outcomes. N (number of subjects analysed): subjects who were evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Group 3: 28 days after first vaccination (Day 29), 14 days after second vaccination (Day 71); Groups 1, 2, 4, 5, and 6: 14 days after second vaccination (Day 71)
    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: Descriptive statistics was done, no inferential statistical analysis was performed.
    [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: Statistical Analysis was not planned for all the arms of Baseline period.
    End point values
    		 Group 1: Ad26.COV2.S 9x10^10 vp Group 2: Ad26.COV2.S 7x10^10 vp Group 4: Ad26.COV2.S 3.5x10^10 vp Group 5: Ad26.COV2.S 2.5x10^10 vp Group 6: Ad26.COV2.S 1.25x10^10 vp
    Number of subjects analysed
    171
    130
    134
    172
    184
    Units: Ratio
    geometric mean (confidence interval 97.5%)
        2 doses at Day 71/1 dose at Day 29
    2.53 (1.992 to 3.207)
    2.37 (1.829 to 3.077)
    2.20 (1.697 to 2.841)
    1.79 (1.408 to 2.265)
    1.70 (1.348 to 2.148)
        2 doses at Day 71/ 2 doses at Day 71
    1.41 (1.088 to 1.815)
    1.32 (1.000 to 1.739)
    1.22 (0.928 to 1.606)
    0.99 (0.769 to 1.282)
    0.95 (0.736 to 1.217)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA

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    End point title
    		 Percentage of Subjects with Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA
    End point description
    Percentage of subjects with serological response to vaccination to SARS-COV-2 S Protein as Measured by ELISA were reported. A subject was considered a responder if one or both of the following conditions were satisfied: (1) the baseline (pre-dose 1) sample value was less than or equal to (<=) lower limit of quantification (LLOQ) and the post-baseline sample was greater than (>) LLOQ; (2) the baseline sample (pre-dose 1) value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>=4-fold) increase from the baseline sample value. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study. The per protocol immunogenicity set included all randomised and vaccinated subjects for whom immunogenicity data were available excluding subjects with major protocol deviations expected to impact the immunogenicity outcomes.
    End point type
    Secondary
    End point timeframe
    Up to Week 60
    End point values
    		 Group 1: Ad26.COV2.S 9x10^10 vp Group 2: Ad26.COV2.S 7x10^10 vp Group 3: Ad26.COV2.S 5x10^10 vp Group 4: Ad26.COV2.S 3.5x10^10 vp Group 5: Ad26.COV2.S 2.5x10^10 vp Group 6: Ad26.COV2.S 1.25x10^10 vp
    Number of subjects analysed
    249
    191
    250
    189
    243
    251
    Units: Percentage of subjects
    number (not applicable)
        Day 29 (n=249,191,250,189,243,251)
    82.7
    90.1
    78.8
    87.8
    80.2
    76.1
        Day 57 (n=216,167,217,162,219,220)
    81.9
    88.6
    80.2
    92.0
    81.3
    77.7
        Day 71 (n=171,130,180,134,172,184)
    81.9
    92.3
    79.4
    91.8
    80.8
    76.1
        Week 32 (n=112,86,128,90,121,136)
    72.3
    83.7
    68.0
    86.7
    68.6
    63.2
        Week 60 (n=45,33,42,37,45,52)
    68.9
    81.8
    61.9
    83.8
    60.0
    53.8
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA

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    End point title
    		 Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA
    End point description
    Geometric mean concentration of SARS-CoV-2 S protein binding antibody measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study. The per protocol immunogenicity set included all randomised and vaccinated subjects for whom immunogenicity data were available excluding subjects with major protocol deviations expected to impact the immunogenicity outcomes. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    Up to Week 60
    End point values
    		 Group 1: Ad26.COV2.S 9x10^10 vp Group 2: Ad26.COV2.S 7x10^10 vp Group 3: Ad26.COV2.S 5x10^10 vp Group 4: Ad26.COV2.S 3.5x10^10 vp Group 5: Ad26.COV2.S 2.5x10^10 vp Group 6: Ad26.COV2.S 1.25x10^10 vp
    Number of subjects analysed
    249
    191
    250
    189
    243
    251
    Units: ELISA Unit (EU)/mL
    geometric mean (confidence interval 95%)
        Day 29 (n=249,191,250,189,243,251)
    2351 (1849 to 2989)
    1714 (1305 to 2250)
    2189 (1726 to 2775)
    1377 (1062 to 1786)
    1626 (1255 to 2106)
    1976 (1521 to 2566)
        Day 57 (n=216,167,217,162,219,220)
    2722 (2156 to 3438)
    1842 (1404 to 2417)
    2089 (1651 to 2643)
    1622 (1233 to 2134)
    1919 (1481 to 2486)
    2293 (1766 to 2978)
        Day 71 (n=171,130,180,134,172,184)
    4997 (4145 to 6023)
    3757 (3030 to 4659)
    3855 (3185 to 4666)
    3460 (2781 to 4304)
    3641 (2969 to 4465)
    3905 (3113 to 4897)
        Week 32 (n=112,86,128,90,121,136)
    3331 (2499 to 4438)
    2903 (2706 to 4058)
    2616 (2001 to 3420)
    2059 (1470 to 2885)
    3067 (2268 to 4148)
    2707 (2000 to 3662)
        Week 60 (n=45,33,42,37,45,52)
    4968 (3119 to 7915)
    5010 (3146 to 7981)
    2363 (1448 to 3857)
    2191 (1224 to 3921)
    2769 (1776 to 4317)
    3664 (2169 to 6190)
    No statistical analyses for this end point

    Secondary: Number of Subjects with Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination

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    End point title
    		 Number of Subjects with Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination
    End point description
    An AE was any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which subjects were specifically questioned and which were noted by subject in their e-diary for 7 days after each vaccination. Solicited local AEs included injection site pain/tenderness, erythema and swelling at the study vaccine injection site. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study. Full analysis set included all subjects with at least one vaccine administration documented. Here, 'n' (number of subjects analysed) signifies number of subjects evaluable for this timepoint.
    End point type
    Secondary
    End point timeframe
    7 days after each vaccination (first [1st] vaccination [at Day 8], second [2nd] vaccination [at Day 64])
    End point values
    		 Group 1: Ad26.COV2.S 9x10^10 vp Group 2: Ad26.COV2.S 7x10^10 vp Group 3: Ad26.COV2.S 5x10^10 vp Group 4: Ad26.COV2.S 3.5x10^10 vp Group 5: Ad26.COV2.S 2.5x10^10 vp Group 6: Ad26.COV2.S 1.25x10^10 vp
    Number of subjects analysed
    288
    221
    291
    220
    288
    285
    Units: Subjects
        After 1st vaccination (n=288,221,291,220,288,285)
    179
    143
    162
    137
    155
    133
        After 2nd vaccination (n=264,200,269,199,270,258)
    130
    100
    124
    95
    111
    104
    No statistical analyses for this end point

    Secondary: Number of Subjects with Solicited Systemic AEs for 7 Days After Each Vaccination

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    End point title
    		 Number of Subjects with Solicited Systemic AEs for 7 Days After Each Vaccination
    End point description
    An AE was any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic AEs (include body temperature, fatigue, headache, nausea, myalgia) were noted in the subject diary after 7 days of each vaccination. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study. Full analysis set included all subjects with at least one vaccine administration documented. Here, 'n' (number of subjects analysed) signifies number of subjects evaluable for this timepoint.
    End point type
    Secondary
    End point timeframe
    7 days after each vaccination (1st vaccination [at Day 8], 2nd vaccination [at Day 64])
    End point values
    		 Group 1: Ad26.COV2.S 9x10^10 vp Group 2: Ad26.COV2.S 7x10^10 vp Group 3: Ad26.COV2.S 5x10^10 vp Group 4: Ad26.COV2.S 3.5x10^10 vp Group 5: Ad26.COV2.S 2.5x10^10 vp Group 6: Ad26.COV2.S 1.25x10^10 vp
    Number of subjects analysed
    288
    221
    291
    220
    288
    285
    Units: Subjects
        After 1st vaccination (n=288,221,291,220,288,285)
    204
    156
    173
    135
    156
    152
        After 2nd vaccination (n=264,200,269,199,270,258)
    144
    98
    111
    91
    105
    109
    No statistical analyses for this end point

    Secondary: Number of Subjects with Unsolicited AEs for 28 Days After Each Vaccination

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    End point title
    		 Number of Subjects with Unsolicited AEs for 28 Days After Each Vaccination
    End point description
    Unsolicited AEs were all AEs for which the subject was not specifically questioned in the subject diary. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study. Full analysis set included all subjects with at least one vaccine administration documented. Here, 'n' (number of subjects analysed) signifies number of subjects evaluable for this timepoint.
    End point type
    Secondary
    End point timeframe
    28 days after each vaccination (1st vaccination [at Day 29], 2nd vaccination [at Day 85])
    End point values
    		 Group 1: Ad26.COV2.S 9x10^10 vp Group 2: Ad26.COV2.S 7x10^10 vp Group 3: Ad26.COV2.S 5x10^10 vp Group 4: Ad26.COV2.S 3.5x10^10 vp Group 5: Ad26.COV2.S 2.5x10^10 vp Group 6: Ad26.COV2.S 1.25x10^10 vp
    Number of subjects analysed
    288
    221
    291
    220
    288
    285
    Units: Subjects
        After 1st vaccination (n=288,221,291,220,288,285)
    78
    60
    55
    58
    69
    59
        After 2nd vaccination (n=264,200,269,199,270,258)
    55
    28
    49
    39
    53
    50
    No statistical analyses for this end point

    Secondary: Number of Subjects with Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects with Serious Adverse Events (SAEs)
    End point description
    SAE was any untoward medical occurrence that at any dose may resulted in death, was life-threatening, required inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study. Full analysis set included all subjects with at least one vaccine administration documented.
    End point type
    Secondary
    End point timeframe
    From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
    End point values
    		 Group 1: Ad26.COV2.S 9x10^10 vp Group 2: Ad26.COV2.S 7x10^10 vp Group 3: Ad26.COV2.S 5x10^10 vp Group 4: Ad26.COV2.S 3.5x10^10 vp Group 5: Ad26.COV2.S 2.5x10^10 vp Group 6: Ad26.COV2.S 1.25x10^10 vp
    Number of subjects analysed
    288
    221
    291
    220
    288
    285
    Units: Subjects
    13
    3
    4
    4
    3
    5
    No statistical analyses for this end point

    Secondary: Number of Subjects with Adverse Events of Special Interest (AESIs)

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    End point title
    		 Number of Subjects with Adverse Events of Special Interest (AESIs)
    End point description
    AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with thrombocytopenia syndrome were considered to be an AESI. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study. Full analysis set included all subjects with at least one vaccine administration documented.
    End point type
    Secondary
    End point timeframe
    From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
    End point values
    		 Group 1: Ad26.COV2.S 9x10^10 vp Group 2: Ad26.COV2.S 7x10^10 vp Group 3: Ad26.COV2.S 5x10^10 vp Group 4: Ad26.COV2.S 3.5x10^10 vp Group 5: Ad26.COV2.S 2.5x10^10 vp Group 6: Ad26.COV2.S 1.25x10^10 vp
    Number of subjects analysed
    288
    221
    291
    220
    288
    285
    Units: Subjects
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with AEs Leading to Study Discontinuation

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    End point title
    		 Number of Subjects with AEs Leading to Study Discontinuation
    End point description
    Number of subjects with AEs leading to study discontinuation were reported. Full analysis set included all subjects with at least one vaccine administration documented.
    End point type
    Secondary
    End point timeframe
    Up to 60 weeks
    End point values
    		 Group 1: Ad26.COV2.S 9x10^10 vp Group 2: Ad26.COV2.S 7x10^10 vp Group 3: Ad26.COV2.S 5x10^10 vp Group 4: Ad26.COV2.S 3.5x10^10 vp Group 5: Ad26.COV2.S 2.5x10^10 vp Group 6: Ad26.COV2.S 1.25x10^10 vp
    Number of subjects analysed
    288
    221
    291
    220
    288
    285
    Units: Subjects
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with Medically-Attended Adverse Events (MAAEs)

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    End point title
    		 Number of Subjects with Medically-Attended Adverse Events (MAAEs)
    End point description
    MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study. Full analysis set included all subjects with at least one vaccine administration documented.
    End point type
    Secondary
    End point timeframe
    6 months after second vaccination (up to 32 weeks)
    End point values
    		 Group 1: Ad26.COV2.S 9x10^10 vp Group 2: Ad26.COV2.S 7x10^10 vp Group 3: Ad26.COV2.S 5x10^10 vp Group 4: Ad26.COV2.S 3.5x10^10 vp Group 5: Ad26.COV2.S 2.5x10^10 vp Group 6: Ad26.COV2.S 1.25x10^10 vp
    Number of subjects analysed
    288
    221
    281
    220
    288
    285
    Units: Subjects
    54
    34
    50
    35
    48
    35
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Day 1 (post-vaccination) up to end of the study (i.e. up to 60 weeks)
    Adverse event reporting additional description
    Full analysis set included all subjects with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Group 1: Ad26.COV2.S 9x10^10 vp
    Reporting group description
    		 Subjects in the main and sub study received a single dose of IM injection of Ad26.COV2.S 9x10^10 vp on Days 1 and 57.

    Reporting group title
    Group 2: Ad26.COV2.S 7x10^10 vp
    Reporting group description
    		 Subjects in the main study received a single dose of IM injection of Ad26.COV2.S 7x10^10 vp on Days 1 and 57.

    Reporting group title
    Group 6: Ad26.COV2.S 1.25x10^10 vp
    Reporting group description
    		 Subjects in the main and sub study received a single dose of IM injection of Ad26.COV2.S 1.25x10^10 vp on Days 1 and 57.

    Reporting group title
    Group 4: Ad26.COV2.S 3.5x10^10 vp
    Reporting group description
    		 Subjects in the main received a single dose of IM injection of Ad26.COV2.S 3.5x10^10 vp on Days 1 and 57.

    Reporting group title
    Group 5: Ad26.COV2.S 2.5x10^10 vp
    Reporting group description
    		 Subjects in the main and sub study received a single dose of IM injection of Ad26.COV2.S 2.5x10^10 vp on Days 1 and 57.

    Reporting group title
    Group 3: Ad26.COV2.S 5x10^10 vp
    Reporting group description
    		 Subjects in the main and sub study received a single dose of IM injection of Ad26.COV2.S 5x10^10 vp on Days 1 and 57.

    Serious adverse events
    		 Group 1: Ad26.COV2.S 9x10^10 vp Group 2: Ad26.COV2.S 7x10^10 vp Group 6: Ad26.COV2.S 1.25x10^10 vp Group 4: Ad26.COV2.S 3.5x10^10 vp Group 5: Ad26.COV2.S 2.5x10^10 vp Group 3: Ad26.COV2.S 5x10^10 vp
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 288 (4.51%)
    3 / 221 (1.36%)
    5 / 285 (1.75%)
    4 / 220 (1.82%)
    3 / 288 (1.04%)
    4 / 291 (1.37%)
         number of deaths (all causes)
    1
    0
    1
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tongue Neoplasm Malignant Stage Unspecified
         subjects affected / exposed
    1 / 288 (0.35%)
    0 / 221 (0.00%)
    0 / 285 (0.00%)
    0 / 220 (0.00%)
    0 / 288 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    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
    Pregnancy, puerperium and perinatal conditions
    Abortion Spontaneous
         subjects affected / exposed
    1 / 288 (0.35%)
    0 / 221 (0.00%)
    0 / 285 (0.00%)
    0 / 220 (0.00%)
    0 / 288 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gestational Diabetes
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 221 (0.00%)
    1 / 285 (0.35%)
    0 / 220 (0.00%)
    0 / 288 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    General disorders and administration site conditions
    Drowning
         subjects affected / exposed
    1 / 288 (0.35%)
    0 / 221 (0.00%)
    0 / 285 (0.00%)
    0 / 220 (0.00%)
    0 / 288 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 221 (0.00%)
    1 / 285 (0.35%)
    0 / 220 (0.00%)
    0 / 288 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Hydrosalpinx
         subjects affected / exposed
    1 / 288 (0.35%)
    0 / 221 (0.00%)
    0 / 285 (0.00%)
    0 / 220 (0.00%)
    0 / 288 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    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
    Ovarian Cyst Torsion
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 221 (0.00%)
    1 / 285 (0.35%)
    0 / 220 (0.00%)
    0 / 288 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Ovarian Disorder
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 221 (0.00%)
    1 / 285 (0.35%)
    0 / 220 (0.00%)
    0 / 288 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaginal Haemorrhage
         subjects affected / exposed
    0 / 288 (0.00%)
    1 / 221 (0.45%)
    0 / 285 (0.00%)
    0 / 220 (0.00%)
    0 / 288 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    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
    Respiratory, thoracic and mediastinal disorders
    Pleural Effusion
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 221 (0.00%)
    0 / 285 (0.00%)
    0 / 220 (0.00%)
    1 / 288 (0.35%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety Disorder
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 221 (0.00%)
    1 / 285 (0.35%)
    0 / 220 (0.00%)
    0 / 288 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    1 / 288 (0.35%)
    0 / 221 (0.00%)
    0 / 285 (0.00%)
    0 / 220 (0.00%)
    0 / 288 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    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
    Depression
         subjects affected / exposed
    0 / 288 (0.00%)
    1 / 221 (0.45%)
    0 / 285 (0.00%)
    0 / 220 (0.00%)
    0 / 288 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    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
    Psychotic Disorder
         subjects affected / exposed
    1 / 288 (0.35%)
    0 / 221 (0.00%)
    0 / 285 (0.00%)
    0 / 220 (0.00%)
    0 / 288 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    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
    Suicide Attempt
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 221 (0.00%)
    0 / 285 (0.00%)
    0 / 220 (0.00%)
    1 / 288 (0.35%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle Fracture
         subjects affected / exposed
    0 / 288 (0.00%)
    1 / 221 (0.45%)
    0 / 285 (0.00%)
    0 / 220 (0.00%)
    0 / 288 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    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
    Gun Shot Wound
         subjects affected / exposed
    1 / 288 (0.35%)
    0 / 221 (0.00%)
    0 / 285 (0.00%)
    0 / 220 (0.00%)
    0 / 288 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    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
    Stab Wound
         subjects affected / exposed
    1 / 288 (0.35%)
    0 / 221 (0.00%)
    0 / 285 (0.00%)
    0 / 220 (0.00%)
    0 / 288 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    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
    Cardiac disorders
    Myopericarditis
         subjects affected / exposed
    1 / 288 (0.35%)
    0 / 221 (0.00%)
    0 / 285 (0.00%)
    0 / 220 (0.00%)
    0 / 288 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    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
    Nervous system disorders
    Carotid Artery Dissection
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 221 (0.00%)
    0 / 285 (0.00%)
    1 / 220 (0.45%)
    0 / 288 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 221 (0.00%)
    0 / 285 (0.00%)
    0 / 220 (0.00%)
    1 / 288 (0.35%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myasthenia Gravis
         subjects affected / exposed
    1 / 288 (0.35%)
    0 / 221 (0.00%)
    0 / 285 (0.00%)
    0 / 220 (0.00%)
    0 / 288 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    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
    Syncope
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 221 (0.00%)
    0 / 285 (0.00%)
    0 / 220 (0.00%)
    0 / 288 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 221 (0.00%)
    0 / 285 (0.00%)
    0 / 220 (0.00%)
    0 / 288 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 221 (0.00%)
    0 / 285 (0.00%)
    0 / 220 (0.00%)
    0 / 288 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal Fistula
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 221 (0.00%)
    1 / 285 (0.35%)
    0 / 220 (0.00%)
    0 / 288 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 221 (0.00%)
    0 / 285 (0.00%)
    0 / 220 (0.00%)
    0 / 288 (0.00%)
    1 / 291 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 221 (0.00%)
    0 / 285 (0.00%)
    1 / 220 (0.45%)
    0 / 288 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral Disc Protrusion
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 221 (0.00%)
    0 / 285 (0.00%)
    1 / 220 (0.45%)
    0 / 288 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 288 (0.35%)
    0 / 221 (0.00%)
    0 / 285 (0.00%)
    0 / 220 (0.00%)
    0 / 288 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    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
    Cellulitis
         subjects affected / exposed
    1 / 288 (0.35%)
    0 / 221 (0.00%)
    0 / 285 (0.00%)
    0 / 220 (0.00%)
    0 / 288 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    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
    Pelvic Abscess
         subjects affected / exposed
    1 / 288 (0.35%)
    0 / 221 (0.00%)
    0 / 285 (0.00%)
    0 / 220 (0.00%)
    0 / 288 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    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
    Pyelonephritis
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 221 (0.00%)
    0 / 285 (0.00%)
    1 / 220 (0.45%)
    0 / 288 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis Acute
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 221 (0.00%)
    0 / 285 (0.00%)
    1 / 220 (0.45%)
    0 / 288 (0.00%)
    0 / 291 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Group 1: Ad26.COV2.S 9x10^10 vp Group 2: Ad26.COV2.S 7x10^10 vp Group 6: Ad26.COV2.S 1.25x10^10 vp Group 4: Ad26.COV2.S 3.5x10^10 vp Group 5: Ad26.COV2.S 2.5x10^10 vp Group 3: Ad26.COV2.S 5x10^10 vp
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    245 / 288 (85.07%)
    187 / 221 (84.62%)
    217 / 285 (76.14%)
    188 / 220 (85.45%)
    228 / 288 (79.17%)
    236 / 291 (81.10%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    6 / 288 (2.08%)
    0 / 221 (0.00%)
    0 / 285 (0.00%)
    4 / 220 (1.82%)
    0 / 288 (0.00%)
    3 / 291 (1.03%)
         occurrences all number
    9
    0
    0
    4
    0
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    26 / 288 (9.03%)
    14 / 221 (6.33%)
    22 / 285 (7.72%)
    21 / 220 (9.55%)
    23 / 288 (7.99%)
    11 / 291 (3.78%)
         occurrences all number
    28
    20
    28
    25
    26
    12
    Headache(Solicited)
         subjects affected / exposed
    184 / 288 (63.89%)
    139 / 221 (62.90%)
    123 / 285 (43.16%)
    109 / 220 (49.55%)
    133 / 288 (46.18%)
    146 / 291 (50.17%)
         occurrences all number
    260
    202
    165
    150
    175
    195
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 288 (1.74%)
    1 / 221 (0.45%)
    0 / 285 (0.00%)
    0 / 220 (0.00%)
    6 / 288 (2.08%)
    8 / 291 (2.75%)
         occurrences all number
    5
    1
    0
    0
    7
    9
    Thrombocytopenia
         subjects affected / exposed
    8 / 288 (2.78%)
    5 / 221 (2.26%)
    9 / 285 (3.16%)
    7 / 220 (3.18%)
    4 / 288 (1.39%)
    1 / 291 (0.34%)
         occurrences all number
    8
    6
    15
    8
    5
    1
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    11 / 288 (3.82%)
    5 / 221 (2.26%)
    0 / 285 (0.00%)
    5 / 220 (2.27%)
    4 / 288 (1.39%)
    2 / 291 (0.69%)
         occurrences all number
    13
    5
    0
    6
    4
    2
    Fatigue
         subjects affected / exposed
    15 / 288 (5.21%)
    11 / 221 (4.98%)
    15 / 285 (5.26%)
    9 / 220 (4.09%)
    5 / 288 (1.74%)
    7 / 291 (2.41%)
         occurrences all number
    19
    14
    22
    9
    5
    9
    Fatigue(Solicited)
         subjects affected / exposed
    171 / 288 (59.38%)
    140 / 221 (63.35%)
    132 / 285 (46.32%)
    113 / 220 (51.36%)
    124 / 288 (43.06%)
    144 / 291 (49.48%)
         occurrences all number
    248
    202
    178
    164
    173
    207
    Pyrexia
         subjects affected / exposed
    9 / 288 (3.13%)
    10 / 221 (4.52%)
    7 / 285 (2.46%)
    4 / 220 (1.82%)
    4 / 288 (1.39%)
    5 / 291 (1.72%)
         occurrences all number
    14
    14
    7
    4
    4
    7
    Vaccination Site Erythema(Solicited)
         subjects affected / exposed
    3 / 288 (1.04%)
    5 / 221 (2.26%)
    5 / 285 (1.75%)
    4 / 220 (1.82%)
    2 / 288 (0.69%)
    9 / 291 (3.09%)
         occurrences all number
    3
    5
    5
    4
    2
    9
    Pyrexia(Solicited)
         subjects affected / exposed
    68 / 288 (23.61%)
    41 / 221 (18.55%)
    16 / 285 (5.61%)
    27 / 220 (12.27%)
    22 / 288 (7.64%)
    33 / 291 (11.34%)
         occurrences all number
    77
    42
    17
    27
    25
    37
    Vaccination Site Pain
         subjects affected / exposed
    7 / 288 (2.43%)
    8 / 221 (3.62%)
    8 / 285 (2.81%)
    3 / 220 (1.36%)
    6 / 288 (2.08%)
    4 / 291 (1.37%)
         occurrences all number
    8
    12
    10
    4
    6
    6
    Vaccination Site Swelling(Solicited)
         subjects affected / exposed
    8 / 288 (2.78%)
    9 / 221 (4.07%)
    8 / 285 (2.81%)
    3 / 220 (1.36%)
    3 / 288 (1.04%)
    9 / 291 (3.09%)
         occurrences all number
    8
    9
    9
    3
    3
    12
    Vaccination Site Pain(Solicited)
         subjects affected / exposed
    198 / 288 (68.75%)
    156 / 221 (70.59%)
    160 / 285 (56.14%)
    153 / 220 (69.55%)
    175 / 288 (60.76%)
    190 / 291 (65.29%)
         occurrences all number
    306
    242
    234
    231
    265
    284
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    6 / 288 (2.08%)
    3 / 221 (1.36%)
    2 / 285 (0.70%)
    3 / 220 (1.36%)
    2 / 288 (0.69%)
    3 / 291 (1.03%)
         occurrences all number
    6
    3
    3
    5
    2
    4
    Nausea
         subjects affected / exposed
    6 / 288 (2.08%)
    5 / 221 (2.26%)
    5 / 285 (1.75%)
    5 / 220 (2.27%)
    5 / 288 (1.74%)
    2 / 291 (0.69%)
         occurrences all number
    7
    6
    6
    5
    5
    2
    Nausea(Solicited)
         subjects affected / exposed
    95 / 288 (32.99%)
    78 / 221 (35.29%)
    65 / 285 (22.81%)
    58 / 220 (26.36%)
    64 / 288 (22.22%)
    67 / 291 (23.02%)
         occurrences all number
    123
    99
    80
    71
    78
    79
    Odynophagia
         subjects affected / exposed
    3 / 288 (1.04%)
    5 / 221 (2.26%)
    5 / 285 (1.75%)
    1 / 220 (0.45%)
    2 / 288 (0.69%)
    3 / 291 (1.03%)
         occurrences all number
    3
    7
    7
    1
    3
    3
    Vomiting
         subjects affected / exposed
    4 / 288 (1.39%)
    1 / 221 (0.45%)
    2 / 285 (0.70%)
    1 / 220 (0.45%)
    1 / 288 (0.35%)
    6 / 291 (2.06%)
         occurrences all number
    4
    1
    3
    1
    1
    6
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 288 (2.43%)
    5 / 221 (2.26%)
    4 / 285 (1.40%)
    7 / 220 (3.18%)
    7 / 288 (2.43%)
    3 / 291 (1.03%)
         occurrences all number
    9
    7
    5
    7
    8
    4
    Dyspnoea
         subjects affected / exposed
    6 / 288 (2.08%)
    0 / 221 (0.00%)
    1 / 285 (0.35%)
    1 / 220 (0.45%)
    2 / 288 (0.69%)
    2 / 291 (0.69%)
         occurrences all number
    6
    0
    1
    2
    2
    3
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    10 / 288 (3.47%)
    12 / 221 (5.43%)
    18 / 285 (6.32%)
    12 / 220 (5.45%)
    7 / 288 (2.43%)
    6 / 291 (2.06%)
         occurrences all number
    12
    17
    20
    15
    7
    8
    Myalgia(Solicited)
         subjects affected / exposed
    183 / 288 (63.54%)
    126 / 221 (57.01%)
    111 / 285 (38.95%)
    115 / 220 (52.27%)
    118 / 288 (40.97%)
    144 / 291 (49.48%)
         occurrences all number
    260
    175
    151
    159
    159
    188
    Infections and infestations
    Influenza
         subjects affected / exposed
    35 / 288 (12.15%)
    26 / 221 (11.76%)
    25 / 285 (8.77%)
    26 / 220 (11.82%)
    37 / 288 (12.85%)
    38 / 291 (13.06%)
         occurrences all number
    57
    31
    35
    41
    52
    50
    Covid-19
         subjects affected / exposed
    9 / 288 (3.13%)
    21 / 221 (9.50%)
    13 / 285 (4.56%)
    20 / 220 (9.09%)
    22 / 288 (7.64%)
    20 / 291 (6.87%)
         occurrences all number
    14
    30
    19
    29
    35
    28
    Nasopharyngitis
         subjects affected / exposed
    3 / 288 (1.04%)
    7 / 221 (3.17%)
    12 / 285 (4.21%)
    6 / 220 (2.73%)
    8 / 288 (2.78%)
    7 / 291 (2.41%)
         occurrences all number
    3
    7
    13
    8
    13
    8
    Rhinitis
         subjects affected / exposed
    8 / 288 (2.78%)
    6 / 221 (2.71%)
    2 / 285 (0.70%)
    4 / 220 (1.82%)
    10 / 288 (3.47%)
    1 / 291 (0.34%)
         occurrences all number
    9
    8
    2
    4
    11
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Mar 2021
    The purpose of this amendment was to remove the placebo arms of the study for ethical reasons. Furthermore, after consideration of additional COV2001 study results, dose groups of 9×10^10 vp, 7×10^10 vp, and 3.5×10^10 vp Ad26.COV2.S were added and the 1-dose regimen was removed, resulting in 6 dose-groups, each receiving 2 doses.
    10 May 2021
    The purpose of this amendment was to include additional safety measures due to reports of adverse events following use of the Ad26.COV2.S vaccine under emergency use authorisation in the United States (US), suggesting an increased risk of thrombosis combined with thrombocytopenia. Based on this, thrombosis with thrombocytopenia syndrome (TTS), which was a very rare event, followed in this protocol as adverse event of special interest (AESI) that needed to be reported to the sponsor within 24 hours of awareness. In addition, the protocol had been adjusted to align with the latest vaccine risk language.
    23 Jun 2021
    The main purpose of this amendment was to move the Day 85 sampling timepoint (28 days post-dose 2) to Day 71 (14 days post-dose 2) in order to align across VAC31518COVID studies. This amendment also updated the amount of blood volume needed (from 12 millilitre [mL] to 15 mL) to be collected at baseline and for AESI evaluations due to the increased volume of blood needed to isolate serum/plasma for the coagulation related assays in the study. An additional exclusion criterion for subjects with a history of capillary leak syndrome was added.
    03 Aug 2021
    The purpose of this amendment was to include the mechanism for the rare thrombosis with TTS events that was reported after vaccination with Johnson & Johnson’s Ad26.COV2.S vaccine was not known.
    30 Nov 2021
    The purpose of this amendment was to clarify that hematology assessment was assessed pre- and post-vaccination in all of the subjects in both the main and sub study. In addition, exploratory endpoints were updated or added in both the main and sub study to include analysis against emerging variants due to the evolving nature of the corona virus-2019 (COVID-19) virus.
    01 Jun 2022
    The purpose of this amendment was to to allow flexibility to stop enrollment in the sub-study of seronegative subjects earlier due to the increasing challenges of recruiting seronegative subjects into the sub study. The amendment also removed the interim analysis after the first vaccination at 28 days post dose 1 of the main study.
    16 Sep 2022
    The purpose of this amendment was to modify the order of the sequential non-inferiority assessment hypothesis testing.

    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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