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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26COVS1 in Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Years and Older

    Summary
    EudraCT number
    2020-001483-28
    Trial protocol
    BE  
    Global end of trial date
    21 Feb 2023

    Results information
    Results version number
    v1(current)
    This version publication date
    08 Mar 2024
    First version publication date
    08 Mar 2024
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    CR108828
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04436276
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Vaccines & Prevention B.V.
    Sponsor organisation address
    Archimedesweg 4-6, Leiden, Netherlands, 2333 CN
    Public contact
    Clinical Registry Group, Janssen Vaccines & Prevention B.V., ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Vaccines & Prevention B.V., ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Feb 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Feb 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Main objective of the study was to assess the safety and reactogenicity of adenovirus type 26 coronavirus-2 virus spike (Ad26.COV2.S) at 2 dose levels, 5*10^10 virus particles (vp) and 1*10^11 vp, administered intramuscularly (IM) as a single-dose or 2-dose schedule in healthy adults aged greater than or equal to (>=) 18 to less than or equal to (<=) 55 years and in adults aged >=65 years in good health with or without stable underlying conditions.
    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
    16 Jul 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 466
    Country: Number of subjects enrolled
    United States: 610
    Worldwide total number of subjects
    1076
    EEA total number of subjects
    466
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    673
    From 65 to 84 years
    401
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 1085 subjects were enrolled in the study, out of which 1076 subjects received treatment. Remaining 9 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
    COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10)
    Arm description
    Healthy adult subjects aged greater than or equal to (>=) 18 to less than or equal to (<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5*10^10 >=6 months after Vaccination 2.
    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 a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2) and an ad hoc booster dose at >= 6 months after Vaccination 2.

    Arm title
    COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10)
    Arm description
    Healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and matching placebo (PL) on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5*10^10 vp >=6 months after Vaccination 2.
    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 a single IM injection of placebo matching to Ad26.COV2.S 5*10^10 vp on Day 57 (Vaccination 2).

    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 a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 and >=6 months after Vaccination 2.

    Arm title
    COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10)
    Arm description
    Healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5*10^10 vp >=6 months after Vaccination 2.
    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 a single ad hoc booster dose of Ad26.COV2.S. 5*10^10 vp, >=6 months after Vaccination 2.

    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 a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2).

    Arm title
    COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10)
    Arm description
    Healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5*10^10 vp >=6 months after Vaccination 2.
    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 a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1).

    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 a single IM injection of ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. >=6 months after Vaccination 2.

    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 a single IM injection of placebo matching to Ad26.COV2.S 1*10^11 vp on Day 57 (Vaccination 2).

    Arm title
    COHORT 1A: Placebo, Placebo
    Arm description
    Healthy adult subjects aged >=18 to <=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled subjects who had initially received placebo were offered a single dose of 5*10^10 vp Ad26.COV2.S.
    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
    As per protocol amendment 10, after unblinding, enrolled subjects who had initially received only placebo were offerred a single dose of 5*10^10 vp Ad26.COV2.S.

    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 a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2).

    Arm title
    COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10)
    Arm description
    Healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5*10^10 vp >=6 months after Vaccination 2.
    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 a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2) and >=6 months after Vaccination 2.

    Arm title
    COHORT 1B: Ad26 5e10, PL(,AHBV: Ad26 5e10)
    Arm description
    Healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5*10^10 vp >=6 months after Vaccination 2.
    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 a single IM injection of placebo matching to Ad26.COV2.S 5*10^10 vp on Day 57 (Vaccination 2).

    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 a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 and >=6 months after Vaccination 2.

    Arm title
    COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10)
    Arm description
    Healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5*10^10 vp >=6 months after Vaccination 2.
    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 a single IM injection of Ad26.COV2.S 5*10^10 vp at >= 6 months after Vaccination 2.

    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 a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2).

    Arm title
    COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10)
    Arm description
    Healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5*10^10 vp >=6 months after Vaccination 2.
    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 a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1).

    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 a single IM injection of 5*10^10 vp Ad26.COV2.S. >= 6 months after Vaccination 2.

    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 a single IM injection of placebo matching to Ad26.COV2.S 1*10^11 vp on Day 57 (Vaccination 2).

    Arm title
    COHORT 1B: Placebo, Placebo
    Arm description
    Healthy adult subjects aged >=18 to <=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled subjects who had initially received placebo were offered a single dose of 5*10^10 vp Ad26.COV2.S.
    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
    As per protocol amendment 10, after unblinding, enrolled subjects who had initially received only placebo were offerred a single dose of 5*10^10 vp Ad26.COV2.S.

    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 a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2).

    Arm title
    COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10)
    Arm description
    Group 1 and Group 4 healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) followed by matching placebo at 6 and 12 months as matching Booster (B) 1 and Booster 2 vaccination. As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S. 5*10^10 vp >=6 months after Booster 2 Vaccination.
    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 a single IM injection of placebo matching to Ad26.COV2.S 5*10^10 vp at 6 and 12 months as matching Booster 1 and Booster 2 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 a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and >=6 months after Booster 2 Vaccination.

    Arm title
    COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL
    Arm description
    Group 2 healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) followed by first booster vaccination with single IM injection of Ad26.COV2.S 5*10^10 vp booster 1 at 6 months and a matching placebo at 12 months to match second Booster vaccination.
    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 a single IM injection of placebo matching to Ad26.COV2.S 5*10^10 vp at 12 months (Booster 2).

    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 a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) at 6 months (Booster 1).

    Arm title
    COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10
    Arm description
    Group 3 healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) followed by a matching placebo booster 1 injection after 6 months and Ad26.COV2.S 5*10^10 vp after 12 months as Booster 2.
    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 a single IM injection of placebo matching to Ad26.COV2.S 5*10^10 vp at 6 months (Booster 1).

    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 a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1), 12 months (Booster 2).

    Arm title
    COHORT 2A: Placebo, B: PL
    Arm description
    Group 5 subjects received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (Vaccination 1), 6 months (Booster 1) and 12 months (Booster 2). As per protocol amendment 10, after unblinding, enrolled subjects who had initially received placebo were offered a single dose of 5*10^10 vp Ad26.COV2.S.
    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
    As per protocol amendment 10, after unblinding, enrolled subjects who had initially received only placebo were offered a single dose of 5*10^10 vp Ad26.COV2.S.

    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 a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (Vaccination 1), 6 months (Booster 1) and 12 months (Booster 2).

    Arm title
    COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10)
    Arm description
    Group 1 and 4 healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2) and matching placebo at 6 and 12 months after vaccination 2 as Booster 1 and Booster 2 vaccines. As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. >=6 months after Booster 2 Vaccination.
    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 a single IM injection of placebo matching to Ad26.COV2.S 5*10^10 vp at 6 and 12 months after vaccination 2 as Booster 1 and Booster 2 vaccines.

    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 a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) Day 57 (Vaccination) and >=6 months after Booster 2 Vaccination.

    Arm title
    COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL
    Arm description
    Group 2 healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1), Day 57 (Vaccination 2) and 6 months after Vaccination 2(Booster 1). At 12 months after vaccination 2, subjects received placebo matching to Ad26.COV2.S vaccine (Booster 2).
    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 a single IM injection of placebo matching to Ad26.COV2.S 5*10^10 vp at 12 months after vaccination 2.

    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 a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1), Day 57 (Vaccination 2) and 6 months after Vaccination 2 (Booster 1).

    Arm title
    COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10
    Arm description
    Group 3 healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2) and matching placebo at 6 months after vaccination 2 as Booster 1 vaccination and Ad26.COV2.S 5*10^10 vp at 12 months after vaccination 2 as Booster 2 vaccination.
    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
    Group 3 subjects received a single IM injection of placebo matching to Ad26.COV2.S 5*10^10 vp at 6 months after vaccination 2 as Booster 1 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 a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2), at 12 months after vaccination 2 as Booster 2 vaccination.

    Arm title
    COHORT 2B: Placebo, B: PL
    Arm description
    Group 5 healthy adult subjects aged >=18 to <=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (Vaccination 1), Day 57 (Vaccination 2), 8 Month (Booster 1) and 14 months (Booster 2). As per protocol amendment 10, after unblinding, enrolled subjects who had initially received placebo were offered a single dose of 5*10^10 vp Ad26.COV2.S.
    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
    As per protocol amendment 10, after unblinding, enrolled subjects who had initially received only placebo were offered a single dose of 5*10^10 vp Ad26.COV2.S.

    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 a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (Vaccination 1), Day 57 (Vaccination 2), 8 Month (Booster 1) and 14 months (Booster 2).

    Arm title
    COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10)
    Arm description
    Adult subjects (with good or stable health) aged >=65 years received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. >=6 months after Vaccination 2.
    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 a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2) and >=6 months after Vaccination 2.

    Arm title
    COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10)
    Arm description
    Adult subjects (with good or stable health) aged >=65 years received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. >=6 months after Vaccination 2.
    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 a single IM injection of placebo matching to Ad26.COV2.S 5*10^10 vp on Day 57 (Vaccination 2).

    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 a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 and >=6 months after Vaccination 2.

    Arm title
    COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10)
    Arm description
    Adult subjects (with good or stable health) aged >=65 years received a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. >=6 months after Vaccination 2.
    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 a single IM injection of Ad26.COV2.S. 5*10^10 vp at >=6 months after Vaccination 2.

    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 a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2).

    Arm title
    COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10)
    Arm description
    Adult subjects (with good or stable health) aged >=65 years received a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. >=6 months after Vaccination 2.
    Arm type
    Experimental

    Investigational medicinal product name
    Ad26.COV2.S 1*10^11
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1).

    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 a single IM injection of Ad26.COV2.S. 5*10^10 vp >=6 months after Vaccination 2.

    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 a single IM injection of placebo matching to Ad26.COV2.S 1*10^11 vp on Day 57 (Vaccination 2).

    Arm title
    COHORT 3: Placebo, Placebo
    Arm description
    Adult subjects (with good or stable health) aged >=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled subjects who had initially received placebo were offered a single dose of 5*10^10 vp Ad26.COV2.S.
    Arm type
    Experimental

    Investigational medicinal product name
    Ad26.COV2.S. 5*10^10
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    As per protocol amendment 10, after unblinding, enrolled subjects who had initially received only placebo were offered a single dose of 5*10^10 vp Ad26.COV2.S.

    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 a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2).

    Number of subjects in period 1
    COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1A: Placebo, Placebo COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1B: Ad26 5e10, PL(,AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1B: Placebo, Placebo COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 COHORT 2A: Placebo, B: PL COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10) COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 COHORT 2B: Placebo, B: PL COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 3: Placebo, Placebo
    Started
    77
    75
    75
    73
    77
    5
    5
    5
    5
    5
    58
    29
    32
    17
    62
    30
    28
    15
    81
    80
    82
    79
    81
    Completed
    48
    49
    42
    39
    36
    3
    5
    4
    4
    4
    33
    15
    14
    7
    31
    16
    15
    5
    65
    53
    53
    57
    6
    Not completed
    29
    26
    33
    34
    41
    2
    0
    1
    1
    1
    25
    14
    18
    10
    31
    14
    13
    10
    16
    27
    29
    22
    75
         Physician decision
    1
    -
    2
    1
    -
    -
    -
    -
    -
    -
    -
    1
    2
    -
    -
    -
    -
    -
    -
    -
    1
    2
    -
         Death
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    1
    -
    -
    -
    -
    2
    -
    1
    -
         Protocol deviation
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    1
    -
    -
    -
    -
    -
    -
    -
         Adverse event
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
         Unspecified
    3
    2
    5
    9
    23
    1
    -
    -
    -
    -
    3
    1
    1
    2
    3
    -
    -
    6
    1
    -
    2
    2
    60
         Lost to follow-up
    -
    2
    2
    1
    4
    1
    -
    -
    1
    -
    5
    5
    4
    1
    7
    7
    1
    -
    1
    1
    2
    1
    1
         Withdrawal by subject
    25
    22
    24
    23
    14
    -
    -
    1
    -
    1
    17
    7
    10
    6
    20
    6
    11
    4
    14
    24
    24
    16
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10)
    Reporting group description
    Healthy adult subjects aged greater than or equal to (>=) 18 to less than or equal to (<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5*10^10 >=6 months after Vaccination 2.

    Reporting group title
    COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10)
    Reporting group description
    Healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and matching placebo (PL) on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5*10^10 vp >=6 months after Vaccination 2.

    Reporting group title
    COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10)
    Reporting group description
    Healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5*10^10 vp >=6 months after Vaccination 2.

    Reporting group title
    COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10)
    Reporting group description
    Healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5*10^10 vp >=6 months after Vaccination 2.

    Reporting group title
    COHORT 1A: Placebo, Placebo
    Reporting group description
    Healthy adult subjects aged >=18 to <=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled subjects who had initially received placebo were offered a single dose of 5*10^10 vp Ad26.COV2.S.

    Reporting group title
    COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10)
    Reporting group description
    Healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5*10^10 vp >=6 months after Vaccination 2.

    Reporting group title
    COHORT 1B: Ad26 5e10, PL(,AHBV: Ad26 5e10)
    Reporting group description
    Healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5*10^10 vp >=6 months after Vaccination 2.

    Reporting group title
    COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10)
    Reporting group description
    Healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5*10^10 vp >=6 months after Vaccination 2.

    Reporting group title
    COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10)
    Reporting group description
    Healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5*10^10 vp >=6 months after Vaccination 2.

    Reporting group title
    COHORT 1B: Placebo, Placebo
    Reporting group description
    Healthy adult subjects aged >=18 to <=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled subjects who had initially received placebo were offered a single dose of 5*10^10 vp Ad26.COV2.S.

    Reporting group title
    COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10)
    Reporting group description
    Group 1 and Group 4 healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) followed by matching placebo at 6 and 12 months as matching Booster (B) 1 and Booster 2 vaccination. As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S. 5*10^10 vp >=6 months after Booster 2 Vaccination.

    Reporting group title
    COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL
    Reporting group description
    Group 2 healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) followed by first booster vaccination with single IM injection of Ad26.COV2.S 5*10^10 vp booster 1 at 6 months and a matching placebo at 12 months to match second Booster vaccination.

    Reporting group title
    COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10
    Reporting group description
    Group 3 healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) followed by a matching placebo booster 1 injection after 6 months and Ad26.COV2.S 5*10^10 vp after 12 months as Booster 2.

    Reporting group title
    COHORT 2A: Placebo, B: PL
    Reporting group description
    Group 5 subjects received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (Vaccination 1), 6 months (Booster 1) and 12 months (Booster 2). As per protocol amendment 10, after unblinding, enrolled subjects who had initially received placebo were offered a single dose of 5*10^10 vp Ad26.COV2.S.

    Reporting group title
    COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10)
    Reporting group description
    Group 1 and 4 healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2) and matching placebo at 6 and 12 months after vaccination 2 as Booster 1 and Booster 2 vaccines. As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. >=6 months after Booster 2 Vaccination.

    Reporting group title
    COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL
    Reporting group description
    Group 2 healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1), Day 57 (Vaccination 2) and 6 months after Vaccination 2(Booster 1). At 12 months after vaccination 2, subjects received placebo matching to Ad26.COV2.S vaccine (Booster 2).

    Reporting group title
    COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10
    Reporting group description
    Group 3 healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2) and matching placebo at 6 months after vaccination 2 as Booster 1 vaccination and Ad26.COV2.S 5*10^10 vp at 12 months after vaccination 2 as Booster 2 vaccination.

    Reporting group title
    COHORT 2B: Placebo, B: PL
    Reporting group description
    Group 5 healthy adult subjects aged >=18 to <=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (Vaccination 1), Day 57 (Vaccination 2), 8 Month (Booster 1) and 14 months (Booster 2). As per protocol amendment 10, after unblinding, enrolled subjects who had initially received placebo were offered a single dose of 5*10^10 vp Ad26.COV2.S.

    Reporting group title
    COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10)
    Reporting group description
    Adult subjects (with good or stable health) aged >=65 years received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. >=6 months after Vaccination 2.

    Reporting group title
    COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10)
    Reporting group description
    Adult subjects (with good or stable health) aged >=65 years received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. >=6 months after Vaccination 2.

    Reporting group title
    COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10)
    Reporting group description
    Adult subjects (with good or stable health) aged >=65 years received a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. >=6 months after Vaccination 2.

    Reporting group title
    COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10)
    Reporting group description
    Adult subjects (with good or stable health) aged >=65 years received a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. >=6 months after Vaccination 2.

    Reporting group title
    COHORT 3: Placebo, Placebo
    Reporting group description
    Adult subjects (with good or stable health) aged >=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled subjects who had initially received placebo were offered a single dose of 5*10^10 vp Ad26.COV2.S.

    Reporting group values
    COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1A: Placebo, Placebo COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1B: Ad26 5e10, PL(,AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1B: Placebo, Placebo COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 COHORT 2A: Placebo, B: PL COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10) COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 COHORT 2B: Placebo, B: PL COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 3: Placebo, Placebo Total
    Number of subjects
    77 75 75 73 77 5 5 5 5 5 58 29 32 17 62 30 28 15 81 80 82 79 81 1076
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0 0 0 0 0 0 0 0 0 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 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Adults (18-64 years)
    77 75 75 73 77 5 5 5 5 5 58 29 32 17 62 30 28 15 0 0 0 0 0 673
        From 65 to 84 years
    0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 81 80 81 78 81 401
        85 years and over
    0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 0 2
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    35.4 ( 10.11 ) 35.7 ( 9.99 ) 34.5 ( 10.59 ) 35.1 ( 10.48 ) 35 ( 9.88 ) 43 ( 11.45 ) 44.4 ( 4.39 ) 29.6 ( 4.34 ) 41.2 ( 5.54 ) 40.8 ( 11.97 ) 36.8 ( 9.27 ) 38.1 ( 9.98 ) 39.2 ( 10.53 ) 37.5 ( 10.41 ) 37.6 ( 9.93 ) 38.3 ( 9.81 ) 36.1 ( 11.48 ) 37 ( 9.99 ) 69.5 ( 4.24 ) 69.8 ( 3.74 ) 69.7 ( 4.33 ) 70.3 ( 4.18 ) 69.9 ( 3.73 ) -
    Title for Gender
    Units: subjects
        Female
    41 38 38 42 39 1 4 2 4 3 33 15 12 10 23 10 15 10 40 36 42 40 43 541
        Male
    36 37 37 31 38 4 1 3 1 2 25 14 20 7 39 20 13 5 41 44 40 39 38 535

    End points

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    End points reporting groups
    Reporting group title
    COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10)
    Reporting group description
    Healthy adult subjects aged greater than or equal to (>=) 18 to less than or equal to (<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5*10^10 >=6 months after Vaccination 2.

    Reporting group title
    COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10)
    Reporting group description
    Healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and matching placebo (PL) on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5*10^10 vp >=6 months after Vaccination 2.

    Reporting group title
    COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10)
    Reporting group description
    Healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5*10^10 vp >=6 months after Vaccination 2.

    Reporting group title
    COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10)
    Reporting group description
    Healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5*10^10 vp >=6 months after Vaccination 2.

    Reporting group title
    COHORT 1A: Placebo, Placebo
    Reporting group description
    Healthy adult subjects aged >=18 to <=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled subjects who had initially received placebo were offered a single dose of 5*10^10 vp Ad26.COV2.S.

    Reporting group title
    COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10)
    Reporting group description
    Healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5*10^10 vp >=6 months after Vaccination 2.

    Reporting group title
    COHORT 1B: Ad26 5e10, PL(,AHBV: Ad26 5e10)
    Reporting group description
    Healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5*10^10 vp >=6 months after Vaccination 2.

    Reporting group title
    COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10)
    Reporting group description
    Healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5*10^10 vp >=6 months after Vaccination 2.

    Reporting group title
    COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10)
    Reporting group description
    Healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5*10^10 vp >=6 months after Vaccination 2.

    Reporting group title
    COHORT 1B: Placebo, Placebo
    Reporting group description
    Healthy adult subjects aged >=18 to <=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled subjects who had initially received placebo were offered a single dose of 5*10^10 vp Ad26.COV2.S.

    Reporting group title
    COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10)
    Reporting group description
    Group 1 and Group 4 healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) followed by matching placebo at 6 and 12 months as matching Booster (B) 1 and Booster 2 vaccination. As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S. 5*10^10 vp >=6 months after Booster 2 Vaccination.

    Reporting group title
    COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL
    Reporting group description
    Group 2 healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) followed by first booster vaccination with single IM injection of Ad26.COV2.S 5*10^10 vp booster 1 at 6 months and a matching placebo at 12 months to match second Booster vaccination.

    Reporting group title
    COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10
    Reporting group description
    Group 3 healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) followed by a matching placebo booster 1 injection after 6 months and Ad26.COV2.S 5*10^10 vp after 12 months as Booster 2.

    Reporting group title
    COHORT 2A: Placebo, B: PL
    Reporting group description
    Group 5 subjects received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (Vaccination 1), 6 months (Booster 1) and 12 months (Booster 2). As per protocol amendment 10, after unblinding, enrolled subjects who had initially received placebo were offered a single dose of 5*10^10 vp Ad26.COV2.S.

    Reporting group title
    COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10)
    Reporting group description
    Group 1 and 4 healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2) and matching placebo at 6 and 12 months after vaccination 2 as Booster 1 and Booster 2 vaccines. As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. >=6 months after Booster 2 Vaccination.

    Reporting group title
    COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL
    Reporting group description
    Group 2 healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1), Day 57 (Vaccination 2) and 6 months after Vaccination 2(Booster 1). At 12 months after vaccination 2, subjects received placebo matching to Ad26.COV2.S vaccine (Booster 2).

    Reporting group title
    COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10
    Reporting group description
    Group 3 healthy adult subjects aged >=18 to <=55 received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2) and matching placebo at 6 months after vaccination 2 as Booster 1 vaccination and Ad26.COV2.S 5*10^10 vp at 12 months after vaccination 2 as Booster 2 vaccination.

    Reporting group title
    COHORT 2B: Placebo, B: PL
    Reporting group description
    Group 5 healthy adult subjects aged >=18 to <=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (Vaccination 1), Day 57 (Vaccination 2), 8 Month (Booster 1) and 14 months (Booster 2). As per protocol amendment 10, after unblinding, enrolled subjects who had initially received placebo were offered a single dose of 5*10^10 vp Ad26.COV2.S.

    Reporting group title
    COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10)
    Reporting group description
    Adult subjects (with good or stable health) aged >=65 years received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. >=6 months after Vaccination 2.

    Reporting group title
    COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10)
    Reporting group description
    Adult subjects (with good or stable health) aged >=65 years received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. >=6 months after Vaccination 2.

    Reporting group title
    COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10)
    Reporting group description
    Adult subjects (with good or stable health) aged >=65 years received a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. >=6 months after Vaccination 2.

    Reporting group title
    COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10)
    Reporting group description
    Adult subjects (with good or stable health) aged >=65 years received a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible subjects who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. >=6 months after Vaccination 2.

    Reporting group title
    COHORT 3: Placebo, Placebo
    Reporting group description
    Adult subjects (with good or stable health) aged >=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled subjects who had initially received placebo were offered a single dose of 5*10^10 vp Ad26.COV2.S.

    Primary: Cohort 1a and 1b: Number of Subjects With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen

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    End point title
    Cohort 1a and 1b: Number of Subjects With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen [1] [2]
    End point description
    Number of Subjects with solicited local AEs for 7 days after vaccination 1 in Cohorts 1a and 1b were reported. An AE is 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 (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Full analysis set (FAS) included all subjects with at least one vaccine administration documented.
    End point type
    Primary
    End point timeframe
    7 days post-vaccination 1 on Day 1 (Day 8)
    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: Only descriptive data was planned to be reported for this endpoint.
    [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: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1A: Placebo, Placebo COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1B: Ad26 5e10, PL(,AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1B: Placebo, Placebo
    Number of subjects analysed
    77
    75
    75
    73
    77
    5
    5
    5
    5
    5
    Units: Subjects
    50
    50
    57
    59
    8
    4
    3
    5
    4
    0
    No statistical analyses for this end point

    Primary: Cohorts 1a and 1b: Number of Subjects With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen

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    End point title
    Cohorts 1a and 1b: Number of Subjects With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen [3] [4]
    End point description
    Number of Subjects with solicited local AEs for 7 days after vaccination 2 in Cohorts 1a and 1b were reported. An AE is 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 (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluated for this endpoint.
    End point type
    Primary
    End point timeframe
    7 days after vaccination 2 on Day 57 (Day 64)
    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: Only descriptive data was planned to be reported for this endpoint.
    [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: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1A: Placebo, Placebo COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1B: Ad26 5e10, PL(,AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1B: Placebo, Placebo
    Number of subjects analysed
    74
    74
    74
    67
    74
    4
    5
    5
    5
    5
    Units: Subjects
    49
    5
    55
    7
    2
    4
    0
    5
    1
    0
    No statistical analyses for this end point

    Primary: Cohorts 1a and 1b: Number of Subjects With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination

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    End point title
    Cohorts 1a and 1b: Number of Subjects With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination [5] [6]
    End point description
    Number of Subjects with solicited local AEs for 7 days after ad hoc booster vaccination in Cohorts 1a and 1b were reported. An AE is 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 (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    7 days after ad hoc booster vaccination
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be reported for this endpoint.
    [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: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1A: Placebo, Placebo COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1B: Ad26 5e10, PL(,AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1B: Placebo, Placebo
    Number of subjects analysed
    6
    8
    7
    7
    0 [7]
    1
    2
    2
    0 [8]
    0 [9]
    Units: Subjects
    5
    5
    6
    5
    0
    1
    2
    Notes
    [7] - 0 subjects were available for the analysis as none received ad hoc booster vaccination..
    [8] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    [9] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    No statistical analyses for this end point

    Primary: Cohorts 2a and 2b: Number of Subjects With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen

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    End point title
    Cohorts 2a and 2b: Number of Subjects With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen [10] [11]
    End point description
    Number of Subjects with solicited local AEs for 7 days after vaccination 1 in Cohorts 2a and 2b were reported. An AE is 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 (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). FAS included all subjects with at least one vaccine administration documented.
    End point type
    Primary
    End point timeframe
    7 days after Vaccination 1 on Day 1 (Day 8)
    Notes
    [10] - 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: Only descriptive data was planned to be reported for this endpoint.
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 COHORT 2A: Placebo, B: PL COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10) COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 COHORT 2B: Placebo, B: PL
    Number of subjects analysed
    58
    29
    32
    17
    62
    30
    28
    15
    Units: Subjects
    48
    24
    19
    4
    52
    23
    18
    0
    No statistical analyses for this end point

    Primary: Cohort 2a: Number of Subjects With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 1

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    End point title
    Cohort 2a: Number of Subjects With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 1 [12] [13]
    End point description
    Number of Subjects with solicited local AEs for 7 days after booster vaccination 1 in Cohort 2a were reported. An AE is 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 (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    7 days after booster vaccination 1 on Day 183 (Day 190)
    Notes
    [12] - 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: Only descriptive data was planned to be reported for this endpoint.
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 COHORT 2A: Placebo, B: PL
    Number of subjects analysed
    42
    19
    20
    1
    Units: Subjects
    6
    15
    3
    0
    No statistical analyses for this end point

    Primary: Cohort 2a: Number of Subjects With Solicited Local (injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination

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    End point title
    Cohort 2a: Number of Subjects With Solicited Local (injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination [14] [15]
    End point description
    Number of Subjects with solicited local AEs for 7 days after ad hoc booster vaccination in Cohort 2a were 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 (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluated for this endpoint.
    End point type
    Primary
    End point timeframe
    7 days after ad hoc booster vaccination
    Notes
    [14] - 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: Only descriptive data was planned to be reported for this endpoint.
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 COHORT 2A: Placebo, B: PL
    Number of subjects analysed
    4
    0 [16]
    0 [17]
    0 [18]
    Units: Subjects
    1
    Notes
    [16] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    [17] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    [18] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    No statistical analyses for this end point

    Primary: Cohort 2a: Number of Subjects With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 2

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    End point title
    Cohort 2a: Number of Subjects With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 2 [19] [20]
    End point description
    Number of Subjects with solicited local AEs for 7 days after booster vaccination 2 in Cohort 2a were 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 (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    7 days after booster vaccination 2 on Day 366 (Day 373)
    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: Only descriptive data was planned to be reported for this endpoint.
    [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: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 COHORT 2A: Placebo, B: PL
    Number of subjects analysed
    19
    13
    10
    0 [21]
    Units: Subjects
    3
    3
    5
    Notes
    [21] - 0 subjects were available for the analysis as none received booster vaccination 2.
    No statistical analyses for this end point

    Primary: Cohort 2b: Number of Subjects With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen

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    End point title
    Cohort 2b: Number of Subjects With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen [22] [23]
    End point description
    Number of Subjects with solicited local AEs for 7 days after Vaccination 2 in Cohort 2b were reported. An AE is 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 (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    7 days after Vaccination 2 on Day 57 (Day 64)
    Notes
    [22] - 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: Only descriptive data was planned to be reported for this endpoint.
    [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10) COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 COHORT 2B: Placebo, B: PL
    Number of subjects analysed
    56
    29
    27
    14
    Units: Subjects
    42
    21
    18
    3
    No statistical analyses for this end point

    Primary: Cohort 2b: Number of Subjects With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 1

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    End point title
    Cohort 2b: Number of Subjects With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 1 [24] [25]
    End point description
    Number of subjects with solicited local AEs for 7 days after booster vaccination 1 in Cohort 2b were 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 (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    7 days after booster vaccination 1 on Day 239 (Day 246)
    Notes
    [24] - 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: Only descriptive data was planned to be reported for this endpoint.
    [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10) COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 COHORT 2B: Placebo, B: PL
    Number of subjects analysed
    45
    21
    20
    0 [26]
    Units: Subjects
    4
    15
    4
    Notes
    [26] - 0 subjects were available for the analysis as none received booster vaccination 1.
    No statistical analyses for this end point

    Primary: Cohort 2b: Number of Subjects With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 2

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    End point title
    Cohort 2b: Number of Subjects With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 2 [27] [28]
    End point description
    Number of subjects with solicited local AEs for 7 days after booster vaccination 2 in Cohort 2b were reported. An AE is 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 (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    7 days after booster vaccination 2 on Day 422 (Day 429)
    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: Only descriptive data was planned to be reported for this endpoint.
    [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: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10) COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 COHORT 2B: Placebo, B: PL
    Number of subjects analysed
    8
    3
    5
    0 [29]
    Units: Subjects
    0
    1
    4
    Notes
    [29] - 0 subjects were available for the analysis as none received booster vaccination 2.
    No statistical analyses for this end point

    Primary: Cohort 2b: Number of Subjects With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination

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    End point title
    Cohort 2b: Number of Subjects With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination [30] [31]
    End point description
    Number of subjects with solicited local AEs for 7 days after ad hoc booster vaccination in Cohort 2b were 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 (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    7 days after ad hoc booster vaccination
    Notes
    [30] - 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: Only descriptive data was planned to be reported for this endpoint.
    [31] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10) COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 COHORT 2B: Placebo, B: PL
    Number of subjects analysed
    7
    0 [32]
    0 [33]
    0 [34]
    Units: Subjects
    4
    Notes
    [32] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    [33] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    [34] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    No statistical analyses for this end point

    Primary: Cohorts 1a and 1b: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen

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    End point title
    Cohorts 1a and 1b: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen [35] [36]
    End point description
    Number of subjects with solicited systemic AEs for 7 days after vaccination 1 in Cohorts 1a and 1b were 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which subjects were specifically questioned and which will be noted by subjects in their subject diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days). FAS included all subjects with at least one vaccine administration documented.
    End point type
    Primary
    End point timeframe
    7 days after vaccination 1 on Day 1 (Day 8)
    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: Only descriptive data was planned to be reported for this endpoint.
    [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: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1A: Placebo, Placebo COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1B: Ad26 5e10, PL(,AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1B: Placebo, Placebo
    Number of subjects analysed
    77
    75
    75
    73
    77
    5
    5
    5
    5
    5
    Units: Subjects
    48
    52
    63
    62
    17
    4
    3
    5
    5
    4
    No statistical analyses for this end point

    Primary: Cohort 1a and 1b: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen

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    End point title
    Cohort 1a and 1b: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen [37] [38]
    End point description
    Number of subjects with solicited systemic AEs for 7 days after vaccination 2 in Cohort 1a and 1b were 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which subjects were specifically questioned and which will be noted by subjects in their subject diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days). FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    7 days after Vaccination 2 on Day 57 (Day 64)
    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: Only descriptive data was planned to be reported for this endpoint.
    [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: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1A: Placebo, Placebo COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1B: Ad26 5e10, PL(,AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1B: Placebo, Placebo
    Number of subjects analysed
    74
    74
    74
    67
    74
    4
    5
    5
    5
    5
    Units: Subjects
    43
    23
    51
    19
    15
    3
    2
    4
    1
    3
    No statistical analyses for this end point

    Primary: Cohort 1a and 1b: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination

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    End point title
    Cohort 1a and 1b: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination [39] [40]
    End point description
    Number of subjects with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohorts 1a and 1b were 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which subjects were specifically questioned and which will be noted by subjects in their subject diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days). FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    7 days after ad hoc booster vaccination
    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: Only descriptive data was planned to be reported for this endpoint.
    [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: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1A: Placebo, Placebo COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1B: Ad26 5e10, PL(,AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1B: Placebo, Placebo
    Number of subjects analysed
    6
    8
    7
    7
    0 [41]
    1
    2
    2
    0 [42]
    0 [43]
    Units: Subjects
    5
    6
    3
    4
    0
    2
    2
    Notes
    [41] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    [42] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    [43] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    No statistical analyses for this end point

    Primary: Cohorts 2a and 2b: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen

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    End point title
    Cohorts 2a and 2b: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen [44] [45]
    End point description
    Number of subjects with solicited systemic AEs for 7 days after vaccination 1 in Cohorts 2a and 2b were 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which subjects were specifically questioned and which will be noted by subjects in their subject diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days). FAS included all subjects with at least one vaccine administration documented.
    End point type
    Primary
    End point timeframe
    7 days after Vaccination 1 on Day 1 (Day 8)
    Notes
    [44] - 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: Only descriptive data was planned to be reported for this endpoint.
    [45] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 COHORT 2A: Placebo, B: PL COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10) COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 COHORT 2B: Placebo, B: PL
    Number of subjects analysed
    58
    29
    32
    17
    62
    30
    28
    15
    Units: Subjects
    47
    23
    21
    8
    50
    23
    21
    5
    No statistical analyses for this end point

    Primary: Cohort 2a: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 1

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    End point title
    Cohort 2a: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 1 [46] [47]
    End point description
    Number of subjects with solicited systemic AEs for 7 days post booster vaccination 1 in Cohort 2a were 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which subjects were specifically questioned and which will be noted by subjects in their subject diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days). FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    7 days after booster vaccination 1 on Day 183 (Day 190)
    Notes
    [46] - 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: Only descriptive data was planned to be reported for this endpoint.
    [47] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 COHORT 2A: Placebo, B: PL
    Number of subjects analysed
    42
    19
    20
    1
    Units: Subjects
    14
    11
    5
    0
    No statistical analyses for this end point

    Primary: Cohort 2a: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 2

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    End point title
    Cohort 2a: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 2 [48] [49]
    End point description
    Number of subjects with solicited systemic AEs for 7 days after booster vaccination 2 in Cohort 2a were 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which subjects were specifically questioned and which will be noted by subjects in their subject diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days). FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    7 days post booster vaccination 2 on Day 366 (Day 373)
    Notes
    [48] - 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: Only descriptive data was planned to be reported for this endpoint.
    [49] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 COHORT 2A: Placebo, B: PL
    Number of subjects analysed
    19
    13
    10
    0 [50]
    Units: Subjects
    6
    2
    2
    Notes
    [50] - 0 subjects were available for the analysis as none received booster vaccination 2.
    No statistical analyses for this end point

    Primary: Cohort 2b: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen

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    End point title
    Cohort 2b: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen [51] [52]
    End point description
    Number of subjects with solicited systemic AEs for 7 days after vaccination 2 in Cohort 2b were 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which subjects were specifically questioned and which will be noted by subjects in their subject diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days). FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluated for this endpoint.
    End point type
    Primary
    End point timeframe
    7 days after Vaccination 2 on Day 57 (Day 64)
    Notes
    [51] - 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: Only descriptive data was planned to be reported for this endpoint.
    [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: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10) COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 COHORT 2B: Placebo, B: PL
    Number of subjects analysed
    56
    29
    27
    14
    Units: Subjects
    40
    17
    15
    6
    No statistical analyses for this end point

    Primary: Cohort 2a: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination

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    End point title
    Cohort 2a: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination [53] [54]
    End point description
    Number of subjects with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohort 2a were 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which subjects were specifically questioned and which will be noted by subjects in their subject diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days). FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    7 days after ad hoc booster vaccination
    Notes
    [53] - 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: Only descriptive data was planned to be reported for this endpoint.
    [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: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 COHORT 2A: Placebo, B: PL
    Number of subjects analysed
    4
    0 [55]
    0 [56]
    0 [57]
    Units: Subjects
    1
    Notes
    [55] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    [56] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    [57] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    No statistical analyses for this end point

    Primary: Cohort 2b: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 1

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    End point title
    Cohort 2b: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 1 [58] [59]
    End point description
    Number of subjects with solicited systemic AEs for 7 days after booster vaccination 1 in Cohort 2b were 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which subjects were specifically questioned and which will be noted by subjects in their subject diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days). FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    7 days after booster vaccination 1 on Day 239 (Day 246)
    Notes
    [58] - 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: Only descriptive data was planned to be reported for this endpoint.
    [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: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10) COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 COHORT 2B: Placebo, B: PL
    Number of subjects analysed
    45
    21
    20
    0 [60]
    Units: Subjects
    14
    13
    4
    Notes
    [60] - 0 subjects were available for the analysis as none received booster vaccination1 .
    No statistical analyses for this end point

    Primary: Cohort 2b: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 2

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    End point title
    Cohort 2b: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 2 [61] [62]
    End point description
    Number of subjects with solicited systemic AEs for 7 days after booster vaccination 2 in Cohort 2b were 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which subjects were specifically questioned and which will be noted by subjects in their subject diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days). FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    7 days after booster vaccination 2 on Day 422 (Day 429)
    Notes
    [61] - 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: Only descriptive data was planned to be reported for this endpoint.
    [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: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10) COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 COHORT 2B: Placebo, B: PL
    Number of subjects analysed
    8
    3
    5
    0 [63]
    Units: Subjects
    2
    2
    4
    Notes
    [63] - 0 subjects were available for the analysis as none received booster vaccination 2.
    No statistical analyses for this end point

    Primary: Cohort 2b: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination

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    End point title
    Cohort 2b: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination [64] [65]
    End point description
    Number of subjects with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohort 2b were 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which subjects were specifically questioned and which will be noted by subjects in their subject diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days). FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    7 days after ad hoc booster vaccination
    Notes
    [64] - 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: Only descriptive data was planned to be reported for this endpoint.
    [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: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10) COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 COHORT 2B: Placebo, B: PL
    Number of subjects analysed
    7
    0 [66]
    0 [67]
    0 [68]
    Units: Subjects
    2
    Notes
    [66] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    [67] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    [68] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    No statistical analyses for this end point

    Primary: Cohort 3: Number of Subjects With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen

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    End point title
    Cohort 3: Number of Subjects With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen [69] [70]
    End point description
    Number of subjects with solicited local AEs for 7 days after vaccination 1 in Cohort 3 were 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 (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site). FAS included all subjects with at least one vaccine administration documented.
    End point type
    Primary
    End point timeframe
    7 days after vaccination 1 on Day 1 (Day 8)
    Notes
    [69] - 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: Only descriptive data was planned to be reported for this endpoint.
    [70] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 3: Placebo, Placebo
    Number of subjects analysed
    81
    80
    82
    79
    81
    Units: Subjects
    38
    30
    33
    34
    7
    No statistical analyses for this end point

    Primary: Cohort 3: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen

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    End point title
    Cohort 3: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen [71] [72]
    End point description
    Number of subjects with solicited systemic AEs for 7 days after vaccination 1 in Cohort 3 were 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which subjects were specifically questioned and which will be noted by subjects in their subject diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days). FAS included all subjects with at least one vaccine administration documented.
    End point type
    Primary
    End point timeframe
    7 days post-vaccination 1 on Day 1 (Day 8)
    Notes
    [71] - 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: Only descriptive data was planned to be reported for this endpoint.
    [72] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 3: Placebo, Placebo
    Number of subjects analysed
    81
    80
    82
    79
    81
    Units: Subjects
    39
    35
    47
    42
    20
    No statistical analyses for this end point

    Primary: Cohort 3: Number of Subjects With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen

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    End point title
    Cohort 3: Number of Subjects With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen [73] [74]
    End point description
    Number of subjects with solicited local AEs for 7 days after vaccination 2 in Cohort 3 were 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 (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site). FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    7 days post-vaccination 2 on Day 57 (Day 64)
    Notes
    [73] - 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: Only descriptive data was planned to be reported for this endpoint.
    [74] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 3: Placebo, Placebo
    Number of subjects analysed
    77
    80
    80
    78
    79
    Units: Subjects
    41
    5
    51
    13
    11
    No statistical analyses for this end point

    Primary: Cohort 3: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen

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    End point title
    Cohort 3: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen [75] [76]
    End point description
    Number of subjects with solicited systemic AEs for 7 days after vaccination 2 in Cohort 3 were 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which subjects were specifically questioned and which will be noted by subjects in their subject diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days). FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    7 after post-vaccination 2 on Day 57 (Day 64)
    Notes
    [75] - 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: Only descriptive data was planned to be reported for this endpoint.
    [76] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 3: Placebo, Placebo
    Number of subjects analysed
    77
    80
    80
    78
    79
    Units: Subjects
    33
    24
    40
    24
    24
    No statistical analyses for this end point

    Primary: Cohort 3: Number of Subjects With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination

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    End point title
    Cohort 3: Number of Subjects With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination [77] [78]
    End point description
    Number of subjects with solicited local AEs for 7 days after ad hoc booster vaccination in Cohort 3 were 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 (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site). FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    7 days post Ad hoc booster vaccination
    Notes
    [77] - 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: Only descriptive data was planned to be reported for this endpoint.
    [78] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 3: Placebo, Placebo
    Number of subjects analysed
    11
    15
    14
    9
    0 [79]
    Units: Subjects
    5
    6
    4
    5
    Notes
    [79] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    No statistical analyses for this end point

    Primary: Cohorts 1a and 1b: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen

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    End point title
    Cohorts 1a and 1b: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen [80] [81]
    End point description
    Number of subjects with unsolicited AEs after vaccination 1 in Cohorts 1a and 1b were 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. Unsolicited AEs were 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.
    End point type
    Primary
    End point timeframe
    28 days after vaccination 1 on Day 1 (Day 29)
    Notes
    [80] - 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: Only descriptive data was planned to be reported for this endpoint.
    [81] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1A: Placebo, Placebo COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1B: Ad26 5e10, PL(,AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1B: Placebo, Placebo
    Number of subjects analysed
    77
    75
    75
    73
    77
    5
    5
    5
    5
    5
    Units: Subjects
    11
    20
    26
    24
    14
    2
    3
    4
    4
    2
    No statistical analyses for this end point

    Primary: Cohort 3: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination

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    End point title
    Cohort 3: Number of Subjects With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination [82] [83]
    End point description
    Number of subjects with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohort 3 were 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which subjects were specifically questioned and which will be noted by subjects in their subject diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days). FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    7 days after ad hoc booster vaccination on Day 239
    Notes
    [82] - 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: Only descriptive data was planned to be reported for this endpoint.
    [83] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 3: Placebo, Placebo
    Number of subjects analysed
    11
    15
    14
    9
    0 [84]
    Units: Subjects
    3
    7
    4
    6
    Notes
    [84] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    No statistical analyses for this end point

    Primary: Cohorts 1a and 1b: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen

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    End point title
    Cohorts 1a and 1b: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen [85] [86]
    End point description
    Number of subjects with unsolicited AEs after vaccination 2 in Cohorts 1a and 1b were 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. Unsolicited AEs were 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 analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    28 days after vaccination 2 on Day 57 (Day 85)
    Notes
    [85] - 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: Only descriptive data was planned to be reported for this endpoint.
    [86] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1A: Placebo, Placebo COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1B: Ad26 5e10, PL(,AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1B: Placebo, Placebo
    Number of subjects analysed
    74
    74
    74
    67
    74
    4
    5
    5
    5
    5
    Units: Subjects
    10
    4
    7
    12
    6
    2
    0
    1
    0
    1
    No statistical analyses for this end point

    Primary: Cohorts 1a and 1b: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination

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    End point title
    Cohorts 1a and 1b: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination [87] [88]
    End point description
    Number of subjects with unsolicited AEs after ad hoc booster vaccination in Cohorts 1a and 1b were 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. Unsolicited AEs were 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 analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    28 days post Ad hoc booster vaccination
    Notes
    [87] - 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: Only descriptive data was planned to be reported for this endpoint.
    [88] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1A: Placebo, Placebo COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1B: Ad26 5e10, PL(,AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1B: Placebo, Placebo
    Number of subjects analysed
    6
    8
    7
    7
    0 [89]
    1
    2
    2
    0 [90]
    0 [91]
    Units: Subjects
    0
    1
    1
    0
    0
    0
    0
    Notes
    [89] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    [90] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    [91] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    No statistical analyses for this end point

    Primary: Cohorts 2a and 2b: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen

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    End point title
    Cohorts 2a and 2b: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen [92] [93]
    End point description
    Number of subjects with unsolicited AEs after vaccination 1 in Cohorts 2a and 2b were 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. Unsolicited AEs were 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.
    End point type
    Primary
    End point timeframe
    28 days after Vaccination 1 on Day 1 (Day 29)
    Notes
    [92] - 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: Only descriptive data was planned to be reported for this endpoint.
    [93] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 COHORT 2A: Placebo, B: PL COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10) COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 COHORT 2B: Placebo, B: PL
    Number of subjects analysed
    58
    29
    32
    17
    62
    30
    28
    15
    Units: Subjects
    15
    5
    7
    5
    11
    6
    5
    2
    No statistical analyses for this end point

    Primary: Cohort 2a: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 1

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    End point title
    Cohort 2a: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 1 [94] [95]
    End point description
    Number of subjects with unsolicited AEs after booster vaccination 1 in Cohort 2a were 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. Unsolicited AEs were 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 analysed) signifies subjects evaluated for this endpoint.
    End point type
    Primary
    End point timeframe
    28 days after booster vaccination 1
    Notes
    [94] - 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: Only descriptive data was planned to be reported for this endpoint.
    [95] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 COHORT 2A: Placebo, B: PL
    Number of subjects analysed
    42
    19
    20
    1
    Units: Subjects
    2
    2
    0
    0
    No statistical analyses for this end point

    Primary: Cohort 2a: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 2

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    End point title
    Cohort 2a: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 2 [96] [97]
    End point description
    Number of subjects with unsolicited AEs after booster vaccination 2 in Cohort 2a were 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. Unsolicited AEs were 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 analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    28 days after booster vaccination 2 on Day 366 (Day 394)
    Notes
    [96] - 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: Only descriptive data was planned to be reported for this endpoint.
    [97] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 COHORT 2A: Placebo, B: PL
    Number of subjects analysed
    19
    13
    10
    0 [98]
    Units: Subjects
    2
    1
    1
    Notes
    [98] - 0 subjects were available for the analysis as none received booster vaccination 2.
    No statistical analyses for this end point

    Primary: Cohort 2a: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination

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    End point title
    Cohort 2a: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination [99] [100]
    End point description
    Number of subjects with unsolicited AEs after ad hoc booster vaccination in Cohort 2a were 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. Unsolicited AEs were 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 analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    28 days after ad hoc booster vaccination
    Notes
    [99] - 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: Only descriptive data was planned to be reported for this endpoint.
    [100] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 COHORT 2A: Placebo, B: PL
    Number of subjects analysed
    4
    0 [101]
    0 [102]
    0 [103]
    Units: Subjects
    0
    Notes
    [101] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    [102] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    [103] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    No statistical analyses for this end point

    Primary: Cohort 2b: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen

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    End point title
    Cohort 2b: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen [104] [105]
    End point description
    Number of subjects with unsolicited AEs after vaccination 1 in Cohort 2b were 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. Unsolicited AEs were 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 analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    28 days after Vaccination 2 on Day 57 (Day 85)
    Notes
    [104] - 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: Only descriptive data was planned to be reported for this endpoint.
    [105] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10) COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 COHORT 2B: Placebo, B: PL
    Number of subjects analysed
    56
    29
    27
    14
    Units: Subjects
    7
    4
    3
    2
    No statistical analyses for this end point

    Primary: Cohort 2b: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 1

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    End point title
    Cohort 2b: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 1 [106] [107]
    End point description
    Number of subjects with unsolicited AEs 28 days after booster vaccination 1 in Cohort 2b were 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. Unsolicited AEs were 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 analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    28 days after booster vaccination 1 on Day 239 (Day 267)
    Notes
    [106] - 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: Only descriptive data was planned to be reported for this endpoint.
    [107] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10) COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 COHORT 2B: Placebo, B: PL
    Number of subjects analysed
    45
    21
    20
    0 [108]
    Units: Subjects
    1
    4
    2
    Notes
    [108] - 0 subjects were available for the analysis as none received booster vaccination 1.
    No statistical analyses for this end point

    Primary: Cohort 2b: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 2

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    End point title
    Cohort 2b: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 2 [109] [110]
    End point description
    Number of subjects with unsolicited AEs 28 days after booster 2 vaccination in Cohort 2b were 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. Unsolicited AEs were 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 analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    28 days after booster vaccination 2 on Day 422 (Day 450)
    Notes
    [109] - 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: Only descriptive data was planned to be reported for this endpoint.
    [110] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10) COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 COHORT 2B: Placebo, B: PL
    Number of subjects analysed
    8
    3
    5
    0 [111]
    Units: Subjects
    0
    0
    0
    Notes
    [111] - 0 subjects were available for the analysis as none received booster vaccination 2.
    No statistical analyses for this end point

    Primary: Cohort 2b: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination

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    End point title
    Cohort 2b: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination [112] [113]
    End point description
    Number of subjects with unsolicited AEs 28 days after ad hoc booster vaccination in Cohort 2b were 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. Unsolicited AEs were 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 analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    28 days after ad hoc booster vaccination on Day 604 (Day 632)
    Notes
    [112] - 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: Only descriptive data was planned to be reported for this endpoint.
    [113] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10) COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 COHORT 2B: Placebo, B: PL
    Number of subjects analysed
    7
    0 [114]
    0 [115]
    0 [116]
    Units: Subjects
    0
    Notes
    [114] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    [115] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    [116] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    No statistical analyses for this end point

    Primary: Cohort 3: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen

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    End point title
    Cohort 3: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen [117] [118]
    End point description
    Number of subjects with unsolicited AEs 28 days after vaccination 1 in Cohort 3 were 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. Unsolicited AEs were 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.
    End point type
    Primary
    End point timeframe
    28 days after vaccination 1 on Day 1 (Day 29)
    Notes
    [117] - 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: Only descriptive data was planned to be reported for this endpoint.
    [118] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 3: Placebo, Placebo
    Number of subjects analysed
    81
    80
    82
    79
    81
    Units: Subjects
    16
    13
    19
    26
    16
    No statistical analyses for this end point

    Primary: Cohort 3: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen

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    End point title
    Cohort 3: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen [119] [120]
    End point description
    Number of subjects with unsolicited AEs 28 days after vaccination 2 in Cohort 3 were 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. Unsolicited AEs were 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 analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    28 days after vaccination 2 on Day 57 (Day 85)
    Notes
    [119] - 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: Only descriptive data was planned to be reported for this endpoint.
    [120] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 3: Placebo, Placebo
    Number of subjects analysed
    77
    80
    80
    78
    79
    Units: Subjects
    11
    9
    12
    12
    9
    No statistical analyses for this end point

    Primary: Cohort 3: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination

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    End point title
    Cohort 3: Number of Subjects With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination [121] [122]
    End point description
    Number of subjects with unsolicited AEs 28 days after ad hoc booster vaccination in Cohort 3 were 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. Unsolicited AEs were 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 analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    28 days after ad hoc booster vaccination on Day 239 (Day 267)
    Notes
    [121] - 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: Only descriptive data was planned to be reported for this endpoint.
    [122] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 3: Placebo, Placebo
    Number of subjects analysed
    11
    15
    14
    9
    0 [123]
    Units: Subjects
    1
    0
    3
    1
    Notes
    [123] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
    No statistical analyses for this end point

    Primary: Cohorts 1a, 1b and Cohort 3: Number of Subjects With Serious Adverse Events (SAEs)

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    End point title
    Cohorts 1a, 1b and Cohort 3: Number of Subjects With Serious Adverse Events (SAEs) [124] [125]
    End point description
    An AE is 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. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. FAS included all subjects with at least one vaccine administration documented.
    End point type
    Primary
    End point timeframe
    Day 1 up to 2 years after Vaccination 2 on Day 57 (Day 787)
    Notes
    [124] - 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: Only descriptive data was planned to be reported for this endpoint.
    [125] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1A: Placebo, Placebo COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1B: Ad26 5e10, PL(,AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1B: Placebo, Placebo COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 3: Placebo, Placebo
    Number of subjects analysed
    77
    75
    75
    73
    77
    5
    5
    5
    5
    5
    81
    80
    82
    79
    81
    Units: Subjects
    0
    1
    1
    1
    2
    1
    0
    0
    0
    0
    3
    2
    2
    1
    2
    No statistical analyses for this end point

    Primary: Cohorts 2a and 2b: Number of Subjects With Serious Adverse Events (SAEs)

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    End point title
    Cohorts 2a and 2b: Number of Subjects With Serious Adverse Events (SAEs) [126] [127]
    End point description
    An AE is 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. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. FAS included all subjects with at least one vaccine administration documented.
    End point type
    Primary
    End point timeframe
    Day 1 up to 6 months (up to Day 183 for Cohort 2a; up to Day 239 for Cohort 2b)
    Notes
    [126] - 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: Only descriptive data was planned to be reported for this endpoint.
    [127] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 COHORT 2A: Placebo, B: PL COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10) COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 COHORT 2B: Placebo, B: PL
    Number of subjects analysed
    58
    29
    32
    17
    62
    30
    28
    15
    Units: Subjects
    0
    0
    1
    0
    0
    1
    0
    0
    No statistical analyses for this end point

    Primary: Cohorts 1a and 1b and Cohort 3: Number of Subjects With Adverse Events of Special Interest (AESIs)

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    End point title
    Cohorts 1a and 1b and Cohort 3: Number of Subjects With Adverse Events of Special Interest (AESIs) [128] [129]
    End point description
    Number of subjects with AESIs was reported. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/microliter. FAS included all subjects with at least one vaccine administration documented.
    End point type
    Primary
    End point timeframe
    Day 1 up to 2 years after Vaccination 2 on Day 57 (Day 787)
    Notes
    [128] - 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: Only descriptive data was planned to be reported for this endpoint.
    [129] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1A: Placebo, Placebo COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1B: Ad26 5e10, PL(,AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1B: Placebo, Placebo COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 3: Placebo, Placebo
    Number of subjects analysed
    77
    75
    75
    73
    77
    5
    5
    5
    5
    5
    81
    80
    82
    79
    81
    Units: Subjects
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Cohorts 2a and 2b: Number of Subjects With Adverse Events of Special Interest (AESIs)

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    End point title
    Cohorts 2a and 2b: Number of Subjects With Adverse Events of Special Interest (AESIs) [130] [131]
    End point description
    Number of subjects with AESIs was reported. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/microliter. FAS included all subjects with at least one vaccine administration documented.
    End point type
    Primary
    End point timeframe
    Day 1 up to 6 months (up to Day 183 for Cohort 2a; up to Day 239 for Cohort 2b)
    Notes
    [130] - 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: Only descriptive data was planned to be reported for this endpoint.
    [131] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 COHORT 2A: Placebo, B: PL COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10) COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 COHORT 2B: Placebo, B: PL
    Number of subjects analysed
    58
    29
    32
    17
    62
    30
    28
    15
    Units: Subjects
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Cohorts 1b: Percentage of Subjects With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)

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    End point title
    Cohorts 1b: Percentage of Subjects With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) [132]
    End point description
    Percentage of subjects with antibodies binding to SARS-CoV-2 S protein as measured by enzyme-linked immunosorbent assay (ELISA) was reported. Per protocol immunogenicity (PPI) population included all randomized and vaccinated subjects for whom immunogenicity data were available excluding subjects with major protocol deviations expecting to impact the immunogenicity outcomes. Here N (number of subjects analysed) signifies subjects evaluable for this endpoint. Here 'n' (number analysed) signifies number of subjects evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Days 29 and 71
    Notes
    [132] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1B: Ad26 5e10, PL(,AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1B: Placebo, Placebo
    Number of subjects analysed
    5
    5
    5
    5
    4
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 29
    80.0 (28.4 to 99.5)
    100.0 (47.8 to 100.0)
    100.0 (47.8 to 100.0)
    100.0 (47.8 to 100.0)
    0.0 (0.0 to 60.2)
        Day 71
    100.0 (39.8 to 100.0)
    100.0 (47.8 to 100.0)
    100.0 (47.8 to 100.0)
    100.0 (47.8 to 100.0)
    0.0 (0.0 to 60.2)
    No statistical analyses for this end point

    Secondary: Cohort 3: Percentage of Subjects With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)

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    End point title
    Cohort 3: Percentage of Subjects With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) [133]
    End point description
    Percentage of subjects with antibodies binding to SARS-CoV-2 S protein as measured by enzyme-linked immunosorbent assay (ELISA) was reported. FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluated for this endpoint. Here 'n' (number analysed) signifies number of subjects evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Days 15, 29, 87, 100, 114 and 268
    Notes
    [133] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 3: Placebo, Placebo
    Number of subjects analysed
    72
    73
    74
    75
    75
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 15 (n =59, 58, 55, 62, 61)
    78.0 (65.3 to 87.7)
    72.4 (59.1 to 83.3)
    79.6 (66.5 to 89.4)
    77.4 (65.0 to 87.1)
    1.6 (0.0 to 8.8)
        Day 29 (n =72, 73, 74, 75, 75)
    95.8 (88.3 to 99.1)
    97.2 (90.3 to 99.7)
    95.8 (88.3 to 99.1)
    97.3 (90.7 to 99.7)
    0.0 (0.0 to 4.9)
        Day 87 (n =67, 67, 66, 71, 69)
    97.0 (89.6 to 99.6)
    97.0 (89.5 to 99.6)
    96.9 (89.2 to 99.6)
    98.6 (92.4 to 100.0)
    1.5 (0.0 to 7.9)
        Day 100 (n =64, 69, 66, 70, 68)
    98.4 (91.6 to 100.0)
    97.1 (89.8 to 99.6)
    98.4 (91.6 to 100.0)
    98.6 (92.3 to 100.0)
    0.0 (0.0 to 5.4)
        Day 114 (n =66, 68, 66, 71, 69)
    98.5 (91.8 to 100.0)
    97.0 (89.6 to 99.6)
    98.4 (91.6 to 100.0)
    98.6 (92.4 to 100.0)
    1.5 (0.0 to 7.9)
        Day 268 (n =60, 56, 55, 57,6)
    98.3 (91.1 to 100.0)
    85.5 (73.3 to 93.5)
    100.0 (93.3 to 100.0)
    87.7 (76.3 to 94.9)
    16.7 (0.4 to 64.1)
    No statistical analyses for this end point

    Secondary: Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus Neutralizing Assay (VNA)

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    End point title
    Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus Neutralizing Assay (VNA) [134]
    End point description
    GMTs of SARS-CoV-2 neutralizing antibodies to the Wild-type VNA were reported. PPI population included all randomized and vaccinated subjects for whom immunogenicity data were available excluding subjects with major protocol deviations expecting to impact the immunogenicity outcomes. Here N (number of subjects analysed) signifies subjects evaluated for this endpoint. Here 'n' (number analysed) signifies number of subjects evaluable at specified time points. Here 'n' (number analysed) signifies number of subjects evaluable at specified time points. Here, "99999" signifies data could not be estimated as the value was below the LLOQ (58) and "9999" signifies that data could not be estimated as no subjects were available for the analysis. Due to the change in planned analysis, data was not collected and analysed for Cohort 1b and thus no data was reported for this endpoint.
    End point type
    Secondary
    End point timeframe
    Days 29, 57, 71, 85, 239, 422
    Notes
    [134] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1A: Placebo, Placebo
    Number of subjects analysed
    22
    24
    24
    23
    25
    Units: Titers
    geometric mean (confidence interval 95%)
        Day 29 (n =22, 24 24, 23, 25)
    233 (170 to 319)
    224 (158 to 319)
    333 (206 to 537)
    219 (170 to 282)
    99999 (99999 to 99999)
        Day 57 (n =22, 24, 22, 21, 23)
    310 (232 to 414)
    284 (220 to 367)
    458 (309 to 677)
    392 (273 to 563)
    99999 (99999 to 99999)
        Day 71 (n =21, 23, 23, 20, 22)
    862 (666 to 1115)
    294 (229 to 378)
    1189 (845 to 1672)
    414 (310 to 553)
    99999 (99999 to 99999)
        Day 85 (n =21, 23, 23, 20, 22)
    919 (727 to 1161)
    317 (217 to 463)
    1127 (801 to 1587)
    422 (305 to 584)
    99999 (99999 to 99999)
        Day 239 (n =21, 21, 20, 20 ,19)
    465 (338 to 641)
    215 (146 to 317)
    771 (514 to 1154)
    408 (232 to 716)
    99999 (99999 to 99999)
        Day 422 (n =17, 19, 19, 18, 0)
    328 (202 to 531)
    235 (132 to 418)
    425 (294 to 613)
    307 (205 to 460)
    9999 (9999 to 9999)
    No statistical analyses for this end point

    Secondary: Cohort 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus Neutralizing Assay (VNA)

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    End point title
    Cohort 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus Neutralizing Assay (VNA) [135]
    End point description
    GMTs of SARS-CoV-2 neutralizing antibodies to the Wild-type VNA were reported. PPI population was analyzed. Here N (number of subjects analysed) =subjects evaluated for this endpoint. 'n' (number analysed) =number of subjects evaluable at specified time points. 99999 signifies data could not be estimated as the value was below the LLOQ (58). Here, "99" and "9999" signifies that lower and upper limit of 95% CI could not be estimated because only one subject was analysed. Here, "88888" signifies that data could not be estimated as the data was greater than upper limit of quantification. "9999" signifies that data could not be estimated as no subjects were available for the analysis. Due to the change in planned analysis, data was not collected and analysed for Cohort 2b and thus no data was reported for this endpoint.
    End point type
    Secondary
    End point timeframe
    Days 29, 183, 190, 211, 366, 373 and 394
    Notes
    [135] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 COHORT 2A: Placebo, B: PL
    Number of subjects analysed
    51
    23
    26
    15
    Units: Titers
    geometric mean (confidence interval 95%)
        Day 29 (n =51, 23, 26, 15)
    311 (235 to 411)
    326 (258 to 411)
    369 (251 to 542)
    99999 (99999 to 99999)
        Day 183 (n =34, 18, 15, 1)
    241 (179 to 324)
    379 (214 to 672)
    172 (107 to 277)
    833 (99 to 9999)
        Day 190 (n =32, 16, 13, 1)
    208 (149 to 290)
    1576 (976 to 2544)
    162 (88 to 301)
    961 (99 to 9999)
        Day 211 (n =28, 14, 14, 1)
    216 (150 to 311)
    2035 (1202 to 3446)
    157 (96 to 256)
    486 (99 to 9999)
        Day 366 (n =21, 13, 6, 0)
    224 (131 to 383)
    1137 (661 to 1955)
    124 (60 to 258)
    9999 (9999 to 9999)
        Day 373 (n =17, 11, 4, 0)
    245 (138 to 435)
    1248 (566 to 2753)
    973 (240 to 3954)
    9999 (9999 to 9999)
        Day 394 (n =13, 11, 3, 0)
    297 (152 to 581)
    1387 (612 to 3143)
    3061 (141 to 88888)
    9999 (9999 to 9999)
    No statistical analyses for this end point

    Secondary: Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus Neutralizing Assay (VNA)

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    End point title
    Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus Neutralizing Assay (VNA) [136]
    End point description
    GMTs of SARS-CoV-2 neutralizing antibodies to the Wild-type VNA were reported. FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluated for this endpoint. Here 'n' (number analysed) signifies number of subjects evaluable at specified time points. Here 'n' (number analysed) signifies number of subjects evaluable at specified time points. Here, 99999 signifies data could not be estimated as the value was below the LLOQ (58). Here, "9999" signifies that data could not be estimated as no subjects were available for the analysis.
    End point type
    Secondary
    End point timeframe
    Days 15, 29, 87, 100, 114 and 268
    Notes
    [136] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 3: Placebo, Placebo
    Number of subjects analysed
    23
    24
    25
    23
    22
    Units: Titers
    geometric mean (confidence interval 95%)
        Day 15 (n =11,10,14,10,10)
    190 (100 to 360)
    153 (90 to 261)
    209 (121 to 361)
    140 (70 to 280)
    99999 (99999 to 99999)
        Day 29 (n =23, 24, 25, 23, 22)
    267 (183 to 389)
    229 (152 to 346)
    261 (168 to 406)
    174 (131 to 233)
    99999 (99999 to 99999)
        Day 87 (19, 21, 22, 20, 19)
    224 (134 to 375)
    165 (114 to 238)
    245 (174 to 346)
    198 (126 to 309)
    99999 (99999 to 99999)
        Day 100 (n =19, 22, 22, 19, 19)
    878 (521 to 1478)
    168 (106 to 266)
    574 (367 to 897)
    178 (97 to 329)
    99999 (99999 to 99999)
        Day 114 (n =19, 22, 22, 19, 19)
    954 (551 to 1652)
    164 (98 to 273)
    895 (498 to 1609)
    158 (78 to 319)
    99999 (99999 to 99999)
        Day 268 (n =0, 19, 0, 0, 0)
    9999 (9999 to 9999)
    114 (65 to 201)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    9999 (9999 to 9999)
    No statistical analyses for this end point

    Secondary: Cohort 1a: Percentage of Subjects With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon (IFN)g+ or Interleukin 2+ (IL2+) not Helper cell type 2 (TH2)

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    End point title
    Cohort 1a: Percentage of Subjects With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon (IFN)g+ or Interleukin 2+ (IL2+) not Helper cell type 2 (TH2) [137]
    End point description
    Percentage of subjects with SARS-Cov2 S Specific CD4+ T-cell Responses for IFNg+ or IL2+ not Helper cell type 2 (TH2) was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. PPI population included all randomized and vaccinated subjects for whom immunogenicity data were available excluding subjects with major protocol deviations expecting to impact the immunogenicity outcomes. Here N (number of subjects analysed) signifies subjects evaluated for this endpoint. Here 'n' (number analysed) signifies number of subjects evaluable at specified time points. Due to the change in planned analysis, data was not collected and analysed for Cohort 1b and thus no data was reported for this endpoint. "99999" signifies that data could not be estimated as no subjects were available for the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 15, 29, 57, 71, 85, 239 and 422
    Notes
    [137] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1A: Placebo, Placebo
    Number of subjects analysed
    37
    39
    35
    35
    39
    Units: Percentage of subjects
    number (confidence interval 95%)
        Baseline (n=37, 39, 35, 35, 39)
    8 (2 to 22)
    8 (2 to 21)
    0 (0 to 10)
    3 (0 to 15)
    0 (0 to 9)
        Day 15 (n =37, 38, 36, 34, 39)
    76 (59 to 88)
    76 (60 to 89)
    83 (67 to 94)
    82 (65 to 93)
    8 (2 to 21)
        Day 29 (n =37, 37, 36, 32, 37)
    73 (56 to 86)
    70 (53 to 84)
    78 (61 to 90)
    72 (53 to 86)
    19 (8 to 35)
        Day 57 (n =36, 36, 35, 30, 33)
    75 (58 to 88)
    53 (35 to 70)
    77 (60 to 90)
    63 (44 to 80)
    12 (3 to 28)
        Day 71 (n =35, 36, 34, 28, 32)
    63 (45 to 79)
    47 (30 to 65)
    91 (76 to 98)
    61 (41 to 79)
    16 (5 to 33)
        Day 85 (n =37, 35, 33, 29, 34)
    68 (50 to 82)
    46 (29 to 63)
    85 (68 to 95)
    59 (39 to 76)
    12 (3 to 27)
        Day 239 (n =34, 34, 12, 13, 0)
    47 (30 to 65)
    47 (30 to 65)
    75 (43 to 95)
    38 (14 to 68)
    99999 (99999 to 99999)
        Day 422 (n =22, 23, 13, 11, 0)
    27 (11 to 50)
    43 (23 to 66)
    54 (25 to 81)
    36 (11 to 69)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Cohort 1a: Percentage of Subjects With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ or IL5+ or IL13+ and CD40L+

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    End point title
    Cohort 1a: Percentage of Subjects With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ or IL5+ or IL13+ and CD40L+ [138]
    End point description
    Percentage of subjects with SARS-Cov2 S Specific CD4+ T-cell responses for IL4+ or IL5+ or IL13+ and CD40L+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. PPI population included all randomized and vaccinated subjects for whom immunogenicity data were available excluding subjects with major protocol deviations expecting to impact the immunogenicity outcomes. Here N (number of subjects analysed) signifies subjects evaluated for this endpoint. Here 'n' (number analysed) signifies number of subjects evaluable at specified time points. Due to the change in planned analysis, data was not collected and analysed for Cohort 1b and thus no data was reported for this endpoint. "99999" signifies that data could not be estimated as no subjects were available for the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 15, 29, 57, 71, 85, 239 and 422
    Notes
    [138] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1A: Placebo, Placebo
    Number of subjects analysed
    37
    39
    36
    39
    39
    Units: Percentage of Subjects
    number (confidence interval 95%)
        Baseline (n =37, 39, 35, 39, 39)
    0 (0 to 9)
    0 (0 to 9)
    0 (0 to 10)
    0 (0 to 10)
    0 (0 to 9)
        Day 15 (n =37, 38, 36, 34, 39)
    0 (0 to 9)
    3 (0 to 14)
    0 (0 to 10)
    0 (0 to 10)
    0 (0 to 9)
        Day 29 (n =37, 37, 36, 32, 37)
    0 (0 to 9)
    0 (0 to 9)
    0 (0 to 10)
    0 (0 to 11)
    0 (0 to 9)
        Day 57 (n =36, 36, 35, 33, 30)
    0 (0 to 10)
    0 (0 to 10)
    0 (0 to 10)
    0 (0 to 12)
    6 (1 to 20)
        Day 71 (n =35, 36, 34, 28, 32)
    0 (0 to 10)
    0 (0 to 10)
    0 (0 to 10)
    4 (0 to 18)
    0 (0 to 11)
        Day 85 (n =37, 35, 33, 29, 34)
    0 (0 to 9)
    0 (0 to 10)
    0 (0 to 11)
    0 (0 to 12)
    0 (0 to 10)
        Day 239 (n =34, 34, 12, 13, 0)
    3 (0 to 15)
    6 (1 to 20)
    17 (2 to 48)
    0 (0 to 25)
    99999 (99999 to 99999)
        Day 422 (n =22, 23, 13, 11, 0)
    5 (0 to 23)
    4 (0 to 22)
    0 (0 to 25)
    9 (0 to 41)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Cohort 1a: Percentage of Subjects With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)

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    End point title
    Cohort 1a: Percentage of Subjects With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) [139]
    End point description
    Percentage of subjects with antibodies binding to SARS-CoV-2 S protein as measured by enzyme-linked immunosorbent assay (ELISA) was reported. Per protocol immunogenicity (PPI) population included all randomized and vaccinated subjects for whom immunogenicity data were available excluding subjects with major protocol deviations expecting to impact the immunogenicity outcomes. Here N (number of subjects analysed) signifies subjects evaluated for this endpoint. Here 'n' (number analysed) signifies number of subjects evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Days 29, 57, 71, 85, 239 and 422
    Notes
    [139] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1A: Placebo, Placebo
    Number of subjects analysed
    64
    63
    67
    64
    70
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 29 (n=64, 63, 67, 64, 70)
    98.4 (91.5 to 100.0)
    98.4 (91.5 to 100.0)
    100.0 (94.6 to 100.0)
    98.4 (91.6 to 100.0)
    1.4 (0.0 to 7.7)
        Day 57 (n=65, 64, 66, 61, 66)
    100.0 (94.4 to 100.0)
    98.4 (91.6 to 100.0)
    100.0 (94.6 to 100.0)
    96.7 (88.7 to 99.6)
    1.5 (0.0 to 8.2)
        Day 71 (n=62, 59, 64, 56, 61)
    100.0 (94.1 to 100.0)
    100.0 (93.9 to 100.0)
    100.0 (94.4 to 100.0)
    96.4 (87.7 to 99.6)
    1.6 (0.0 to 8.8)
        Day 85 (n =64, 61, 63, 58, 64 )
    100.0 (94.3 to 100.0)
    98.4 (91.2 to 100.0)
    100.0 (94.3 to 100.0)
    96.6 (88.1 to 99.6)
    4.7 (1.0 to 13.1)
        Day 239 (n =61, 59, 56, 52, 49)
    100.0 (94.0 to 100.0)
    98.3 (90.9 to 100.0)
    100.0 (93.6 to 100.0)
    94.2 (84.1 to 98.8)
    2.0 (0.1 to 10.9)
        Day 422 (n =44, 50, 46, 42, 6)
    100.0 (91.8 to 100.0)
    92.0 (80.8 to 97.8)
    100.0 (92.3 to 100.0)
    100.0 (91.6 to 100.0)
    66.7 (22.3 to 95.7)
    No statistical analyses for this end point

    Secondary: Cohorts 2a: Percentage of Subjects With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon (IFN)g+ or Interleukin 2+ (IL2+) not Helper cell type 2 (TH2)

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    End point title
    Cohorts 2a: Percentage of Subjects With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon (IFN)g+ or Interleukin 2+ (IL2+) not Helper cell type 2 (TH2) [140]
    End point description
    Percentage of subjects with SARS-Cov2 S Specific CD4+ T-cell Responses for IFNg+ or IL2+ not Helper cell type 2 (TH2) was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. PPI population included all randomized and vaccinated subjects for whom immunogenicity data were available excluding subjects with major protocol deviations expecting to impact the immunogenicity outcomes. Here N (number of subjects analysed) signifies subjects evaluated for this endpoint. Here 'n' (number analysed) signifies number of subjects evaluable at specified time points. Here, "99999" signifies that data could not be estimated as no subjects were available for the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 29 and 366
    Notes
    [140] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 COHORT 2A: Placebo, B: PL
    Number of subjects analysed
    11
    5
    5
    3
    Units: Percentage of subjects
    number (confidence interval 95%)
        Baseline (n= 11, 5, 5, 3)
    9 (0 to 41)
    20 (1 to 72)
    0 (0 to 52)
    33 (1 to 91)
        Day 29 (n =11, 5, 5, 3)
    82 (48 to 98)
    100 (48 to 100.0)
    80 (28 to 99)
    0 (0 to 71)
        Day 366 (n =9, 5, 3, 0)
    11 (0 to 48)
    20 (1 to 72)
    0 (0 to 71)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Cohorts 2a: Percentage of Subjects With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)

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    End point title
    Cohorts 2a: Percentage of Subjects With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) [141]
    End point description
    Percentage of subjects with antibodies binding to SARS-CoV-2 S protein 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 expecting to impact the immunogenicity outcomes. Here N (number of subjects analysed) signifies subjects evaluated for this endpoint. Here 'n' (number analysed) signifies number of subjects evaluable at specified time points. Here, 99999 signifies data could not be estimated and reported as no subjects were analysed.
    End point type
    Secondary
    End point timeframe
    Days 8, 29, 183, 190, 211, 366, 373 and 394
    Notes
    [141] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 COHORT 2A: Placebo, B: PL
    Number of subjects analysed
    51
    23
    26
    15
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 8 (n= 50, 23, 26, 15)
    6.0 (1.3 to 16.5)
    0.0 (0.0 to 14.8)
    0.0 (0.0 to 13.2)
    0.0 (0.0 to 21.8)
        Day 29 (n= 51, 23, 26, 15)
    98.0 (89.4 to 99.9)
    100.0 (85.2 to 100.0)
    100.0 (86.8 to 100.0)
    6.7 (0.2 to 31.9)
        Day 183 (n =34, 18, 15, 1)
    97.0 (84.2 to 99.9)
    100.0 (81.5 to 100.0)
    86.7 (59.5 to 98.3)
    100.0 (2.5 to 100.0)
        Day 190 (n =32, 16, 13, 1)
    96.8 (83.3 to 99.9)
    100.0 (79.4 to 100.0)
    92.3 (64.0 to 99.8)
    100.0 (2.5 to 100.0)
        Day 211 (n =28, 14, 14, 1)
    100.0 (87.2 to 100.0)
    100.0 (76.8 to 100.0)
    85.7 (57.2 to 98.2)
    100.0 (2.5 to 100.0)
        Day 366 (n= 21, 13, 6, 0)
    95.2 (76.2 to 99.9)
    100.0 (75.3 to 100.0)
    83.3 (35.9 to 99.6)
    99999 (99999 to 99999)
        Day 373 (n =17, 11, 4, 0)
    94.1 (71.3 to 99.9)
    100.0 (71.5 to 100.0)
    100.0 (39.8 to 100.0)
    99999 (99999 to 99999)
        Day 394 (n =13, 11, 3, 0)
    92.3 (64.0 to 99.8)
    100.0 (71.5 to 100.0)
    100.0 (29.2 to 100.0)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Cohort 2b: Percentage of Subjects With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ or IL5+ or IL13+ and CD40L+

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    End point title
    Cohort 2b: Percentage of Subjects With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ or IL5+ or IL13+ and CD40L+ [142]
    End point description
    Percentage of subjects with SARS-Cov2 S Specific CD4+ T-cell responses for IL4+ or IL5+ or IL13+ and CD40L+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. PPI population included all randomized and vaccinated subjects for whom immunogenicity data were available excluding subjects with major protocol deviations expecting to impact the immunogenicity outcomes. Here N (number of subjects analysed) signifies subjects evaluated for this endpoint. Here 'n' (number analysed) signifies number of subjects evaluable at specified time points. Here, "99999" signifies that data could not be estimated as no subjects were available for the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 29, 57, 85 and 422
    Notes
    [142] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10) COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 COHORT 2B: Placebo, B: PL
    Number of subjects analysed
    12
    5
    6
    2
    Units: Percentage of subjects
    number (confidence interval 95%)
        Baseline (n =12, 5, 6, 2)
    0 (0 to 26)
    0 (0 to 52)
    0 (0 to 46)
    0 (0 to 84)
        Day 29 (n =11, 5, 6, 2)
    0 (0 to 28)
    0 (0 to 52)
    0 (0 to 46)
    0 (0 to 84)
        Day 57 (n =12, 5, 5, 2)
    0 (0 to 26)
    0 (0 to 52)
    0 (0 to 52)
    0 (0 to 84)
        Day 85 (n =10, 5, 6, 2)
    0 (0 to 31)
    0 (0 to 52)
    0 (0 to 46)
    0 (0 to 84)
        Day 422 (n =1,1, 1, 0)
    0 (0 to 98)
    0 (0 to 98)
    0 (0 to 98)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Cohorts 2b: Percentage of Subjects With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA)

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    End point title
    Cohorts 2b: Percentage of Subjects With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) [143]
    End point description
    Percentage of subjects with antibodies binding to SARS-CoV-2 S protein 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 expecting to impact the immunogenicity outcomes. Here N (number of subjects analysed) signifies subjects evaluated for this endpoint. Here 'n' (number analysed) signifies number of subjects evaluable at specified time points. Here, 99999 signifies data could not be estimated and reported as no subjects were analysed.
    End point type
    Secondary
    End point timeframe
    Days 8, 29, 57, 64, 85, 239, 246, 267 and 422
    Notes
    [143] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10) COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 COHORT 2B: Placebo, B: PL
    Number of subjects analysed
    51
    28
    24
    12
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 8 (n =51, 26, 23, 12)
    0.0 (0.0 to 7.0)
    3.8 (0.1 to 19.6)
    4.5 (0.1 to 22.8)
    0.0 (0.0 to 26.5)
        Day 29 (n =49, 28, 24, 12)
    95.9 (86.0 to 99.5)
    96.4 (81.7 to 99.9)
    100.0 (84.6 to 100.0)
    0.0 (0.0 to 26.5)
        Day 57 (n =49, 26, 24, 12)
    95.8 (85.7 to 99.5)
    100.0 (86.8 to 100.0)
    100.0 (84.6 to 100.0)
    0.0 (0.0 to 26.5)
        Day 64 (n =46, 24, 23, 11)
    100.0 (92.1 to 100.0)
    100.0 (85.8 to 100.0)
    100.0 (83.9 to 100.0)
    0.0 (0.0 to 28.5)
        Day 85 (n =46, 26, 21, 11)
    97.8 (88.2 to 99.9)
    100.0 (86.8 to 100.0)
    100.0 (82.4 to 100.0)
    0.0 (0.0 to 28.5)
        Day 239 (n =40, 22, 20, 0)
    97.4 (86.5 to 99.9)
    95.5 (77.2 to 99.9)
    94.4 (72.7 to 99.9)
    99999 (99999 to 99999)
        Day 246 (n =38, 15, 17, 0)
    97.4 (86.2 to 99.9)
    100.0 (78.2 to 100.0)
    93.8 (69.8 to 99.8)
    99999 (99999 to 99999)
        Day 267 (n =37, 18, 18, 0)
    97.2 (85.5 to 99.9)
    100.0 (81.5 to 100.0)
    93.8 (69.8 to 99.8)
    99999 (99999 to 99999)
        Day 422 (n =5, 3, 4, 0)
    100.0 (47.8 to 100.0)
    100.0 (29.2 to 100.0)
    100.0 (29.2 to 100.0)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Cohort 1a: Percentage of Subjects With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+

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    End point title
    Cohort 1a: Percentage of Subjects With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ [144]
    End point description
    Percentage of subjects with SARS-Cov2 S Specific CD8+ T-cell Responses for IFNg+ or IL2+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. PPI population included all randomized and vaccinated subjects for whom immunogenicity data were available excluding subjects with major protocol deviations expecting to impact the immunogenicity outcomes. Here N (number of subjects analysed) signifies subjects evaluated for this endpoint. Here 'n' (number analysed) signifies number of subjects evaluable at specified time points. Here, "99999" signifies that data could not be estimated as no subjects were available for the analysis. Due to the change in planned analysis, data was not collected and analysed for Cohort 1b and thus no data was reported for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 15, 29, 57, 71, 85, 239 and 422
    Notes
    [144] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1A: Placebo, Placebo
    Number of subjects analysed
    37
    39
    36
    35
    39
    Units: Percentage of subjects
    number (confidence interval 95%)
        Baseline (n =37, 39, 35, 35, 39)
    0 (0 to 9)
    3 (0 to 13)
    0 (0 to 10)
    3 (0 to 15)
    5 (1 to 17)
        Day 15 (n =37, 38, 36, 34, 39)
    54 (37 to 71)
    45 (29 to 62)
    56 (38 to 72)
    71 (53 to 85)
    8 (2 to 21)
        Day 29 (n =37, 37, 36, 32, 37)
    68 (50 to 82)
    59 (42 to 75)
    81 (64 to 92)
    75 (57 to 89)
    3 (0 to 14)
        Day 57 (n =36, 36, 35, 30 33)
    72 (55 to 86)
    81 (64 to 92)
    89 (73 to 97)
    83 (65 to 94)
    6 (1 to 20)
        Day 71 (n =34, 36, 35, 28, 32)
    68 (49 to 83)
    72 (55 to 86)
    86 (70 to 95)
    79 (59 to 92)
    9 (2 to 25)
        Day 85 (n =37, 35, 33, 29, 34)
    73 (56 to 86)
    69 (51 to 83)
    88 (72 to 97)
    83 (64 to 94)
    9 (2 to 24)
        Day 239 (n =34, 34, 12, 13, 0)
    62 (44 to 78)
    62 (44 to 78)
    92 (62 to 100)
    85 (55 to 98)
    99999 (99999 to 99999)
        Day 422 (n =23, 23, 13, 11, 0)
    52 (31 to 73)
    57 (34 to 77)
    77 (46 to 95)
    82 (48 to 98)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Cohort 2a: Percentage of Subjects With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+

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    End point title
    Cohort 2a: Percentage of Subjects With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ [145]
    End point description
    Percentage of subjects with SARS-Cov2 S Specific CD8+ T-cell Responses for IFNg+ or IL2+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. PPI population included all randomized and vaccinated subjects for whom immunogenicity data were available excluding subjects with major protocol deviations expecting to impact the immunogenicity outcomes. Here N (number of subjects analysed) signifies subjects evaluated for this endpoint. Here 'n' (number analysed) signifies number of subjects evaluable at specified time points. Here, "99999" signifies that data could not be estimated as no subjects were available for the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 29 and 366
    Notes
    [145] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 COHORT 2A: Placebo, B: PL
    Number of subjects analysed
    11
    5
    5
    3
    Units: Percentage of subjects
    number (confidence interval 95%)
        Baseline (n =11, 5, 5, 3)
    0 (0 to 28)
    0 (0 to 52)
    0 (0 to 52)
    0 (0 to 71)
        Day 29 (n =11,5, 5, 3)
    91 (59 to 100)
    100 (48 to 100)
    100 (48 to 100)
    0 (0 to 71)
        Day 366 (n =9, 4, 3, 0)
    78 (40 to 97)
    75 (19 to 99)
    100 (29 to 100)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Cohort 3: Percentage of Subjects With SARS-Cov2 S Specific CD4+ T-cell Responses: IFN g+ or IL2+ not Helper cell type 2 (TH2)

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    End point title
    Cohort 3: Percentage of Subjects With SARS-Cov2 S Specific CD4+ T-cell Responses: IFN g+ or IL2+ not Helper cell type 2 (TH2) [146]
    End point description
    Percentage of subjects with SARS-Cov2 S Specific CD4+ T-cell Responses for IFNg+ or IL2+ not Helper cell type 2 (TH2) was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluated for this endpoint. Here 'n' (number analysed) signifies number of subjects evaluable at specified time points. Here, "99999" signifies that data could not be estimated as no subjects were available for the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 15, 29, 87, 100, 114 and 268
    Notes
    [146] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 3: Placebo, Placebo
    Number of subjects analysed
    37
    35
    33
    40
    35
    Units: Percentage of subjects
    number (confidence interval 95%)
        Baseline (n =37, 35, 33, 40, 35)
    0 (0 to 9)
    0 (0 to 10)
    3 (0 to 16)
    0 (0 to 9)
    6 (1 to 19)
        Day 15 (n =38, 35, 33, 39, 35)
    61 (43 to 76)
    63 (45 to 79)
    67 (48 to 82)
    62 (45 to 77)
    6 (1 to 19)
        Day 29 (n =38, 36, 34, 41, 35)
    66 (49 to 80)
    69 (52 to 84)
    68 (49 to 83)
    76 (60 to 88)
    14 (5 to 30)
        Day 87 (n =31, 27, 23, 33, 26)
    42 (25 to 61)
    48 (29 to 68)
    39 (20 to 61)
    52 (34 to 69)
    4 (0 to 20)
        Day 100 (n =33, 33, 27, 36, 30)
    61 (42 to 77)
    61 (42 to 77)
    78 (58 to 91)
    58 (41 to 74)
    3 (0 to 17)
        Day 114 (n =34, 32, 29, 36, 29)
    71 (53 to 85)
    69 (50 to 84)
    69 (49 to 85)
    44 (28 to 62)
    17 (6 to 36)
        Day 268 (n =29, 26, 10, 14, 0)
    59 (39 to 76)
    73 (52 to 88)
    40 (12 to 74)
    57 (29 to 82)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Cohorts 3: Percentage of Subjects With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ or IL5+ or IL13+ and CD40L+

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    End point title
    Cohorts 3: Percentage of Subjects With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ or IL5+ or IL13+ and CD40L+ [147]
    End point description
    Percentage of subjects with SARS-Cov2 S Specific CD4+ T-cell responses for IL4+ or IL5+ or IL13+ and CD40L+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluated for this endpoint. Here 'n' (number analysed) signifies number of subjects evaluable at specified time points. Here, "99999" signifies that data could not be estimated as no subjects were available for the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 15, 29, 87, 100, 114 and 268
    Notes
    [147] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 3: Placebo, Placebo
    Number of subjects analysed
    37
    35
    33
    40
    35
    Units: Percentage of subjects
    number (confidence interval 95%)
        Baseline (n =37, 35, 33, 40, 35)
    0 (0 to 9)
    0 (0 to 10)
    0 (0 to 11)
    0 (0 to 9)
    0 (0 to 10)
        Day 15 (n =38, 35, 33, 39, 35)
    0 (0 to 9)
    0 (0 to 10)
    3 (0 to 16)
    0 (0 to 9)
    0 (0 to 10)
        Day 29 (n =38, 36, 34, 41, 35)
    0 (0 to 9)
    0 (0 to 10)
    0 (0 to 10)
    0 (0 to 9)
    0 (0 to 10)
        Day 87 (n =31, 27, 23, 33, 26)
    0 (0 to 11)
    0 (0 to 13)
    4 (0 to 22)
    0 (0 to 11)
    0 (0 to 13)
        Day 100 (n =33, 33, 27, 36, 30)
    6 (1 to 20)
    0 (0 to 11)
    0 (0 to 13)
    0 (0 to 10)
    0 (0 to 12)
        Day 114 (n =34, 32, 29, 36, 29)
    0 (0 to 10)
    0 (0 to 11)
    0 (0 to 12)
    0 (0 to 10)
    0 (0 to 12)
        Day 268 (n =29, 26, 10, 14, 0)
    7 (1 to 23)
    8 (1 to 25)
    20 (3 to 56)
    7 (0 to 34)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Cohort 3: Percentage of Subjects With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+

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    End point title
    Cohort 3: Percentage of Subjects With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ [148]
    End point description
    Percentage of subjects with SARS-Cov2 S Specific CD8+ T-cell Responses for IFNg+ or IL2+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluated for this endpoint. Here 'n' (number analysed) signifies number of subjects evaluable at specified time points. Here, "99999" signifies that data could not be estimated as no subjects were available for the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 15, 29, 87, 100, 114 and 268
    Notes
    [148] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 3: Placebo, Placebo
    Number of subjects analysed
    36
    35
    33
    39
    33
    Units: Percentage of subjets
    number (confidence interval 95%)
        Baseline (n =36, 34, 31, 39, 31)
    3 (0 to 15)
    0 (0 to 10)
    6 (1 to 21)
    0 (0 to 9)
    0 (0 to 11)
        Day 15 (n =34, 35, 31, 38, 33)
    35 (20 to 54)
    23 (10 to 40)
    26 (12 to 45)
    26 (13 to 43)
    3 (0 to 16)
        Day 29 (n =36, 35, 33, 39, 33)
    58 (41 to 74)
    51 (34 to 69)
    52 (34 to 69)
    64 (47 to 79)
    0 (0 to 11)
        Day 87 (n =29, 26, 22, 31, 23)
    59 (39 to 76)
    58 (37 to 77)
    45 (24 to 68)
    71 (52 to 86)
    0 (0 to 15)
        Day 100 (n =31, 33, 26, 36, 27)
    65 (45 to 81)
    52 (34 to 69)
    65 (44 to 83)
    67 (49 to 81)
    0 (0 to 13)
        Day 114 (n =32, 32, 26, 34, 26)
    75 (57 to 89)
    47 (29 to 65)
    62 (41 to 80)
    68 (49 to 83)
    0 (0 to 13)
        Day 268 (n =28, 26, 9, 14, 0)
    57 (37 to 76)
    50 (30 to 70)
    78 (40 to 97)
    71 (42 to 92)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Cohort 2b: Percentage of Subjects With T helper cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1

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    End point title
    Cohort 2b: Percentage of Subjects With T helper cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 [149]
    End point description
    Percentage of subjects with Th1 (IFN-g OR IL2 NOT TH2) /Th2 (IL4 OR IL5 OR IL13 AND CD40L) ratio >=1 and <1 was reported. PPI population included all randomized and vaccinated subjects for whom immunogenicity data were available excluding subjects with major protocol deviations expecting to impact the immunogenicity outcomes. Here N (number of subjects analysed) signifies subjects evaluated for this endpoint. Here 'n' (number analysed) signifies number of subjects evaluable at specified time points. Here, 99999 signifies data could not be estimated and reported as no subjects were analysed.
    End point type
    Secondary
    End point timeframe
    Days 29, 57, 85 and 422
    Notes
    [149] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10) COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 COHORT 2B: Placebo, B: PL
    Number of subjects analysed
    9
    4
    3
    0 [150]
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 29: Th1/Th2 >=1 (n =9, 2, 3, 0)
    100 (66 to 100)
    100 (16 to 100)
    100 (29 to 100)
    ( to )
        Day 29: Th1/Th2 <1 (n =9, 2, 3, 0)
    0 (0 to 34)
    0 (0 to 84)
    0 (0 to 71)
    ( to )
        Day 57: Th1/Th2 >=1 (n =9, 4, 1, 0)
    100 (66 to 100)
    100 (40 to 100)
    100 (3 to 100)
    ( to )
        Day 57: Th1/Th2 <1 (n =9, 4, 1, 0)
    0 (0 to 34)
    0 (0 to 60)
    0 (0 to 98)
    ( to )
        Day 85: Th1/Th2 >=1 (n =6, 4, 3, 0)
    100 (54 to 100)
    100 (40 to 100)
    100 (29 to 100)
    ( to )
        Day 85: Th1/Th2 <1 (n =6, 4, 3, 0)
    0 (0 to 46)
    0 (0 to 60)
    0 (0 to 71)
    ( to )
        Day 422: Th1/Th2 >=1 (n =0, 0, 1, 0)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    100 (3 to 100)
    ( to )
        Day 422: Th1/Th2 <1 (n =0, 0, 1, 0)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    0 (0 to 98)
    ( to )
    Notes
    [150] - No subjects was available for the analysis at the specified timepoint.
    No statistical analyses for this end point

    Secondary: Cohort 3: Percentage of Subjects With T helper cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1

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    End point title
    Cohort 3: Percentage of Subjects With T helper cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 [151]
    End point description
    Percentage of subjects with Th1 (IFN-g OR IL2 NOT TH2) /Th2 (IL4 OR IL5 OR IL13 AND CD40L) ratio >=1 and <1 was reported. FAS included all subjects with at least one vaccine administration documented. Here N (number of subjects analysed) signifies subjects evaluated for this endpoint. Here 'n' (number analysed) signifies number of subjects evaluable at specified time points. Here, "99999" signifies that data could not be estimated as no subjects were available for the analysis.
    End point type
    Secondary
    End point timeframe
    Days 15, 29, 87, 100, 114 and 268
    Notes
    [151] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 3: Placebo, Placebo
    Number of subjects analysed
    25
    25
    23
    30
    4
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 15: Th1/Th2 ratio >=1 (n =23, 22, 22, 24, 2)
    100 (85 to 100)
    100 (85 to 100)
    100 (85 to 100)
    100 (86 to 100)
    100 (16 to 100)
        Day 15: Th1/Th2 ratio <1 (n =23, 22, 22, 24, 2)
    0 (0 to 15)
    0 (0 to 15)
    0 (0 to 15)
    0 (0 to 14)
    0 (0 to 84)
        Day 29: Th1/Th2 ratio >=1 (n =25, 25, 23, 30, 4)
    100 (86 to 100)
    100 (86 to 100)
    100 (85 to 100)
    100 (88 to 100)
    100 (40 to 100)
        Day 29: Th1/Th2 ratio <1 (n =25, 25, 23, 30, 4)
    0 (0 to 14)
    0 (0 to 14)
    0 (0 to 15)
    0 (0 to 12)
    0 (0 to 60)
        Day 87: Th1/Th2 ratio >=1 (n=13,12,9,17,1)
    100 (75 to 100)
    100 (74 to 100)
    100 (66 to 100)
    100 (80 to 100)
    100 (3 to 100)
        Day 87: Th1/Th2 ratio <1 (n=13,12,9,17,1)
    0 (0 to 25)
    0 (0 to 26)
    0 (0 to 34)
    0 (0 to 20)
    0 (0 to 98)
        Day 100: Th1/Th2 ratio >=1 (n=20,19,21,21,1)
    100 (83 to 100)
    100 (82 to 100)
    100 (84 to 100)
    100 (84 to 100)
    100 (3 to 100)
        Day 100: Th1/Th2 ratio <1 (n=20,19,21,21,1)
    0 (0 to 17)
    0 (0 to 18)
    0 (0 to 16)
    0 (0 to 16)
    0 (0 to 98)
        Day 114: Th1/Th2 ratio >=1 (n=24,20,20,16,5)
    100 (86 to 100)
    100 (83 to 100)
    100 (83 to 100)
    100 (79 to 100)
    100 (48 to 100)
        Day 114: Th1/Th2 ratio <1 (n=24,20,20,16,5)
    0 (0 to 14)
    0 (0 to 17)
    0 (0 to 17)
    0 (0 to 21)
    0 (0 to 52)
        Day 268: Th1/Th2 ratio >=1 (n=16,17,4,8,0)
    100 (79 to 100)
    94 (73 to 100)
    80 (28 to 99)
    89 (52 to 100)
    99999 (99999 to 99999)
        Day 268: Th1/Th2 ratio <1 (n=16,17,4,8,0)
    0 (0 to 21)
    6 (0 to 27)
    20 (1 to 72)
    11 (0 to 48)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Cohort 2b: Percentage of Subjects With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon (IFN)g+ or Interleukin 2+ (IL2+) not Helper cell type 2 (TH2)

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    End point title
    Cohort 2b: Percentage of Subjects With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon (IFN)g+ or Interleukin 2+ (IL2+) not Helper cell type 2 (TH2) [152]
    End point description
    Percentage of subjects with SARS-Cov2 S Specific CD4+ T-cell Responses for IFNg+ or IL2+ not Helper cell type 2 (TH2) was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. PPI population included all randomized and vaccinated subjects for whom immunogenicity data were available excluding subjects with major protocol deviations expecting to impact the immunogenicity outcomes. Here N (number of subjects analysed) signifies subjects evaluated for this endpoint. Here 'n' (number analysed) signifies number of subjects evaluable at specified time points. Here, "99999" signifies that data could not be estimated as no subjects were available for the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 15, 29, 57, 85 and 422
    Notes
    [152] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10) COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 COHORT 2B: Placebo, B: PL
    Number of subjects analysed
    12
    5
    6
    2
    Units: Percentage of subjects
    number (confidence interval 95%)
        Baseline (n= 12, 5, 6, 2)
    25 (5 to 57)
    20 (1 to 72)
    17 (0 to 64)
    0 (0 to 84)
        Day 29 (n =11, 5, 6, 2)
    82 (48 to 98)
    40 (5 to 85)
    67 (22 to 96)
    0 (0 to 84)
        Day 57 (n =12, 5, 5, 2)
    75 (43 to 95)
    80 (28 to 99)
    40 (5 to 85)
    0 (0 to 84)
        Day 85 (n =12, 5, 6, 2)
    60 (26 to 88)
    80 (28 to 99)
    50 (12 to 88)
    0 (0 to 84)
        Day 422 (n =1,1,1,0)
    0 (0 to 98)
    0 (0 to 98)
    100 (3 to 100)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Cohort 2a: Percentage of Subjects With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ or IL5+ or IL13+ and CD40L+

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    End point title
    Cohort 2a: Percentage of Subjects With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ or IL5+ or IL13+ and CD40L+ [153]
    End point description
    Percentage of subjects with SARS-Cov2 S Specific CD4+ T-cell responses for IL4+ or IL5+ or IL13+ and CD40L+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. PPI population included all randomized and vaccinated subjects for whom immunogenicity data were available excluding subjects with major protocol deviations expecting to impact the immunogenicity outcomes. Here N (number of subjects analysed) signifies subjects evaluated for this endpoint. Here 'n' (number analysed) signifies number of subjects evaluable at specified time points. Here, "99999" signifies that data could not be estimated as no subjects were available for the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 29 and 366
    Notes
    [153] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 COHORT 2A: Placebo, B: PL
    Number of subjects analysed
    11
    5
    5
    3
    Units: Percentage of subjects
    number (confidence interval 95%)
        Baseline (n =11, 5, 5, 3)
    0 (0 to 28)
    0 (0 to 52)
    0 (0 to 52)
    0 (0 to 71)
        Day 29 (n =11, 5, 5, 3)
    0 (0 to 28)
    0 (0 to 52)
    0 (0 to 52)
    0 (0 to 71)
        Day 366 (n =9, 5, 3, 0)
    0 (0 to 34)
    0 (0 to 52)
    0 (0 to 71)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Cohort 2b: Percentage of Subjects With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+

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    End point title
    Cohort 2b: Percentage of Subjects With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ [154]
    End point description
    Percentage of subjects with SARS-Cov2 S Specific CD8+ T-cell Responses for IFNg+ or IL2+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination. PPI population included all randomized and vaccinated subjects for whom immunogenicity data were available excluding subjects with major protocol deviations expecting to impact the immunogenicity outcomes. Here N (number of subjects analysed) signifies subjects evaluated for this endpoint. Here 'n' (number analysed) signifies number of subjects evaluable at specified time points. Here, "99999" signifies that data could not be estimated as no subjects were available for the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 29, 57, 85 and 422
    Notes
    [154] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10) COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 COHORT 2B: Placebo, B: PL
    Number of subjects analysed
    12
    5
    6
    2
    Units: Percentage of subjects
    number (confidence interval 95%)
        Baseline (n =12, 5, 6, 2)
    8 (0 to 38)
    20 (1 to 72)
    0 (0 to 46)
    0 (0 to 84)
        Day 29 (n =11, 5, 6, 2)
    82 (48 to 98)
    80 (28 to 99)
    83 (36 to 100)
    0 (0 to 84)
        Day 57 (n =12, 5, 5, 2)
    92 (62 to 100)
    100 (48 to 100)
    80 (28 to 99)
    0 (0 to 84)
        Day 85 (n =10, 5, 6, 2)
    80 (44 to 97)
    100 (48 to 100)
    83 (36 to 100)
    0 (0 to 84)
        Day 422 (n =1, 1, 1, 0)
    100 (3 to 100)
    100 (3 to 100)
    100 (3 to 100)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Cohort 1a: Percentage of Subjects With T helper cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1

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    End point title
    Cohort 1a: Percentage of Subjects With T helper cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 [155]
    End point description
    Percentage of subjects with Th1 (IFN-g OR IL2 NOT TH2) /Th2 (IL4 OR IL5 OR IL13 AND CD40L) ratio >=1 and <1 was reported. PPI population included all randomized and vaccinated subjects for whom immunogenicity data were available excluding subjects with major protocol deviations expecting to impact the immunogenicity outcomes. Here N (number of subjects analysed) signifies subjects evaluated for this endpoint. Here 'n' (number analysed) signifies number of subjects evaluable at specified time points. Here, 99999 signifies data could not be estimated and reported as no subjects were analysed. Due to the change in planned analysis, data was not collected and analysed for Cohort 1b and thus no data was reported for this endpoint.
    End point type
    Secondary
    End point timeframe
    Days 29, 57, 71, 85, 239 and 422
    Notes
    [155] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) COHORT 1A: Placebo, Placebo
    Number of subjects analysed
    27
    29
    29
    28
    6
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 15: Th1/Th2 >=1 (n =27, 29, 29, 28, 3)
    100 (87 to 100)
    100 (88 to 100)
    100 (88 to 100)
    100 (88 to 100)
    100 (29 to 100)
        Day 15: Th1/Th2 <1 (n =27, 29, 29, 28, 3)
    0 (0 to 13)
    0 (0 to 12)
    0 (0 to 12)
    0 (0 to 12)
    0 (0 to 71)
        Day 29: Th1/Th2 >=1 (n =27, 25, 28, 23, 6)
    100 (87 to 100)
    100 (86 to 100)
    100 (88 to 100)
    100 (85 to 100)
    100 (54 to 100)
        Day 29: Th1/Th2 <1 (n =27, 25, 28, 23, 6)
    0 (0 to 13)
    0 (0 to 14)
    0 (0 to 12)
    0 (0 to 15)
    0 (0 to 46)
        Day 57: Th1/Th2 >=1 (n =27, 19, 27, 19, 4)
    100 (87 to 100)
    100 (82 to 100)
    100 (87 to 100)
    100 (82 to 100)
    100 (40 to 100)
        Day 57: Th1/Th2 <1 (n =27, 19, 27, 19, 4)
    0 (0 to 13)
    0 (0 to 18)
    0 (0 to 13)
    0 (0 to 18)
    0 (0 to 60)
        Day 71: Th1/Th2 >=1 (n =22, 17, 30, 17, 4)
    100 (85 to 100)
    100 (80 to 100)
    100 (88 to 100)
    100 (80 to 100)
    100 (40 to 100)
        Day 71: Th1/Th2 <1 (n =22, 17, 30, 17, 4)
    0 (0 to 15)
    0 (0 to 20)
    0 (0 to 12)
    0 (0 to 20)
    0 (0 to 60)
        Day 85: Th1/Th2 >=1 (n =25, 15, 28, 16, 4)
    100 (86 to 100)
    100 (78 to 100)
    100 (88 to 100)
    100 (79 to 100)
    100 (40 to 100)
        Day 85: Th1/Th2 <1 (n =25, 15, 28, 16, 4)
    0 (0 to 14)
    0 (0 to 22)
    0 (0 to 12)
    0 (0 to 21)
    0 (0 to 60)
        Day 239: Th1/Th2 >=1 (n =15, 16, 9, 4, 0)
    100 (78 to 100)
    100 (79 to 100)
    100 (66 to 100)
    100 (40 to 100)
    99999 (99999 to 99999)
        Day 239: Th1/Th2 <1 (n =15, 16, 9, 4, 0)
    0 (0 to 22)
    0 (0 to 21)
    0 (0 to 34)
    0 (0 to 60)
    99999 (99999 to 99999)
        Day 422: Th1/Th2 >=1 (n =6, 10, 7, 4, 0)
    86 (42 to 100)
    100 (69 to 100)
    100 (59 to 100)
    100 (40 to 100)
    99999 (99999 to 99999)
        Day 422: Th1/Th2 <1 (n =6, 10, 7, 4, 0)
    14 (0 to 58)
    0 (0 to 31)
    0 (0 to 41)
    0 (0 to 60)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Cohort 2a: Percentage of Subjects With T helper cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1

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    End point title
    Cohort 2a: Percentage of Subjects With T helper cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 [156]
    End point description
    Percentage of subjects with Th1 (IFN-g OR IL2 NOT TH2) /Th2 (IL4 OR IL5 OR IL13 AND CD40L) ratio >=1 and <1 was reported. PPI population included all randomized and vaccinated subjects for whom immunogenicity data were available excluding subjects with major protocol deviations expecting to impact the immunogenicity outcomes. Here N (number of subjects analysed) signifies subjects evaluated for this endpoint. Here 'n' (number analysed) signifies number of subjects evaluable at specified time points. Here, 99999 signifies data could not be estimated and reported as no subjects were analysed.
    End point type
    Secondary
    End point timeframe
    Days 29 and 366
    Notes
    [156] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be reported for specified arms only.
    End point values
    COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 COHORT 2A: Placebo, B: PL
    Number of subjects analysed
    9
    4
    4
    0 [157]
    Units: Percentage of subjects
    number (confidence interval 95%)
        Day 29: Th1/Th2 >=1 (n =9, 4, 4, 0)
    100 (66 to 100)
    100 (40 to 100)
    100 (40 to 100)
    ( to )
        Day 29: Th1/Th2 <1 (n =9, 4, 4, 0)
    0 (0 to 34)
    0 (0 to 60)
    0 (0 to 60)
    ( to )
        Day 366: Th1/Th2 >=1 (n =1, 1, 0, 0)
    100 (3 to 100)
    100 (3 to 100)
    99999 (99999 to 99999)
    ( to )
        Day 366: Th1/Th2 <1 (n =1, 1, 0, 0)
    0 (0 to 98)
    0 (0 to 98)
    99999 (99999 to 99999)
    ( to )
    Notes
    [157] - No subject was available for the analysis at the specified timepoint.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Cohorts 1, 2b and 3: From Day 1 up to 787 days; Cohort 2a: Day 1 up to 731 days
    Adverse event reporting additional description
    FAS included all subjects with at least one vaccine administration documented.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    COHORT 1A: Placebo, Placebo
    Reporting group description
    Subjects received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). Subjects who had previously received 1 or more doses of any COVID-19 vaccine received a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. 6 months after Vaccination 2.

    Reporting group title
    COHORT 1A: Ad26 1e11, PL(,AHBV: Ad26 5e10)
    Reporting group description
    Subjects received a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). Subjects who had previously received 1 or more doses of any COVID-19 vaccine received a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. 6 months after Vaccination 2.

    Reporting group title
    COHORT 1A: Ad26 1e11, Ad26 1e11(,AHBV: Ad26 5e10)
    Reporting group description
    Subjects received a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). Subjects who had previously received 1 or more doses of any COVID-19 vaccine received a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. 6 months after Vaccination 2.

    Reporting group title
    COHORT 1A: Ad26 5e10, PL(,AHBV: Ad26 5e10)
    Reporting group description
    Subjects received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). Subjects who had previously received 1 or more doses of any COVID-19 vaccine received a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. 6 months after Vaccination 2.

    Reporting group title
    COHORT 1A: Ad26 5e10, Ad26 5e10(,AHBV: Ad26 5e10)
    Reporting group description
    Subjects received a single intramuscular (IM) injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). Subjects who had previously received 1 or more doses of any COVID-19 vaccine received a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. 6 months after Vaccination 2.

    Reporting group title
    COHORT 1B: Ad26 5e10, Ad26 5e10(,AHBV: Ad26 5e10)
    Reporting group description
    Subjects received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). Subjects who had previously received 1 or more doses of any COVID-19 vaccine received a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. 6 months after Vaccination 2.

    Reporting group title
    COHORT 2A: Ad26 5e10, B: PL(,PL/AHBV: Ad26 5e10)
    Reporting group description
    Group 1 and Group 4 subjects received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and matching placebo at 6 and 12 months as Booster 1 and Booster 2 vaccines. Subjects who had previously received 1 or more doses of any COVID-19 vaccine received a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. 6 months after Booster 2 Vaccination.

    Reporting group title
    COHORT 1B: Placebo, Placebo
    Reporting group description
    Subjects received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). Subjects who had previously received 1 or more doses of any COVID-19 vaccine received a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. 6 months after Vaccination 2.

    Reporting group title
    COHORT 1B: Ad26 1e11, PL(,AHBV: Ad26 5e10)
    Reporting group description
    Subjects received a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). Subjects who had previously received 1 or more doses of any COVID-19 vaccine received a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. 6 months after Vaccination 2.

    Reporting group title
    COHORT 1B: Ad26 1e11, Ad26 1e11(,AHBV: Ad26 5e10)
    Reporting group description
    Subjects received a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). Subjects who had previously received 1 or more doses of any COVID-19 vaccine received a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. 6 months after Vaccination 2.

    Reporting group title
    COHORT 1B: Ad26 5e10, PL(,AHBV: Ad26 5e10)
    Reporting group description
    Subjects received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). Subjects who had previously received 1 or more doses of any COVID-19 vaccine received a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. 6 months after Vaccination 2.

    Reporting group title
    COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL
    Reporting group description
    Group 2 subjects received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and single IM injection of Ad26.COV2.S 5*10^10 vp after 6 months (Booster 1) and matching placebo after 12 months (Booster 2). Subjects who had previously received 1 or more doses of any COVID-19 vaccine received a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. 6 months after Booster 2 Vaccination.

    Reporting group title
    COHORT 3: Ad26 5e10, Ad26 5e10(,AHBV: Ad26 5e10)
    Reporting group description
    Subjects received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). Subjects who had previously received 1 or more doses of any COVID-19 vaccine received a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. 6 months after Vaccination 2.

    Reporting group title
    COHORT 2B: Placebo, B: PL
    Reporting group description
    Group 5 subjects received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (Vaccination 1), Day 57 (Vaccination 2), 8 Month (Booster 1) and 14 months (Booster 2). Subjects who had previously received 1 or more doses of any COVID-19 vaccine received a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. 6 months after Booster 2 vaccination.

    Reporting group title
    COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10
    Reporting group description
    Group 3 subjects received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2) and matching placebo at 6 months after vaccination 2 as Booster 1 vaccination and Ad26.COV2.S 5*10^10 vp at 12 months after vaccination 2 as Booster 2 vaccination. Subjects who had previously received 1 or more doses of any COVID-19 vaccine received a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. 6 months after Booster 2 Vaccination.

    Reporting group title
    COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10
    Reporting group description
    Group 3 subjects received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and a matching placebo injection after 6 months (Booster 1) and Ad26.COV2.S 5*10^10 vp after 12 months (Booster 2). Subjects who had previously received 1 or more doses of any COVID-19 vaccine received a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. 6 months after Booster 2 Vaccination.

    Reporting group title
    COHORT 2A: Placebo, B: Placebo
    Reporting group description
    Group 5 subjects received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (Vaccination 1), 6 months (Booster 1) and 12 months (Booster 2). Subjects who had previously received 1 or more doses of any COVID-19 vaccine received a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. 6 months after Booster 2 Vaccination.

    Reporting group title
    COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL(,PL/AHBV: Ad26 5e10)
    Reporting group description
    Subjects received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2) and matching placebo at 6 and 12 months after vaccination 2 as Booster 1 and Booster 2 vaccines. Subjects who had previously received 1 or more doses of any COVID-19 vaccine received a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. 6 months after Booster 2 Vaccination.

    Reporting group title
    COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL
    Reporting group description
    Group 2 subjects received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1), Day 57 (Vaccination 2) and 6 months after Vaccination 2(Booster 1). At 12 months after vaccination 2, subjects received placebo matching to Ad26.COV2.S vaccine (Booster 2). Subjects who had previously received 1 or more doses of any COVID-19 vaccine received a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. 6 months after Booster 2 Vaccination.

    Reporting group title
    COHORT 3: Ad26 1e11, Ad26 1e11(,AHBV: Ad26 5e10)
    Reporting group description
    Subjects received a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). Subjects who had previously received 1 or more doses of any COVID-19 vaccine received a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. 6 months after Vaccination 2.

    Reporting group title
    COHORT 3: Ad26 5e10, PL(,AHBV: Ad26 5e10)
    Reporting group description
    Subjects received a single IM injection of Ad26.COV2.S 5*10^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). Subjects who had previously received 1 or more doses of any COVID-19 vaccine received a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. 6 months after Vaccination 2.

    Reporting group title
    COHORT 3: Ad26 1e11, PL(,AHBV: Ad26 5e10)
    Reporting group description
    Subjects received a single IM injection of Ad26.COV2.S 1*10^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). Subjects who had previously received 1 or more doses of any COVID-19 vaccine received a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. 6 months after Vaccination 2.

    Reporting group title
    COHORT 3: Placebo, Placebo
    Reporting group description
    Subjects received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). Subjects who had previously received 1 or more doses of any COVID-19 vaccine received a single ad hoc booster dose of 5*10^10 vp Ad26.COV2.S. 6 months after Vaccination 2.

    Serious adverse events
    COHORT 1A: Placebo, Placebo COHORT 1A: Ad26 1e11, PL(,AHBV: Ad26 5e10) COHORT 1A: Ad26 1e11, Ad26 1e11(,AHBV: Ad26 5e10) COHORT 1A: Ad26 5e10, PL(,AHBV: Ad26 5e10) COHORT 1A: Ad26 5e10, Ad26 5e10(,AHBV: Ad26 5e10) COHORT 1B: Ad26 5e10, Ad26 5e10(,AHBV: Ad26 5e10) COHORT 2A: Ad26 5e10, B: PL(,PL/AHBV: Ad26 5e10) COHORT 1B: Placebo, Placebo COHORT 1B: Ad26 1e11, PL(,AHBV: Ad26 5e10) COHORT 1B: Ad26 1e11, Ad26 1e11(,AHBV: Ad26 5e10) COHORT 1B: Ad26 5e10, PL(,AHBV: Ad26 5e10) COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL COHORT 3: Ad26 5e10, Ad26 5e10(,AHBV: Ad26 5e10) COHORT 2B: Placebo, B: PL COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 COHORT 2A: Placebo, B: Placebo COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL(,PL/AHBV: Ad26 5e10) COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL COHORT 3: Ad26 1e11, Ad26 1e11(,AHBV: Ad26 5e10) COHORT 3: Ad26 5e10, PL(,AHBV: Ad26 5e10) COHORT 3: Ad26 1e11, PL(,AHBV: Ad26 5e10) COHORT 3: Placebo, Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 77 (2.60%)
    1 / 73 (1.37%)
    1 / 75 (1.33%)
    1 / 75 (1.33%)
    0 / 77 (0.00%)
    1 / 5 (20.00%)
    1 / 58 (1.72%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 29 (0.00%)
    3 / 81 (3.70%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
    1 / 32 (3.13%)
    0 / 17 (0.00%)
    1 / 62 (1.61%)
    1 / 30 (3.33%)
    2 / 82 (2.44%)
    2 / 80 (2.50%)
    1 / 79 (1.27%)
    2 / 81 (2.47%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    2
    1
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast Cancer Stage Ii
         subjects affected / exposed
    0 / 77 (0.00%)
    0 / 73 (0.00%)
    0 / 75 (0.00%)
    1 / 75 (1.33%)
    0 / 77 (0.00%)
    0 / 5 (0.00%)
    0 / 58 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 29 (0.00%)
    0 / 81 (0.00%)
    0 / 15 (0.00%)
    0 / 28 (0.00%)
    0 / 32 (0.00%)
    0 / 17 (0.00%)
    0 / 62 (0.00%)
    0 / 30 (0.00%)
    0 / 82 (0.00%)
    0 / 80 (0.00%)
    0 / 79 (0.00%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0