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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
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

CR108828

ISRCTN number

US NCT number

NCT04436276

WHO universal trial number (UTN)

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

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

21 Feb 2023

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

21 Feb 2023

Was the trial ended prematurely?

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

Independent data monitoring committee (IDMC) involvement?

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

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

673

From 65 to 84 years

401

85 years and over

Subject disposition

Top of page

Recruitment details

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 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

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.

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.

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).

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).

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).

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.

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.

COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10)

Arm description

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).

COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10)

Arm description

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).

COHORT 1B: Placebo, Placebo

Arm description

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).

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.

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).

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).

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).

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.

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).

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.

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).

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.

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.

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).

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).

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

Top of page

Reporting group title

COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 1A: Placebo, Placebo

Reporting group description

Reporting group title

COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 1B: Ad26 5e10, PL(,AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 1B: Placebo, Placebo

Reporting group description

Reporting group title

COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL

Reporting group description

Reporting group title

COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10

Reporting group description

Reporting group title

COHORT 2A: Placebo, B: PL

Reporting group description

Reporting group title

COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10)

Reporting group description

Reporting group title

COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL

Reporting group description

Reporting group title

COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10

Reporting group description

Reporting group title

COHORT 2B: Placebo, B: PL

Reporting group description

Reporting group title

COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 3: Placebo, Placebo

Reporting group description

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

Top of page

Reporting group title

COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 1A: Placebo, Placebo

Reporting group description

Reporting group title

COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 1B: Ad26 5e10, PL(,AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 1B: Placebo, Placebo

Reporting group description

Reporting group title

COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL

Reporting group description

Reporting group title

COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10

Reporting group description

Reporting group title

COHORT 2A: Placebo, B: PL

Reporting group description

Reporting group title

COHORT 2B:Ad265e10, Ad26 5e10, B:PL(PL/Ad265e10)

Reporting group description

Reporting group title

COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL

Reporting group description

Reporting group title

COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10

Reporting group description

Reporting group title

COHORT 2B: Placebo, B: PL

Reporting group description

Reporting group title

COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 3: Placebo, Placebo

Reporting group description

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

Top of page

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

Top of page

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

Top of page

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

Top of page

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

Top of page

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

Top of page

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 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 ^[109] ^[110]

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
[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	7	0 ^[111]	0 ^[112]	0 ^[113]
Units: Subjects	0

Notes
[111] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
[112] - 0 subjects were available for the analysis as none received ad hoc booster vaccination.
[113] - 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 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 ^[114] ^[115]

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
[114] - 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.
[115] - 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 ^[116]
Units: Subjects	0	0	0

Notes
[116] - 0 subjects were available for the analysis as none received booster vaccination 2.

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 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 ^[119] ^[120]

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
[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	11	15	14	9	0 ^[121]
Units: Subjects	1	0	3	1

Notes
[121] - 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 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 ^[122] ^[123]

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
[122] - 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.
[123] - 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: 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

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

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 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) ^[140]

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
[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	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: 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) ^[141]

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
[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	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: 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

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

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 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+ ^[153]

End point description

End point type

Secondary

End point timeframe

Baseline, Days 29, 57, 85 and 422

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 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 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+ ^[154]

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
[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 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 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

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

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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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 name

MedDRA

Dictionary version

25.1

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

Reporting group title

COHORT 1B: Ad26 1e11, PL(,AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 1B: Ad26 1e11, Ad26 1e11(,AHBV: Ad26 5e10)

Reporting group description

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

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

Reporting group title

COHORT 3: Ad26 5e10, PL(,AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 3: Ad26 1e11, PL(,AHBV: Ad26 5e10)

Reporting group description

Reporting group title

COHORT 3: Placebo, Placebo

Reporting group description

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%)

0 / 77 (0.00%)

1 / 5 (20.00%)

1 / 58 (1.72%)

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)

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 / 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 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Surgical and medical procedures

Mastectomy

subjects affected / exposed

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 75 (0.00%)

0 / 77 (0.00%)

0 / 5 (0.00%)

0 / 58 (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%)

1 / 79 (1.27%)

0 / 81 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

General disorders and administration site conditions

Hanging

subjects affected / exposed

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 75 (0.00%)

0 / 77 (0.00%)

0 / 5 (0.00%)

0 / 58 (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%)

1 / 62 (1.61%)

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 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Pyrexia

subjects affected / exposed

0 / 77 (0.00%)

1 / 73 (1.37%)

0 / 75 (0.00%)

0 / 77 (0.00%)

0 / 5 (0.00%)

0 / 58 (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

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Immune system disorders

Anaphylactic Shock

subjects affected / exposed

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 75 (0.00%)

0 / 77 (0.00%)

0 / 5 (0.00%)

0 / 58 (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%)

1 / 30 (3.33%)

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 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Reproductive system and breast disorders

Uterine Prolapse

subjects affected / exposed

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 75 (0.00%)

0 / 77 (0.00%)

0 / 5 (0.00%)

0 / 58 (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%)

1 / 30 (3.33%)

1 / 82 (1.22%)

0 / 80 (0.00%)

0 / 79 (0.00%)

0 / 81 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory, thoracic and mediastinal disorders

Asphyxia

subjects affected / exposed

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 75 (0.00%)

0 / 77 (0.00%)

0 / 5 (0.00%)

0 / 58 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 81 (0.00%)

0 / 15 (0.00%)

0 / 28 (0.00%)

1 / 32 (3.13%)

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 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Investigations

Blood Pressure Decreased

subjects affected / exposed

0 / 77 (0.00%)

0 / 73 (0.00%)

1 / 75 (1.33%)

0 / 75 (0.00%)

0 / 77 (0.00%)

0 / 5 (0.00%)

0 / 58 (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 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Injury, poisoning and procedural complications

Craniocerebral Injury

subjects affected / exposed

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 75 (0.00%)

0 / 77 (0.00%)

0 / 5 (0.00%)

0 / 58 (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%)

1 / 80 (1.25%)

0 / 79 (0.00%)

0 / 81 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hip Fracture

subjects affected / exposed

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 75 (0.00%)

0 / 77 (0.00%)

0 / 5 (0.00%)

0 / 58 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

1 / 81 (1.23%)

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 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Procedural Vomiting

subjects affected / exposed

1 / 77 (1.30%)

0 / 73 (0.00%)

0 / 75 (0.00%)

0 / 77 (0.00%)

0 / 5 (0.00%)

0 / 58 (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 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Procedural Nausea

subjects affected / exposed

1 / 77 (1.30%)

0 / 73 (0.00%)

0 / 75 (0.00%)

0 / 77 (0.00%)

0 / 5 (0.00%)

0 / 58 (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 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Rib Fracture

subjects affected / exposed

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 75 (0.00%)

0 / 77 (0.00%)

0 / 5 (0.00%)

0 / 58 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

1 / 81 (1.23%)

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 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Traumatic Fracture

subjects affected / exposed

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 75 (0.00%)

0 / 77 (0.00%)

0 / 5 (0.00%)

0 / 58 (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%)

1 / 80 (1.25%)

0 / 79 (0.00%)

0 / 81 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Wrist Fracture

subjects affected / exposed

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 75 (0.00%)

0 / 77 (0.00%)

0 / 5 (0.00%)

1 / 58 (1.72%)

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 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

Atrial Fibrillation

subjects affected / exposed

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 75 (0.00%)

0 / 77 (0.00%)

0 / 5 (0.00%)

0 / 58 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

1 / 81 (1.23%)

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 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Coronary Artery Disease

subjects affected / exposed

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 75 (0.00%)

0 / 77 (0.00%)

0 / 5 (0.00%)

0 / 58 (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%)

1 / 82 (1.22%)

0 / 80 (0.00%)

0 / 79 (0.00%)

0 / 81 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Nervous system disorders

Multiple Sclerosis

subjects affected / exposed

1 / 77 (1.30%)

0 / 73 (0.00%)

0 / 75 (0.00%)

0 / 77 (0.00%)

0 / 5 (0.00%)

0 / 58 (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

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Ear and labyrinth disorders

Aural Polyp

subjects affected / exposed

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 75 (0.00%)

0 / 77 (0.00%)

0 / 5 (0.00%)

0 / 58 (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%)

1 / 81 (1.23%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Renal and urinary disorders

Nephrolithiasis

subjects affected / exposed

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 75 (0.00%)

0 / 77 (0.00%)

1 / 5 (20.00%)

0 / 58 (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 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Musculoskeletal and connective tissue disorders

Osteoarthritis

subjects affected / exposed

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 75 (0.00%)

0 / 77 (0.00%)

0 / 5 (0.00%)

0 / 58 (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%)

1 / 81 (1.23%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Infections and infestations

Pneumonia Legionella

subjects affected / exposed

0 / 77 (0.00%)

0 / 73 (0.00%)

0 / 75 (0.00%)

0 / 77 (0.00%)

0 / 5 (0.00%)

0 / 58 (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%)

1 / 80 (1.25%)

0 / 79 (0.00%)

0 / 81 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-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 non serious adverse events
subjects affected / exposed	29 / 77 (37.66%)	66 / 73 (90.41%)	69 / 75 (92.00%)	64 / 75 (85.33%)	68 / 77 (88.31%)	5 / 5 (100.00%)	53 / 58 (91.38%)	5 / 5 (100.00%)	5 / 5 (100.00%)	5 / 5 (100.00%)	5 / 5 (100.00%)	27 / 29 (93.10%)	63 / 81 (77.78%)	9 / 15 (60.00%)	23 / 28 (82.14%)	27 / 32 (84.38%)	10 / 17 (58.82%)	59 / 62 (95.16%)	28 / 30 (93.33%)	69 / 82 (84.15%)	55 / 80 (68.75%)	61 / 79 (77.22%)	42 / 81 (51.85%)
Vascular disorders
Hypertension
subjects affected / exposed	0 / 77 (0.00%)	1 / 73 (1.37%)	0 / 75 (0.00%)	0 / 75 (0.00%)	0 / 77 (0.00%)	0 / 5 (0.00%)	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%)	0 / 32 (0.00%)	1 / 17 (5.88%)	0 / 62 (0.00%)	0 / 30 (0.00%)	2 / 82 (2.44%)	0 / 80 (0.00%)	4 / 79 (5.06%)	1 / 81 (1.23%)
occurrences all number	0	1	0	0	0	0	1	0	0	0	0	0	3	0	0	0	1	0	0	3	0	5	1
General disorders and administration site conditions
Chills
subjects affected / exposed	2 / 77 (2.60%)	11 / 73 (15.07%)	6 / 75 (8.00%)	3 / 75 (4.00%)	3 / 77 (3.90%)	0 / 5 (0.00%)	3 / 58 (5.17%)	0 / 5 (0.00%)	3 / 5 (60.00%)	4 / 5 (80.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	1 / 81 (1.23%)	0 / 15 (0.00%)	1 / 28 (3.57%)	1 / 32 (3.13%)	1 / 17 (5.88%)	4 / 62 (6.45%)	2 / 30 (6.67%)	6 / 82 (7.32%)	2 / 80 (2.50%)	6 / 79 (7.59%)	1 / 81 (1.23%)
occurrences all number	2	11	6	3	3	0	3	0	3	4	0	0	1	0	1	1	1	4	2	6	2	6	1
Fatigue
subjects affected / exposed	5 / 77 (6.49%)	1 / 73 (1.37%)	1 / 75 (1.33%)	3 / 75 (4.00%)	0 / 77 (0.00%)	0 / 5 (0.00%)	2 / 58 (3.45%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	1 / 81 (1.23%)	1 / 15 (6.67%)	1 / 28 (3.57%)	0 / 32 (0.00%)	2 / 17 (11.76%)	2 / 62 (3.23%)	1 / 30 (3.33%)	2 / 82 (2.44%)	2 / 80 (2.50%)	0 / 79 (0.00%)	1 / 81 (1.23%)
occurrences all number	6	1	1	3	0	0	2	0	0	0	0	0	1	1	4	0	2	3	1	2	2	0	1
Fatigue(Solicited)
subjects affected / exposed	17 / 77 (22.08%)	53 / 73 (72.60%)	58 / 75 (77.33%)	41 / 75 (54.67%)	50 / 77 (64.94%)	4 / 5 (80.00%)	37 / 58 (63.79%)	4 / 5 (80.00%)	5 / 5 (100.00%)	5 / 5 (100.00%)	3 / 5 (60.00%)	17 / 29 (58.62%)	38 / 81 (46.91%)	4 / 15 (26.67%)	19 / 28 (67.86%)	15 / 32 (46.88%)	7 / 17 (41.18%)	43 / 62 (69.35%)	15 / 30 (50.00%)	42 / 82 (51.22%)	32 / 80 (40.00%)	39 / 79 (49.37%)	22 / 81 (27.16%)
occurrences all number	21	63	89	52	72	5	37	6	6	8	4	17	49	5	30	15	7	67	26	59	40	48	29
Injection Site Haemorrhage
subjects affected / exposed	0 / 77 (0.00%)	0 / 73 (0.00%)	0 / 75 (0.00%)	1 / 75 (1.33%)	0 / 77 (0.00%)	1 / 5 (20.00%)	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%)	1 / 82 (1.22%)	1 / 80 (1.25%)	2 / 79 (2.53%)	1 / 81 (1.23%)
occurrences all number	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	2	1
Pyrexia(Solicited)
subjects affected / exposed	0 / 77 (0.00%)	28 / 73 (38.36%)	33 / 75 (44.00%)	14 / 75 (18.67%)	13 / 77 (16.88%)	0 / 5 (0.00%)	15 / 58 (25.86%)	0 / 5 (0.00%)	2 / 5 (40.00%)	3 / 5 (60.00%)	0 / 5 (0.00%)	3 / 29 (10.34%)	5 / 81 (6.17%)	0 / 15 (0.00%)	6 / 28 (21.43%)	4 / 32 (12.50%)	0 / 17 (0.00%)	17 / 62 (27.42%)	3 / 30 (10.00%)	7 / 82 (8.54%)	3 / 80 (3.75%)	7 / 79 (8.86%)	1 / 81 (1.23%)
occurrences all number	0	29	43	14	14	0	15	0	2	4	0	3	5	0	8	4	0	19	4	8	3	7	1
Pyrexia
subjects affected / exposed	1 / 77 (1.30%)	0 / 73 (0.00%)	3 / 75 (4.00%)	2 / 75 (2.67%)	2 / 77 (2.60%)	0 / 5 (0.00%)	0 / 58 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	2 / 29 (6.90%)	0 / 81 (0.00%)	0 / 15 (0.00%)	0 / 28 (0.00%)	0 / 32 (0.00%)	0 / 17 (0.00%)	1 / 62 (1.61%)	0 / 30 (0.00%)	0 / 82 (0.00%)	0 / 80 (0.00%)	2 / 79 (2.53%)	0 / 81 (0.00%)
occurrences all number	1	0	3	2	2	0	0	0	0	0	0	2	0	0	0	0	0	1	0	0	0	2	0
Vaccination Site Erythema(Solicited)
subjects affected / exposed	0 / 77 (0.00%)	1 / 73 (1.37%)	3 / 75 (4.00%)	0 / 75 (0.00%)	2 / 77 (2.60%)	1 / 5 (20.00%)	1 / 58 (1.72%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	1 / 81 (1.23%)	0 / 15 (0.00%)	2 / 28 (7.14%)	1 / 32 (3.13%)	0 / 17 (0.00%)	1 / 62 (1.61%)	0 / 30 (0.00%)	1 / 82 (1.22%)	2 / 80 (2.50%)	3 / 79 (3.80%)	0 / 81 (0.00%)
occurrences all number	0	1	4	0	2	1	1	0	0	0	0	1	1	0	2	1	0	1	0	1	2	3	0
Vaccination Site Pain(Solicited)
subjects affected / exposed	9 / 77 (11.69%)	60 / 73 (82.19%)	64 / 75 (85.33%)	51 / 75 (68.00%)	58 / 77 (75.32%)	5 / 5 (100.00%)	48 / 58 (82.76%)	0 / 5 (0.00%)	4 / 5 (80.00%)	5 / 5 (100.00%)	3 / 5 (60.00%)	23 / 29 (79.31%)	50 / 81 (61.73%)	3 / 15 (20.00%)	20 / 28 (71.43%)	19 / 32 (59.38%)	4 / 17 (23.53%)	53 / 62 (85.48%)	26 / 30 (86.67%)	55 / 82 (67.07%)	32 / 80 (40.00%)	37 / 79 (46.84%)	14 / 81 (17.28%)
occurrences all number	10	66	112	55	99	8	48	0	5	10	3	23	79	3	36	19	4	93	44	83	34	45	17
Vaccination Site Swelling(Solicited)
subjects affected / exposed	0 / 77 (0.00%)	2 / 73 (2.74%)	4 / 75 (5.33%)	0 / 75 (0.00%)	3 / 77 (3.90%)	1 / 5 (20.00%)	0 / 58 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	2 / 81 (2.47%)	0 / 15 (0.00%)	1 / 28 (3.57%)	1 / 32 (3.13%)	0 / 17 (0.00%)	2 / 62 (3.23%)	0 / 30 (0.00%)	2 / 82 (2.44%)	1 / 80 (1.25%)	2 / 79 (2.53%)	1 / 81 (1.23%)
occurrences all number	0	2	5	0	4	1	0	0	0	0	0	1	3	0	2	1	0	2	0	2	1	2	1
Reproductive system and breast disorders
Uterine Spasm
subjects affected / exposed	0 / 77 (0.00%)	0 / 73 (0.00%)	0 / 75 (0.00%)	0 / 75 (0.00%)	0 / 77 (0.00%)	0 / 5 (0.00%)	0 / 58 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	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 all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	0 / 77 (0.00%)	1 / 73 (1.37%)	0 / 75 (0.00%)	0 / 75 (0.00%)	0 / 77 (0.00%)	0 / 5 (0.00%)	1 / 58 (1.72%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 81 (0.00%)	1 / 15 (6.67%)	0 / 28 (0.00%)	0 / 32 (0.00%)	1 / 17 (5.88%)	0 / 62 (0.00%)	0 / 30 (0.00%)	0 / 82 (0.00%)	2 / 80 (2.50%)	0 / 79 (0.00%)	0 / 81 (0.00%)
occurrences all number	0	1	0	0	0	0	1	0	0	0	0	0	0	1	0	0	1	0	0	0	2	0	0
Rhinitis Allergic
subjects affected / exposed	0 / 77 (0.00%)	0 / 73 (0.00%)	0 / 75 (0.00%)	0 / 75 (0.00%)	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%)	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 all number	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Investigations
Haemoglobin Decreased
subjects affected / exposed	0 / 77 (0.00%)	0 / 73 (0.00%)	0 / 75 (0.00%)	0 / 75 (0.00%)	0 / 77 (0.00%)	0 / 5 (0.00%)	0 / 58 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 81 (0.00%)	0 / 15 (0.00%)	0 / 28 (0.00%)	1 / 32 (3.13%)	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 all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0
Neutrophil Count Decreased
subjects affected / exposed	0 / 77 (0.00%)	0 / 73 (0.00%)	0 / 75 (0.00%)	0 / 75 (0.00%)	0 / 77 (0.00%)	0 / 5 (0.00%)	0 / 58 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	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 all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Injury, poisoning and procedural complications
Limb Injury
subjects affected / exposed	0 / 77 (0.00%)	0 / 73 (0.00%)	0 / 75 (0.00%)	0 / 75 (0.00%)	0 / 77 (0.00%)	0 / 5 (0.00%)	0 / 58 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	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%)	1 / 30 (3.33%)	0 / 82 (0.00%)	0 / 80 (0.00%)	1 / 79 (1.27%)	0 / 81 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0	0	1	0
Nervous system disorders
Carpal Tunnel Syndrome
subjects affected / exposed	0 / 77 (0.00%)	0 / 73 (0.00%)	0 / 75 (0.00%)	0 / 75 (0.00%)	0 / 77 (0.00%)	1 / 5 (20.00%)	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 all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Headache
subjects affected / exposed	2 / 77 (2.60%)	3 / 73 (4.11%)	2 / 75 (2.67%)	0 / 75 (0.00%)	3 / 77 (3.90%)	0 / 5 (0.00%)	3 / 58 (5.17%)	1 / 5 (20.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 81 (0.00%)	1 / 15 (6.67%)	0 / 28 (0.00%)	0 / 32 (0.00%)	1 / 17 (5.88%)	2 / 62 (3.23%)	2 / 30 (6.67%)	4 / 82 (4.88%)	1 / 80 (1.25%)	3 / 79 (3.80%)	1 / 81 (1.23%)
occurrences all number	2	3	2	0	3	0	3	1	0	0	0	1	0	1	0	0	1	2	2	4	1	3	1
Headache(Solicited)
subjects affected / exposed	14 / 77 (18.18%)	54 / 73 (73.97%)	52 / 75 (69.33%)	36 / 75 (48.00%)	41 / 77 (53.25%)	2 / 5 (40.00%)	35 / 58 (60.34%)	3 / 5 (60.00%)	5 / 5 (100.00%)	5 / 5 (100.00%)	3 / 5 (60.00%)	16 / 29 (55.17%)	32 / 81 (39.51%)	7 / 15 (46.67%)	18 / 28 (64.29%)	11 / 32 (34.38%)	4 / 17 (23.53%)	43 / 62 (69.35%)	23 / 30 (76.67%)	39 / 82 (47.56%)	27 / 80 (33.75%)	28 / 79 (35.44%)	21 / 81 (25.93%)
occurrences all number	19	64	79	48	59	3	35	3	5	9	5	16	43	8	29	11	4	69	30	58	32	41	27
Migraine
subjects affected / exposed	1 / 77 (1.30%)	0 / 73 (0.00%)	0 / 75 (0.00%)	0 / 75 (0.00%)	0 / 77 (0.00%)	0 / 5 (0.00%)	0 / 58 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	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 all number	1	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Paraesthesia
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%)	1 / 58 (1.72%)	0 / 5 (0.00%)	1 / 5 (20.00%)	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 all number	0	0	0	1	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Sinus Headache
subjects affected / exposed	0 / 77 (0.00%)	0 / 73 (0.00%)	0 / 75 (0.00%)	0 / 75 (0.00%)	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%)	1 / 17 (5.88%)	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 all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Presyncope
subjects affected / exposed	0 / 77 (0.00%)	0 / 73 (0.00%)	0 / 75 (0.00%)	0 / 75 (0.00%)	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%)	2 / 29 (6.90%)	0 / 81 (0.00%)	0 / 15 (0.00%)	1 / 28 (3.57%)	1 / 32 (3.13%)	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 all number	0	0	0	0	0	0	0	0	0	0	0	2	0	0	1	1	0	0	0	0	0	0	0
Blood and lymphatic system disorders
Leukopenia
subjects affected / exposed	0 / 77 (0.00%)	0 / 73 (0.00%)	0 / 75 (0.00%)	0 / 75 (0.00%)	0 / 77 (0.00%)	0 / 5 (0.00%)	0 / 58 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	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 all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Gastrointestinal disorders
Nausea
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%)	1 / 58 (1.72%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	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%)	1 / 62 (1.61%)	0 / 30 (0.00%)	0 / 82 (0.00%)	0 / 80 (0.00%)	1 / 79 (1.27%)	0 / 81 (0.00%)
occurrences all number	0	0	0	1	0	0	1	0	0	1	0	0	0	0	0	0	0	1	0	0	0	1	0
Nausea(Solicited)
subjects affected / exposed	5 / 77 (6.49%)	27 / 73 (36.99%)	25 / 75 (33.33%)	22 / 75 (29.33%)	19 / 77 (24.68%)	2 / 5 (40.00%)	19 / 58 (32.76%)	2 / 5 (40.00%)	3 / 5 (60.00%)	3 / 5 (60.00%)	2 / 5 (40.00%)	8 / 29 (27.59%)	5 / 81 (6.17%)	2 / 15 (13.33%)	9 / 28 (32.14%)	4 / 32 (12.50%)	2 / 17 (11.76%)	22 / 62 (35.48%)	8 / 30 (26.67%)	11 / 82 (13.41%)	7 / 80 (8.75%)	9 / 79 (11.39%)	11 / 81 (13.58%)
occurrences all number	5	31	29	27	22	2	19	2	3	3	2	8	5	3	10	4	2	27	10	11	7	12	11
Skin and subcutaneous tissue disorders
Dermatitis Contact
subjects affected / exposed	0 / 77 (0.00%)	0 / 73 (0.00%)	0 / 75 (0.00%)	0 / 75 (0.00%)	0 / 77 (0.00%)	0 / 5 (0.00%)	1 / 58 (1.72%)	1 / 5 (20.00%)	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 all number	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hyperhidrosis
subjects affected / exposed	0 / 77 (0.00%)	0 / 73 (0.00%)	1 / 75 (1.33%)	0 / 75 (0.00%)	1 / 77 (1.30%)	0 / 5 (0.00%)	0 / 58 (0.00%)	0 / 5 (0.00%)	2 / 5 (40.00%)	3 / 5 (60.00%)	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 all number	0	0	1	0	1	0	0	0	2	3	0	0	0	0	0	0	0	0	0	0	0	0	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	1 / 77 (1.30%)	1 / 73 (1.37%)	1 / 75 (1.33%)	1 / 75 (1.33%)	1 / 77 (1.30%)	0 / 5 (0.00%)	0 / 58 (0.00%)	0 / 5 (0.00%)	2 / 5 (40.00%)	1 / 5 (20.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	2 / 81 (2.47%)	0 / 15 (0.00%)	1 / 28 (3.57%)	0 / 32 (0.00%)	0 / 17 (0.00%)	0 / 62 (0.00%)	0 / 30 (0.00%)	3 / 82 (3.66%)	0 / 80 (0.00%)	2 / 79 (2.53%)	2 / 81 (2.47%)
occurrences all number	1	1	1	1	1	0	0	0	2	1	0	1	2	0	1	0	0	0	0	3	0	2	2
Back Pain
subjects affected / exposed	0 / 77 (0.00%)	2 / 73 (2.74%)	2 / 75 (2.67%)	2 / 75 (2.67%)	2 / 77 (2.60%)	1 / 5 (20.00%)	0 / 58 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	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%)	3 / 82 (3.66%)	0 / 80 (0.00%)	0 / 79 (0.00%)	2 / 81 (2.47%)
occurrences all number	0	2	2	2	4	1	0	0	0	1	0	0	0	0	0	0	0	0	0	3	0	0	2
Myalgia
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%)	2 / 58 (3.45%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 81 (0.00%)	1 / 15 (6.67%)	1 / 28 (3.57%)	0 / 32 (0.00%)	0 / 17 (0.00%)	0 / 62 (0.00%)	0 / 30 (0.00%)	1 / 82 (1.22%)	1 / 80 (1.25%)	0 / 79 (0.00%)	2 / 81 (2.47%)
occurrences all number	0	0	0	1	0	0	2	0	0	0	0	0	0	1	1	0	0	0	0	1	1	0	2
Myalgia(Solicited)
subjects affected / exposed	4 / 77 (5.19%)	48 / 73 (65.75%)	52 / 75 (69.33%)	34 / 75 (45.33%)	31 / 77 (40.26%)	2 / 5 (40.00%)	34 / 58 (58.62%)	1 / 5 (20.00%)	5 / 5 (100.00%)	5 / 5 (100.00%)	3 / 5 (60.00%)	17 / 29 (58.62%)	26 / 81 (32.10%)	2 / 15 (13.33%)	16 / 28 (57.14%)	13 / 32 (40.63%)	4 / 17 (23.53%)	32 / 62 (51.61%)	20 / 30 (66.67%)	35 / 82 (42.68%)	18 / 80 (22.50%)	27 / 79 (34.18%)	12 / 81 (14.81%)
occurrences all number	4	51	77	37	48	3	34	1	5	7	3	17	34	2	25	13	4	51	27	39	23	31	13
Pain in Extremity
subjects affected / exposed	0 / 77 (0.00%)	1 / 73 (1.37%)	0 / 75 (0.00%)	0 / 75 (0.00%)	0 / 77 (0.00%)	0 / 5 (0.00%)	1 / 58 (1.72%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 81 (0.00%)	0 / 15 (0.00%)	0 / 28 (0.00%)	0 / 32 (0.00%)	1 / 17 (5.88%)	0 / 62 (0.00%)	0 / 30 (0.00%)	0 / 82 (0.00%)	1 / 80 (1.25%)	1 / 79 (1.27%)	0 / 81 (0.00%)
occurrences all number	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0	0	0	1	2	0
Infections and infestations
Asymptomatic Bacteriuria
subjects affected / exposed	0 / 77 (0.00%)	0 / 73 (0.00%)	0 / 75 (0.00%)	0 / 75 (0.00%)	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%)	1 / 17 (5.88%)	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 all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Ear Lobe Infection
subjects affected / exposed	0 / 77 (0.00%)	0 / 73 (0.00%)	0 / 75 (0.00%)	0 / 75 (0.00%)	0 / 77 (0.00%)	1 / 5 (20.00%)	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 all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Oral Herpes
subjects affected / exposed	0 / 77 (0.00%)	0 / 73 (0.00%)	1 / 75 (1.33%)	0 / 75 (0.00%)	0 / 77 (0.00%)	0 / 5 (0.00%)	0 / 58 (0.00%)	0 / 5 (0.00%)	1 / 5 (20.00%)	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 all number	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Rhinitis
subjects affected / exposed	0 / 77 (0.00%)	0 / 73 (0.00%)	0 / 75 (0.00%)	0 / 75 (0.00%)	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%)	1 / 15 (6.67%)	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 all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Sinusitis
subjects affected / exposed	0 / 77 (0.00%)	0 / 73 (0.00%)	0 / 75 (0.00%)	0 / 75 (0.00%)	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%)	1 / 15 (6.67%)	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%)	1 / 79 (1.27%)	1 / 81 (1.23%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1	1
Upper Respiratory Tract Infection
subjects affected / exposed	0 / 77 (0.00%)	1 / 73 (1.37%)	0 / 75 (0.00%)	1 / 75 (1.33%)	4 / 77 (5.19%)	1 / 5 (20.00%)	0 / 58 (0.00%)	1 / 5 (20.00%)	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%)	3 / 79 (3.80%)	1 / 81 (1.23%)
occurrences all number	0	1	0	1	4	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	3	1
Metabolism and nutrition disorders
Vitamin D Deficiency
subjects affected / exposed	0 / 77 (0.00%)	0 / 73 (0.00%)	0 / 75 (0.00%)	0 / 75 (0.00%)	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%)	1 / 15 (6.67%)	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 all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0

More information

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Were there any global substantial amendments to the protocol? Yes

29 Jul 2021

This amendment was created to add another year of follow-up and its related safety and immunogenicity assessments for Cohorts 1a, 1b and 3 subjects in order to collect additional long-term safety and immunogenicity data for more than one year after second vaccination.

07 Oct 2021

The main purpose of this amendment was to remove planned Ad26.COV2.S booster vaccinations at 24 months after the primary regimen for Cohort 2 subjects, due to the smaller number of subjects remaining than expected, mostly related to severe acute respiratory syndrome (coronavirus-2SARS-CoV-2) infections and receiving authorized/licensed coronavirus disease-2019 (COVID-19) vaccines outside of the study.

16 Aug 2022

The main purpose of this amendment was to remove planned Ad26.COV2.S booster vaccinations at 24 months after the primary regimen for Cohort 2 participants, due to the smaller number of subjects remaining than expected, mostly related to severe acute respiratory syndrome (coronavirus-2SARS-CoV-2) infections and receiving authorized/licensed coronavirus disease-2019 (COVID-19) vaccines outside of the study.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

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

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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