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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Years and Older and to Evaluate 2 Dose Levels of Ad26.COV2.S in Healthy Adolescents Aged 12 to 17 Years Inclusive

    Summary
    EudraCT number
    2020-002584-63
    Trial protocol
    DE   NL   ES   Outside EU/EEA  
    Global end of trial date
    09 Mar 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    25 Sep 2022
    First version publication date
    25 Sep 2022
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    CR108854
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04535453
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Vaccines & Prevention B.V.
    Sponsor organisation address
    Newtonweg 1, Leiden, Netherlands, 2333 CP
    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)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-002880-PIP01-20
    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
    09 Mar 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Mar 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Mar 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the humoral immune response to 3 dose levels (5*10^10 virus particle [vp], 2.5*10^10 vp, 1.25*10^10 vp) of Ad26.COV2.S, administered intramuscularly (IM) as a 2-dose schedule at a 56-day interval, 28 days after Vaccination 2 and to assess the humoral immune response to 2 dose levels (1*10^11 vp and 5*10^10 vp) of Ad26.COV2.S, administered intramuscularly (IM) as a single vaccination, 28 days after Vaccination 1 and to assess the humoral immune response to Ad26.COV2.S at the 5*10^10 vp dose level, administered IM as a 2-dose schedule at a 28-day and at an 84-day interval, 28 days after Vaccination 2 and to assess the safety and reactogenicity of Ad26.COV2.S, administered IM at several dose levels, as a 2-dose or a single-dose schedule.
    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 (GCP) and applicable regulatory requirements.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    31 Aug 2020
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    12 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 233
    Country: Number of subjects enrolled
    Spain: 218
    Country: Number of subjects enrolled
    United Kingdom: 14
    Country: Number of subjects enrolled
    Netherlands: 152
    Worldwide total number of subjects
    617
    EEA total number of subjects
    603
    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)
    33
    Adults (18-64 years)
    375
    From 65 to 84 years
    209
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 635 subjects were enrolled in the study, out of which 617 subjects received treatment. Remaining 18 subjects did not receive any treatment and are excluded from the analyses.

    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 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10
    Arm description
    Adult subjects received 2-dose regimen intramuscular (IM) injection of Ad26.COV2.S vaccine at a dose level of 5*10^10 virus particle (vp) on Days 1 and 57. Subjects also received a single antigen presentation IM injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.
    Arm type
    Experimental

    Investigational medicinal product name
    Ad26.COV2.S 5*10^10 vp
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particle (vp) on Days 1 and 57.

    Investigational medicinal product name
    Ad26.COV2.S 1.25*10^10 vp
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single antigen presentation IM injection of Ad26.COV2.S at a dose level of 1.25*10^10 vp at 4 months after second vaccination.

    Arm title
    Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10
    Arm description
    Adult subjects received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5*10^10 vp on Days 1 and 57. Subjects also received a single antigen presentation IM injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.
    Arm type
    Experimental

    Investigational medicinal product name
    Ad26.COV2.S 1.25*10^10 vp
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single antigen presentation IM injection of Ad26.COV2.S at a dose level of 1.25*10^10 vp at 4 months after second vaccination.

    Investigational medicinal product name
    Ad26.COV2.S 2.5*10^10 vp
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received IM injection of Ad26.COV2.S vaccine at dose level of 2.5*10^10 vp on Days 1 and 57.

    Arm title
    Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10
    Arm description
    Adult subjects received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25*10^10 vp on Days 1 and 57. Subjects also received a single antigen presentation IM injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.
    Arm type
    Experimental

    Investigational medicinal product name
    Ad26.COV2.S 1.25*10^10 vp
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single antigen presentation IM injection of Ad26.COV2.S at a dose level of 1.25*10^10 vp at 4 months after second vaccination.

    Investigational medicinal product name
    Ad26.COV2.S 1.25*10^10 vp
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received IM injection of Ad26.COV2.S vaccine at dose level of 1.25*10^10 vp on Days 1 and 57.

    Arm title
    Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10
    Arm description
    Adult subjects received single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1*10^11 vp on Day 1 and placebo at Day 57. Subjects also received a single antigen presentation IM injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.
    Arm type
    Experimental

    Investigational medicinal product name
    Ad26.COV2.S 1*10^11 vp
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1*10^11 vp on Day 1.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received IM injection of placebo matching to Ad26.COV2.S on Day 57.

    Investigational medicinal product name
    Ad26.COV2.S 1.25*10^10 vp
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single antigen presentation IM injection of Ad26.COV2.S at dose level of 1.25*10^10 vp at 4 months after second vaccination.

    Arm title
    Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10
    Arm description
    Adult subjects received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5*10^10 vp on Day 1 and placebo at Day 57. Subjects also received a single antigen presentation IM injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.
    Arm type
    Experimental

    Investigational medicinal product name
    Ad26.COV2.S 5*10^10 vp
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received IM injection of Ad26.COV2.S vaccine at dose level of 5*10^10 vp on Day 1.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received IM injection of placebo matching to Ad26.COV2.S on Day 57.

    Investigational medicinal product name
    Ad26.COV2.S 1.25*10^10 vp
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single antigen presentation IM injection of Ad26.COV2.S at dose level of 1.25*10^10 vp at 4 months after second vaccination.

    Arm title
    Group 6: Placebo, Placebo, Placebo, Placebo
    Arm description
    Adult subjects received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 57. Subjects also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 57.

    Arm title
    Group 7: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10
    Arm description
    Adult subjects received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5*10^10 vp on Days 1 and 29. Subjects also received a single antigen presentation IM injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.
    Arm type
    Experimental

    Investigational medicinal product name
    Ad26.COV2.S 1.25*10^10 vp
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single antigen presentation IM injection of Ad26.COV2.S at a dose level of 1.25*10^10 vp at 4 months after second vaccination.

    Investigational medicinal product name
    Ad26.COV2.S 5*10^10 vp
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received IM injection of Ad26.COV2.S vaccine at dose level of 5*10^10 vp on Days 1 and 29.

    Arm title
    Group 8: Placebo, Placebo, Placebo
    Arm description
    Adult subjects received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 29. Subjects also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
    Arm type
    Placebo

    Investigational medicinal product name
    Ad26.COV2.S 1.25*10^10 vp
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single antigen presentation IM injection of Ad26.COV2.S at dose level of 1.25*10^10 vp at 4 months after second vaccination.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 29.

    Arm title
    Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10
    Arm description
    Adult subjects received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5*10^10 vp on Days 1 and 85. Subjects also received a single antigen presentation injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.
    Arm type
    Experimental

    Investigational medicinal product name
    Ad26.COV2.S 1.25*10^10 vp
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single antigen presentation IM injection of Ad26.COV2.S at a dose level of 1.25*10^10 vp at 4 months after second vaccination.

    Investigational medicinal product name
    Ad26.COV2.S 5x10^10 vp
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received IM injection of Ad26.COV2.S vaccine at dose level of 5x10^10 vp on Days 1 and 85.

    Arm title
    Group 10: Placebo, Placebo, Placebo
    Arm description
    Adult subjects received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Subjects also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received IM injection of placebo matching to Ad26.COV2.S Placebo on Days 1 and 85.

    Arm title
    Group A and B Combined: Ad26 2.5*10^10
    Arm description
    Adolescent subjects aged 12 to 15 years (Group A) and 16 to 17 years (Group B) received single dose IM injection of Ad26.COV2.S vaccine at a dose of 2.5*10^10 vp on Day 1.
    Arm type
    Placebo

    Investigational medicinal product name
    Ad26.COV2.S 2.5*10^10 vp
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received single dose IM injection of Ad26.COV2.S vaccine at a dose level of 2.5*10^10 vp on Day 1

    Arm title
    Group C: Placebo
    Arm description
    Adolescent subjects aged 12 to 17 years received single dose IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received single dose IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1.

    Number of subjects in period 1
    Group 1: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10 Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10 Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10 Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10 Group 6: Placebo, Placebo, Placebo, Placebo Group 7: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 8: Placebo, Placebo, Placebo Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 10: Placebo, Placebo, Placebo Group A and B Combined: Ad26 2.5*10^10 Group C: Placebo
    Started
    86
    81
    75
    74
    81
    26
    56
    27
    53
    25
    30
    3
    Completed
    82
    73
    70
    70
    75
    24
    54
    25
    50
    23
    30
    2
    Not completed
    4
    8
    5
    4
    6
    2
    2
    2
    3
    2
    0
    1
         Physician decision
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
         Death
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Unspecified
    -
    -
    1
    -
    1
    -
    1
    1
    1
    -
    -
    -
         Lost to follow-up
    1
    1
    1
    -
    3
    1
    -
    -
    1
    1
    -
    -
         Withdrawal by subject
    3
    6
    3
    3
    2
    1
    1
    1
    1
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10
    Reporting group description
    Adult subjects received 2-dose regimen intramuscular (IM) injection of Ad26.COV2.S vaccine at a dose level of 5*10^10 virus particle (vp) on Days 1 and 57. Subjects also received a single antigen presentation IM injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.

    Reporting group title
    Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10
    Reporting group description
    Adult subjects received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5*10^10 vp on Days 1 and 57. Subjects also received a single antigen presentation IM injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.

    Reporting group title
    Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10
    Reporting group description
    Adult subjects received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25*10^10 vp on Days 1 and 57. Subjects also received a single antigen presentation IM injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.

    Reporting group title
    Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10
    Reporting group description
    Adult subjects received single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1*10^11 vp on Day 1 and placebo at Day 57. Subjects also received a single antigen presentation IM injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.

    Reporting group title
    Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10
    Reporting group description
    Adult subjects received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5*10^10 vp on Day 1 and placebo at Day 57. Subjects also received a single antigen presentation IM injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.

    Reporting group title
    Group 6: Placebo, Placebo, Placebo, Placebo
    Reporting group description
    Adult subjects received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 57. Subjects also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.

    Reporting group title
    Group 7: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10
    Reporting group description
    Adult subjects received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5*10^10 vp on Days 1 and 29. Subjects also received a single antigen presentation IM injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.

    Reporting group title
    Group 8: Placebo, Placebo, Placebo
    Reporting group description
    Adult subjects received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 29. Subjects also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.

    Reporting group title
    Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10
    Reporting group description
    Adult subjects received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5*10^10 vp on Days 1 and 85. Subjects also received a single antigen presentation injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.

    Reporting group title
    Group 10: Placebo, Placebo, Placebo
    Reporting group description
    Adult subjects received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Subjects also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.

    Reporting group title
    Group A and B Combined: Ad26 2.5*10^10
    Reporting group description
    Adolescent subjects aged 12 to 15 years (Group A) and 16 to 17 years (Group B) received single dose IM injection of Ad26.COV2.S vaccine at a dose of 2.5*10^10 vp on Day 1.

    Reporting group title
    Group C: Placebo
    Reporting group description
    Adolescent subjects aged 12 to 17 years received single dose IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1.

    Reporting group values
    Group 1: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10 Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10 Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10 Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10 Group 6: Placebo, Placebo, Placebo, Placebo Group 7: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 8: Placebo, Placebo, Placebo Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 10: Placebo, Placebo, Placebo Group A and B Combined: Ad26 2.5*10^10 Group C: Placebo Total
    Number of subjects
    86 81 75 74 81 26 56 27 53 25 30 3 617
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0 0 0 0 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0 0 0 0 0 0 30 3 33
        Adults (18-64 years)
    57 48 52 48 51 16 37 17 33 16 0 0 375
        From 65 to 84 years
    29 33 23 26 30 10 19 10 20 9 0 0 209
        85 years and over
    0 0 0 0 0 0 0 0 0 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    49.1 ± 18.12 49.1 ± 19.44 49.2 ± 17.33 50.3 ± 17.1 48.6 ± 18.5 48.4 ± 16.88 48.8 ± 17.15 49.0 ± 17.63 48.1 ± 18.99 52.4 ± 13.63 16.3 ± 0.47 16.3 ± 0.58 -
    Title for Gender
    Units: subjects
        Female
    26 30 22 32 35 13 14 10 19 13 20 2 236
        Male
    60 51 53 42 46 13 42 17 34 12 10 1 381

    End points

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    End points reporting groups
    Reporting group title
    Group 1: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10
    Reporting group description
    Adult subjects received 2-dose regimen intramuscular (IM) injection of Ad26.COV2.S vaccine at a dose level of 5*10^10 virus particle (vp) on Days 1 and 57. Subjects also received a single antigen presentation IM injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.

    Reporting group title
    Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10
    Reporting group description
    Adult subjects received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5*10^10 vp on Days 1 and 57. Subjects also received a single antigen presentation IM injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.

    Reporting group title
    Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10
    Reporting group description
    Adult subjects received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25*10^10 vp on Days 1 and 57. Subjects also received a single antigen presentation IM injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.

    Reporting group title
    Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10
    Reporting group description
    Adult subjects received single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1*10^11 vp on Day 1 and placebo at Day 57. Subjects also received a single antigen presentation IM injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.

    Reporting group title
    Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10
    Reporting group description
    Adult subjects received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5*10^10 vp on Day 1 and placebo at Day 57. Subjects also received a single antigen presentation IM injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.

    Reporting group title
    Group 6: Placebo, Placebo, Placebo, Placebo
    Reporting group description
    Adult subjects received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 57. Subjects also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.

    Reporting group title
    Group 7: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10
    Reporting group description
    Adult subjects received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5*10^10 vp on Days 1 and 29. Subjects also received a single antigen presentation IM injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.

    Reporting group title
    Group 8: Placebo, Placebo, Placebo
    Reporting group description
    Adult subjects received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 29. Subjects also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.

    Reporting group title
    Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10
    Reporting group description
    Adult subjects received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5*10^10 vp on Days 1 and 85. Subjects also received a single antigen presentation injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.

    Reporting group title
    Group 10: Placebo, Placebo, Placebo
    Reporting group description
    Adult subjects received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Subjects also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.

    Reporting group title
    Group A and B Combined: Ad26 2.5*10^10
    Reporting group description
    Adolescent subjects aged 12 to 15 years (Group A) and 16 to 17 years (Group B) received single dose IM injection of Ad26.COV2.S vaccine at a dose of 2.5*10^10 vp on Day 1.

    Reporting group title
    Group C: Placebo
    Reporting group description
    Adolescent subjects aged 12 to 17 years received single dose IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1.

    Subject analysis set title
    Group 1 and 7 Combined
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Adult subjects received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5*10^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25*10^10 vp at 4 months after second vaccination.

    Subject analysis set title
    Group 6 and 8 Combined
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Adult subjects received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.

    Primary: Adults of Groups 1, 2 and 3: Percentage of Subjects With Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers at 28 days After Vaccination 2

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    End point title
    Adults of Groups 1, 2 and 3: Percentage of Subjects With Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers at 28 days After Vaccination 2 [1] [2]
    End point description
    Percentage of subjects with serological response to vaccination as measured by VNA titers were reported. A subject was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was less than or equal to the lower limit of quantification (<=LLOQ) and the post-baseline sample was greater than (>) LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (greater than or equal to [>=] 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were 50% inhibitory concentration (IC50) of 58 and 12,800, respectively. Per protocol immunogenicity (PPI) population 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 analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Primary
    End point timeframe
    28 days after Vaccination 2 (Day 85)
    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.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 1: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10 Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10
    Number of subjects analysed
    31
    36
    36
    Units: Percentage of subjects
        number (confidence interval 95%)
    96.8 (83.3 to 99.9)
    100.0 (90.3 to 100.0)
    88.9 (73.9 to 96.9)
    No statistical analyses for this end point

    Primary: Adults of Groups 1, 2 and 3: Percentage of Subjects With Serological Response to Vaccination as Measured by Spike Binding Antibodies Enzyme-linked Immunosorbent Assay (S-ELISA) at 28 Days After Vaccination 2

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    End point title
    Adults of Groups 1, 2 and 3: Percentage of Subjects With Serological Response to Vaccination as Measured by Spike Binding Antibodies Enzyme-linked Immunosorbent Assay (S-ELISA) at 28 Days After Vaccination 2 [3] [4]
    End point description
    Percentage of subjects with serological response to vaccination as measured by S-ELISA were reported. A subject was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800, respectively. PPI population 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 analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Primary
    End point timeframe
    28 days After Vaccination 2 (Day 85)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics was done, no inferential statistical analysis was performed.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 1: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10 Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10
    Number of subjects analysed
    68
    67
    60
    Units: Percentage of subjects
        number (confidence interval 95%)
    100.0 (94.7 to 100.0)
    100.0 (94.6 to 100.0)
    96.7 (88.5 to 99.6)
    No statistical analyses for this end point

    Primary: Adults of Groups 1, 2 and 3: Antibody Geometric Mean Titers (GMTs) as Measured by VNA at 28 Days After Vaccination 2

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    End point title
    Adults of Groups 1, 2 and 3: Antibody Geometric Mean Titers (GMTs) as Measured by VNA at 28 Days After Vaccination 2 [5] [6]
    End point description
    Antibody GMTs as measured by VNA at 28 days after Vaccination 2 were reported. PPI population 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 analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Primary
    End point timeframe
    28 days After Vaccination 2 (Day 85)
    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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 1: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10 Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10
    Number of subjects analysed
    32
    36
    37
    Units: Titer
        geometric mean (confidence interval 95%)
    455 (321 to 645)
    490 (376 to 637)
    364 (239 to 556)
    No statistical analyses for this end point

    Primary: Adults of Groups 1, 2 and 3: Antibody Geometric Mean Concentrations (GMCs) as Measured by (S-ELISA) at 28 Days After Vaccination 2

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    End point title
    Adults of Groups 1, 2 and 3: Antibody Geometric Mean Concentrations (GMCs) as Measured by (S-ELISA) at 28 Days After Vaccination 2 [7] [8]
    End point description
    Antibody GMCs as measured by S-ELISA at 28 days after Vaccination 2 were reported. PPI population 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 analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Primary
    End point timeframe
    28 days After Vaccination 2 (Day 85)
    Notes
    [7] - 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.
    [8] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 1: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10 Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10
    Number of subjects analysed
    71
    68
    60
    Units: ELISA unit per millilitre (EU/mL)
        geometric mean (confidence interval 95%)
    1742 (1400 to 2168)
    1563 (1273 to 1918)
    1130 (802 to 1593)
    No statistical analyses for this end point

    Primary: Adults of Groups 4, 5 and 6: Percentage of Subjects With Serological Response to Vaccination as Measured by VNA Titers at 28 days After Vaccination 1

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    End point title
    Adults of Groups 4, 5 and 6: Percentage of Subjects With Serological Response to Vaccination as Measured by VNA Titers at 28 days After Vaccination 1 [9] [10]
    End point description
    Percentage of subjects with serological response to vaccination as measured by VNA titers were reported. A subject was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800, respectively. PPI population 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 analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Primary
    End point timeframe
    28 days After Vaccination 1 (Day 29)
    Notes
    [9] - 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.
    [10] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10 Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10 Group 6: Placebo, Placebo, Placebo, Placebo
    Number of subjects analysed
    37
    34
    14
    Units: Percentage of subjects
        number (confidence interval 95%)
    97.3 (85.8 to 99.9)
    100.0 (89.7 to 100.0)
    0.0 (0.0 to 23.2)
    No statistical analyses for this end point

    Primary: Adults of Groups 4, 5 and 6: Percentage of Subjects With Serological Response to Vaccination as Measured by S-ELISA at 28 Days After Vaccination 1

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    End point title
    Adults of Groups 4, 5 and 6: Percentage of Subjects With Serological Response to Vaccination as Measured by S-ELISA at 28 Days After Vaccination 1 [11] [12]
    End point description
    Percentage of subjects with serological response to vaccination as measured by S-ELISA were reported. A subject was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800, respectively. PPI population 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 analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Primary
    End point timeframe
    28 days After Vaccination 1 (Day 29)
    Notes
    [11] - 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.
    [12] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10 Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10 Group 6: Placebo, Placebo, Placebo, Placebo
    Number of subjects analysed
    65
    65
    19
    Units: Percentage of subjects
        number (confidence interval 95%)
    98.5 (91.7 to 100.0)
    95.4 (87.1 to 99.0)
    0.0 (0.0 to 17.6)
    No statistical analyses for this end point

    Primary: Adults of Groups 4, 5 and 6: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 1

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    End point title
    Adults of Groups 4, 5 and 6: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 1 [13] [14]
    End point description
    Antibody GMTs as measured by VNA at 28 days after vaccination 1 were reported. PPI population 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 analyzed) signifies subjects evaluated for this endpoint. Here, 99999 signifies that ‘Geometric mean’ and ‘confidence interval’ for Group 6 could not be estimated as the analyzed values were below the LLOQ.
    End point type
    Primary
    End point timeframe
    28 days After Vaccination 1 (Day 29)
    Notes
    [13] - 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.
    [14] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10 Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10 Group 6: Placebo, Placebo, Placebo, Placebo
    Number of subjects analysed
    37
    35
    14
    Units: Titer
        geometric mean (confidence interval 95%)
    263 (201 to 345)
    253 (207 to 308)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Primary: Adults of Groups 4, 5 and 6: Antibody GMCs as Measured by S-ELISA 28 Days After Vaccination 1

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    End point title
    Adults of Groups 4, 5 and 6: Antibody GMCs as Measured by S-ELISA 28 Days After Vaccination 1 [15] [16]
    End point description
    Antibody GMCs as measured by S-ELISA at 28 days after Vaccination 1 were reported. PPI population 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 analyzed) signifies subjects evaluated for this endpoint. Here, 99999 signifies that ‘Geometric mean’ and ‘confidence interval’ for Group 6 could not be estimated as the analyzed values were below the LLOQ.
    End point type
    Primary
    End point timeframe
    28 days After Vaccination 1 (Day 29)
    Notes
    [15] - 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.
    [16] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10 Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10 Group 6: Placebo, Placebo, Placebo, Placebo
    Number of subjects analysed
    66
    65
    19
    Units: EU/mL
        geometric mean (confidence interval 95%)
    505 (415 to 614)
    360 (276 to 471)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Primary: Adults of Groups 9 and 10: Percentage of Subjects With Serological Response to Vaccination as Measured by VNA Titers 28 days After Vaccination 2

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    End point title
    Adults of Groups 9 and 10: Percentage of Subjects With Serological Response to Vaccination as Measured by VNA Titers 28 days After Vaccination 2 [17] [18]
    End point description
    Percentage of subjects with serological response to vaccination as measured by VNA titers were reported. A subject was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800, respectively. PPI population 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 analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Primary
    End point timeframe
    28 days After Vaccination 2 ( Day 113)
    Notes
    [17] - 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.
    [18] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 10: Placebo, Placebo, Placebo
    Number of subjects analysed
    35
    13
    Units: Percentage of subjects
        number (confidence interval 95%)
    100.0 (90.0 to 100.0)
    15.4 (1.9 to 45.4)
    No statistical analyses for this end point

    Primary: Adults of Groups 9 and 10: Percentage of Subjects With Serological Response to Vaccination as Measured by S-ELISA at 28 Days After Vaccination 2

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    End point title
    Adults of Groups 9 and 10: Percentage of Subjects With Serological Response to Vaccination as Measured by S-ELISA at 28 Days After Vaccination 2 [19] [20]
    End point description
    Percentage of subjects with serological response to vaccination as measured by S-ELISA were reported. A subject was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800, respectively. PPI population 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 analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Primary
    End point timeframe
    28 days After Vaccination 2 (Day 113)
    Notes
    [19] - 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.
    [20] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 10: Placebo, Placebo, Placebo
    Number of subjects analysed
    46
    23
    Units: Percentage of subjects
        number (confidence interval 95%)
    100.0 (92.3 to 100.0)
    4.3 (0.1 to 21.9)
    No statistical analyses for this end point

    Primary: Adults of Groups 9 and 10: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 2

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    End point title
    Adults of Groups 9 and 10: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 2 [21] [22]
    End point description
    Antibody GMTs as measured by VNA at 28 days after Vaccination 2 were reported. PPI population 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 analyzed) signifies subjects evaluated for this endpoint. Here, 99999 signifies that ‘Geometric mean’ and ‘confidence interval’ for Group 10 could not be estimated as the analyzed values were below the LLOQ.
    End point type
    Primary
    End point timeframe
    28 days After Vaccination 2 (Day 113)
    Notes
    [21] - 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.
    [22] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 10: Placebo, Placebo, Placebo
    Number of subjects analysed
    35
    13
    Units: Titer
        geometric mean (confidence interval 95%)
    901 (686 to 1185)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Primary: Adults of Groups 9 and 10: Antibody GMCs as Measured by S-ELISA at 28 Days After Vaccination 2

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    End point title
    Adults of Groups 9 and 10: Antibody GMCs as Measured by S-ELISA at 28 Days After Vaccination 2 [23] [24]
    End point description
    Antibody GMCs as measured by S-ELISA at 28 days after Vaccination 2 were reported. PPI population 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 analyzed) signifies subjects evaluated for this endpoint. Here, 99999 signifies that ‘Geometric mean’ and ‘confidence interval’ for Group 10 could not be estimated as the analyzed values were below the LLOQ.
    End point type
    Primary
    End point timeframe
    28 Days After Vaccination 2 (Day 113)
    Notes
    [23] - 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.
    [24] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 10: Placebo, Placebo, Placebo
    Number of subjects analysed
    46
    23
    Units: EU/mL
        geometric mean (confidence interval 95%)
    2391 (1811 to 3156)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Primary: Adults of Groups 2 to 5, Group 9, 10, Groups (1 and 7 Combined) and Groups (6 and 8 Combined): Number of Subjects With Solicited Local Adverse Events (AEs) for 7 Days After Vaccination 1

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    End point title
    Adults of Groups 2 to 5, Group 9, 10, Groups (1 and 7 Combined) and Groups (6 and 8 Combined): Number of Subjects With Solicited Local Adverse Events (AEs) for 7 Days After Vaccination 1 [25] [26]
    End point description
    Number of subjects with solicited local AEs at 7 days after vaccination 1 are reported. 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 subjects in their e-diary for 7 days after vaccination 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site. FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analyzed) signifies subjects evaluated for this endpoint. Subjects from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS. Hence, Group 7 and 8 are not reported.
    End point type
    Primary
    End point timeframe
    7 days After Vaccination 1 (Day 8)
    Notes
    [25] - 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.
    [26] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10 Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10 Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10 Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10 Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 10: Placebo, Placebo, Placebo Group 1 and 7 Combined Group 6 and 8 Combined
    Number of subjects analysed
    81
    75
    74
    81
    53
    25
    141
    52
    Units: Subjects
    27
    24
    39
    42
    21
    2
    75
    7
    No statistical analyses for this end point

    Primary: Adults of Groups 2 to 5, Group 9, 10, Groups (1 and 7 Combined) and Groups (6 and 8 Combined): Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1

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    End point title
    Adults of Groups 2 to 5, Group 9, 10, Groups (1 and 7 Combined) and Groups (6 and 8 Combined): Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 [27] [28]
    End point description
    Number of subjects with solicited systemic AEs at 7 days after vaccination 1 are reported. 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. Subjects were instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to [>=] 38 degree C). FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analyzed) signifies subjects evaluated for this endpoint. Subjects from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS. Hence, Group 7 and 8 are not reported.
    End point type
    Primary
    End point timeframe
    7 days After Vaccination 1 (Day 8)
    Notes
    [27] - 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.
    [28] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10 Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10 Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10 Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10 Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 10: Placebo, Placebo, Placebo Group 1 and 7 Combined Group 6 and 8 Combined
    Number of subjects analysed
    81
    75
    74
    81
    53
    25
    141
    52
    Units: Subjects
    35
    31
    56
    50
    32
    10
    84
    18
    No statistical analyses for this end point

    Primary: Adults of Groups 2 to 5, Group 9, 10, Groups (1 and 7 Combined) and Groups (6 and 8 Combined): Number of Subjects With Solicited Local AEs at 7 Days After Vaccination 2

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    End point title
    Adults of Groups 2 to 5, Group 9, 10, Groups (1 and 7 Combined) and Groups (6 and 8 Combined): Number of Subjects With Solicited Local AEs at 7 Days After Vaccination 2 [29] [30]
    End point description
    Number of subjects with solicited local AEs at 7 days after vaccination 2 are reported. 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 subjects in their e-diary for 7 days post vaccination 2 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site. FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analyzed) signifies subjects evaluated for this endpoint. Subjects from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS. Hence, Group 7 and 8 are not reported.
    End point type
    Primary
    End point timeframe
    7 days after Vaccination 2 (Day 64 for Group 1-6; Day 92 for Group 9 and 10)
    Notes
    [29] - 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.
    [30] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10 Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10 Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10 Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10 Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 10: Placebo, Placebo, Placebo Group 1 and 7 Combined Group 6 and 8 Combined
    Number of subjects analysed
    81
    75
    74
    81
    53
    25
    141
    52
    Units: Subjects
    33
    29
    5
    4
    20
    2
    63
    3
    No statistical analyses for this end point

    Primary: Adults of Groups 2 to 5, Group 9, 10, Groups (1 and 7 Combined) and Groups (6 and 8 Combined): Number of Subjects With Solicited Systemic AEs at 7 Days After Vaccination 2

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    End point title
    Adults of Groups 2 to 5, Group 9, 10, Groups (1 and 7 Combined) and Groups (6 and 8 Combined): Number of Subjects With Solicited Systemic AEs at 7 Days After Vaccination 2 [31] [32]
    End point description
    Number of subjects with solicited systemic AEs at 7 days after vaccination 2 are reported. 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. Subjects were instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination 2 (Day of vaccination 2 and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to [>=] 38 degree C). FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analyzed) signifies subjects evaluated for this endpoint. Subjects from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS. Hence, Group 7 and 8 are not reported.
    End point type
    Primary
    End point timeframe
    7 days after Vaccination 2 (Day 64 for Group 1-6; Day 92 for Group 9 and 10)
    Notes
    [31] - 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.
    [32] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10 Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10 Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10 Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10 Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 10: Placebo, Placebo, Placebo Group 1 and 7 Combined Group 6 and 8 Combined
    Number of subjects analysed
    81
    75
    74
    81
    53
    25
    141
    52
    Units: Subjects
    32
    25
    24
    20
    26
    6
    81
    14
    No statistical analyses for this end point

    Primary: Adults of Groups 2 to 5, Group 9, 10, Groups (1 and 7 Combined) and Groups (6 and 8 Combined): Number of Subjects With Unsolicited AEs at 28 Days After Vaccination 1

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    End point title
    Adults of Groups 2 to 5, Group 9, 10, Groups (1 and 7 Combined) and Groups (6 and 8 Combined): Number of Subjects With Unsolicited AEs at 28 Days After Vaccination 1 [33] [34]
    End point description
    Unsolicited AEs are all AEs for which the subject is not specifically questioned in the subject diary. FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analyzed) signifies subjects evaluated for this endpoint. Subjects from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS. Hence, Group 7 and 8 are not reported.
    End point type
    Primary
    End point timeframe
    28 days after Vaccination 1 (Day 29)
    Notes
    [33] - 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.
    [34] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10 Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10 Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10 Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10 Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 10: Placebo, Placebo, Placebo Group 1 and 7 Combined Group 6 and 8 Combined
    Number of subjects analysed
    81
    75
    74
    81
    53
    25
    141
    52
    Units: Subjects
    25
    15
    33
    30
    8
    5
    39
    9
    No statistical analyses for this end point

    Primary: Adults of Groups 2 to 5, Group 9, 10, Groups (1 and 7 Combined) and Groups (6 and 8 Combined): Number of Subjects With Unsolicited AEs at 28 Days After Vaccination 2

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    End point title
    Adults of Groups 2 to 5, Group 9, 10, Groups (1 and 7 Combined) and Groups (6 and 8 Combined): Number of Subjects With Unsolicited AEs at 28 Days After Vaccination 2 [35] [36]
    End point description
    Unsolicited AEs are all AEs for which the subject is not specifically questioned in the subject diary. FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analyzed) signifies subjects evaluated for this endpoint. Subjects from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS. Hence, Group 7 and 8 are not reported.
    End point type
    Primary
    End point timeframe
    28 days After Vaccination 2 (Day 85 for Group 1-6; Day 113 for Group 9 and 10)
    Notes
    [35] - 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.
    [36] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10 Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10 Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10 Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10 Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 10: Placebo, Placebo, Placebo Group 1 and 7 Combined Group 6 and 8 Combined
    Number of subjects analysed
    81
    75
    74
    81
    53
    25
    141
    52
    Units: Subjects
    17
    15
    16
    22
    10
    4
    34
    9
    No statistical analyses for this end point

    Primary: Adults of Groups 2 to 5, Group 9, 10, Groups (1 and 7 Combined) and Groups (6 and 8 Combined): Number of Subjects With Serious Adverse Events (SAEs)

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    End point title
    Adults of Groups 2 to 5, Group 9, 10, Groups (1 and 7 Combined) and Groups (6 and 8 Combined): Number of Subjects With Serious Adverse Events (SAEs) [37] [38]
    End point description
    SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analyzed) signifies subjects evaluated for this endpoint. Subjects from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS. Hence, Group 7 and 8 are not reported.
    End point type
    Primary
    End point timeframe
    Up to 1.5 years
    Notes
    [37] - 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.
    [38] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10 Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10 Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10 Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10 Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 10: Placebo, Placebo, Placebo Group 1 and 7 Combined Group 6 and 8 Combined
    Number of subjects analysed
    81
    75
    74
    81
    53
    25
    141
    52
    Units: Subjects
    1
    1
    1
    2
    1
    0
    7
    0
    No statistical analyses for this end point

    Primary: Adults of Groups 2 to 5, Group 9, 10, Groups (1 and 7 Combined) and Groups (6 and 8 Combined): Number of Subjects With Adverse Events of Special Interest (AESIs)

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    End point title
    Adults of Groups 2 to 5, Group 9, 10, Groups (1 and 7 Combined) and Groups (6 and 8 Combined): Number of Subjects With Adverse Events of Special Interest (AESIs) [39] [40]
    End point description
    AESIs are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, is considered to be an AESI in this study. A suspected TTS case is defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter. FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analyzed) signifies subjects evaluated for this endpoint. Subjects from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS. Hence, Group 7 and 8 are not reported.
    End point type
    Primary
    End point timeframe
    Up to 1.5 years
    Notes
    [39] - 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.
    [40] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10 Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10 Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10 Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10 Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 10: Placebo, Placebo, Placebo Group 1 and 7 Combined Group 6 and 8 Combined
    Number of subjects analysed
    37
    26
    37
    44
    19
    9
    141
    52
    Units: Subjects
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Adolescents: Number of Subjects With Solicited Local AEs at 7 Days After Vaccination 1

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    End point title
    Adolescents: Number of Subjects With Solicited Local AEs at 7 Days After Vaccination 1 [41] [42]
    End point description
    Number of subjects with solicited local AEs at 7 days after vaccination 1 are reported. 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 subjects in their e-diary for 7 days post vaccination 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site. FAS included all subjects with at least one vaccine administration documented.
    End point type
    Primary
    End point timeframe
    7 Days After Vaccination 1 (Day 8)
    Notes
    [41] - 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.
    [42] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group A and B Combined: Ad26 2.5*10^10 Group C: Placebo
    Number of subjects analysed
    30
    3
    Units: Subjects
    29
    1
    No statistical analyses for this end point

    Primary: Adolescents: Number of Subjects With Solicited Systemic AEs at 7 Days After Vaccination 1

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    End point title
    Adolescents: Number of Subjects With Solicited Systemic AEs at 7 Days After Vaccination 1 [43] [44]
    End point description
    Number of subjects with solicited systemic AEs at 7 days after vaccination 1 are reported. 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. Subjects were instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination 1 (Day of vaccination1 and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to [>=] 38 degree C). FAS included all subjects with at least one vaccine administration documented.
    End point type
    Primary
    End point timeframe
    7 Days After Vaccination 1 (Day 8)
    Notes
    [43] - 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.
    [44] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group A and B Combined: Ad26 2.5*10^10 Group C: Placebo
    Number of subjects analysed
    30
    3
    Units: Subjects
    28
    3
    No statistical analyses for this end point

    Primary: Adolescents: Number of Subjects With Unsolicited AEs at 28 Days After Vaccination 1

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    End point title
    Adolescents: Number of Subjects With Unsolicited AEs at 28 Days After Vaccination 1 [45] [46]
    End point description
    Unsolicited AEs are all AEs for which the subject is not specifically questioned in the subject diary. Full analysis set included all subjects with at least one vaccine administration documented. Subjects from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS. Hence, Group 7 and 8 are not reported.
    End point type
    Primary
    End point timeframe
    28 Days After Vaccination 1 (Day 29)
    Notes
    [45] - 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.
    [46] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group A and B Combined: Ad26 2.5*10^10 Group C: Placebo
    Number of subjects analysed
    30
    3
    Units: Subjects
    12
    2
    No statistical analyses for this end point

    Primary: Adolescent Subjects: Number of Subjects With SAEs (inclusive Multisystem Inflammatory Syndrome in Children [MIS-C])

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    End point title
    Adolescent Subjects: Number of Subjects With SAEs (inclusive Multisystem Inflammatory Syndrome in Children [MIS-C]) [47] [48]
    End point description
    SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. FAS included all subjects with at least one vaccine administration documented. Subjects from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS. Hence, Group 7 and 8 are not reported.
    End point type
    Primary
    End point timeframe
    up to unblinding date / receipt of a new Covid vaccine (Up to 1.5 years)
    Notes
    [47] - 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.
    [48] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group A and B Combined: Ad26 2.5*10^10 Group C: Placebo
    Number of subjects analysed
    30
    3
    Units: Subjects
    0
    0
    No statistical analyses for this end point

    Primary: Adolescent Subjects: Number of Subjects With AESIs

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    End point title
    Adolescent Subjects: Number of Subjects With AESIs [49] [50]
    End point description
    AESIs are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, is considered to be an AESI in this study. A suspected TTS case is defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter. FAS included all subjects with at least one vaccine administration documented. Subjects from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS. Hence, Group 7 and 8 are not reported.
    End point type
    Primary
    End point timeframe
    up to unblinding date / receipt of a new Covid vaccine (Up to 1.5 years)
    Notes
    [49] - 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.
    [50] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group A and B Combined: Ad26 2.5*10^10 Group C: Placebo
    Number of subjects analysed
    30
    3
    Units: Subjects
    0
    0
    No statistical analyses for this end point

    Secondary: Adults: Percentage of Subjects With Serological Response to Vaccination as Measured by VNA Titers 7 Days After Antigen Presentation

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    End point title
    Adults: Percentage of Subjects With Serological Response to Vaccination as Measured by VNA Titers 7 Days After Antigen Presentation [51]
    End point description
    Percentage of subjects with serological response to vaccination as measured by VNA titers were reported. A subject was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800, respectively. PPI population 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 analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    7 Days After Antigen Presentation (Day 176 for Groups 1-5 ; Day 204 for Group 9)
    Notes
    [51] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 1: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10 Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10 Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10 Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10 Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10
    Number of subjects analysed
    25
    33
    31
    33
    27
    32
    Units: Percentage of subjects
        number (confidence interval 95%)
    92.0 (74.0 to 99.0)
    97.0 (84.2 to 99.9)
    83.9 (66.3 to 94.5)
    84.8 (68.1 to 94.9)
    96.3 (81.0 to 99.9)
    100.0 (89.1 to 100.0)
    No statistical analyses for this end point

    Secondary: Adults: Percentage of Subjects With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation

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    End point title
    Adults: Percentage of Subjects With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation [52]
    End point description
    Percentage of subjects with serological response to vaccination as measured by S-ELISA were reported. A subject was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800, respectively. PPI population 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 analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    7 Days After Antigen Presentation (Day 176 for Groups 1-5 ; Day 204 for Group 9)
    Notes
    [52] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 1: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10 Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10 Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10 Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10 Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10
    Number of subjects analysed
    62
    62
    57
    57
    57
    43
    Units: Percentage of subjects
        number (confidence interval 95%)
    100.0 (94.2 to 100.0)
    100.0 (94.2 to 100.0)
    96.5 (87.9 to 99.6)
    100.0 (93.7 to 100.0)
    91.2 (80.7 to 97.1)
    100.0 (91.8 to 100.0)
    No statistical analyses for this end point

    Secondary: Adults: GMTs as Measured by VNA 7 Days After Antigen Presentation

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    End point title
    Adults: GMTs as Measured by VNA 7 Days After Antigen Presentation [53]
    End point description
    Antibody GMTs as measured by VNA at 7 days after antigen presentation were reported. PPI population 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 analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    7 days after antigen presentation (Day 176 for Groups 1-5 ; Day 204 for Group 9)
    Notes
    [53] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 1: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10 Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10 Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10 Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10 Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10
    Number of subjects analysed
    26
    33
    32
    33
    28
    32
    Units: Titer
        geometric mean (confidence interval 95%)
    318 (207 to 489)
    393 (272 to 568)
    279 (171 to 457)
    275 (182 to 415)
    525 (339 to 814)
    616 (462 to 822)
    No statistical analyses for this end point

    Secondary: Adult: Antibody GMCs as Measured by S-ELISA 7 Days After Antigen Presentation

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    End point title
    Adult: Antibody GMCs as Measured by S-ELISA 7 Days After Antigen Presentation [54]
    End point description
    Antibody GMCs as measured by S-ELISA 7 days after antigen presentation were reported. PPI population 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 analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    7 Days After Antigen Presentation (Day 176 for Groups 1-5 ; Day 176 for Group 7; Day 204 for Group 9)
    Notes
    [54] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 1: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10 Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10 Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10 Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10 Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10
    Number of subjects analysed
    65
    63
    57
    58
    58
    43
    Units: EU/mL
        geometric mean (confidence interval 95%)
    1146 (904 to 1452)
    1179 (933 to 1490)
    1038 (730 to 1475)
    1024 (721 to 1454)
    1262 (937 to 1702)
    1963 (1514 to 2545)
    No statistical analyses for this end point

    Secondary: Adults of Groups 2 to 5, Group 9, 10, Groups (1 and 7 Combined) and Groups (6 and 8 Combined): Number of Subjects With Solicited Local AEs at 7 Days After Antigen Presentation

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    End point title
    Adults of Groups 2 to 5, Group 9, 10, Groups (1 and 7 Combined) and Groups (6 and 8 Combined): Number of Subjects With Solicited Local AEs at 7 Days After Antigen Presentation [55]
    End point description
    Number of subjects with solicited local AEs at 7 days after antigen presentation are reported. 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 subjects in their e-diary for 7 days after antigen presentation (day of antigen presentation and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site. FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analyzed) signifies subjects evaluated for this endpoint. Subjects from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS. Hence, Group 7 and 8 are not reported.
    End point type
    Secondary
    End point timeframe
    7 Days After Antigen Presentation (Day 176 for Groups 1-5 ; Day 176 for Group 7; Day 204 for Group 9 and 10)
    Notes
    [55] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10 Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10 Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10 Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10 Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 10: Placebo, Placebo, Placebo Group 1 and 7 Combined Group 6 and 8 Combined
    Number of subjects analysed
    69
    68
    68
    74
    47
    18
    127
    44
    Units: Subjects
    28
    29
    31
    35
    16
    2
    50
    1
    No statistical analyses for this end point

    Secondary: Adults of Groups 2 to 5, Group 9, 10, Groups (1 and 7 Combined) and Groups (6 and 8 Combined): Number of Subjects With Solicited Systemic AEs at 7 Days After Antigen Presentation

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    End point title
    Adults of Groups 2 to 5, Group 9, 10, Groups (1 and 7 Combined) and Groups (6 and 8 Combined): Number of Subjects With Solicited Systemic AEs at 7 Days After Antigen Presentation [56]
    End point description
    Number of subjects with solicited systemic AEs at 7 days after antigen presentation are reported. 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. Subjects were instructed on how to note signs and symptoms in their diary on a daily basis for 7 days after antigen presentation (Day of antigen presentation and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to [>=] 38 degree C). FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analyzed) signifies subjects evaluated for this endpoint. Subjects from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS. Hence, Group 7 and 8 are not reported.
    End point type
    Secondary
    End point timeframe
    7 Days After Antigen Presentation (Day 176 for Groups 1-5 ; Day 176 for Group 7; Day 204 for Group 9 and 10)
    Notes
    [56] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10 Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10 Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10 Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10 Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 10: Placebo, Placebo, Placebo Group 1 and 7 Combined Group 6 and 8 Combined
    Number of subjects analysed
    69
    68
    68
    74
    47
    18
    127
    44
    Units: Subjects
    30
    24
    23
    28
    15
    4
    51
    10
    No statistical analyses for this end point

    Secondary: Adults of Groups 2 to 5, Group 9, 10, Groups (1 and 7 Combined) and Groups (6 and 8 Combined): Number of Subjects With Unsolicited AEs at 28 Days After Antigen Presentation

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    End point title
    Adults of Groups 2 to 5, Group 9, 10, Groups (1 and 7 Combined) and Groups (6 and 8 Combined): Number of Subjects With Unsolicited AEs at 28 Days After Antigen Presentation [57]
    End point description
    Unsolicited AEs are all AEs for which the subject is not specifically questioned in the subject diary. Full analysis set included all subjects with at least one vaccine administration documented. Full analysis set included all subjects with at least one vaccine administration documented. Here N (number of subjects analyzed) signifies subjects evaluated for this endpoint. Subjects from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS. Hence, Group 7 and 8 are not reported.
    End point type
    Secondary
    End point timeframe
    28 Days After Antigen Presentation (Day 197 for Groups 1-5; Day 197 for Group 7; Day 225 for Group 9)
    Notes
    [57] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10 Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10 Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10 Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10 Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 10: Placebo, Placebo, Placebo Group 1 and 7 Combined Group 6 and 8 Combined
    Number of subjects analysed
    69
    68
    68
    74
    47
    18
    127
    44
    Units: Subjects
    10
    7
    6
    12
    6
    4
    15
    4
    No statistical analyses for this end point

    Secondary: Adults of Groups 2 to 5, Group 9, 10, Groups (1 and 7 Combined) and Groups (6 and 8 Combined): Number of Subjects With SAEs After Antigen Presentation

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    End point title
    Adults of Groups 2 to 5, Group 9, 10, Groups (1 and 7 Combined) and Groups (6 and 8 Combined): Number of Subjects With SAEs After Antigen Presentation [58]
    End point description
    SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analyzed) signifies subjects evaluated for this endpoint. Subjects from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS. Hence, Group 7 and 8 are not reported.
    End point type
    Secondary
    End point timeframe
    After antigen presentation until end of study (Day 170 up to 1.5 years for Groups 1 to 6, Day 198 up to 1.5 years for Group 9 and 10)
    Notes
    [58] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10 Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10 Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10 Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10 Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 10: Placebo, Placebo, Placebo Group 1 and 7 Combined Group 6 and 8 Combined
    Number of subjects analysed
    69
    68
    68
    74
    47
    18
    127
    44
    Units: Subjects
    0
    0
    1
    0
    0
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Adults of Groups 2 to 5, Group 9, 10, Groups (1 and 7 Combined) and Groups (6 and 8 Combined): Number of Subjects With AESIs After Antigen Presentation

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    End point title
    Adults of Groups 2 to 5, Group 9, 10, Groups (1 and 7 Combined) and Groups (6 and 8 Combined): Number of Subjects With AESIs After Antigen Presentation [59]
    End point description
    AESIs are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, is considered to be an AESI in this study. A suspected TTS case is defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter. FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analyzed) signifies subjects evaluated for this endpoint. Subjects from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS. Hence, Group 7 and 8 are not reported.
    End point type
    Secondary
    End point timeframe
    After antigen presentation until end of study (Day 170 up to 1.5 years for Groups 1 to 6, Day 198 up to 1.5 years for Group 9 and 10)
    Notes
    [59] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10 Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10 Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10 Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10 Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 10: Placebo, Placebo, Placebo Group 1 and 7 Combined Group 6 and 8 Combined
    Number of subjects analysed
    69
    68
    68
    74
    47
    18
    127
    44
    Units: Subjects
    0
    0
    0
    1
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Adults Groups 1 to 6: Percentage of Subjects With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA

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    End point title
    Adults Groups 1 to 6: Percentage of Subjects With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA [60]
    End point description
    Percentage of subjects with neutralizing antibody titers to the wild-type SARS-CoV-2 virus expressing S-protein as measured by VNA were reported. PPI population 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 analyzed) signifies subjects evaluated for this endpoint. Here 'n' (number analyzed) signifies number of subjects evaluable at specified time points. Here, 99999 signifies data could not be estimated and reported as no subjects were analyzed.
    End point type
    Secondary
    End point timeframe
    Days 197 and 393
    Notes
    [60] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 1: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10 Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10 Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10 Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10 Group 6: Placebo, Placebo, Placebo, Placebo
    Number of subjects analysed
    29
    31
    29
    31
    26
    12
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 197 (n =26, 31, 29, 31, 26, 12)
    100.0 (86.8 to 100.0)
    100.0 (88.8 to 100.0)
    96.6 (82.2 to 99.9)
    96.8 (83.3 to 99.9)
    80.8 (60.6 to 93.4)
    0.0 (0.0 to 26.5)
        Day 393 (n =29, 21, 19, 30, 26, 0)
    93.1 (77.2 to 99.2)
    95.2 (76.2 to 99.9)
    84.2 (60.4 to 96.6)
    80.0 (61.4 to 92.3)
    92.0 (74.0 to 99.0)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Adults Group 9 and 10: Percentage of Subjects With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA

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    End point title
    Adults Group 9 and 10: Percentage of Subjects With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA [61]
    End point description
    Percentage of subjects with neutralizing antibody titers to the wild-type SARS-CoV-2 virus expressing S-protein as measured by VNA were reported. PPI population 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 analyzed) signifies subjects evaluated for this endpoint. Here 'n' (number analyzed) signifies number of subjects evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Days 225 and 421
    Notes
    [61] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 10: Placebo, Placebo, Placebo
    Number of subjects analysed
    31
    10
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 225 (n =29, 10)
    100.0 (88.1 to 100.0)
    0.0 (0.0 to 30.8)
        Day 421 (n =31, 1)
    100.0 (88.8 to 100.0)
    0.0 (0.0 to 97.5)
    No statistical analyses for this end point

    Secondary: Adults Groups 1 to 6: Percentage of Subjects With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins

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    End point title
    Adults Groups 1 to 6: Percentage of Subjects With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins [62]
    End point description
    Percentage of subjects with binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 proteins were reported. PPI population 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 analyzed) signifies subjects evaluated for this endpoint. Here 'n' (number analyzed) signifies number of subjects evaluable at specified time points. Here, 99999 signifies data could not be estimated and reported as no subjects were analyzed.
    End point type
    Secondary
    End point timeframe
    Days 197 and 393
    Notes
    [62] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 1: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10 Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10 Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10 Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10 Group 6: Placebo, Placebo, Placebo, Placebo
    Number of subjects analysed
    63
    60
    55
    55
    56
    16
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 197 (n= 62, 60, 55, 55, 56, 16)
    100.0 (94.2 to 100.0)
    100.0 (94.0 to 100.0)
    98.2 (90.3 to 100.0)
    100.0 (93.5 to 100.0)
    98.2 (90.4 to 100.0)
    0.0 (0.0 to 20.6)
        Day 393 (n =63, 33, 28, 51, 51, 0)
    100.0 (94.3 to 100.0)
    100.0 (89.4 to 100.0)
    85.7 (67.3 to 96.0)
    92.2 (81.1 to 97.8)
    98.0 (89.6 to 100.0)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Adults Groups 9 and 10: Percentage of Subjects With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins

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    End point title
    Adults Groups 9 and 10: Percentage of Subjects With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins [63]
    End point description
    Percentage of subjects with binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 proteins were reported. PPI population 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 analyzed) signifies subjects evaluated for this endpoint. Here 'n' (number analyzed) signifies number of subjects evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Days 225 and 421
    Notes
    [63] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 10: Placebo, Placebo, Placebo
    Number of subjects analysed
    39
    14
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 225 (n =37, 14)
    100.0 (90.5 to 100.0)
    0.0 (0.0 to 23.2)
        Day 421 (n =39, 1)
    97.4 (86.5 to 99.9)
    0.0 (0.0 to 97.5)
    No statistical analyses for this end point

    Secondary: Adolescents: Percentage of Subjects With Serological Response to Vaccination as Measured by VNA Titers 28 Days After Vaccination 1 (Day 29)

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    End point title
    Adolescents: Percentage of Subjects With Serological Response to Vaccination as Measured by VNA Titers 28 Days After Vaccination 1 (Day 29) [64]
    End point description
    Percentage of subjects with serological response to vaccination as measured by VNA titers were reported. A subject was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800, respectively. PPI population included all randomized 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
    28 Days After Vaccination 1 (Day 29)
    Notes
    [64] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group A and B Combined: Ad26 2.5*10^10 Group C: Placebo
    Number of subjects analysed
    27
    3
    Units: Percentage of subjects
        number (confidence interval 95%)
    100.0 (87.2 to 100.0)
    0.0 (0.0 to 70.8)
    No statistical analyses for this end point

    Secondary: Adolescents: Percentage of Subjects With Serological Response to Vaccination as Measured by S-ELISA 28 Days After Vaccination 1 (Day 29)

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    End point title
    Adolescents: Percentage of Subjects With Serological Response to Vaccination as Measured by S-ELISA 28 Days After Vaccination 1 (Day 29) [65]
    End point description
    Percentage of subjects with serological response to vaccination as measured by S-ELISA were reported. A subject was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800, respectively. PPI population included all randomized 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
    28 Days After Vaccination 1 (Day 29)
    Notes
    [65] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group A and B Combined: Ad26 2.5*10^10 Group C: Placebo
    Number of subjects analysed
    27
    3
    Units: Percentage of subjects
        number (confidence interval 95%)
    100.0 (86.8 to 100.0)
    0.0 (0.0 to 70.8)
    No statistical analyses for this end point

    Secondary: Adolescents: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 1 (Day 29)

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    End point title
    Adolescents: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 1 (Day 29) [66]
    End point description
    Antibody GMTs as measured by VNA at 28 days after vaccination (Day 29) were reported. PPI population 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, 99999 signifies that ‘Geometric mean’ and ‘confidence interval’ for Group C could not be estimated as the analyzed values were below the LLOQ.
    End point type
    Secondary
    End point timeframe
    28 days After Vaccination 1 (Day 29)
    Notes
    [66] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group A and B Combined: Ad26 2.5*10^10 Group C: Placebo
    Number of subjects analysed
    27
    3
    Units: Titer
        geometric mean (confidence interval 95%)
    305 (245 to 378)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Adolescents: Antibody GMCs as Measured by S-ELISA 28 Days After Vaccination 1

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    End point title
    Adolescents: Antibody GMCs as Measured by S-ELISA 28 Days After Vaccination 1 [67]
    End point description
    Antibody GMCs as measured by S-ELISA 28 days after vaccination was reported. PPI population 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, 99999 signifies data could not be estimated as the analyzed value were below the LLOQ.
    End point type
    Secondary
    End point timeframe
    28 days After Vaccination 1 (Day 29)
    Notes
    [67] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group A and B Combined: Ad26 2.5*10^10 Group C: Placebo
    Number of subjects analysed
    27
    3
    Units: EU/mL
        geometric mean (confidence interval 95%)
    682 (506 to 920)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Adolescents: Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S Protein as Measured by VNA

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    End point title
    Adolescents: Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S Protein as Measured by VNA [68]
    End point description
    Neutralizing antibody titers to the Wild-type SARS-CoV-2 virus expressing S protein measured by VNA was reported. PPI population 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 analyzed) signifies number of subjects evaluable at specified time points. Here, 99999 signifies data could not be estimated as the analyzed value were below the LLOQ.
    End point type
    Secondary
    End point timeframe
    Days 57, 85 and 169
    Notes
    [68] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group A and B Combined: Ad26 2.5*10^10 Group C: Placebo
    Number of subjects analysed
    27
    3
    Units: Titer
    geometric mean (confidence interval 95%)
        Day 57 (n =27, 3)
    323 (262 to 399)
    99999 (99999 to 99999)
        Day 85 (n =22, 3)
    306 (227 to 413)
    99999 (99999 to 99999)
        Day 169 (n =15, 0)
    342 (219 to 532)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Adolescents: Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins as Measured by ELISA

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    End point title
    Adolescents: Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins as Measured by ELISA [69]
    End point description
    Binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 proteins as measured by ELISA was reported. PPI population 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 analyzed) signifies number of subjects evaluable at specified time points. Here, 99999 signifies data could not be estimated as the analyzed value were below the LLOQ.
    End point type
    Secondary
    End point timeframe
    Days 57, 85, 169
    Notes
    [69] - 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: Endpoint was planned to be analyzed for specified arms only.
    End point values
    Group A and B Combined: Ad26 2.5*10^10 Group C: Placebo
    Number of subjects analysed
    27
    3
    Units: Titer
    geometric mean (confidence interval 95%)
        Day 57 (n =27, 3)
    770 (593 to 1000)
    99999 (99999 to 99999)
        Day 85 (n =22, 3)
    773 (547 to 1093)
    99999 (99999 to 99999)
        Day 169 (n =15, 0)
    796 (449 to 1411)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 1.5 years
    Adverse event reporting additional description
    Subjects from groups 7 and 8 (with vaccination 2 delayed due to study pause) were analyzed with groups 1 and 6 in FAS. However, 1 subject in Groups 7 and 1 subject in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, AEs for these 2 subjects were included in Group 7 and 8 reporting arms.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Group 1: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10
    Reporting group description
    Adult subjects received 2-dose regimen intramuscular (IM) injection of Ad26.COV2.S vaccine at a dose level of 5*10^10 virus particle (vp) on Days 1 and 57. Subjects also received a single antigen presentation IM injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.

    Reporting group title
    Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10
    Reporting group description
    Adult subjects received 2-dose regimen intramuscular (IM) injection of Ad26.COV2.S vaccine at dose level of 2.5*10^10 vp on Days 1 and 57. Subjects also received a single antigen presentation IM injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.

    Reporting group title
    Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10
    Reporting group description
    Adult subjects received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.5*10^10 vp on Days 1 and 57. Subjects also received a single antigen presentation IM injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.

    Reporting group title
    Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10
    Reporting group description
    Adult subjects received single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1*10^11 vp on Day 1 and placebo at Day 57. Subjects also received a single antigen presentation IM injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.

    Reporting group title
    Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10
    Reporting group description
    Adult subjects received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5*10^10 vp on Day 1 and placebo at Day 57. Subjects also received a single antigen presentation IM injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.

    Reporting group title
    Group 6: Placebo, Placebo, Placebo
    Reporting group description
    Adult subjects received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 57. Subjects also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.

    Reporting group title
    Group 10: Placebo, Placebo, Placebo
    Reporting group description
    Adult subjects received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Subjects also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S vaccine at 4 months after second vaccination.

    Reporting group title
    Group 7: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10
    Reporting group description
    Adult subjects received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5*10^10 vp on Days 1 and 29. Subjects also received a single antigen presentation IM injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.

    Reporting group title
    Group 8: Placebo, Placebo, Placebo
    Reporting group description
    Adult subjects received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 29. Subjects also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.

    Reporting group title
    Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10
    Reporting group description
    Adult subjects received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5*10^10 vp on Days 1 and 85. Subjects also received a single antigen presentation injection with single dose level of Ad26.COV2.S (1.25*10^10 vp) at 4 months after second vaccination.

    Reporting group title
    Group A and B Combined: Ad26 2.5*10^10
    Reporting group description
    Adolescent subjects aged 12 to 15 years (Group A) and 16 to 17 years (Group B) received single dose IM injection of Ad26.COV2.S vaccine at a dose of 2.5*10^10 vp on Day 1.

    Reporting group title
    Group C: Placebo
    Reporting group description
    Adolescent subjects aged 12 to 17 years received single dose IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1

    Serious adverse events
    Group 1: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10 Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10 Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10 Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10 Group 6: Placebo, Placebo, Placebo Group 10: Placebo, Placebo, Placebo Group 7: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 8: Placebo, Placebo, Placebo Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group A and B Combined: Ad26 2.5*10^10 Group C: Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 141 (4.96%)
    1 / 81 (1.23%)
    1 / 75 (1.33%)
    1 / 74 (1.35%)
    2 / 81 (2.47%)
    0 / 52 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 53 (1.89%)
    0 / 30 (0.00%)
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute Myeloid Leukaemia
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 81 (0.00%)
    0 / 75 (0.00%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
    0 / 52 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 53 (0.00%)
    0 / 30 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma of Colon
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 81 (0.00%)
    0 / 75 (0.00%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
    0 / 52 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 53 (0.00%)
    0 / 30 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung Adenocarcinoma
         subjects affected / exposed
    0 / 141 (0.00%)
    0 / 81 (0.00%)
    0 / 75 (0.00%)
    0 / 74 (0.00%)
    1 / 81 (1.23%)
    0 / 52 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 53 (0.00%)
    0 / 30 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate Cancer
         subjects affected / exposed
    0 / 141 (0.00%)
    0 / 81 (0.00%)
    0 / 75 (0.00%)
    1 / 74 (1.35%)
    0 / 81 (0.00%)
    0 / 52 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 53 (0.00%)
    0 / 30 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Lower Limb Fracture
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 81 (0.00%)
    0 / 75 (0.00%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
    0 / 52 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 53 (0.00%)
    0 / 30 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrospinal Fluid Leakage
         subjects affected / exposed
    0 / 141 (0.00%)
    0 / 81 (0.00%)
    0 / 75 (0.00%)
    0 / 74 (0.00%)
    1 / 81 (1.23%)
    0 / 52 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 53 (0.00%)
    0 / 30 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic Stroke
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 81 (0.00%)
    0 / 75 (0.00%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
    0 / 52 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 53 (0.00%)
    0 / 30 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Pancytopenia
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 81 (0.00%)
    0 / 75 (0.00%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
    0 / 52 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 53 (0.00%)
    0 / 30 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 81 (1.23%)
    0 / 75 (0.00%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
    0 / 52 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 53 (0.00%)
    0 / 30 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 81 (0.00%)
    0 / 75 (0.00%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
    0 / 52 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 53 (0.00%)
    0 / 30 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic Cyst
         subjects affected / exposed
    0 / 141 (0.00%)
    0 / 81 (0.00%)
    1 / 75 (1.33%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
    0 / 52 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 53 (0.00%)
    0 / 30 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 81 (0.00%)
    0 / 75 (0.00%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
    0 / 52 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 53 (0.00%)
    0 / 30 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthropathy
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 81 (0.00%)
    0 / 75 (0.00%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
    0 / 52 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 53 (0.00%)
    0 / 30 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 141 (0.00%)
    0 / 81 (0.00%)
    0 / 75 (0.00%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
    0 / 52 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 53 (1.89%)
    0 / 30 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    0 / 141 (0.00%)
    0 / 81 (0.00%)
    0 / 75 (0.00%)
    0 / 74 (0.00%)
    1 / 81 (1.23%)
    0 / 52 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 53 (0.00%)
    0 / 30 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 81 (0.00%)
    0 / 75 (0.00%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
    0 / 52 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 53 (0.00%)
    0 / 30 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Systemic Candida
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 81 (0.00%)
    0 / 75 (0.00%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
    0 / 52 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 53 (0.00%)
    0 / 30 (0.00%)
    0 / 3 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Group 1: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 2: Ad26 2.5*10^10, Ad26 2.5*10^10, Ad26 1.25*10^10 Group 3: Ad26 1.25*10^10, Ad26 1.25*10^10, Ad26 1.25*10^10 Group 4: Ad26 1*10^10, Placebo, Ad26 1.25*10^10 Group 5: Ad26 5*10^10, Placebo, Ad26 1.25*10^10 Group 6: Placebo, Placebo, Placebo Group 10: Placebo, Placebo, Placebo Group 7: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group 8: Placebo, Placebo, Placebo Group 9: Ad26 5*10^10, Ad26 5*10^10, Ad26 1.25*10^10 Group A and B Combined: Ad26 2.5*10^10 Group C: Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 141 (24.82%)
    24 / 81 (29.63%)
    20 / 75 (26.67%)
    20 / 74 (27.03%)
    33 / 81 (40.74%)
    11 / 52 (21.15%)
    9 / 25 (36.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    16 / 53 (30.19%)
    11 / 30 (36.67%)
    2 / 3 (66.67%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    18 / 141 (12.77%)
    11 / 81 (13.58%)
    8 / 75 (10.67%)
    11 / 74 (14.86%)
    15 / 81 (18.52%)
    7 / 52 (13.46%)
    6 / 25 (24.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    9 / 53 (16.98%)
    0 / 30 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    18
    17
    10
    14
    19
    9
    9
    0
    0
    12
    0
    0
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    5 / 141 (3.55%)
    5 / 81 (6.17%)
    1 / 75 (1.33%)
    2 / 74 (2.70%)
    4 / 81 (4.94%)
    1 / 52 (1.92%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 53 (1.89%)
    3 / 30 (10.00%)
    0 / 3 (0.00%)
         occurrences all number
    6
    6
    1
    2
    4
    2
    0
    0
    0
    1
    3
    0
    Fatigue
         subjects affected / exposed
    5 / 141 (3.55%)
    5 / 81 (6.17%)
    2 / 75 (2.67%)
    4 / 74 (5.41%)
    1 / 81 (1.23%)
    1 / 52 (1.92%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    4 / 53 (7.55%)
    0 / 30 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    6
    7
    2
    5
    1
    2
    0
    0
    0
    4
    0
    2
    Eye disorders
    Eye Pain
         subjects affected / exposed
    0 / 141 (0.00%)
    0 / 81 (0.00%)
    0 / 75 (0.00%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
    0 / 52 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 53 (0.00%)
    0 / 30 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    1 / 141 (0.71%)
    3 / 81 (3.70%)
    1 / 75 (1.33%)
    1 / 74 (1.35%)
    0 / 81 (0.00%)
    0 / 52 (0.00%)
    2 / 25 (8.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 53 (0.00%)
    0 / 30 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    1
    3
    1
    1
    0
    0
    2
    0
    0
    0
    0
    3
    Reproductive system and breast disorders
    Premenstrual Pain
         subjects affected / exposed
    0 / 141 (0.00%)
    0 / 81 (0.00%)
    0 / 75 (0.00%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
    0 / 52 (0.00%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 53 (0.00%)
    0 / 30 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 141 (1.42%)
    3 / 81 (3.70%)
    2 / 75 (2.67%)
    3 / 74 (4.05%)
    2 / 81 (2.47%)
    1 / 52 (1.92%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    4 / 53 (7.55%)
    0 / 30 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    2
    4
    3
    4
    2
    1
    0
    0
    0
    4
    0
    0
    Oropharyngeal Pain
         subjects affected / exposed
    3 / 141 (2.13%)
    3 / 81 (3.70%)
    1 / 75 (1.33%)
    4 / 74 (5.41%)
    4 / 81 (4.94%)
    1 / 52 (1.92%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    3 / 53 (5.66%)
    3 / 30 (10.00%)
    0 / 3 (0.00%)
         occurrences all number
    3
    3
    1
    5
    4
    1
    0
    0
    0
    5
    3
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 141 (0.71%)
    3 / 81 (3.70%)
    5 / 75 (6.67%)
    4 / 74 (5.41%)
    4 / 81 (4.94%)
    1 / 52 (1.92%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 53 (1.89%)
    0 / 30 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    3
    6
    5
    4
    1
    0
    0
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    6 / 141 (4.26%)
    2 / 81 (2.47%)
    2 / 75 (2.67%)
    4 / 74 (5.41%)
    5 / 81 (6.17%)
    1 / 52 (1.92%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    2 / 53 (3.77%)
    0 / 30 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    6
    2
    2
    5
    5
    1
    0
    0
    0
    2
    0
    0
    Infections and infestations
    Covid-19
         subjects affected / exposed
    3 / 141 (2.13%)
    3 / 81 (3.70%)
    4 / 75 (5.33%)
    0 / 74 (0.00%)
    4 / 81 (4.94%)
    5 / 52 (9.62%)
    2 / 25 (8.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 53 (1.89%)
    7 / 30 (23.33%)
    0 / 3 (0.00%)
         occurrences all number
    5
    3
    5
    0
    4
    5
    2
    0
    0
    1
    8
    0
    Herpes Zoster
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 81 (0.00%)
    0 / 75 (0.00%)
    0 / 74 (0.00%)
    0 / 81 (0.00%)
    0 / 52 (0.00%)
    2 / 25 (8.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 53 (0.00%)
    0 / 30 (0.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    4
    0
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    4 / 141 (2.84%)
    1 / 81 (1.23%)
    7 / 75 (9.33%)
    5 / 74 (6.76%)
    8 / 81 (9.88%)
    2 / 52 (3.85%)
    0 / 25 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    2 / 53 (3.77%)
    2 / 30 (6.67%)
    0 / 3 (0.00%)
         occurrences all number
    5
    1
    7
    6
    8
    3
    0
    0
    0
    2
    2
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Aug 2020
    This amendment included the following changes: allowing a more flexible window between molecular test for SARS-CoV-2 infection and vaccination and a clarification on the eligibility criteria on blood pressure for subjects greater than or equal to (>=) 65 years of age. In addition, other changes were made for alignment with other study protocols within the program, together with minor editorial changes. The amendments to the protocol were adopted before any study-related procedures had begun.
    29 Oct 2020
    This amendment concerned the inclusion of adolescent subjects (aged 12 to 17 years, inclusive) in the study to demonstrate non-inferiority of the immune responses in adolescents (5*10^10 and 2.5*10^10 vp dose levels, 1- and 2-dose regimens) to the immune responses of adults in this study (5*10^10 vp dose levels, 1- and 2-dose regimens). Text was added to clarify the request from authorities after a study pause and to include laboratory tests to assess potential vaccine-induced anti-phospholipid syndrome (APS) and potential vaccine-induced activation of coagulation.
    22 Dec 2020
    This amendment included the following changes: Change primary endpoint for adolescents to enzyme-linked immunosorbent assay (ELISA) instead of pseudovirion neutralization assay (psVNA) assay, due to lack of sensitivity of the psVNA, and the high correlation between the wild-type virus neutralization assay (wtVNA) and ELISA assays and high throughput of the ELISA assay; Addition of 2 exploratory endpoints, for in-depth analysis of the binding antibody generated by Ad26.COV2.S and to further confirm the correlation between ELISA and wtVNA at different timepoints; Clarification of exclusion criteria for systemic corticosteroids and investigational drugs; Allowance of unblinding on a subject level in the event that an authorized/licensed COVID-19 vaccine became available prior to the end of the study. Protocol Amendment 3 was never implemented at any of the study sites.
    04 Mar 2021
    The amendment included the following changes: Stratification by age of adolescent subjects into 2 groups (16 to 17 years of age, inclusive, and 12 to 15 years of age, inclusive) and the implementation of a staggered age-based approach to collect safety data in the older adolescents (16 to 17 years of age) at 2.5*10^10 vp dose level, prior to proceeding to the younger adolescent cohort and/or to the higher dose level of 5*10^10 vp; Adolescents who were initially assigned to receive a single dose of Ad26.COV2.S at 2.5*10^10 vp, were now to receive 2 doses of Ad26.COV2.S at 2.5*10^10 (56-day interval); Outline of procedures to be followed after Emergency Use Authorization (EUA), or similar program/authorization or approval, or approval in any country for both the Ad26.COV2.S vaccine and protocol Amendment 4 by both health authority and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) where a single dose of Ad26.COV2.S was offered to enrolled subjects who initially received placebo, resulting in de facto unblinding of subjects and investigators.
    18 May 2021
    This amendment concerned the inclusion of additional safety measures due to reports of AEs following use of the Ad26.COV2.S vaccine under EUA in the United States (US), suggesting an increased risk of thrombosis combined with thrombocytopenia.
    21 Jul 2021
    This amendment concerned the adolescent recruitment stop.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    11 Oct 2020
    Sponsor was informed of an SAE in Study VAC31518COV3001 that met a study pausing rule. As a precautionary measure, vaccinations in all studies in the program, including Study VAC31518COV2001, were paused. After Data Safety Monitoring Board (DSMB) review, resumption of study vaccinations was recommended by the DSMB. When the pause in Study VAC31518COV2001 was lifted after Health Authority assessment, all but 2 subjects in Groups 7 and 8 had missed their visit window for Vaccination 2 (Visit 4), rendering it impossible to evaluate the intended 28 day vaccination interval. As the de facto vaccination interval in Groups 7 and 8 matched the vaccination interval in Groups 1 and 6, the data were combined.
    04 Nov 2020
    13 Apr 2021
    A safety signal was identified for thrombosis with thrombocytopenia syndrome (TTS) in post marketing data in the USA following EUA. Out of an abundance of caution, the Centers for Disease Control and Prevention (CDC) and FDA had recommended a pause in the use of Ad26.COV.S vaccine. With the recommendation from CDC and FDA, the sponsor decided to voluntarily pause vaccinations in all studies in the program. This study pause did not impact any vaccinations in Study VAC31518COV2001 as Injection 3 (antigen presentation) was completed prior to implementation of the study pause.
    15 Jul 2021

    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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