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Clinical Trial Results:
Immunogenicity and Safety of SARS-CoV-2 Recombinant Protein Vaccines with AS03 Adjuvant in Adults 18 Years of Age and Older as a Primary Series and Immunogenicity and Safety of a Booster Dose of SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (two Monovalent and one Bivalent)

Summary
EudraCT number	2020-003370-41
Trial protocol	ES
Global end of trial date	29 Jun 2023

Results information
Results version number	v1(current)
This version publication date	27 Feb 2025
First version publication date	27 Feb 2025
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

VAT00002

ISRCTN number

US NCT number

NCT04762680

WHO universal trial number (UTN)

U1111-1251-4616

Sponsor organisation name

Sanofi Pasteur Inc

Sponsor organisation address

Discovery Drive, Swiftwater, Pennsylvania, United States, 18370-0187

Public contact

Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com

Scientific contact

Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.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

06 Sep 2024

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

29 Jun 2023

Was the trial ended prematurely?

Main objective of the trial

- To assess the safety profile of all participants in each age group and in each study Intervention group. - To assess the neutralizing antibody profile after primary series vaccination in severe acute respiratory syndrome coronavirus (SARS-CoV-2) naïve participants. - To demonstrate that a booster dose of monovalent or bivalent SARS-CoV-2 vaccine given to participants previously vaccinated with an authorized/approved coronavirus disease (COVID-19) vaccine induces an immune response that is non-inferior to the response induced by a 2-dose priming series with the monovalent vaccine, and superior to that observed immediately before booster. CoV2 preS dTM= SARS-CoV2 prefusion Spike delta TM, PBP= Pfizer/BioNTech Primed, MP= Moderna Primed, OUAP= Oxford University/AstraZeneca Primed, JJJP= J&J/Janssen Primed and PP= Protein Primed.

Protection of trial subjects

Vaccinations were performed by qualified and trained study personnel. Participants with allergy to any of the vaccine components were not vaccinated. After vaccination, participants were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment were also available on site in case of any immediate allergic reactions.

Background therapy

Evidence for comparator

Actual start date of recruitment

24 Feb 2021

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 363

Country: Number of subjects enrolled

France: 375

Country: Number of subjects enrolled

Honduras: 220

Country: Number of subjects enrolled

New Zealand: 30

Country: Number of subjects enrolled

Spain: 83

Country: Number of subjects enrolled

United Kingdom: 307

Country: Number of subjects enrolled

United States: 1991

Worldwide total number of subjects

3369

EEA total number of subjects

458

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)

2924

From 65 to 84 years

430

85 years and over

Subject disposition

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Recruitment details

The Phase 2 of study was conducted at 20 centers in Honduras and the United States between 24 February 2021 and 01 May 2021. The Phase 3 of study was conducted at 110 centers in Australia, France, Honduras, New Zealand, Spain, United Kingdom, and the United States between 29 July 2021 and 06 January 2023.

Screening details

722 participants were enrolled in Phase 2 and 2647 participants (supplemental Phase 3=2617 and exploratory Phase 3=30) were enrolled in Phase 3 of the study. A total of 3159 unique participants were enrolled in the study.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Investigator, Monitor, Carer, Data analyst, Assessor, Subject

Are arms mutually exclusive

Yes

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1

Arm description

Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant intermuscular (IM) injection once daily on Days 1 and 22.

Arm type

Experimental

Investigational medicinal product name

Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine

Investigational medicinal product code

Other name

SARS-CoV-2 prefusion Spike delta TM protein, recombinant

Pharmaceutical forms

Emulsion for injection

Routes of administration

Intramuscular use

Dosage and administration details

CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2

Arm description

Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.

Arm type

Experimental

Investigational medicinal product name

Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine

Investigational medicinal product code

Other name

SARS-CoV-2 prefusion Spike delta TM protein, recombinant

Pharmaceutical forms

Emulsion for injection

Routes of administration

Intramuscular use

Dosage and administration details

CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3

Arm description

Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.

Arm type

Experimental

Investigational medicinal product name

Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine

Investigational medicinal product code

Other name

SARS-CoV-2 prefusion Spike delta TM protein, recombinant

Pharmaceutical forms

Emulsion for injection

Routes of administration

Intramuscular use

Dosage and administration details

CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)

Arm description

Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

Arm type

Experimental

Investigational medicinal product name

Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine

Investigational medicinal product code

Other name

SARS-CoV-2 prefusion Spike delta TM protein, recombinant

Pharmaceutical forms

Emulsion for injection

Routes of administration

Intramuscular use

Dosage and administration details

CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)

Arm description

Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

Arm type

Experimental

Investigational medicinal product name

Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine

Investigational medicinal product code

Other name

SARS-CoV-2 prefusion Spike delta TM protein, recombinant

Pharmaceutical forms

Emulsion for injection

Routes of administration

Intramuscular use

Dosage and administration details

CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Arm description

Participants previously vaccinated with Pfizer/BioNTech vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

Arm type

Experimental

Investigational medicinal product name

Bivalent CoV2 preS dTM-AS03 COVID-19 vaccine

Investigational medicinal product code

Other name

SARS-CoV-2 prefusion Spike delta TM protein, recombinant

Pharmaceutical forms

Emulsion for injection

Routes of administration

Intramuscular use

Dosage and administration details

CoV2 preS dTM bivalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)

Arm description

Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

Arm type

Experimental

Investigational medicinal product name

Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine

Investigational medicinal product code

Other name

SARS-CoV-2 prefusion Spike delta TM protein, recombinant

Pharmaceutical forms

Emulsion for injection

Routes of administration

Intramuscular use

Dosage and administration details

CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)

Arm description

Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

Arm type

Experimental

Investigational medicinal product name

Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine

Investigational medicinal product code

Other name

SARS-CoV-2 prefusion Spike delta TM protein, recombinant

Pharmaceutical forms

Emulsion for injection

Routes of administration

Intramuscular use

Dosage and administration details

CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Arm description

Participants previously vaccinated with Moderna vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

Arm type

Experimental

Investigational medicinal product name

Bivalent CoV2 preS dTM-AS03 COVID-19 vaccine

Investigational medicinal product code

Other name

SARS-CoV-2 prefusion Spike delta TM protein, recombinant

Pharmaceutical forms

Emulsion for injection

Routes of administration

Intramuscular use

Dosage and administration details

CoV2 preS dTM bivalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)

Arm description

Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

Arm type

Experimental

Investigational medicinal product name

Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine

Investigational medicinal product code

Other name

SARS-CoV-2 prefusion Spike delta TM protein, recombinant

Pharmaceutical forms

Emulsion for injection

Routes of administration

Intramuscular use

Dosage and administration details

CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)

Arm description

Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

Arm type

Experimental

Investigational medicinal product name

Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine

Investigational medicinal product code

Other name

SARS-CoV-2 prefusion Spike delta TM protein, recombinant

Pharmaceutical forms

Emulsion for injection

Routes of administration

Intramuscular use

Dosage and administration details

CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Arm description

Participants previously vaccinated with Oxford University/AstraZeneca vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

Arm type

Experimental

Investigational medicinal product name

Bivalent CoV2 preS dTM-AS03 COVID-19 vaccine

Investigational medicinal product code

Other name

SARS-CoV-2 prefusion Spike delta TM protein, recombinant

Pharmaceutical forms

Emulsion for injection

Routes of administration

Intramuscular use

Dosage and administration details

CoV2 preS dTM bivalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)

Arm description

Participants previously vaccinated with J&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

Arm type

Experimental

Investigational medicinal product name

Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine

Investigational medicinal product code

Other name

SARS-CoV-2 prefusion Spike delta TM protein, recombinant

Pharmaceutical forms

Emulsion for injection

Routes of administration

Intramuscular use

Dosage and administration details

CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)

Arm description

Participants previously vaccinated with J&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

Arm type

Experimental

Investigational medicinal product name

Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine

Investigational medicinal product code

Other name

SARS-CoV-2 prefusion Spike delta TM protein, recombinant

Pharmaceutical forms

Emulsion for injection

Routes of administration

Intramuscular use

Dosage and administration details

CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Arm description

Participants previously vaccinated with J&J/Janssen vaccine received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

Arm type

Experimental

Investigational medicinal product name

Bivalent CoV2 preS dTM-AS03 COVID-19 vaccine

Investigational medicinal product code

Other name

SARS-CoV-2 prefusion Spike delta TM protein, recombinant

Pharmaceutical forms

Emulsion for injection

Routes of administration

Intramuscular use

Dosage and administration details

CoV2 preS dTM bivalent D614 antigen dose 4 plus B.1.351 antigen dose 4 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)

Arm description

Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

Arm type

Experimental

Investigational medicinal product name

Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine

Investigational medicinal product code

Other name

SARS-CoV-2 prefusion Spike delta TM protein, recombinant

Pharmaceutical forms

Emulsion for injection

Routes of administration

Intramuscular use

Dosage and administration details

CoV2 preS dTM monovalent D614 antigen dose 1 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)

Arm description

Participants previously vaccinated with protein based vaccine in Phase 2 of the study received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

Arm type

Experimental

Investigational medicinal product name

Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine

Investigational medicinal product code

Other name

SARS-CoV-2 prefusion Spike delta TM protein, recombinant

Pharmaceutical forms

Emulsion for injection

Routes of administration

Intramuscular use

Dosage and administration details

CoV2 preS dTM monovalent B.1.351 antigen dose 1 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)

Arm description

SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.

Arm type

Active comparator

Investigational medicinal product name

Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine

Investigational medicinal product code

Other name

SARS-CoV-2 prefusion Spike delta TM protein, recombinant

Pharmaceutical forms

Emulsion for injection

Routes of administration

Intramuscular use

Dosage and administration details

CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

Phase 3: Exploratory 1: PBP - CoV2 preS dTM (B.1.351)

Arm description

Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 4 with full-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

Arm type

Experimental

Investigational medicinal product name

Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine

Investigational medicinal product code

Other name

SARS-CoV-2 prefusion Spike delta TM protein, recombinant

Pharmaceutical forms

Emulsion for injection

Routes of administration

Intramuscular use

Dosage and administration details

CoV2 preS dTM monovalent B.1.351 antigen dose 4 with full-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

Phase 3: Exploratory 2: PBP - CoV2 preS dTM (B.1.351)

Arm description

Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 4 with half-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

Arm type

Experimental

Investigational medicinal product name

Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine

Investigational medicinal product code

Other name

SARS-CoV-2 prefusion Spike delta TM protein, recombinant

Pharmaceutical forms

Emulsion for injection

Routes of administration

Intramuscular use

Dosage and administration details

CoV2 preS dTM monovalent B.1.351 antigen dose 4 with half-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

Phase 3: Exploratory 3: PBP - CoV2 preS dTM (B.1.351)

Arm description

Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with half-dose of AS03 adjuvant IM injection between 4 to 10 months after priming vaccine.

Arm type

Experimental

Investigational medicinal product name

Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine

Investigational medicinal product code

Other name

SARS-CoV-2 prefusion Spike delta TM protein, recombinant

Pharmaceutical forms

Emulsion for injection

Routes of administration

Intramuscular use

Dosage and administration details

CoV2 preS dTM monovalent B.1.351 antigen dose 1 with half-dose of AS03 adjuvant was administered to deltoid muscle in the upper arm by IM injection.

Phase 3: Exploratory 4: PBP - CoV2 preS dTM (B.1.351)

Arm description

Participants previously vaccinated with Pfizer mRNA vaccine received a single booster dose of CoV2 preS dTM monovalent B.1.351 antigen dose 1 with no adjuvant IM injection between 4 to 10 months after priming vaccine.

Arm type

Experimental

Investigational medicinal product name

Monovalent CoV2 preS dTM-AS03 COVID-19 vaccine

Investigational medicinal product code

Other name

SARS-CoV-2 prefusion Spike delta TM protein, recombinant

Pharmaceutical forms

Emulsion for injection

Routes of administration

Intramuscular use

Dosage and administration details

CoV2 preS dTM monovalent B.1.351 antigen dose 1 with no adjuvant was administered to deltoid muscle in the upper arm by IM injection.

Number of subjects in period 1	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3	Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)	Phase 3: Exploratory 1: PBP - CoV2 preS dTM (B.1.351)	Phase 3: Exploratory 2: PBP - CoV2 preS dTM (B.1.351)	Phase 3: Exploratory 3: PBP - CoV2 preS dTM (B.1.351)	Phase 3: Exploratory 4: PBP - CoV2 preS dTM (B.1.351)
Started	241	239	242	329	378	378	113	112	108	127	101	101	105	38	38	132	78	479	4	8	9	9
Completed	199	204	204	302	338	337	102	105	100	119	95	98	94	32	31	126	71	368	4	7	9	8
Not completed	42	35	38	27	40	41	11	7	8	8	6	3	11	6	7	6	7	111	0	1	0	1
Consent withdrawn by subject	23	21	28	13	17	12	8	3	2	4	3	1	3	2	1	4	6	32	-	-	-	1
Adverse event, non-fatal	-	1	-	1	-	-	-	-	-	-	-	-	-	-	-	-	-	3	-	-	-	-
Lost to follow-up	14	8	9	9	22	24	2	4	6	4	3	-	5	4	6	1	1	66	-	1	-	-
Protocol deviation	5	5	1	4	1	5	1	-	-	-	-	2	3	-	-	1	-	10	-	-	-	-

Baseline characteristics

Top of page

Reporting group title

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1

Reporting group description

Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant intermuscular (IM) injection once daily on Days 1 and 22.

Reporting group title

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2

Reporting group description

Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.

Reporting group title

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3

Reporting group description

Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.

Reporting group title

Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)

Reporting group description

Reporting group title

Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)

Reporting group description

Reporting group title

Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Reporting group description

Reporting group title

Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)

Reporting group description

Reporting group title

Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)

Reporting group description

Reporting group title

Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Reporting group description

Reporting group title

Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)

Reporting group description

Reporting group title

Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)

Reporting group description

Reporting group title

Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Reporting group description

Reporting group title

Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)

Reporting group description

Reporting group title

Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)

Reporting group description

Reporting group title

Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Reporting group description

Reporting group title

Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)

Reporting group description

Reporting group title

Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)

Reporting group description

Reporting group title

Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)

Reporting group description

SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.

Reporting group title

Phase 3: Exploratory 1: PBP - CoV2 preS dTM (B.1.351)

Reporting group description

Reporting group title

Phase 3: Exploratory 2: PBP - CoV2 preS dTM (B.1.351)

Reporting group description

Reporting group title

Phase 3: Exploratory 3: PBP - CoV2 preS dTM (B.1.351)

Reporting group description

Reporting group title

Phase 3: Exploratory 4: PBP - CoV2 preS dTM (B.1.351)

Reporting group description

Reporting group values	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3	Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)	Phase 3: Exploratory 1: PBP - CoV2 preS dTM (B.1.351)	Phase 3: Exploratory 2: PBP - CoV2 preS dTM (B.1.351)	Phase 3: Exploratory 3: PBP - CoV2 preS dTM (B.1.351)	Phase 3: Exploratory 4: PBP - CoV2 preS dTM (B.1.351)	Total
Number of subjects	241	239	242	329	378	378	113	112	108	127	101	101	105	38	38	132	78	479	4	8	9	9	3369
Age Categorical
Units: participants
Age Continuous
Units: years
arithmetic mean (standard deviation)	53.8 ( 15.3 )	53.5 ( 14.9 )	53.1 ( 15.9 )	49.0 ( 15.5 )	40.6 ( 14.0 )	40.5 ( 13.9 )	47.7 ( 16.4 )	44.4 ( 15.8 )	46.6 ( 13.9 )	54.5 ( 12.2 )	51.6 ( 11.7 )	51.1 ( 13.2 )	46.8 ( 13.2 )	47.1 ( 12.0 )	47.4 ( 12.6 )	54.9 ( 14.8 )	65.9 ( 11.5 )	37.6 ( 11.3 )	33.8 ( 9.50 )	35.5 ( 14.9 )	42.7 ( 12.5 )	44.6 ( 16.9 )	-
Gender Categorical
Units: participants
Female	123	114	122	181	208	199	68	60	64	59	42	48	63	19	20	64	38	215	3	3	8	6	1727
Male	118	125	120	148	170	179	45	52	44	68	59	53	42	19	18	68	40	264	1	5	1	3	1642
Race
Units: Subjects
American Indian or Alaska Native	22	24	20	5	5	6	2	6	2	0	0	0	1	4	2	20	14	15	0	0	0	0	148
Asian	13	10	10	19	12	13	7	1	3	11	4	7	0	2	2	2	2	18	0	0	0	0	136
Black or African American	14	23	20	15	54	61	3	16	32	2	3	2	5	16	10	7	2	52	0	0	0	0	337
Multiple	5	2	4	1	6	6	1	3	1	0	0	1	0	0	0	0	1	8	0	0	0	0	39
Native Hawaiian or Other Pacific Islander	2	1	2	0	2	1	0	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0	10
White	156	149	156	252	247	240	100	79	61	104	92	87	99	15	21	80	37	372	0	0	0	0	2347
Not Reported	4	4	2	33	44	49	0	1	6	10	1	2	0	0	2	0	0	3	4	7	8	9	189
Unknown	25	26	28	4	8	2	0	6	3	0	1	2	0	0	1	23	22	10	0	1	1	0	163

End points

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Reporting group title

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1

Reporting group description

Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant intermuscular (IM) injection once daily on Days 1 and 22.

Reporting group title

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2

Reporting group description

Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.

Reporting group title

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3

Reporting group description

Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.

Reporting group title

Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)

Reporting group description

Reporting group title

Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)

Reporting group description

Reporting group title

Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Reporting group description

Reporting group title

Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)

Reporting group description

Reporting group title

Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)

Reporting group description

Reporting group title

Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Reporting group description

Reporting group title

Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)

Reporting group description

Reporting group title

Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)

Reporting group description

Reporting group title

Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Reporting group description

Reporting group title

Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)

Reporting group description

Reporting group title

Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)

Reporting group description

Reporting group title

Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Reporting group description

Reporting group title

Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)

Reporting group description

Reporting group title

Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)

Reporting group description

Reporting group title

Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)

Reporting group description

SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.

Reporting group title

Phase 3: Exploratory 1: PBP - CoV2 preS dTM (B.1.351)

Reporting group description

Reporting group title

Phase 3: Exploratory 2: PBP - CoV2 preS dTM (B.1.351)

Reporting group description

Reporting group title

Phase 3: Exploratory 3: PBP - CoV2 preS dTM (B.1.351)

Reporting group description

Reporting group title

Phase 3: Exploratory 4: PBP - CoV2 preS dTM (B.1.351)

Reporting group description

Subject analysis set title

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.

Primary: Number of Participants With Immediate Unsolicited Adverse Events (AEs)

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End point title

Number of Participants With Immediate Unsolicited Adverse Events (AEs) ^[1] ^[2]

End point description

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Immediate events were recorded to capture medically relevant unsolicited systemic AEs which occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. The Safety analysis set included participants randomized and who had received at least 1 dose of the study vaccines. Safety analysis was performed according to the actual study vaccine received by the participants.

End point type

Primary

End point timeframe

Up to 30 minutes after each vaccination

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: As the endpoint is descriptive in nature, no statistical analysis is provided.
[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: Participants treated in Phase 3 exploratory reporting groups were not analyzed in this endpoint.

End point values	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3	Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
Number of subjects analysed	240	241	328	378	375	113	111	108	127	100	100	103	38	38	132	78	473	240
Units: participants	2	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	9	1

No statistical analyses for this end point

Primary: Number of Participants With Solicited Injection Site Reactions and Systemic Reactions

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End point title

Number of Participants With Solicited Injection Site Reactions and Systemic Reactions ^[3] ^[4]

End point description

A solicited reaction was an “expected” adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF, and were considered to be related to the study vaccine administered. An injection site reaction was an AR at and around the injection site of the study vaccine. Systemic AR were all ARs that were not injection site reactions. The Safety analysis set included participants randomized and who had received at least 1 dose of the study vaccines. Safety analysis was performed according to the actual study vaccine received by the participants.

End point type

Primary

End point timeframe

Up to 7 days after each vaccination

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: As the endpoint is descriptive in nature, no statistical analysis is provided.
[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: Participants treated in Phase 3 exploratory reporting groups were not analyzed in this endpoint.

End point values	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3	Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
Number of subjects analysed	238	239	326	367	370	113	110	108	127	100	100	102	38	38	132	78	460	237
Units: participants
Injection site reaction	201	200	262	300	303	90	82	74	104	87	87	81	19	19	98	46	375	196
Systemic reaction	191	185	198	238	242	67	67	65	75	61	75	62	14	17	88	36	359	191

No statistical analyses for this end point

Primary: Number of Participants With Unsolicited Adverse Events

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End point title

Number of Participants With Unsolicited Adverse Events ^[5] ^[6]

End point description

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, pre-listed in the CRF in terms of diagnosis and onset window post-vaccination. The Safety analysis set included participants randomized and who had received at least 1 dose of the study vaccines. Safety analysis was performed according to the actual study vaccine received by the participants.

End point type

Primary

End point timeframe

Up to 21 days after each 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: As the endpoint is descriptive in nature, no statistical analysis is provided.
[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: Participants treated in Phase 3 exploratory reporting groups were not analyzed in this endpoint.

End point values	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3	Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
Number of subjects analysed	240	241	328	378	375	113	111	108	127	100	100	103	38	38	132	78	473	240
Units: participants	88	91	76	106	96	29	18	22	34	27	35	16	7	7	25	11	199	81

No statistical analyses for this end point

Primary: Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)

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End point title

Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) ^[7] ^[8]

End point description

An SAE was defined as any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was 1 of scientific and medical concern specific to the Sponsor’s study intervention or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor could be appropriate. An MAAE was a new onset or a worsening of a condition that prompted the participant or participant’s parent/guardian to seek unplanned medical advice at a physician’s office or Emergency Department. The Safety analysis set included participants randomized and who had received at least 1 dose of the study vaccines. Safety analysis was performed according to the actual study vaccine received by the participants.

End point type

Primary

End point timeframe

Phase 2 and Phase 3 Comparator: From first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: From first dose of study vaccine administration (Day 1) up to 366 days.

Notes
[7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
[8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Participants treated in Phase 3 exploratory reporting groups were not analyzed in this endpoint.

End point values	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3	Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
Number of subjects analysed	240	241	328	378	375	113	111	108	127	100	100	103	38	38	132	78	473	240
Units: participants
SAE	2	4	8	9	11	3	1	4	3	4	0	1	2	3	3	3	14	6
AESI	0	0	2	0	1	1	0	0	0	0	1	0	0	0	0	1	1	0
MAAE	42	59	80	106	117	28	25	19	31	24	29	19	7	7	42	32	110	48

No statistical analyses for this end point

Primary: Phase 2: Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) D614G Strain at Day 1

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End point title

Phase 2: Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) D614G Strain at Day 1 ^[9] ^[10]

End point description

Neutralizing antibodies activity against SARS-CoV-2 D614G strain was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers. The per-protocol analysis set (PPAS) Naïve-D01+D22 is a subset of the FAS. Here, -99999 and 99999= The upper and lower limits of 95% confidence interval was not calculable.

End point type

Primary

End point timeframe

Pre-vaccination on Day 1

Notes
[9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
[10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only participants treated in Phase 2 of the study were analyzed in this endpoint.

End point values	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
Number of subjects analysed	167	170	171
Units: titers
geometric mean (confidence interval 95%)	20.0 (-99999 to 99999)	20.0 (-99999 to 99999)	20.0 (-99999 to 99999)

No statistical analyses for this end point

Primary: Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Day 36

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End point title

Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Day 36 ^[11] ^[12]

End point description

End point type

Primary

End point timeframe

Day 36

Notes
[11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
[12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only participants treated in Phase 2 of the study were analyzed in this endpoint.

End point values	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
Number of subjects analysed	162	163	167
Units: titers
geometric mean (confidence interval 95%)	2132 (1690 to 2688)	2376 (1873 to 3015)	2903 (2289 to 3683)

No statistical analyses for this end point

Primary: Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Day 36

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End point title

Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Day 36 ^[13] ^[14]

End point description

Neutralizing antibodies activity against SARS-CoV-2 D614G strain was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers >=2-fold and >=4-fold increase from baseline (pre-vaccination) were analyzed. The PPAS Naïve-D01+D22 is a subset of the FAS.

End point type

Primary

End point timeframe

Day 1 (pre-vaccination) and Day 36

Notes
[13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
[14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only participants treated in Phase 2 of the study were analyzed in this endpoint.

End point values	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
Number of subjects analysed	159	158	161
Units: participants
>=2-fold rise	155	156	158
>=4-fold rise	154	154	157

No statistical analyses for this end point

Primary: Phase 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Day 36

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End point title

Phase 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Day 36 ^[15] ^[16]

End point description

Responders were participants who had baseline values below lower limit of quantification (LLOQ) with detectable neutralization titer above assay LLOQ at each pre-defined post-vaccination time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination time point. The PPAS Naïve-D01+D22 is a subset of the FAS.

End point type

Primary

End point timeframe

Day 36

Notes
[15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
[16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only participants treated in Phase 2 of the study were analyzed in this endpoint.

End point values	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
Number of subjects analysed	159	158	161
Units: participants	155	156	158

No statistical analyses for this end point

Primary: Phase 3: Cohorts 1 and 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Day 1

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End point title

Phase 3: Cohorts 1 and 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Day 1 ^[17] ^[18]

End point description

Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 variant was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers. The PPAS is a subset of the FAS. Here, n= number of participants analyzed for each parameter.

End point type

Primary

End point timeframe

Pre-vaccination on Day 1

Notes
[17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
[18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only participants treated in Phase 3 Cohorts 1 and 2 reporting groups were analyzed in this endpoint.

Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)

Number of subjects analysed

301 ^[19]

348 ^[20]

345 ^[21]

107 ^[22]

107 ^[23]

101 ^[24]

120 ^[25]

90 ^[26]

97 ^[27]

89 ^[28]

36 ^[29]

36 ^[30]

108 ^[31]

68 ^[32]

Units: titers

geometric mean (confidence interval 95%)

D614G

320 (275 to 373)

678 (558 to 824)

579 (478 to 701)

668 (537 to 830)

1107 (816 to 1503)

1347 (977 to 1858)

265 (190 to 369)

137 (98.0 to 193)

134 (95.7 to 186)

222 (155 to 318)

1188 (567 to 2490)

447 (217 to 921)

274 (182 to 413)

159 (97.4 to 260)

B.1.351

70.1 (60.3 to 81.4)

176 (142 to 217)

149 (120 to 184)

122 (95.4 to 157)

258 (182 to 364)

296 (207 to 424)

54.1 (41.4 to 70.7)

43.3 (32.0 to 58.5)

36.8 (28.8 to 47.1)

42.6 (32.5 to 55.7)

345 (167 to 714)

122 (55.3 to 268)

97.7 (68.0 to 140)

70.3 (47.9 to 103)

Notes
[19] - D614G (n=301) B.1.351 (n=290)
[20] - D614G (n=348) B.1.351 (n=336)
[21] - D614G (n=345) B.1.351 (n=324)
[22] - D614G (n=107) B.1.351 (n=88)
[23] - D614G (n=107) B.1.351 (n=97)
[24] - D614G (n=101) B.1.351 (n=94)
[25] - D614G (n=107) B.1.351 (n=120)
[26] - D614G (n=89) B.1.351 (n=90)
[27] - D614G (n=93) B.1.351 (n=97)
[28] - D614G (n=82) B.1.351 (n=89)
[29] - D614G (n=36) B.1.351 (n=36)
[30] - D614G (n=36) B.1.351 (n=34)
[31] - D614G (n=107) B.1.351 (n=108)
[32] - D614G (n=67) B.1.351 (n=68)

No statistical analyses for this end point

Primary: Phase 3: Cohorts 1, 2 and Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at 14 Days Post-Vaccination

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End point title

Phase 3: Cohorts 1, 2 and Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at 14 Days Post-Vaccination ^[33] ^[34]

End point description

End point type

Primary

End point timeframe

Cohorts 1 and 2: 14 days post-vaccination on Day 1, Day 15; Comparator: 14 days post-vaccination on Day 22, Day 36

Notes
[33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: As the endpoint is descriptive in nature, no statistical analysis is provided.
[34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only participants treated in Phase 3 Cohorts 1, 2 and comparator reporting groups were analyzed in this endpoint.

Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)

Number of subjects analysed

301 ^[35]

325 ^[36]

334 ^[37]

101 ^[38]

93 ^[39]

96 ^[40]

118 ^[41]

94 ^[42]

93 ^[43]

91 ^[44]

31 ^[45]

34 ^[46]

119 ^[47]

72 ^[48]

307 ^[49]

Units: titers

geometric mean (confidence interval 95%)

D614G

6964 (6268 to 7737)

9995 (8976 to 11129)

8430 (7572 to 9386)

6347 (5207 to 7736)

14240 (11257 to 18013)

12522 (10368 to 15123)

6257 (5313 to 7369)

5536 (4436 to 6910)

5855 (4669 to 7344)

6875 (5587 to 8460)

11005 (7533 to 16078)

11624 (8086 to 16710)

22457 (19123 to 26374)

25002 (18441 to 33897)

3611 (3086 to 4224)

B.1.351

2610 (2316 to 2942)

7021 (6262 to 7873)

4900 (4370 to 5494)

2222 (1754 to 2814)

9449 (7376 to 12104)

6581 (5340 to 8111)

2062 (1708 to 2489)

4610 (3689 to 5760)

3099 (2386 to 4026)

2054 (1642 to 2568)

6872 (4482 to 10537)

5057 (3416 to 7488)

7452 (6212 to 8939)

13300 (9817 to 18018)

413 (346 to 493)

Notes
[35] - D614G (n=301) B.1.351 (n=299)
[36] - D614G (n=325) B.1.351 (n=325)
[37] - D614G (n=334) B.1.351 (n=334)
[38] - D614G (n=101) B.1.351 (n=98)
[39] - D614G (n=93) B.1.351 (n=93)
[40] - D614G (n=96) B.1.351 (n=95)
[41] - D614G (n=118) B.1.351 (n=118)
[42] - D614G (n=94) B.1.351 (n=94)
[43] - D614G (n=93) B.1.351 (n=93)
[44] - D614G (n=91) B.1.351 (n=89)
[45] - D614G (n=31) B.1.351 (n=30)
[46] - D614G (n=34) B.1.351 (n=34)
[47] - D614G (n=119) B.1.351 (n=119)
[48] - D614G (n=72) B.1.351 (n=72)
[49] - D614G (n=307) B.1.351 (n=296)

No statistical analyses for this end point

Primary: Phase 3: Comparator: Percentage of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Day 36

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End point title

Phase 3: Comparator: Percentage of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Day 36 ^[50] ^[51]

End point description

Responders were participants who had baseline values below LLOQ with detectable neutralization titer above assay LLOQ at each pre-defined post-vaccination time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination time point. The PPAS is a subset of the FAS. Here, n= number of participants analyzed for each parameter. Percentages are rounded off to the tenth decimal place.

End point type

Primary

End point timeframe

Day 36

Notes
[50] - 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: As the endpoint is descriptive in nature, no statistical analysis is provided.
[51] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only participants treated in Phase 3 comparator reporting group were analyzed in this endpoint.

End point values	Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
Number of subjects analysed	301
Units: percentage of participants
number (confidence interval 95%)
D614G (n=301)	99.3 (97.6 to 99.9)
B.1.351 (n=290)	91.0 (87.1 to 94.1)

No statistical analyses for this end point

Secondary: Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387

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End point title

Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387 ^[52]

End point description

Neutralizing antibodies activity against SARS-CoV-2 D614G strain was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers. The PPAS Naïve-D01+D22 is a subset of the FAS. Here, n= number of participants analyzed at specific timepoint.

End point type

Secondary

End point timeframe

Post-vaccination on Days 22, 78, 134, 202, 292, and 387

Notes
[52] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only participants treated in Phase 2 of the study were analyzed in this endpoint.

End point values	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
Number of subjects analysed	159 ^[53]	160 ^[54]	160 ^[55]
Units: titers
geometric mean (confidence interval 95%)
Day 22	36.0 (29.4 to 44.2)	39.6 (32.3 to 48.6)	47.3 (37.8 to 59.1)
Day 78	467 (361 to 606)	558 (438 to 711)	569 (458 to 707)
Day 134	225 (160 to 318)	249 (182 to 340)	260 (190 to 358)
Day 202	254 (158 to 408)	344 (208 to 570)	259 (159 to 421)
Day 292	12145 (3643 to 40491)	2518 (335 to 18928)	804 (108 to 6014)
Day 387	17837 (9491 to 33522)	46305 (24179 to 88677)	8353 (1414 to 49336)

Notes
[53] - Day 22 (n=159) Day 78 (n=118) Day 134 (n=99) Day 202 (n=73) Day 292 (n=11) Day 387 (n=11)
[54] - Day 22 (n=160) Day 78 (n=124) Day 134 (n=103) Day 202 (n=76) Day 292 (n=11) Day 387 (n=9)
[55] - Day 22 (n=160) Day 78 (n=121) Day 134 (n=94) Day 202 (n=77) Day 292 (n=13) Day 387 (n=12)

No statistical analyses for this end point

Secondary: Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387

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End point title

Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387 ^[56]

End point description

End point type

Secondary

End point timeframe

Pre-vaccination on Day 1 and Post-vaccination on Days 22, 78, 134, 202, 292, and 387

Notes
[56] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only participants treated in Phase 2 of the study were analyzed in this endpoint.

End point values	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
Number of subjects analysed	159 ^[57]	160 ^[58]	159 ^[59]
Units: participants
Day 22: >=2-fold rise	35	44	53
Day 22: >=4-fold rise	28	36	44
Day 78: >=2-fold rise	108	116	113
Day 78: >=4-fold rise	105	115	110
Day 134: >=2-fold rise	85	87	82
Day 134: >=4-fold rise	75	83	76
Day 202: >=2-fold rise	57	62	62
Day 202: >=4-fold rise	53	57	60
Day 292: >=2-fold rise	10	10	11
Day 292: >=4-fold rise	10	9	8
Day 387: >=2-fold rise	10	9	11
Day 387: >=4-fold rise	10	9	11

Notes
[57] - Day 22 (n=159) Day 78 (n=116) Day 134 (n=98) Day 202 (n=72) Day 292 (n=10) Day 387 (n=10)
[58] - Day 22 (n=160) Day 78 (n=123) Day 134 (n=102) Day 202 (n=75) Day 292 (n=11) Day 387 (n=9)
[59] - Day 22 (n=159) Day 78 (n=117) Day 134 (n=93) Day 202 (n=77) Day 292 (n=13) Day 387 (n=12)

No statistical analyses for this end point

Secondary: Phase 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387

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End point title

Phase 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387 ^[60]

End point description

Responders were participants who had baseline values below LLOQ with detectable neutralization titer above assay LLOQ at each pre-defined post-vaccination time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination time point. Neutralizing antibodies activity against SARS-CoV-2 D614G strain was measured with serum neutralization assay (monogram assay). The PPAS Naïve-D01+D22 is a subset of the FAS. Here, n= number of participants analyzed at specific timepoint.

End point type

Secondary

End point timeframe

Post-vaccination on Days 22, 78, 134, 202, 292, and 387

Notes
[60] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only participants treated in Phase 2 of the study were analyzed in this endpoint.

End point values	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
Number of subjects analysed	159 ^[61]	160 ^[62]	159 ^[63]
Units: participants
Day 22	35	44	53
Day 78	108	116	113
Day 134	85	87	82
Day 202	57	62	62
Day 292	10	10	11
Day 387	10	9	11

Notes
[61] - Day 22 (n=159) Day 78 (n=116) Day 134 (n=98) Day 202 (n=72) Day 292 (n=10) Day 387 (n=10)
[62] - Day 22 (n=160) Day 78 (n=123) Day 134 (n=102) Day 202 (n=75) Day 292 (n=11) Day 387 (n=9)
[63] - Day 22 (n=159) Day 78 (n=117) Day 134 (n=93) Day 202 (n=77) Day 292 (n=13) Day 387 (n=12)

No statistical analyses for this end point

Secondary: Phase 2: Geometric Mean Concentration (GMC) of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 78, 134, 202, 292, and 387

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End point title

Phase 2: Geometric Mean Concentration (GMC) of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 78, 134, 202, 292, and 387 ^[64]

End point description

Binding antibodies activity against SARS-CoV-2 D614G strain was measured with Nexelis GCN4 S-enzyme-linked immunosorbent assay (ELISA) and the results were expressed as geometric mean concentrations. The PPAS Naïve-D01+D22 is a subset of the FAS. Here, n= number of participants analyzed at specific timepoint.

End point type

Secondary

End point timeframe

Pre-vaccination on Day 1 and post-vaccination on Days 22, 36, 78, 134, 202, 292, and 387

Notes
[64] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only participants treated in Phase 2 of the study were analyzed in this endpoint.

End point values	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
Number of subjects analysed	169	172	176
Units: titers
geometric mean (confidence interval 95%)
Day 1 (n=166,170,175)	10.3 (9.54 to 11.1)	9.99 (9.52 to 10.5)	10.2 (9.77 to 10.7)
Day 22 (n=169,172,176)	103 (80.6 to 131)	149 (119 to 187)	228 (182 to 285)
Day 36 (n=165,167,171)	15533 (13000 to 18560)	17176 (14468 to 20390)	18003 (15039 to 21550)
Day 78 (n=126,127,127)	6572 (5469 to 7897)	7526 (6112 to 9267)	7133 (5848 to 8700)
Day 134 (n=105,111,100)	2750 (2104 to 3594)	2977 (2305 to 3846)	2696 (2064 to 3521)
Day 202 (n=87,93,87)	1414 (983 to 2033)	1961 (1369 to 2809)	1438 (978 to 2113)
Day 292 (n=12,12,14)	40589 (10633 to 155000)	9247 (1625 to 52615)	5557 (1183 to 26116)
Day 387 (n=11,10,13)	61087 (40242 to 92728)	58674 (12370 to 278000)	16234 (3146 to 83760)

No statistical analyses for this end point

Secondary: Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387

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End point title

Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387 ^[65]

End point description

Binding antibodies concentration against SARS-CoV-2 D614G strain was measured with Nexelis GCN4 S-ELISA assay. Participants with binding antibodies concentration >=2-fold and >=4-fold increase from baseline (pre-vaccination) were analyzed. The PPAS Naïve-D01+D22 is a subset of the FAS. Here, n= number of participants analyzed at specific timepoint.

End point type

Secondary

End point timeframe

Pre-vaccination on Day 1 and Post-vaccination on Days 22, 36, 78, 134, 202, 292, and 387

Notes
[65] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only participants treated in Phase 2 of the study were analyzed in this endpoint.

End point values	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
Number of subjects analysed	166 ^[66]	170 ^[67]	175 ^[68]
Units: participants
Day 22: >=2-fold rise	141	155	161
Day 22: >=4-fold rise	117	136	156
Day 36: >=2-fold rise	159	160	165
Day 36: >=4-fold rise	158	160	165
Day 78: >=2-fold rise	121	124	124
Day 78: >=4-fold rise	121	124	124
Day 134: >=2-fold rise	101	109	100
Day 134: >=4-fold rise	101	109	100
Day 202: >=2-fold rise	85	91	86
Day 202: >=4-fold rise	85	91	85
Day 292: >=2-fold rise	11	12	14
Day 292: >=4-fold rise	11	12	14
Day 387: >=2-fold rise	10	10	13
Day 387: >=4-fold rise	10	10	13

Notes
[66] - Day 22(n=166) Day 36(n=159) Day 78(n=121) Day 134(n=101) Day 202(n=85) Day 292(n=11) Day 387(n=10)
[67] - Day 22(n=170) Day 36(n=161) Day 78(n=125) Day 134(n=110) Day 202(n=92) Day 292(n=12) Day 387(n=10)
[68] - Day 22(n=175) Day 36(n=166) Day 78(n=124) Day 134(n=100) Day 202(n=87) Day 292(n=14) Day 387(n=13)

No statistical analyses for this end point

Secondary: Phase 2: Number of Responders as Determined by Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387

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End point title

Phase 2: Number of Responders as Determined by Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387 ^[69]

End point description

Responders were participants who had baseline values below LLOQ with detectable antibody concentration above assay LLOQ at each pre-defined post-vaccination time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination time point. Binding antibodies concentration against SARS-CoV-2 D614G strain was measured with Nexelis GCN4 S-ELISA assay. The PPAS Naïve-D01+D22 is a subset of the FAS. Here, n= number of participants analyzed at specific timepoint.

End point type

Secondary

End point timeframe

Post-vaccination on Days 22, 36, 78, 134, 202, 292, and 387

Notes
[69] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only participants treated in Phase 2 of the study were analyzed in this endpoint.

End point values	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
Number of subjects analysed	166 ^[70]	170 ^[71]	175 ^[72]
Units: participants
Day 22	139	154	161
Day 36	159	160	165
Day 78	121	124	124
Day 134	101	109	100
Day 202	85	91	86
Day 292	11	12	14
Day 387	10	10	13

Notes
[70] - Day 22(n=166) Day 36(n=159) Day 78(n=121) Day 134(n=101) Day 202(n=85) Day 292(n=11) Day 387(n=10)
[71] - Day 22(n=170) Day 36(n=161) Day 78(n=125) Day 134(n=110) Day 202(n=92) Day 292(n=12) Day 387(n=10)
[72] - Day 22(n=175) Day 36(n=166) Day 78(n=124) Day 134(n=100) Day 202(n=87) Day 292(n=14) Day 387(n=13)

No statistical analyses for this end point

Secondary: Phase 3: Cohort 1: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 29, 91, 181, and 366

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End point title

Phase 3: Cohort 1: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 29, 91, 181, and 366 ^[73]

End point description

End point type

Secondary

End point timeframe

Post-vaccination on Days 29, 91, 181, and 366

Notes
[73] - 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: Only participants treated in Phase 3 Cohort 1 reporting groups were analyzed in this endpoint.

End point values	Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
Number of subjects analysed	311	106	117	96
Units: titers
geometric mean (confidence interval 95%)
Day 29: D614G (n=311,106,117,96)	5795 (5222 to 6432)	5743 (4668 to 7065)	4869 (4113 to 5764)	4400 (3566 to 5430)
Day 29: B.1.351 (n=307,104,117,96)	2078 (1844 to 2342)	1726 (1355 to 2198)	1790 (1452 to 2207)	1390 (1095 to 1764)
Day 91: D614G (n=249,91,86,84)	4623 (4037 to 5295)	4879 (3774 to 6308)	2704 (2065 to 3541)	2509 (1954 to 3223)
Day 91: B.1.351 (n=248,90,83,83)	1522 (1304 to 1776)	1254 (920 to 1711)	949 (702 to 1281)	711 (540 to 936)
Day 181: D614G (n=197,59,74,66)	7502 (6161 to 9135)	10068 (6940 to 14605)	2658 (1834 to 3852)	5649 (3695 to 8635)
Day 181: B.1.351 (n=196,56,70,64)	2328 (1827 to 2966)	3217 (2073 to 4992)	1035 (650 to 1648)	1853 (1095 to 3134)
Day 366: D614G (n=161,47,46,42)	10224 (8101 to 12903)	10567 (6608 to 16898)	2940 (1779 to 4858)	6314 (3847 to 10361)
Day 366: B.1.351 (n=162,47,46,41)	3419 (2572 to 4545)	3349 (1929 to 5812)	942 (533 to 1664)	2233 (1267 to 3937)

No statistical analyses for this end point

Secondary: Phase 3: Cohort 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366

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End point title

Phase 3: Cohort 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366 ^[74]

End point description

Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 variant was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers >=2-fold and >=4-fold increase from baseline (pre-vaccination) were analyzed. The PPAS is a subset of the FAS. Here, n= number of participants analyzed for each parameter at specific timepoint.

End point type

Secondary

End point timeframe

Pre-vaccination on Day 1 and Post-vaccination on Days 15, 29, 91, 181, and 366

Notes
[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: Only participants treated in Phase 3 Cohort 1 reporting groups were analyzed in this endpoint.

End point values	Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)
Number of subjects analysed	290	104	114	87
Units: participants
D614G; Day 15: >=2-fold rise (n=278,98,101,75)	263	86	95	70
D614G; Day 15: >=4-fold rise (n=278,98,101,75)	252	70	87	66
D614G; Day 29: >=2-fold rise (n=290,104,102,80)	266	91	97	73
D614G; Day 29: >=4-fold rise (n=290,104,102,80)	250	79	87	68
D614G; Day 91: >=2-fold rise (n=233,89,74,72)	208	74	67	62
D614G; Day 91: >=4-fold rise (n=233,89,74,72)	187	57	58	56
D614G; Day 181: >=2-fold rise (n=182,58,63,55)	167	50	54	51
D614G; Day 181: >=4-fold rise (n=182,58,63,55)	149	44	42	41
D614G; Day 366: >=2-fold rise (n=152,45,37,37)	141	38	33	31
D614G; Day 366: >=4-fold rise (n=152,45,37,37)	129	34	28	31
B.1.351; Day 15: >=2-fold rise (n=266,79,114,81)	258	76	109	78
B.1.351; Day 15: >=4-fold rise (n=266,79,114,81)	246	67	103	76
B.1.351; Day 29: >=2-fold rise (n=273,85,113,87)	261	79	109	83
B.1.351; Day 29: >=4-fold rise (n=273,85,113,87)	245	70	103	80
B.1.351; Day 91: >=2-fold rise (n=224,74,79,75)	203	64	75	68
B.1.351; Day 91: >=4-fold rise (n=224,74,79,75)	189	54	67	66
B.1.351; Day 181: >=2-fold rise (n=173,44,68,58)	162	38	59	54
B.1.351; Day 181: >=4-fold rise (n=173,44,68,58)	145	38	51	46
B.1.351; Day 366: >=2-fold rise (n=147,35,43,36)	137	32	36	34
B.1.351; Day 366: >=4-fold rise (n=147,35,43,36)	127	30	34	30

No statistical analyses for this end point

Secondary: Phase 3: Cohorts 1, 2 and Comparator: Percentage of Participants With Seroresponse Against SARS-CoV-2 D614G Strain and B.1.351 Variant at 14 Days Post-Vaccination

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End point title

Phase 3: Cohorts 1, 2 and Comparator: Percentage of Participants With Seroresponse Against SARS-CoV-2 D614G Strain and B.1.351 Variant at 14 Days Post-Vaccination ^[75]

End point description

Seroresponse was defined as a >=4-fold rise in serum neutralization titer against SARS-CoV-2 D614G strain and B.1.351 variant (post/pre) at Day 15 or Day 36 relative to Day 0 or Day 22. Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 variant was measured with serum neutralization assay (monogram assay). The PPAS is a subset of the FAS. Here, n= number of participants analyzed for each parameter at specific timepoint. Percentages are rounded off to the tenth decimal place.

End point type

Secondary

End point timeframe

Cohorts 1 and 2: 14 days post-vaccination on Day 1 (Day 15); Comparator: 14 days post-vaccination on Day 22 (Day 36)

Notes
[75] - 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: Only participants treated in Phase 3 Cohorts 1, 2 and comparator reporting groups were analyzed in this endpoint.

Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)

Number of subjects analysed

278 ^[76]

315 ^[77]

320 ^[78]

98 ^[79]

92 ^[80]

91 ^[81]

114 ^[82]

87 ^[83]

91 ^[84]

81 ^[85]

31 ^[86]

33 ^[87]

99 ^[88]

64 ^[89]

301 ^[90]

Units: percentage of participants

number (confidence interval 95%)

D614G

90.6 (86.6 to 93.8)

73.7 (68.4 to 78.4)

75.6 (70.5 to 80.2)

71.4 (61.4 to 80.1)

72.8 (62.6 to 81.6)

63.7 (53.0 to 73.6)

86.1 (77.8 to 92.2)

89.7 (81.3 to 95.2)

89.8 (81.5 to 95.2)

88.0 (78.4 to 94.4)

58.1 (39.1 to 75.5)

78.8 (61.1 to 91.0)

84.8 (76.2 to 91.3)

90.6 (80.7 to 96.5)

99.0 (97.1 to 99.8)

B.1.351

92.5 (88.6 to 95.3)

83.3 (78.6 to 87.3)

82.9 (78.1 to 87.0)

84.8 (75.0 to 91.9)

83.3 (73.6 to 90.6)

80.0 (69.9 to 87.9)

90.4 (83.4 to 95.1)

95.4 (88.6 to 98.7)

96.7 (90.7 to 99.3)

93.8 (86.2 to 98.0)

75.9 (56.5 to 89.7)

77.4 (58.9 to 90.4)

85.9 (77.4 to 92.0)

90.6 (80.7 to 96.5)

86.6 (82.1 to 90.3)

Notes
[76] - D614G (n=278) B.1.351 (n=266)
[77] - D614G (n=315) B.1.351 (n=299)
[78] - D614G (n=320) B.1.351 (n=298)
[79] - D614G (n=98) B.1.351 (n=79)
[80] - D614G (n=92) B.1.351 (n=84)
[81] - D614G (n=91) B.1.351 (n=85)
[82] - D614G (n=101) B.1.351 (n=114)
[83] - D614G (n=87) B.1.351 (n=87)
[84] - D614G (n=88) B.1.351 (n=91)
[85] - D614G (n=75) B.1.351 (n=81)
[86] - D614G (n=31) B.1.351 (n=29)
[87] - D614G (n=33) B.1.351 (n=31)
[88] - D614G (n=99) B.1.351 (n=99)
[89] - D614G (n=64) B.1.351 (n=64)
[90] - D614G (n=301) B.1.351 (n=290)

No statistical analyses for this end point

Secondary: Phase 3: Cohorts 1 and 2: Geometric Mean Concentration of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 15, 29, 91, 181, and 366

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End point title

Phase 3: Cohorts 1 and 2: Geometric Mean Concentration of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 15, 29, 91, 181, and 366 ^[91]

End point description

Binding antibodies activity against SARS-CoV-2 D614G strain was measured with Nexelis GCN4 S-ELISA and the results were expressed as geometric mean concentrations. The PPAS is a subset of the FAS. Here, n= number of participants analyzed at specific timepoint and 99999= no participants were analyzed.

End point type

Secondary

End point timeframe

Pre-vaccination on Day 1 and post-vaccination on Days 15, 29, 91, 181, and 366

Notes
[91] - 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: Only participants treated in Phase 3 Cohorts 1 and 2 reporting groups were analyzed in this endpoint.

Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)

Number of subjects analysed

326 ^[92]

362 ^[93]

361 ^[94]

110 ^[95]

108 ^[96]

107 ^[97]

125 ^[98]

97 ^[99]

99 ^[100]

99 ^[101]

37 ^[102]

37 ^[103]

130 ^[104]

77 ^[105]

Units: titers

geometric mean (confidence interval 95%)

Day 1

1888 (1687 to 2114)

3032 (2621 to 3507)

2580 (2228 to 2987)

3236 (2729 to 3839)

3285 (2534 to 4259)

3505 (2747 to 4471)

993 (781 to 1262)

564 (427 to 747)

537 (420 to 687)

608 (457 to 809)

2290 (1068 to 4908)

996 (491 to 2021)

1357 (1004 to 1834)

969 (688 to 1365)

Day 15

26710 (24337 to 29314)

36428 (33227 to 39938)

30892 (27925 to 34174)

27390 (23220 to 32309)

43611 (35852 to 53049)

34704 (29398 to 40968)

21654 (18927 to 24775)

23775 (19137 to 29537)

28783 (24417 to 33930)

21758 (18254 to 25935)

31067 (24221 to 39849)

34534 (26146 to 45614)

65824 (57576 to 75254)

77057 (61772 to 96125)

Day 29

20212 (18487 to 22097)

33416 (30407 to 36723)

27083 (24480 to 29964)

23079 (19417 to 27431)

48428 (39336 to 59623)

41018 (34290 to 49065)

13305 (11657 to 15186)

16401 (13253 to 20296)

17729 (14944 to 21034)

14014 (11798 to 16647)

29315 (22236 to 38647)

24388 (17369 to 34243)

60707 (52764 to 69845)

65974 (53800 to 80902)

Day 91

18845 (16780 to 21165)

29384 (25972 to 33244)

23908 (20860 to 27402)

20758 (16506 to 26107)

37791 (29062 to 49140)

35363 (28656 to 43639)

9792 (8093 to 11849)

10365 (8105 to 13255)

13189 (10078 to 17261)

9032 (7387 to 11043)

18463 (13497 to 25255)

16236 (9684 to 27219)

41282 (34967 to 48736)

40566 (32032 to 51373)

Day 181

20073 (17076 to 23596)

20450 (18029 to 23195)

18628 (16117 to 21530)

25701 (17854 to 36998)

25615 (20346 to 32248)

24500 (19714 to 30448)

7281 (5366 to 9880)

8665 (6100 to 12311)

10649 (7312 to 15510)

12342 (8420 to 18092)

11275 (7727 to 16451)

19231 (12448 to 29712)

21387 (17825 to 25661)

20803 (16151 to 26794)

Day 366

41232 (28233 to 60218)

19545 (17037 to 22422)

19989 (17351 to 23028)

32368 (16026 to 65374)

25800 (20031 to 33232)

19848 (15543 to 25345)

99999 (99999 to 99999)

10382 (6531 to 16505)

10937 (6565 to 18220)

14545 (4542 to 46582)

12176 (8897 to 16664)

12002 (8266 to 17425)

32168 (25602 to 40417)

33194 (24774 to 44476)

Notes
[92] - Day 1 (n=326) Day 15 (n=302) Day 29 (n=312) Day 91 (n=251) Day 181 (n=198) Day 366 (n=28)
[93] - Day 1 (n=362) Day 15 (n=323) Day 29 (n=334) Day 91 (n=267) Day 181 (n=257) Day 366 (n=234)
[94] - Day 1 (n=361) Day 15 (n=335) Day 29 (n=341) Day 91 (n=280) Day 181 (n=269) Day 366 (n=241)
[95] - Day 1 (n=110) Day 15 (n=102) Day 29 (n=107) Day 91 (n=92) Day 181 (n=59) Day 366 (n=20)
[96] - Day 1 (n=108) Day 15 (n=93) Day 29 (n=98) Day 91 (n=84) Day 181 (n=85) Day 366 (n=81)
[97] - Day 1 (n=107) Day 15 (n=98) Day 29 (n=101) Day 91 (n=91) Day 181 (n=83) Day 366 (n=72)
[98] - Day 1 (n=125) Day 15 (n=119) Day 29 (n=118) Day 91 (n=87) Day 181 (n=74) Day 366 (n=0)
[99] - Day 1 (n=97) Day 15 (n=94) Day 29 (n=94) Day 91 (n=61) Day 181 (n=57) Day 366 (n=30)
[100] - Day 1 (n=99) Day 15 (n=93) Day 29 (n=92) Day 91 (n=60) Day 181 (n=51) Day 366 (n=32)
[101] - Day 1 (n=99) Day 15 (n=92) Day 29 (n=97) Day 91 (n=87) Day 181 (n=66) Day 366 (n=10)
[102] - Day 1 (n=37) Day 15 (n=31) Day 29 (n=34) Day 91 (n=29) Day 181 (n=25) Day 366 (n=22)
[103] - Day 1 (n=37) Day 15 (n=34) Day 29 (n=31) Day 91 (n=26) Day 181 (n=25) Day 366 (n=22)
[104] - Day 1 (n=130) Day 15 (n=120) Day 29 (n=124) Day 91 (n=114) Day 181 (n=116) Day 366 (n=99)
[105] - Day 1 (n=77) Day 15 (n=72) Day 29 (n=71) Day 91 (n=69) Day 181 (n=68) Day 366 (n=57)

No statistical analyses for this end point

Secondary: Phase 3: Cohorts 1 and 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 15, 29, 91, 181, and 366

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End point title

Phase 3: Cohorts 1 and 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 15, 29, 91, 181, and 366 ^[106]

End point description

Binding antibodies concentration against SARS-CoV-2 D614G strain was measured with Nexelis GCN4 S-ELISA assay. Participants with binding antibodies concentration >=2-fold and >=4-fold increase from baseline (pre-vaccination) were analyzed. The PPAS is a subset of the FAS. Here, n= number of participants analyzed for each parameter at specific timepoint and 99999= no participants were analyzed.

End point type

Secondary

End point timeframe

Pre-vaccination on Day 1 and Post-vaccination on Days 15, 29, 91, 181, and 366

Notes
[106] - 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: Only participants treated in Phase 3 Cohorts 1 and 2 reporting groups were analyzed in this endpoint.

End point values	Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Number of subjects analysed	312 ^[107]	332 ^[108]	340 ^[109]	106 ^[110]	98 ^[111]	101 ^[112]	119 ^[113]	94 ^[114]	93 ^[115]	96 ^[116]	34 ^[117]	34 ^[118]	124 ^[119]	72 ^[120]
Units: participants
Day 15: >=2-fold rise	287	276	292	94	84	87	114	92	92	88	24	29	108	69
Day 15: >=4-fold rise	265	234	265	72	73	69	106	85	90	84	19	28	103	67
Day 29: >=2-fold rise	285	278	285	93	87	87	111	92	90	91	24	27	115	69
Day 29: >=4-fold rise	253	243	254	71	75	74	96	85	86	84	19	27	109	66
Day 91: >=2-fold rise	227	210	217	73	70	76	82	61	59	79	17	23	105	65
Day 91: >=4-fold rise	197	183	184	60	62	58	69	57	56	72	14	22	98	62
Day 181: >=2-fold rise	175	189	193	43	63	59	59	53	49	56	14	20	98	62
Day 181: >=4-fold rise	146	160	167	38	55	48	45	45	40	51	11	17	89	59
Day 366: >=2-fold rise	27	174	184	15	62	49	99999	26	27	9	12	17	83	53
Day 366: >=4-fold rise	26	147	165	13	56	37	99999	23	23	7	11	14	77	52

Notes
[107] - Day 15 (n=302) Day 29 (n=312) Day 91 (n=251) Day 181 (n=198) Day 366 (n=28)
[108] - Day 15 (n=322) Day 29 (n=332) Day 91 (n=266) Day 181 (n=255) Day 366 (n=232)
[109] - Day 15 (n=334) Day 29 (n=340) Day 91 (n=279) Day 181 (n=269) Day 366 (n=240)
[110] - Day 15 (n=101) Day 29 (n=106) Day 91 (n=91) Day 181 (n=59) Day 366 (n=19)
[111] - Day 15 (n=93) Day 29 (n=98) Day 91 (n=84) Day 181 (n=85) Day 366 (n=81)
[112] - Day 15 (n=98) Day 29 (n=101) Day 91 (n=91) Day 181 (n=83) Day 366 (n=72)
[113] - Day 15 (n=119) Day 29 (n=118) Day 91 (n=87) Day 181 (n=74) Day 366 (n=0)
[114] - Day 15 (n=94) Day 29 (n=94) Day 91 (n=61) Day 181 (n=57) Day 366 (n=30)
[115] - Day 15 (n=93) Day 29 (n=92) Day 91 (n=60) Day 181 (n=51) Day 366 (n=32)
[116] - Day 15 (n=91) Day 29 (n=96) Day 91 (n=86) Day 181 (n=65) Day 366 (n=10)
[117] - Day 15 (n=31) Day 29 (n=34) Day 91 (n=29) Day 181 (n=25) Day 366 (n=22)
[118] - Day 15 (n=34) Day 29 (n=31) Day 91 (n=26) Day 181 (n=25) Day 366 (n=22)
[119] - Day 15 (n=120) Day 29 (n=124) Day 91 (n=114) Day 181 (n=116) Day 366 (n=99)
[120] - Day 15 (n=72) Day 29 (n=71) Day 91 (n=69) Day 181 (n=68) Day 366 (n=57)

No statistical analyses for this end point

Secondary: Phase 3: Cohort 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 15, 29, 91, 181, and 366

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End point title

Phase 3: Cohort 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 15, 29, 91, 181, and 366 ^[121]

End point description

End point type

Secondary

End point timeframe

Pre-vaccination on Day 1 and post-vaccination on Days 15, 29, 91, 181, and 366

Notes
[121] - 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: Only participants treated in Phase 3 Cohort 2 reporting groups were analyzed in this endpoint.

End point values	Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Number of subjects analysed	348	345	107	101	94	97	36	36	123	72
Units: titers
geometric mean (confidence interval 95%)
Day 1: D614G(n=348,345,107,101,89,93,36,36,107,67)	678 (558 to 824)	579 (478 to 701)	1107 (816 to 1503)	1347 (977 to 1858)	137 (98.0 to 193)	134 (95.7 to 186)	1188 (567 to 2490)	447 (217 to 921)	274 (182 to 413)	159 (97.4 to 260)
Day 1: B.1.351(n=336,324,97,94,90,97,36,34,108,68)	176 (142 to 217)	149 (120 to 184)	258 (182 to 364)	296 (207 to 424)	43.3 (32.0 to 58.5)	36.8 (28.8 to 47.1)	345 (167 to 714)	122 (55.3 to 268)	97.7 (68.0 to 140)	70.3 (47.9 to 103)
Day 15: D614G (n=325,334,93,96,94,93,31,34,119,72)	9995 (8976 to 11129)	8430 (7572 to 9386)	14240 (11257 to 18013)	12522 (10368 to 15123)	5536 (4436 to 6910)	5855 (4669 to 7344)	11005 (7533 to 16078)	11624 (8086 to 16710)	22457 (19123 to 26374)	25002 (18441 to 33897)
Day 15:B.1.351(n=325,334,93,95,94,93,30,34,119,72)	7021 (6262 to 7873)	4900 (4370 to 5494)	9449 (7376 to 12104)	6581 (5340 to 8111)	4610 (3689 to 5760)	3099 (2386 to 4026)	6872 (4482 to 10537)	5057 (3416 to 7488)	7452 (6212 to 8939)	13300 (9817 to 18018)
Day 29: D614G(n=333,341,99,100,93,92,34,31,123,71)	14065 (12399 to 15954)	10885 (9664 to 12261)	16286 (12808 to 20710)	16874 (13763 to 20688)	6320 (4941 to 8083)	6370 (5014 to 8093)	9711 (6526 to 14450)	9521 (6555 to 13828)	16032 (13535 to 18989)	16425 (12103 to 22291)
Day 29:B.1.351(n=333,340,99,98,93,92,34,31,123,71)	8947 (7845 to 10203)	6045 (5307 to 6886)	10264 (7924 to 13296)	8139 (6470 to 10239)	4736 (3680 to 6096)	3103 (2340 to 4115)	6028 (3889 to 9342)	4007 (2553 to 6290)	7185 (5841 to 8838)	12712 (9376 to 17234)
Day 91: D614G (n=264,279,84,89,61,60,29,26,112,69)	11037 (9530 to 12782)	8523 (7284 to 9973)	13701 (10206 to 18392)	12424 (9586 to 16103)	3620 (2680 to 4891)	3981 (2812 to 5637)	5797 (3725 to 9024)	5880 (3125 to 11064)	14498 (11931 to 17618)	13641 (9766 to 19055)
Day 91:B.1.351(n=264,279,84,89,61,60,29,26,112,69)	6557 (5617 to 7654)	4359 (3673 to 5172)	8141 (5982 to 11080)	5474 (4176 to 7175)	2456 (1792 to 3364)	2029 (1376 to 2993)	3374 (2161 to 5269)	2405 (1093 to 5295)	6455 (5117 to 8143)	8990 (6284 to 12861)
Day 181: D614G (n=0,0,0,0,0,0,0,0,0,0)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)
Day 181: B.1.351 (n=0,0,0,0,0,0,0,0,0,0)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)
Day 366: D614G (n=0,0,0,0,0,0,0,0,0,0)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)
Day 366: B.1.351 (n=0,0,0,0,0,0,0,0,0,0)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)

No statistical analyses for this end point

Secondary: Phase 3: Cohort 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366

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End point title

Phase 3: Cohort 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366 ^[122]

End point description

End point type

Secondary

End point timeframe

Pre-vaccination on Day 1 and Post-vaccination on Days 15, 29, 91, 181, and 366

Notes
[122] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Only participants treated in Phase 3 Cohort 2 reporting groups were analyzed in this endpoint.

End point values	Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)
Number of subjects analysed	318 ^[123]	324 ^[124]	99 ^[125]	95 ^[126]	87 ^[127]	91 ^[128]	33 ^[129]	33 ^[130]	103 ^[131]	64 ^[132]
Units: participants
D614G; Day 15: >=2-fold rise	267	269	79	77	85	84	26	30	86	60
D614G; Day 15: >=4-fold rise	232	242	67	58	78	79	18	26	84	58
D614G; Day 29: >=2-fold rise	272	283	83	76	84	83	22	28	89	58
D614G; Day 29: >=4-fold rise	240	251	74	67	80	80	15	23	85	56
D614G; Day 91: >=2-fold rise	199	208	69	70	57	51	16	20	81	57
D614G; Day 91: >=4-fold rise	175	187	57	54	55	48	12	16	78	53
D614G; Day 181: >=2-fold rise	99999	99999	99999	99999	99999	99999	99999	99999	99999	99999
D614G; Day 181: >=4-fold rise	99999	99999	99999	99999	99999	99999	99999	99999	99999	99999
D614G; Day 366: >=2-fold rise	99999	99999	99999	99999	99999	99999	99999	99999	99999	99999
D614G; Day 366: >=4-fold rise	99999	99999	99999	99999	99999	99999	99999	99999	99999	99999
B.1.351; Day 15: >=2-fold rise	275	269	77	79	85	88	28	28	88	62
B.1.351; Day 15: >=4-fold rise	249	247	70	68	83	88	22	24	85	58
B.1.351; Day 29: >=2-fold rise	278	277	81	79	86	87	28	26	95	62
B.1.351; Day 29: >=4-fold rise	258	261	75	70	84	87	20	25	92	58
B.1.351; Day 91: >=2-fold rise	212	207	69	68	56	56	22	21	87	58
B.1.351; Day 91: >=4-fold rise	195	197	62	60	56	53	16	17	80	55
B.1.351; Day 181: >=2-fold rise	99999	99999	99999	99999	99999	99999	99999	99999	99999	99999
B.1.351; Day 181: >=4-fold rise	99999	99999	99999	99999	99999	99999	99999	99999	99999	99999
B.1.351; Day 366: >=2-fold rise	99999	99999	99999	99999	99999	99999	99999	99999	99999	99999
B.1.351; Day 366: >=4-fold rise	99999	99999	99999	99999	99999	99999	99999	99999	99999	99999

Notes
[123] - D614G:D15(n=315),D29(n=318),D91(n=251);B.1.351:D15(n=299),D29(n=306),D91(n=246);D181:(n=0),D366:(n=0
[124] - D614G:D15(n=320),D29(n=324),D91(n=265);B.1.351:D15(n=298),D29(n=304),D91(n=252);D181:(n=0),D366:(n=0
[125] - D614G:D15(n=92),D29(n=99),D91(n=84);B.1.351:D15(n=84),D29(n=90),D91(n=76);D181:(n=0),D366:(n=0)
[126] - D614G:D15(n=91),D29(n=95),D91(n=86);B.1.351:D15(n=85),D29(n=88),D91(n=82);D181:(n=0),D366:(n=0)
[127] - D614G:D15(n=87),D29(n=86),D91(n=58);B.1.351:D15(n=87),D29(n=87),D91(n=56);D181:(n=0),D366:(n=0)
[128] - D614G:D15(n=88),D29(n=86),D91(n=55);B.1.351:D15(n=91),D29(n=90),D91(n=58);D181:(n=0),D366:(n=0)
[129] - D614G:D15(n=31),D29(n=33),D91(n=28);B.1.351:D15(n=29),D29(n=33),D91(n=29);D181:(n=0),D366:(n=0)
[130] - D614G:D15(n=33),D29(n=30),D91(n=25);B.1.351:D15(n=31),D29(n=28),D91(n=25);D181:(n=0),D366:(n=0)
[131] - D614G:D15(n=99),D29(n=101),D91(n=93);B.1.351:D15(n=99),D29(n=103),D91(n=94);D181:(n=0),D366:(n=0)
[132] - D614G:D15(n=64),D29(n=62),D91(n=61);B.1.351:D15(n=64),D29(n=64),D91(n=62);D181:(n=0),D366:(n=0)

No statistical analyses for this end point

Secondary: Phase 3: Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 22, 36, 134, 202, 292, and 387

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End point title

Phase 3: Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 22, 36, 134, 202, 292, and 387 ^[133]

End point description

End point type

Secondary

End point timeframe

Pre-vaccination on Day 1 and post-vaccination on Days 22, 36, 134, 202, 292, and 387

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: Only participants treated in Phase 3 comparator reporting group were analyzed in this endpoint.

End point values	Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
Number of subjects analysed	330
Units: titers
geometric mean (confidence interval 95%)
D614G: Day 1 (n=330)	20.3 (19.7 to 21.0)
D614G: Day 22 (n=281)	53.3 (44.6 to 63.8)
D614G: Day 36 (n=302)	3658 (3123 to 4286)
D614G: Day 134 (n=143)	1050 (743 to 1486)
D614G: Day 202 (n=128)	1685 (1142 to 2487)
D614G: Day 292 (n=117)	1943 (1294 to 2918)
D614G: Day 387 (n=112)	1973 (1344 to 2897)
B.1.351: Day 1 (n=329)	20.3 (19.7 to 20.8)
B.1.351: Day 22 (n=326)	29.4 (25.7 to 33.5)
B.1.351: Day 36 (n=291)	413 (346 to 493)
B.1.351: Day 134 (n=113)	496 (330 to 745)
B.1.351: Day 202 (n=123)	671 (441 to 1022)
B.1.351: Day 292 (n=120)	867 (560 to 1342)
B.1.351: Day 387 (n=112)	1033 (686 to 1555)

No statistical analyses for this end point

Secondary: Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387

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End point title

Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387 ^[134]

End point description

End point type

Secondary

End point timeframe

Pre-vaccination on Day 1 and Post-vaccination on Days 22, 36, 134, 202, 292, and 387

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: Only participants treated in Phase 3 comparator reporting group were analyzed in this endpoint.

End point values	Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
Number of subjects analysed	325
Units: participants
D614G; Day 22: >=2-fold rise (n=281)	99
D614G; Day 22: >=4-fold rise (n=281)	88
D614G; Day 36: >=2-fold rise (n=301)	299
D614G; Day 36: >=4-fold rise (n=301)	298
D614G; Day 134: >=2-fold rise (n=143)	134
D614G; Day 134: >=4-fold rise (n=143)	131
D614G; Day 202: >=2-fold rise (n=127)	120
D614G; Day 202: >=4-fold rise (n=127)	119
D614G; Day 292: >=2-fold rise (n=117)	108
D614G; Day 292: >=4-fold rise (n=117)	105
D614G; Day 387: >=2-fold rise (n=111)	105
D614G; Day 387: >=4-fold rise (n=111)	101
B.1.351; Day 22: >=2-fold rise (n=325)	39
B.1.351; Day 22: >=4-fold rise (n=325)	32
B.1.351; Day 36: >=2-fold rise (n=290)	264
B.1.351; Day 36: >=4-fold rise (n=290)	251
B.1.351; Day 134: >=2-fold rise (n=112)	99
B.1.351; Day 134: >=4-fold rise (n=112)	89
B.1.351; Day 202: >=2-fold rise (n=122)	100
B.1.351; Day 202: >=4-fold rise (n=122)	97
B.1.351; Day 292: >=2-fold rise (n=119)	98
B.1.351; Day 292: >=4-fold rise (n=119)	91
B.1.351; Day 387: >=2-fold rise (n=111)	96
B.1.351; Day 387: >=4-fold rise (n=111)	94

No statistical analyses for this end point

Secondary: Phase 3: Comparator: Geometric Mean Concentration of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 134, 202, 292, and 387

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End point title

Phase 3: Comparator: Geometric Mean Concentration of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 134, 202, 292, and 387 ^[135]

End point description

End point type

Secondary

End point timeframe

Pre-vaccination on Day 1 and post-vaccination on Days 22, 36, 134, 202, 292, and 387

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: Only participants treated in Phase 3 comparator reporting group were analyzed in this endpoint.

End point values	Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
Number of subjects analysed	330
Units: titers
geometric mean (confidence interval 95%)
Day 1 (n=326)	10.7 (9.91 to 11.6)
Day 22 (n=330)	212 (183 to 246)
Day 36 (n=303)	24278 (21681 to 27185)
Day 134 (n=147)	6593 (4952 to 8779)
Day 202 (n=132)	6667 (4833 to 9197)
Day 292 (n=122)	6868 (4919 to 9587)
Day 387 (n=115)	7112 (5216 to 9697)

No statistical analyses for this end point

Secondary: Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387

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End point title

Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387 ^[136]

End point description

Binding antibodies concentration against SARS-CoV-2 D614G strain was measured with Nexelis GCN4 S-ELISA assay. Participants with binding antibodies concentration >=2-fold and >=4-fold increase from baseline (pre-vaccination) were analyzed. The PPAS is a subset of the FAS. Here, n= number of participants analyzed for each parameter at specific timepoint.

End point type

Secondary

End point timeframe

Pre-vaccination on Day 1 and Post-vaccination on Days 22, 36, 134, 202, 292, and 387

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: Only participants treated in Phase 3 comparator reporting group were analyzed in this endpoint.

End point values	Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
Number of subjects analysed	331
Units: participants
Day 22: >=2-fold rise (n=331)	312
Day 22: >=4-fold rise (n=331)	290
Day 36: >=2-fold rise (n=303)	302
Day 36: >=4-fold rise (n=303)	302
Day 134: >=2-fold rise (n=150)	149
Day 134: >=4-fold rise (n=150)	148
Day 202: >=2-fold rise (n=134)	133
Day 202: >=4-fold rise (n=134)	133
Day 292: >=2-fold rise (n=124)	123
Day 292: >=4-fold rise (n=124)	123
Day 387: >=2-fold rise (n=118)	117
Day 387: >=4-fold rise (n=118)	117

No statistical analyses for this end point

Secondary: Phase 3: Comparator: Percentage of Responders as Determined by Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387

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End point title

Phase 3: Comparator: Percentage of Responders as Determined by Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387 ^[137]

End point description

Responders were participants who had baseline values below LLOQ with detectable antibody concentration above assay LLOQ at each pre-defined post-vaccination time point and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination time point. Binding antibodies activity against SARS-CoV-2 D614G strain was measured with Nexelis GCN4 S-ELISA. The PPAS is a subset of the FAS. Here, n= number of participants analyzed at specific timepoint. Percentages are rounded off to the tenth decimal place.

End point type

Secondary

End point timeframe

Post-vaccination on Days 22, 36, 134, 202, 292, and 387

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: Only participants treated in Phase 3 comparator reporting group were analyzed in this endpoint.

End point values	Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
Number of subjects analysed	331
Units: percentage of participants
number (confidence interval 95%)
Day 22 (n=331)	94.3 (91.2 to 96.5)
Day 36 (n=325)	99.7 (98.3 to 100)
Day 134 (n=159)	98.7 (95.5 to 99.8)
Day 202 (n=141)	99.3 (96.1 to 100)
Day 292 (n=134)	99.3 (95.9 to 100)
Day 387 (n=127)	99.2 (95.7 to 100)

No statistical analyses for this end point

Secondary: Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19

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End point title

Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19 ^[138]

End point description

Laboratory-confirmed SARS-CoV-2 infection was defined as a positive result for SARS-CoV-2 by nucleic acid amplification test (done by the central laboratory or locally) on at least 1 respiratory sample. The Safety analysis set included participants randomized and who had received at least 1 dose of the study vaccines. Safety analysis was performed according to the actual study vaccine received by the participants. Percentages are rounded off to the tenth decimal place.

End point type

Secondary

End point timeframe

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: Participants treated in Phase 3 exploratory reporting groups were not analyzed in this endpoint.

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3

Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2

Number of subjects analysed

240

241

328

378

375

113

111

108

127

100

103

132

473

240

Units: percentage of participants

number (confidence interval 95%)

3.3 (1.4 to 6.5)

5.4 (2.9 to 9.0)

14.0 (10.5 to 18.3)

20.9 (16.9 to 25.4)

23.5 (19.3 to 28.1)

12.4 (6.9 to 19.9)

10.8 (5.7 to 18.1)

10.2 (5.2 to 17.5)

24.4 (17.2 to 32.8)

25.0 (16.9 to 34.7)

29.0 (20.4 to 38.9)

9.7 (4.8 to 17.1)

0 (0 to 9.3)

18.4 (7.7 to 34.3)

18.9 (12.6 to 26.7)

19.2 (11.2 to 29.7)

8.2 (5.9 to 11.1)

1.7 (0.5 to 4.2)

No statistical analyses for this end point

Secondary: Phase 2: Percentage of Participants With Serologically-Confirmed SARS-CoV-2 Infection

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End point title

Phase 2: Percentage of Participants With Serologically-Confirmed SARS-CoV-2 Infection ^[139]

End point description

Blood samples collected from participants were used for serological assessments in the study. Serologically-confirmed SARS-CoV-2 infection was defined as a positive result in a serum sample for antibodies specific to the nucleocapsid of SARS-CoV-2 detected by electrochemiluminescence immunoassay. The Safety analysis set included participants randomized and who had received at least 1 dose of the study vaccines. Percentages are rounded off to the tenth decimal place.

End point type

Secondary

End point timeframe

From first dose of study vaccine administration (Day 1) up to 387 days

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: Only participants treated in Phase 2 of the study were analyzed in this endpoint.

End point values	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
Number of subjects analysed	240	241	240
Units: percentage of participants
number (confidence interval 95%)	12.1 (8.2 to 16.9)	14.1 (10.0 to 19.2)	10.8 (7.2 to 15.5)

No statistical analyses for this end point

Secondary: Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization

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End point title

Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization ^[140]

End point description

Symptomatic COVID-19 was defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness. The Safety analysis set included participants randomized and who had received at least 1 dose of the study vaccines. Safety analysis was performed according to the actual study vaccine received by the participants. Percentages are rounded off to the tenth decimal place.

End point type

Secondary

End point timeframe

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: Participants treated in Phase 3 exploratory reporting groups were not analyzed in this endpoint.

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3

Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2

Number of subjects analysed

240

241

328

378

375

113

111

108

127

100

103

132

473

240

Units: percentage of participants

number (confidence interval 95%)

0 (0 to 1.5)

0 (0 to 1.1)

0 (0 to 1.0)

0.3 (0 to 1.5)

0 (0 to 3.2)

0 (0 to 3.3)

0 (0 to 3.4)

0.8 (0 to 4.3)

0 (0 to 3.6)

0 (0 to 3.5)

0 (0 to 9.3)

0 (0 to 2.8)

0 (0 to 4.6)

0 (0 to 0.8)

0 (0 to 1.5)

No statistical analyses for this end point

Secondary: Percentage of Participants With Severe Symptomatic COVID-19

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End point title

Percentage of Participants With Severe Symptomatic COVID-19 ^[141]

End point description

Severe COVID-19 was defined as COVID-19 with any 1: Any clinical signs of severe illness measured at least on 2 occasions separated by 30 minutes, supplemental oxygen administration for >1 hour, use of invasive or non-invasive ventilation or Extracorporeal Membrane Oxygenation, clinical diagnosis of respiratory failure, significant acute renal, hepatic, or neurologic dysfunction, shock (defined by systolic blood pressure ˂ 90 mm Hg, or diastolic blood pressure ˂ 60 mm Hg or requiring vasopressors), admission to an intensive care unit, or death. Symptomatic COVID-19 was defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness. The Safety analysis set included participants randomized and who had received at least 1 dose of the study vaccines. Safety analysis was performed according to the actual study vaccine received by the participants. Percentages are rounded off to the tenth decimal place.

End point type

Secondary

End point timeframe

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: Participants treated in Phase 3 exploratory reporting groups were not analyzed in this endpoint.

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3

Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2

Number of subjects analysed

240

241

328

378

375

113

111

108

127

100

103

132

473

240

Units: percentage of participants

number (confidence interval 95%)

0 (0 to 1.5)

0 (0 to 1.1)

0 (0 to 1.0)

0.3 (0 to 1.5)

0 (0 to 3.2)

0 (0 to 3.3)

0 (0 to 3.4)

0 (0 to 2.9)

0 (0 to 3.6)

0 (0 to 3.5)

0 (0 to 9.3)

0.8 (0 to 4.1)

0 (0 to 4.6)

0 (0 to 0.8)

0 (0 to 1.5)

No statistical analyses for this end point

Secondary: Percentage of Participants With Death Associated With Symptomatic COVID-19

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End point title

Percentage of Participants With Death Associated With Symptomatic COVID-19 ^[142]

End point description

Death associated with COVID-19 was defined as death in a participant with COVID-19 who died within 28 days of the first positive specimen date OR died more than 28 days after the first specimen date and COVID-19 was mentioned as an immediate or underlying cause of death on the death certificate. Symptomatic COVID-19 was defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness. The Safety analysis set included participants randomized and who had received at least 1 dose of the study vaccines. Safety analysis was performed according to the actual study vaccine received by the participants. Percentages are rounded off to the tenth decimal place.

End point type

Secondary

End point timeframe

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: Participants treated in Phase 3 exploratory reporting groups were not analyzed in this endpoint.

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3

Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2

Number of subjects analysed

240

241

328

378

375

113

111

108

127

100

103

132

473

240

Units: percentage of participants

number (confidence interval 95%)

0 (0 to 1.5)

0 (0 to 1.1)

0 (0 to 1.0)

0 (0 to 3.2)

0 (0 to 3.3)

0 (0 to 3.4)

0 (0 to 2.9)

0 (0 to 3.6)

0 (0 to 3.5)

0 (0 to 9.3)

0 (0 to 2.8)

0 (0 to 4.6)

0 (0 to 0.8)

0 (0 to 1.5)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Phase 2 and Phase 3 Comparator: AEs data was collected from first dose of study vaccine administration (Day 1) up to 387 days. Phase 3 Cohorts 1 and 2: AEs data was collected from first dose of study vaccine administration (Day 1) up to 366 days.

Adverse event reporting additional description

Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

26.0

Reporting group title

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1

Reporting group description

Participants received CoV2 preS dTM monovalent D614 antigen dose 1 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.

Reporting group title

Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)

Reporting group description

Reporting group title

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3

Reporting group description

Participants received CoV2 preS dTM monovalent D614 antigen dose 3 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.

Reporting group title

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2

Reporting group description

Participants received CoV2 preS dTM monovalent D614 antigen dose 2 with fixed dose of AS03 adjuvant IM injection once daily on Days 1 and 22.

Reporting group title

Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)

Reporting group description

Reporting group title

Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Reporting group description

Reporting group title

Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)

Reporting group description

Reporting group title

Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Reporting group description

Reporting group title

Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)

Reporting group description

Reporting group title

Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)

Reporting group description

Reporting group title

Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)

Reporting group description

Reporting group title

Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)

Reporting group description

Reporting group title

Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)

Reporting group description

Reporting group title

Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Reporting group description

Reporting group title

Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)

Reporting group description

Reporting group title

Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Reporting group description

Reporting group title

Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)

Reporting group description

Reporting group title

Phase 3: Exploratory 1: PBP - CoV2 preS dTM (B.1.351)

Reporting group description

Reporting group title

Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)

Reporting group description

SARS CoV 2 naïve and unvaccinated participants received CoV2 preS dTM monovalent D614 antigen dose 2 with full-dose of AS03 adjuvant IM injection once daily on Days 1 and 22.

Reporting group title

Phase 3: Exploratory 3: PBP - CoV2 preS dTM (B.1.351)

Reporting group description

Reporting group title

Phase 3: Exploratory 2: PBP - CoV2 preS dTM (B.1.351)

Reporting group description

Reporting group title

Phase 3: Exploratory 4: PBP - CoV2 preS dTM (B.1.351)

Reporting group description

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1

Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3

Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2

Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)

Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)

Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)

Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)

Phase 3: Exploratory 1: PBP - CoV2 preS dTM (B.1.351)

Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)

Phase 3: Exploratory 3: PBP - CoV2 preS dTM (B.1.351)

Phase 3: Exploratory 2: PBP - CoV2 preS dTM (B.1.351)

Phase 3: Exploratory 4: PBP - CoV2 preS dTM (B.1.351)

Total subjects affected by serious adverse events

subjects affected / exposed

2 / 240 (0.83%)

8 / 328 (2.44%)

4 / 241 (1.66%)

6 / 240 (2.50%)

9 / 378 (2.38%)

11 / 375 (2.93%)

3 / 127 (2.36%)

4 / 108 (3.70%)

1 / 111 (0.90%)

3 / 113 (2.65%)

4 / 100 (4.00%)

3 / 78 (3.85%)

3 / 132 (2.27%)

3 / 38 (7.89%)

2 / 38 (5.26%)

0 / 100 (0.00%)

1 / 103 (0.97%)

2 / 4 (50.00%)

14 / 473 (2.96%)

1 / 9 (11.11%)

0 / 8 (0.00%)

1 / 9 (11.11%)

number of deaths (all causes)

number of deaths resulting from adverse events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Basal Cell Carcinoma

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

1 / 127 (0.79%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

1 / 100 (1.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Breast Cancer

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

1 / 375 (0.27%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

1 / 473 (0.21%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Malignant Melanoma

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

1 / 100 (1.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Prostate Cancer

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

1 / 378 (0.26%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Peritoneal Neoplasm

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

1 / 132 (0.76%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Invasive Breast Carcinoma

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

1 / 240 (0.42%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vascular disorders

Hypertension

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

1 / 38 (2.63%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pregnancy, puerperium and perinatal conditions

Ectopic Pregnancy

subjects affected / exposed

0 / 240 (0.00%)

1 / 328 (0.30%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (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

Antidepressant Discontinuation Syndrome

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

1 / 473 (0.21%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Immune system disorders

Serum Sickness-Like Reaction

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

1 / 108 (0.93%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Social circumstances

Loss Of Personal Independence In Daily Activities

subjects affected / exposed

0 / 240 (0.00%)

1 / 328 (0.30%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (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

Chronic Obstructive Pulmonary Disease

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

1 / 108 (0.93%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pulmonary Embolism

subjects affected / exposed

0 / 240 (0.00%)

1 / 328 (0.30%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Psychiatric disorders

Anxiety

subjects affected / exposed

0 / 240 (0.00%)

1 / 328 (0.30%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Confusional State

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

1 / 375 (0.27%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Suicidal Ideation

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

1 / 127 (0.79%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

1 / 473 (0.21%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Injury, poisoning and procedural complications

Animal Bite

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

1 / 473 (0.21%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Fall

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

1 / 108 (0.93%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal Stoma Complication

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

1 / 473 (0.21%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hand Fracture

subjects affected / exposed

0 / 240 (0.00%)

1 / 328 (0.30%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Head Injury

subjects affected / exposed

0 / 240 (0.00%)

1 / 328 (0.30%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Intentional Overdose

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

1 / 127 (0.79%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Multiple Fractures

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

1 / 375 (0.27%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Multiple Injuries

subjects affected / exposed

0 / 240 (0.00%)

1 / 328 (0.30%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Procedural Pain

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

1 / 375 (0.27%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Road Traffic Accident

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

1 / 473 (0.21%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (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

Spinal Compression Fracture

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

1 / 378 (0.26%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Stoma Site Pain

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

1 / 113 (0.88%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Wound

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

1 / 378 (0.26%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Femur Fracture

subjects affected / exposed

1 / 240 (0.42%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

Acute Myocardial Infarction

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

1 / 108 (0.93%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Angina Pectoris

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

1 / 38 (2.63%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Atrial Fibrillation

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

1 / 100 (1.00%)

0 / 78 (0.00%)

1 / 132 (0.76%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Palpitations

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

1 / 473 (0.21%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Supraventricular Tachycardia

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

1 / 113 (0.88%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (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

Alcoholic Seizure

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

1 / 38 (2.63%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cerebrovascular Accident

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

1 / 240 (0.42%)

1 / 378 (0.26%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

1 / 38 (2.63%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cervicobrachial Syndrome

subjects affected / exposed

0 / 240 (0.00%)

1 / 328 (0.30%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Loss Of Consciousness

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

1 / 100 (1.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Motor Neurone Disease

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

1 / 9 (11.11%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Trigeminal Neuralgia

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

1 / 78 (1.28%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Sciatica

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

1 / 241 (0.41%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Blood and lymphatic system disorders

Iron Deficiency Anaemia

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

1 / 473 (0.21%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Eye disorders

Blindness Unilateral

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

1 / 375 (0.27%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

Abdominal Pain

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

1 / 113 (0.88%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal Haemorrhage

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

1 / 378 (0.26%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pancreatitis

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

1 / 375 (0.27%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pancreatitis Acute

subjects affected / exposed

0 / 240 (0.00%)

1 / 328 (0.30%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Small Intestinal Obstruction

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

1 / 375 (0.27%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vomiting

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

1 / 113 (0.88%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Lower Gastrointestinal Haemorrhage

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

1 / 241 (0.41%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatobiliary disorders

Cholangitis

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

1 / 473 (0.21%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cholecystitis

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

1 / 375 (0.27%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

1 / 103 (0.97%)

1 / 4 (25.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cholecystitis Chronic

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

1 / 378 (0.26%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cholelithiasis

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

1 / 241 (0.41%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Renal and urinary disorders

Acute Kidney Injury

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

1 / 240 (0.42%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Calculus Urinary

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

1 / 240 (0.42%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Urinary Tract Obstruction

subjects affected / exposed

1 / 240 (0.42%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Nephrolithiasis

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

1 / 240 (0.42%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Endocrine disorders

Inappropriate Antidiuretic Hormone Secretion

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

1 / 78 (1.28%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (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

Arthralgia

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

1 / 375 (0.27%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Osteoarthritis

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

2 / 378 (0.53%)

1 / 375 (0.27%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Intervertebral Disc Disorder

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

1 / 375 (0.27%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Intervertebral Disc Degeneration

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

1 / 240 (0.42%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

Abscess

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

1 / 9 (11.11%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Anal Abscess

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

1 / 4 (25.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Appendicitis

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

1 / 378 (0.26%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Covid-19

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

1 / 240 (0.42%)

0 / 378 (0.00%)

1 / 375 (0.27%)

1 / 127 (0.79%)

1 / 108 (0.93%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

1 / 78 (1.28%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cellulitis

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

1 / 375 (0.27%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Localised Infection

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

1 / 473 (0.21%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Necrotising Fasciitis

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

1 / 473 (0.21%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Lung Abscess

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

1 / 473 (0.21%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Osteomyelitis

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

1 / 473 (0.21%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Neurological Infection

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

1 / 132 (0.76%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Ovarian Abscess

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

1 / 38 (2.63%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Periumbilical Abscess

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

1 / 9 (11.11%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pilonidal Disease

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

1 / 375 (0.27%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pyelonephritis Acute

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

1 / 113 (0.88%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Urinary Tract Infection

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

1 / 240 (0.42%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metabolism and nutrition disorders

Diabetes Mellitus

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

1 / 38 (2.63%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Diabetic Ketoacidosis

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

1 / 241 (0.41%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

1 / 111 (0.90%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

0 / 132 (0.00%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

1 / 473 (0.21%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

Electrolyte Imbalance

subjects affected / exposed

0 / 240 (0.00%)

0 / 328 (0.00%)

0 / 241 (0.00%)

0 / 240 (0.00%)

0 / 378 (0.00%)

0 / 375 (0.00%)

0 / 127 (0.00%)

0 / 108 (0.00%)

0 / 111 (0.00%)

0 / 113 (0.00%)

0 / 100 (0.00%)

0 / 78 (0.00%)

1 / 132 (0.76%)

0 / 38 (0.00%)

0 / 100 (0.00%)

0 / 103 (0.00%)

0 / 4 (0.00%)

0 / 473 (0.00%)

0 / 9 (0.00%)

0 / 8 (0.00%)

0 / 9 (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	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1	Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614)	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3	Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2	Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)	Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351)	Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351)	Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614)	Phase 3: Exploratory 1: PBP - CoV2 preS dTM (B.1.351)	Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)	Phase 3: Exploratory 3: PBP - CoV2 preS dTM (B.1.351)	Phase 3: Exploratory 2: PBP - CoV2 preS dTM (B.1.351)	Phase 3: Exploratory 4: PBP - CoV2 preS dTM (B.1.351)
Total subjects affected by non serious adverse events
subjects affected / exposed	217 / 240 (90.42%)	281 / 328 (85.67%)	219 / 241 (90.87%)	215 / 240 (89.58%)	328 / 378 (86.77%)	331 / 375 (88.27%)	115 / 127 (90.55%)	83 / 108 (76.85%)	88 / 111 (79.28%)	97 / 113 (85.84%)	92 / 100 (92.00%)	59 / 78 (75.64%)	112 / 132 (84.85%)	24 / 38 (63.16%)	21 / 38 (55.26%)	97 / 100 (97.00%)	89 / 103 (86.41%)	4 / 4 (100.00%)	421 / 473 (89.01%)	8 / 9 (88.89%)	7 / 8 (87.50%)	6 / 9 (66.67%)
General disorders and administration site conditions
Injection Site Pain
subjects affected / exposed	199 / 240 (82.92%)	259 / 328 (78.96%)	200 / 241 (82.99%)	194 / 240 (80.83%)	297 / 378 (78.57%)	301 / 375 (80.27%)	100 / 127 (78.74%)	75 / 108 (69.44%)	81 / 111 (72.97%)	89 / 113 (78.76%)	86 / 100 (86.00%)	46 / 78 (58.97%)	96 / 132 (72.73%)	19 / 38 (50.00%)	18 / 38 (47.37%)	85 / 100 (85.00%)	80 / 103 (77.67%)	4 / 4 (100.00%)	372 / 473 (78.65%)	7 / 9 (77.78%)	5 / 8 (62.50%)	3 / 9 (33.33%)
occurrences all number	336	260	339	331	298	302	100	75	81	89	86	46	96	19	18	85	80	4	590	7	5	3
Injection Site Erythema
subjects affected / exposed	28 / 240 (11.67%)	32 / 328 (9.76%)	26 / 241 (10.79%)	41 / 240 (17.08%)	23 / 378 (6.08%)	19 / 375 (5.07%)	22 / 127 (17.32%)	4 / 108 (3.70%)	7 / 111 (6.31%)	8 / 113 (7.08%)	8 / 100 (8.00%)	2 / 78 (2.56%)	9 / 132 (6.82%)	3 / 38 (7.89%)	1 / 38 (2.63%)	9 / 100 (9.00%)	5 / 103 (4.85%)	0 / 4 (0.00%)	77 / 473 (16.28%)	0 / 9 (0.00%)	0 / 8 (0.00%)	0 / 9 (0.00%)
occurrences all number	31	32	29	46	23	19	22	4	7	8	8	2	9	3	1	9	5	0	92	0	0	0
Fatigue
subjects affected / exposed	22 / 240 (9.17%)	9 / 328 (2.74%)	17 / 241 (7.05%)	9 / 240 (3.75%)	17 / 378 (4.50%)	13 / 375 (3.47%)	4 / 127 (3.15%)	3 / 108 (2.78%)	3 / 111 (2.70%)	2 / 113 (1.77%)	1 / 100 (1.00%)	0 / 78 (0.00%)	4 / 132 (3.03%)	0 / 38 (0.00%)	1 / 38 (2.63%)	6 / 100 (6.00%)	4 / 103 (3.88%)	0 / 4 (0.00%)	40 / 473 (8.46%)	0 / 9 (0.00%)	0 / 8 (0.00%)	0 / 9 (0.00%)
occurrences all number	25	9	19	11	18	13	4	3	3	2	1	0	4	0	1	6	4	0	46	0	0	0
Injection Site Swelling
subjects affected / exposed	40 / 240 (16.67%)	32 / 328 (9.76%)	37 / 241 (15.35%)	39 / 240 (16.25%)	37 / 378 (9.79%)	25 / 375 (6.67%)	24 / 127 (18.90%)	4 / 108 (3.70%)	7 / 111 (6.31%)	10 / 113 (8.85%)	8 / 100 (8.00%)	3 / 78 (3.85%)	11 / 132 (8.33%)	3 / 38 (7.89%)	0 / 38 (0.00%)	5 / 100 (5.00%)	6 / 103 (5.83%)	0 / 4 (0.00%)	72 / 473 (15.22%)	0 / 9 (0.00%)	1 / 8 (12.50%)	0 / 9 (0.00%)
occurrences all number	42	33	41	46	37	25	24	4	7	10	8	3	11	3	0	5	6	0	86	0	1	0
Chills
subjects affected / exposed	97 / 240 (40.42%)	50 / 328 (15.24%)	77 / 241 (31.95%)	93 / 240 (38.75%)	74 / 378 (19.58%)	77 / 375 (20.53%)	23 / 127 (18.11%)	23 / 108 (21.30%)	23 / 111 (20.72%)	16 / 113 (14.16%)	23 / 100 (23.00%)	15 / 78 (19.23%)	38 / 132 (28.79%)	5 / 38 (13.16%)	5 / 38 (13.16%)	31 / 100 (31.00%)	10 / 103 (9.71%)	0 / 4 (0.00%)	160 / 473 (33.83%)	1 / 9 (11.11%)	1 / 8 (12.50%)	1 / 9 (11.11%)
occurrences all number	113	50	90	103	75	77	23	23	23	16	23	15	38	5	5	31	10	0	193	1	1	1
Malaise
subjects affected / exposed	138 / 240 (57.50%)	101 / 328 (30.79%)	146 / 241 (60.58%)	142 / 240 (59.17%)	122 / 378 (32.28%)	122 / 375 (32.53%)	40 / 127 (31.50%)	33 / 108 (30.56%)	39 / 111 (35.14%)	42 / 113 (37.17%)	35 / 100 (35.00%)	25 / 78 (32.05%)	61 / 132 (46.21%)	7 / 38 (18.42%)	8 / 38 (21.05%)	43 / 100 (43.00%)	31 / 103 (30.10%)	1 / 4 (25.00%)	241 / 473 (50.95%)	2 / 9 (22.22%)	3 / 8 (37.50%)	3 / 9 (33.33%)
occurrences all number	189	101	190	183	124	126	40	33	39	43	38	25	61	7	8	43	31	1	331	2	4	3
Pyrexia
subjects affected / exposed	34 / 240 (14.17%)	15 / 328 (4.57%)	29 / 241 (12.03%)	35 / 240 (14.58%)	12 / 378 (3.17%)	18 / 375 (4.80%)	3 / 127 (2.36%)	6 / 108 (5.56%)	5 / 111 (4.50%)	1 / 113 (0.88%)	4 / 100 (4.00%)	3 / 78 (3.85%)	11 / 132 (8.33%)	1 / 38 (2.63%)	0 / 38 (0.00%)	7 / 100 (7.00%)	2 / 103 (1.94%)	0 / 4 (0.00%)	42 / 473 (8.88%)	0 / 9 (0.00%)	0 / 8 (0.00%)	1 / 9 (11.11%)
occurrences all number	35	16	29	36	12	19	3	6	5	1	4	3	11	1	0	7	2	0	44	0	0	1
Injection Site Pruritus
subjects affected / exposed	7 / 240 (2.92%)	4 / 328 (1.22%)	6 / 241 (2.49%)	14 / 240 (5.83%)	4 / 378 (1.06%)	2 / 375 (0.53%)	1 / 127 (0.79%)	3 / 108 (2.78%)	1 / 111 (0.90%)	0 / 113 (0.00%)	0 / 100 (0.00%)	1 / 78 (1.28%)	3 / 132 (2.27%)	1 / 38 (2.63%)	0 / 38 (0.00%)	0 / 100 (0.00%)	0 / 103 (0.00%)	0 / 4 (0.00%)	13 / 473 (2.75%)	0 / 9 (0.00%)	0 / 8 (0.00%)	0 / 9 (0.00%)
occurrences all number	7	4	8	15	4	2	1	3	1	0	0	1	3	1	0	0	0	0	15	0	0	0
Immune system disorders
Dust Allergy
subjects affected / exposed	0 / 240 (0.00%)	0 / 328 (0.00%)	0 / 241 (0.00%)	0 / 240 (0.00%)	0 / 378 (0.00%)	0 / 375 (0.00%)	0 / 127 (0.00%)	0 / 108 (0.00%)	0 / 111 (0.00%)	0 / 113 (0.00%)	0 / 100 (0.00%)	0 / 78 (0.00%)	0 / 132 (0.00%)	0 / 38 (0.00%)	0 / 38 (0.00%)	0 / 100 (0.00%)	0 / 103 (0.00%)	0 / 4 (0.00%)	0 / 473 (0.00%)	0 / 9 (0.00%)	0 / 8 (0.00%)	1 / 9 (11.11%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Reproductive system and breast disorders
Dysmenorrhoea
subjects affected / exposed	1 / 240 (0.42%)	0 / 328 (0.00%)	0 / 241 (0.00%)	0 / 240 (0.00%)	1 / 378 (0.26%)	2 / 375 (0.53%)	0 / 127 (0.00%)	0 / 108 (0.00%)	1 / 111 (0.90%)	0 / 113 (0.00%)	0 / 100 (0.00%)	0 / 78 (0.00%)	0 / 132 (0.00%)	0 / 38 (0.00%)	0 / 38 (0.00%)	1 / 100 (1.00%)	0 / 103 (0.00%)	0 / 4 (0.00%)	3 / 473 (0.63%)	1 / 9 (11.11%)	0 / 8 (0.00%)	0 / 9 (0.00%)
occurrences all number	1	0	0	0	1	2	0	0	1	0	0	0	0	0	0	1	0	0	3	1	0	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	4 / 240 (1.67%)	8 / 328 (2.44%)	2 / 241 (0.83%)	3 / 240 (1.25%)	13 / 378 (3.44%)	12 / 375 (3.20%)	7 / 127 (5.51%)	4 / 108 (3.70%)	3 / 111 (2.70%)	4 / 113 (3.54%)	4 / 100 (4.00%)	1 / 78 (1.28%)	4 / 132 (3.03%)	2 / 38 (5.26%)	1 / 38 (2.63%)	4 / 100 (4.00%)	1 / 103 (0.97%)	0 / 4 (0.00%)	33 / 473 (6.98%)	0 / 9 (0.00%)	1 / 8 (12.50%)	0 / 9 (0.00%)
occurrences all number	4	8	2	4	14	12	7	4	3	4	4	1	4	2	1	4	1	0	36	0	1	0
Dyspnoea
subjects affected / exposed	1 / 240 (0.42%)	2 / 328 (0.61%)	0 / 241 (0.00%)	2 / 240 (0.83%)	3 / 378 (0.79%)	1 / 375 (0.27%)	1 / 127 (0.79%)	0 / 108 (0.00%)	0 / 111 (0.00%)	0 / 113 (0.00%)	1 / 100 (1.00%)	0 / 78 (0.00%)	0 / 132 (0.00%)	0 / 38 (0.00%)	0 / 38 (0.00%)	2 / 100 (2.00%)	0 / 103 (0.00%)	0 / 4 (0.00%)	7 / 473 (1.48%)	0 / 9 (0.00%)	1 / 8 (12.50%)	0 / 9 (0.00%)
occurrences all number	1	2	0	2	3	1	1	0	0	0	1	0	0	0	0	2	0	0	7	0	1	0
Rhinorrhoea
subjects affected / exposed	4 / 240 (1.67%)	6 / 328 (1.83%)	1 / 241 (0.41%)	4 / 240 (1.67%)	9 / 378 (2.38%)	11 / 375 (2.93%)	2 / 127 (1.57%)	3 / 108 (2.78%)	3 / 111 (2.70%)	4 / 113 (3.54%)	5 / 100 (5.00%)	0 / 78 (0.00%)	1 / 132 (0.76%)	0 / 38 (0.00%)	0 / 38 (0.00%)	2 / 100 (2.00%)	1 / 103 (0.97%)	0 / 4 (0.00%)	22 / 473 (4.65%)	0 / 9 (0.00%)	1 / 8 (12.50%)	0 / 9 (0.00%)
occurrences all number	4	6	1	4	10	11	2	3	3	4	5	0	1	0	0	2	1	0	24	0	1	0
Nasal Congestion
subjects affected / exposed	0 / 240 (0.00%)	4 / 328 (1.22%)	4 / 241 (1.66%)	2 / 240 (0.83%)	6 / 378 (1.59%)	5 / 375 (1.33%)	2 / 127 (1.57%)	2 / 108 (1.85%)	1 / 111 (0.90%)	1 / 113 (0.88%)	3 / 100 (3.00%)	0 / 78 (0.00%)	0 / 132 (0.00%)	0 / 38 (0.00%)	0 / 38 (0.00%)	4 / 100 (4.00%)	0 / 103 (0.00%)	0 / 4 (0.00%)	13 / 473 (2.75%)	0 / 9 (0.00%)	1 / 8 (12.50%)	0 / 9 (0.00%)
occurrences all number	0	4	4	2	6	5	2	2	1	1	3	0	0	0	0	4	0	0	14	0	1	0
Psychiatric disorders
Depression
subjects affected / exposed	1 / 240 (0.42%)	1 / 328 (0.30%)	1 / 241 (0.41%)	0 / 240 (0.00%)	3 / 378 (0.79%)	1 / 375 (0.27%)	0 / 127 (0.00%)	0 / 108 (0.00%)	0 / 111 (0.00%)	0 / 113 (0.00%)	0 / 100 (0.00%)	0 / 78 (0.00%)	0 / 132 (0.00%)	0 / 38 (0.00%)	0 / 38 (0.00%)	1 / 100 (1.00%)	0 / 103 (0.00%)	0 / 4 (0.00%)	1 / 473 (0.21%)	0 / 9 (0.00%)	1 / 8 (12.50%)	0 / 9 (0.00%)
occurrences all number	1	1	1	0	3	1	0	0	0	0	0	0	0	0	0	1	0	0	1	0	1	0
Injury, poisoning and procedural complications
Foot Fracture
subjects affected / exposed	1 / 240 (0.42%)	1 / 328 (0.30%)	0 / 241 (0.00%)	0 / 240 (0.00%)	1 / 378 (0.26%)	0 / 375 (0.00%)	0 / 127 (0.00%)	0 / 108 (0.00%)	0 / 111 (0.00%)	0 / 113 (0.00%)	0 / 100 (0.00%)	0 / 78 (0.00%)	0 / 132 (0.00%)	1 / 38 (2.63%)	0 / 38 (0.00%)	0 / 100 (0.00%)	0 / 103 (0.00%)	0 / 4 (0.00%)	0 / 473 (0.00%)	0 / 9 (0.00%)	0 / 8 (0.00%)	1 / 9 (11.11%)
occurrences all number	2	1	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1
Muscle Strain
subjects affected / exposed	0 / 240 (0.00%)	0 / 328 (0.00%)	0 / 241 (0.00%)	0 / 240 (0.00%)	2 / 378 (0.53%)	0 / 375 (0.00%)	0 / 127 (0.00%)	0 / 108 (0.00%)	0 / 111 (0.00%)	1 / 113 (0.88%)	0 / 100 (0.00%)	0 / 78 (0.00%)	1 / 132 (0.76%)	0 / 38 (0.00%)	0 / 38 (0.00%)	0 / 100 (0.00%)	0 / 103 (0.00%)	0 / 4 (0.00%)	0 / 473 (0.00%)	1 / 9 (11.11%)	0 / 8 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0	1	0	0	1	0	0	0	0	0	0	1	0	0
Skin Laceration
subjects affected / exposed	0 / 240 (0.00%)	0 / 328 (0.00%)	0 / 241 (0.00%)	0 / 240 (0.00%)	2 / 378 (0.53%)	0 / 375 (0.00%)	0 / 127 (0.00%)	0 / 108 (0.00%)	0 / 111 (0.00%)	1 / 113 (0.88%)	0 / 100 (0.00%)	0 / 78 (0.00%)	0 / 132 (0.00%)	0 / 38 (0.00%)	0 / 38 (0.00%)	0 / 100 (0.00%)	0 / 103 (0.00%)	0 / 4 (0.00%)	2 / 473 (0.42%)	1 / 9 (11.11%)	0 / 8 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0	1	0	0	0	0	0	0	0	0	2	1	0	0
Nervous system disorders
Headache
subjects affected / exposed	141 / 240 (58.75%)	130 / 328 (39.63%)	134 / 241 (55.60%)	134 / 240 (55.83%)	167 / 378 (44.18%)	165 / 375 (44.00%)	45 / 127 (35.43%)	39 / 108 (36.11%)	50 / 111 (45.05%)	47 / 113 (41.59%)	48 / 100 (48.00%)	20 / 78 (25.64%)	51 / 132 (38.64%)	10 / 38 (26.32%)	10 / 38 (26.32%)	55 / 100 (55.00%)	37 / 103 (35.92%)	2 / 4 (50.00%)	278 / 473 (58.77%)	6 / 9 (66.67%)	3 / 8 (37.50%)	3 / 9 (33.33%)
occurrences all number	195	133	198	187	176	179	46	39	51	49	51	20	52	10	10	56	37	2	406	6	3	3
Blood and lymphatic system disorders
Lymphadenitis
subjects affected / exposed	0 / 240 (0.00%)	0 / 328 (0.00%)	0 / 241 (0.00%)	0 / 240 (0.00%)	0 / 378 (0.00%)	0 / 375 (0.00%)	0 / 127 (0.00%)	0 / 108 (0.00%)	0 / 111 (0.00%)	0 / 113 (0.00%)	0 / 100 (0.00%)	0 / 78 (0.00%)	1 / 132 (0.76%)	0 / 38 (0.00%)	0 / 38 (0.00%)	0 / 100 (0.00%)	0 / 103 (0.00%)	0 / 4 (0.00%)	0 / 473 (0.00%)	0 / 9 (0.00%)	0 / 8 (0.00%)	1 / 9 (11.11%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1
Lymphadenopathy
subjects affected / exposed	2 / 240 (0.83%)	2 / 328 (0.61%)	3 / 241 (1.24%)	1 / 240 (0.42%)	5 / 378 (1.32%)	4 / 375 (1.07%)	0 / 127 (0.00%)	0 / 108 (0.00%)	0 / 111 (0.00%)	0 / 113 (0.00%)	0 / 100 (0.00%)	0 / 78 (0.00%)	1 / 132 (0.76%)	1 / 38 (2.63%)	1 / 38 (2.63%)	1 / 100 (1.00%)	0 / 103 (0.00%)	0 / 4 (0.00%)	5 / 473 (1.06%)	0 / 9 (0.00%)	0 / 8 (0.00%)	1 / 9 (11.11%)
occurrences all number	3	2	3	1	5	5	0	0	0	0	0	0	1	1	1	1	0	0	6	0	0	1
Gastrointestinal disorders
Dental Caries
subjects affected / exposed	0 / 240 (0.00%)	1 / 328 (0.30%)	0 / 241 (0.00%)	1 / 240 (0.42%)	1 / 378 (0.26%)	2 / 375 (0.53%)	0 / 127 (0.00%)	0 / 108 (0.00%)	0 / 111 (0.00%)	0 / 113 (0.00%)	0 / 100 (0.00%)	0 / 78 (0.00%)	2 / 132 (1.52%)	0 / 38 (0.00%)	0 / 38 (0.00%)	0 / 100 (0.00%)	0 / 103 (0.00%)	0 / 4 (0.00%)	0 / 473 (0.00%)	0 / 9 (0.00%)	1 / 8 (12.50%)	0 / 9 (0.00%)
occurrences all number	0	1	0	1	1	2	0	0	0	0	0	0	2	0	0	0	0	0	0	0	1	0
Abdominal Pain Lower
subjects affected / exposed	0 / 240 (0.00%)	0 / 328 (0.00%)	0 / 241 (0.00%)	0 / 240 (0.00%)	0 / 378 (0.00%)	0 / 375 (0.00%)	0 / 127 (0.00%)	0 / 108 (0.00%)	0 / 111 (0.00%)	0 / 113 (0.00%)	0 / 100 (0.00%)	0 / 78 (0.00%)	0 / 132 (0.00%)	0 / 38 (0.00%)	0 / 38 (0.00%)	0 / 100 (0.00%)	0 / 103 (0.00%)	0 / 4 (0.00%)	2 / 473 (0.42%)	0 / 9 (0.00%)	0 / 8 (0.00%)	1 / 9 (11.11%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	1
Nausea
subjects affected / exposed	11 / 240 (4.58%)	2 / 328 (0.61%)	8 / 241 (3.32%)	7 / 240 (2.92%)	9 / 378 (2.38%)	8 / 375 (2.13%)	0 / 127 (0.00%)	0 / 108 (0.00%)	1 / 111 (0.90%)	1 / 113 (0.88%)	0 / 100 (0.00%)	0 / 78 (0.00%)	1 / 132 (0.76%)	0 / 38 (0.00%)	3 / 38 (7.89%)	2 / 100 (2.00%)	1 / 103 (0.97%)	0 / 4 (0.00%)	26 / 473 (5.50%)	0 / 9 (0.00%)	0 / 8 (0.00%)	0 / 9 (0.00%)
occurrences all number	11	2	9	8	9	8	0	0	1	1	0	0	1	0	3	2	1	0	30	0	0	0
Tooth Impacted
subjects affected / exposed	0 / 240 (0.00%)	0 / 328 (0.00%)	0 / 241 (0.00%)	0 / 240 (0.00%)	0 / 378 (0.00%)	1 / 375 (0.27%)	0 / 127 (0.00%)	0 / 108 (0.00%)	0 / 111 (0.00%)	0 / 113 (0.00%)	0 / 100 (0.00%)	0 / 78 (0.00%)	0 / 132 (0.00%)	0 / 38 (0.00%)	0 / 38 (0.00%)	0 / 100 (0.00%)	0 / 103 (0.00%)	0 / 4 (0.00%)	0 / 473 (0.00%)	1 / 9 (11.11%)	0 / 8 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Hepatobiliary disorders
Biliary Colic
subjects affected / exposed	0 / 240 (0.00%)	0 / 328 (0.00%)	0 / 241 (0.00%)	0 / 240 (0.00%)	0 / 378 (0.00%)	1 / 375 (0.27%)	0 / 127 (0.00%)	0 / 108 (0.00%)	0 / 111 (0.00%)	0 / 113 (0.00%)	0 / 100 (0.00%)	0 / 78 (0.00%)	0 / 132 (0.00%)	0 / 38 (0.00%)	0 / 38 (0.00%)	0 / 100 (0.00%)	0 / 103 (0.00%)	1 / 4 (25.00%)	0 / 473 (0.00%)	0 / 9 (0.00%)	0 / 8 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Skin and subcutaneous tissue disorders
Skin Reaction
subjects affected / exposed	0 / 240 (0.00%)	0 / 328 (0.00%)	0 / 241 (0.00%)	0 / 240 (0.00%)	0 / 378 (0.00%)	0 / 375 (0.00%)	0 / 127 (0.00%)	0 / 108 (0.00%)	0 / 111 (0.00%)	0 / 113 (0.00%)	0 / 100 (0.00%)	0 / 78 (0.00%)	0 / 132 (0.00%)	0 / 38 (0.00%)	0 / 38 (0.00%)	0 / 100 (0.00%)	0 / 103 (0.00%)	0 / 4 (0.00%)	0 / 473 (0.00%)	0 / 9 (0.00%)	0 / 8 (0.00%)	1 / 9 (11.11%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	107 / 240 (44.58%)	91 / 328 (27.74%)	104 / 241 (43.15%)	102 / 240 (42.50%)	110 / 378 (29.10%)	114 / 375 (30.40%)	22 / 127 (17.32%)	31 / 108 (28.70%)	39 / 111 (35.14%)	31 / 113 (27.43%)	30 / 100 (30.00%)	18 / 78 (23.08%)	42 / 132 (31.82%)	7 / 38 (18.42%)	6 / 38 (15.79%)	35 / 100 (35.00%)	24 / 103 (23.30%)	0 / 4 (0.00%)	228 / 473 (48.20%)	1 / 9 (11.11%)	1 / 8 (12.50%)	1 / 9 (11.11%)
occurrences all number	132	94	131	134	113	115	22	31	40	32	30	18	42	7	6	36	24	0	308	1	1	1
Myalgia
subjects affected / exposed	143 / 240 (59.58%)	123 / 328 (37.50%)	123 / 241 (51.04%)	135 / 240 (56.25%)	145 / 378 (38.36%)	153 / 375 (40.80%)	40 / 127 (31.50%)	43 / 108 (39.81%)	48 / 111 (43.24%)	41 / 113 (36.28%)	36 / 100 (36.00%)	27 / 78 (34.62%)	61 / 132 (46.21%)	11 / 38 (28.95%)	9 / 38 (23.68%)	54 / 100 (54.00%)	33 / 103 (32.04%)	2 / 4 (50.00%)	275 / 473 (58.14%)	4 / 9 (44.44%)	2 / 8 (25.00%)	4 / 9 (44.44%)
occurrences all number	196	124	166	176	148	153	41	43	51	41	38	27	61	11	9	54	33	2	371	4	2	4
Infections and infestations
Breast Abscess
subjects affected / exposed	0 / 240 (0.00%)	0 / 328 (0.00%)	0 / 241 (0.00%)	0 / 240 (0.00%)	0 / 378 (0.00%)	0 / 375 (0.00%)	0 / 127 (0.00%)	0 / 108 (0.00%)	0 / 111 (0.00%)	0 / 113 (0.00%)	0 / 100 (0.00%)	0 / 78 (0.00%)	0 / 132 (0.00%)	0 / 38 (0.00%)	0 / 38 (0.00%)	0 / 100 (0.00%)	0 / 103 (0.00%)	0 / 4 (0.00%)	0 / 473 (0.00%)	1 / 9 (11.11%)	0 / 8 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Covid-19
subjects affected / exposed	5 / 240 (2.08%)	16 / 328 (4.88%)	7 / 241 (2.90%)	3 / 240 (1.25%)	34 / 378 (8.99%)	37 / 375 (9.87%)	2 / 127 (1.57%)	9 / 108 (8.33%)	4 / 111 (3.60%)	6 / 113 (5.31%)	9 / 100 (9.00%)	13 / 78 (16.67%)	20 / 132 (15.15%)	1 / 38 (2.63%)	0 / 38 (0.00%)	6 / 100 (6.00%)	5 / 103 (4.85%)	0 / 4 (0.00%)	21 / 473 (4.44%)	1 / 9 (11.11%)	0 / 8 (0.00%)	1 / 9 (11.11%)
occurrences all number	5	16	7	3	35	38	2	9	4	6	9	13	20	1	0	6	5	0	21	1	0	1
Nasopharyngitis
subjects affected / exposed	2 / 240 (0.83%)	3 / 328 (0.91%)	0 / 241 (0.00%)	1 / 240 (0.42%)	7 / 378 (1.85%)	2 / 375 (0.53%)	5 / 127 (3.94%)	0 / 108 (0.00%)	0 / 111 (0.00%)	0 / 113 (0.00%)	1 / 100 (1.00%)	6 / 78 (7.69%)	3 / 132 (2.27%)	0 / 38 (0.00%)	0 / 38 (0.00%)	2 / 100 (2.00%)	0 / 103 (0.00%)	0 / 4 (0.00%)	2 / 473 (0.42%)	0 / 9 (0.00%)	0 / 8 (0.00%)	0 / 9 (0.00%)
occurrences all number	2	3	0	1	9	2	5	0	0	0	1	6	4	0	0	2	0	0	2	0	0	0
Otitis Externa
subjects affected / exposed	0 / 240 (0.00%)	0 / 328 (0.00%)	0 / 241 (0.00%)	0 / 240 (0.00%)	1 / 378 (0.26%)	0 / 375 (0.00%)	0 / 127 (0.00%)	0 / 108 (0.00%)	0 / 111 (0.00%)	0 / 113 (0.00%)	0 / 100 (0.00%)	0 / 78 (0.00%)	0 / 132 (0.00%)	0 / 38 (0.00%)	0 / 38 (0.00%)	0 / 100 (0.00%)	0 / 103 (0.00%)	0 / 4 (0.00%)	0 / 473 (0.00%)	1 / 9 (11.11%)	0 / 8 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Pharyngitis
subjects affected / exposed	1 / 240 (0.42%)	2 / 328 (0.61%)	3 / 241 (1.24%)	3 / 240 (1.25%)	7 / 378 (1.85%)	4 / 375 (1.07%)	2 / 127 (1.57%)	1 / 108 (0.93%)	3 / 111 (2.70%)	2 / 113 (1.77%)	2 / 100 (2.00%)	0 / 78 (0.00%)	2 / 132 (1.52%)	1 / 38 (2.63%)	0 / 38 (0.00%)	2 / 100 (2.00%)	1 / 103 (0.97%)	0 / 4 (0.00%)	7 / 473 (1.48%)	0 / 9 (0.00%)	1 / 8 (12.50%)	0 / 9 (0.00%)
occurrences all number	1	2	3	3	7	4	2	1	3	2	2	0	2	1	0	2	1	0	7	0	1	0
Sinusitis
subjects affected / exposed	2 / 240 (0.83%)	0 / 328 (0.00%)	0 / 241 (0.00%)	1 / 240 (0.42%)	4 / 378 (1.06%)	7 / 375 (1.87%)	1 / 127 (0.79%)	0 / 108 (0.00%)	3 / 111 (2.70%)	3 / 113 (2.65%)	0 / 100 (0.00%)	0 / 78 (0.00%)	1 / 132 (0.76%)	0 / 38 (0.00%)	1 / 38 (2.63%)	0 / 100 (0.00%)	2 / 103 (1.94%)	0 / 4 (0.00%)	3 / 473 (0.63%)	1 / 9 (11.11%)	0 / 8 (0.00%)	0 / 9 (0.00%)
occurrences all number	2	0	0	1	4	8	1	0	3	3	0	0	1	0	1	0	2	0	3	2	0	0
Post-Acute Covid-19 Syndrome
subjects affected / exposed	0 / 240 (0.00%)	0 / 328 (0.00%)	0 / 241 (0.00%)	1 / 240 (0.42%)	0 / 378 (0.00%)	0 / 375 (0.00%)	0 / 127 (0.00%)	0 / 108 (0.00%)	0 / 111 (0.00%)	0 / 113 (0.00%)	0 / 100 (0.00%)	0 / 78 (0.00%)	0 / 132 (0.00%)	0 / 38 (0.00%)	0 / 38 (0.00%)	1 / 100 (1.00%)	0 / 103 (0.00%)	0 / 4 (0.00%)	0 / 473 (0.00%)	0 / 9 (0.00%)	0 / 8 (0.00%)	1 / 9 (11.11%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1
Suspected Covid-19
subjects affected / exposed	0 / 240 (0.00%)	0 / 328 (0.00%)	0 / 241 (0.00%)	0 / 240 (0.00%)	2 / 378 (0.53%)	3 / 375 (0.80%)	0 / 127 (0.00%)	0 / 108 (0.00%)	0 / 111 (0.00%)	0 / 113 (0.00%)	2 / 100 (2.00%)	2 / 78 (2.56%)	4 / 132 (3.03%)	2 / 38 (5.26%)	0 / 38 (0.00%)	0 / 100 (0.00%)	0 / 103 (0.00%)	0 / 4 (0.00%)	1 / 473 (0.21%)	1 / 9 (11.11%)	0 / 8 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	3	3	0	0	0	0	2	2	4	2	0	0	0	0	1	1	0	0
Tonsillitis
subjects affected / exposed	0 / 240 (0.00%)	0 / 328 (0.00%)	0 / 241 (0.00%)	0 / 240 (0.00%)	1 / 378 (0.26%)	3 / 375 (0.80%)	0 / 127 (0.00%)	0 / 108 (0.00%)	1 / 111 (0.90%)	0 / 113 (0.00%)	0 / 100 (0.00%)	0 / 78 (0.00%)	0 / 132 (0.00%)	0 / 38 (0.00%)	0 / 38 (0.00%)	0 / 100 (0.00%)	0 / 103 (0.00%)	0 / 4 (0.00%)	4 / 473 (0.85%)	0 / 9 (0.00%)	0 / 8 (0.00%)	1 / 9 (11.11%)
occurrences all number	0	0	0	0	1	3	0	0	1	0	0	0	0	0	0	0	0	0	5	0	0	1
Viral Upper Respiratory Tract Infection
subjects affected / exposed	0 / 240 (0.00%)	0 / 328 (0.00%)	0 / 241 (0.00%)	0 / 240 (0.00%)	0 / 378 (0.00%)	0 / 375 (0.00%)	0 / 127 (0.00%)	1 / 108 (0.93%)	0 / 111 (0.00%)	0 / 113 (0.00%)	0 / 100 (0.00%)	0 / 78 (0.00%)	0 / 132 (0.00%)	0 / 38 (0.00%)	0 / 38 (0.00%)	0 / 100 (0.00%)	0 / 103 (0.00%)	0 / 4 (0.00%)	0 / 473 (0.00%)	1 / 9 (11.11%)	0 / 8 (0.00%)	0 / 9 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Urinary Tract Infection
subjects affected / exposed	4 / 240 (1.67%)	2 / 328 (0.61%)	2 / 241 (0.83%)	3 / 240 (1.25%)	6 / 378 (1.59%)	5 / 375 (1.33%)	3 / 127 (2.36%)	0 / 108 (0.00%)	0 / 111 (0.00%)	1 / 113 (0.88%)	1 / 100 (1.00%)	1 / 78 (1.28%)	0 / 132 (0.00%)	0 / 38 (0.00%)	0 / 38 (0.00%)	1 / 100 (1.00%)	1 / 103 (0.97%)	0 / 4 (0.00%)	5 / 473 (1.06%)	0 / 9 (0.00%)	0 / 8 (0.00%)	1 / 9 (11.11%)
occurrences all number	4	2	2	3	6	6	3	0	0	1	1	1	0	0	0	1	2	0	5	0	0	1
Upper Respiratory Tract Infection
subjects affected / exposed	0 / 240 (0.00%)	3 / 328 (0.91%)	3 / 241 (1.24%)	1 / 240 (0.42%)	5 / 378 (1.32%)	2 / 375 (0.53%)	0 / 127 (0.00%)	4 / 108 (3.70%)	1 / 111 (0.90%)	2 / 113 (1.77%)	0 / 100 (0.00%)	2 / 78 (2.56%)	1 / 132 (0.76%)	0 / 38 (0.00%)	0 / 38 (0.00%)	1 / 100 (1.00%)	3 / 103 (2.91%)	0 / 4 (0.00%)	4 / 473 (0.85%)	0 / 9 (0.00%)	1 / 8 (12.50%)	1 / 9 (11.11%)
occurrences all number	0	4	3	1	5	2	0	4	1	2	0	3	1	0	0	1	3	0	4	0	1	1

More information

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Were there any global substantial amendments to the protocol? Yes

08 Apr 2021

Amended to clarify that safety, reactogenicity, and immunogenicity data from the Phase 2 study used to determine progression to a Phase 3 and inform dose selection. Revised text to clarify the onset of COVID-like-illness. Halting rule added per Center for Biologics Evaluation and Research non-hold comment.

10 Jun 2021

The study design changed to add a Supplemental Phase 3 Cohorts (Booster Study 1). Study phase changed. Study name changed to add Supplemental Phase 3 Cohorts. Titles changed to add Supplemental Phase 3 Cohorts. New formulations added for the Supplemental Phase 3 Cohorts. Study Design changed to add the Supplemental Phase 3 Cohorts. Objectives and Endpoints added for the Supplemental Phase 3 Cohorts. Schemas added for the Supplemental Phase 3 Cohorts. Schedule of Activities added for the Supplemental Phase 3 Cohorts.

31 Aug 2021

Shortened names of vaccine candidates changed. Greek letter names for the virus variants was added, that is Alpha (B.1.1.7), Beta (B.1.351), Delta (B.1.617). Text added to replace pandemic scope text in previous versions. Nonclinical studies text added for monovalent and bivalent vaccine data. Additional objectives for Supplemental Cohorts 1 and 2 added. Modified participant numbers for Cohort 3 subset to 87. Dose formulation text updated. Updated inclusion and exclusion criteria. Removed text for SARS-CoV-2 Virus Neutralization Assays.

12 Oct 2021

Clarification added to protein-primed dosing groups only. Seroresponse included as conditional secondary endpoint for powered comparisons. New subsection "A Pooled Primary Series Cohort as Supplemental Cohorts 1 and 2 Comparator Group" was added.

19 Nov 2021

Removed bivalent vaccine candidate arm from Variant Prime Cohort 3. Participants numbers changed in monovalent arms. Total participant numbers changed due to no bivalent arm in Variant Prime Cohort 3. Definition of COVID-19 was changed. Updated the Section "Variant Prime Cohort 3 statistical analysis".

20 Jan 2022

Removed Supplemental Variant Prime Cohort 3. Total participant numbers changed for removal of Variant Prime Cohort 3 participants. Updated the Section "List of potential immune-mediated diseases".

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

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of Participants With Immediate Unsolicited Adverse Events (AEs)

Primary: Number of Participants With Immediate Unsolicited Adverse Events (AEs)

Primary: Number of Participants With Solicited Injection Site Reactions and Systemic Reactions

Primary: Number of Participants With Solicited Injection Site Reactions and Systemic Reactions

Primary: Number of Participants With Unsolicited Adverse Events

Primary: Number of Participants With Unsolicited Adverse Events

Primary: Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)

Primary: Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)

Primary: Phase 2: Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) D614G Strain at Day 1

Primary: Phase 2: Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) D614G Strain at Day 1

Primary: Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Day 36

Primary: Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Day 36

Primary: Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Day 36

Primary: Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Day 36

Primary: Phase 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Day 36

Primary: Phase 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Day 36

Primary: Phase 3: Cohorts 1 and 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Day 1

Primary: Phase 3: Cohorts 1 and 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Day 1

Primary: Phase 3: Cohorts 1, 2 and Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at 14 Days Post-Vaccination

Primary: Phase 3: Cohorts 1, 2 and Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at 14 Days Post-Vaccination

Primary: Phase 3: Comparator: Percentage of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Day 36

Primary: Phase 3: Comparator: Percentage of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Day 36

Secondary: Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387

Secondary: Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387

Secondary: Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387

Secondary: Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387

Secondary: Phase 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387

Secondary: Phase 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387

Secondary: Phase 2: Geometric Mean Concentration (GMC) of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 78, 134, 202, 292, and 387

Secondary: Phase 2: Geometric Mean Concentration (GMC) of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 78, 134, 202, 292, and 387

Secondary: Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387

Secondary: Phase 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387

Secondary: Phase 2: Number of Responders as Determined by Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387

Secondary: Phase 2: Number of Responders as Determined by Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 78, 134, 202, 292, and 387

Secondary: Phase 3: Cohort 1: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 29, 91, 181, and 366

Secondary: Phase 3: Cohort 1: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 29, 91, 181, and 366

Secondary: Phase 3: Cohort 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366

Secondary: Phase 3: Cohort 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366

Secondary: Phase 3: Cohorts 1, 2 and Comparator: Percentage of Participants With Seroresponse Against SARS-CoV-2 D614G Strain and B.1.351 Variant at 14 Days Post-Vaccination

Secondary: Phase 3: Cohorts 1, 2 and Comparator: Percentage of Participants With Seroresponse Against SARS-CoV-2 D614G Strain and B.1.351 Variant at 14 Days Post-Vaccination

Secondary: Phase 3: Cohorts 1 and 2: Geometric Mean Concentration of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 15, 29, 91, 181, and 366

Secondary: Phase 3: Cohorts 1 and 2: Geometric Mean Concentration of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 15, 29, 91, 181, and 366

Secondary: Phase 3: Cohorts 1 and 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 15, 29, 91, 181, and 366

Secondary: Phase 3: Cohorts 1 and 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 15, 29, 91, 181, and 366

Secondary: Phase 3: Cohort 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 15, 29, 91, 181, and 366

Secondary: Phase 3: Cohort 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 15, 29, 91, 181, and 366

Secondary: Phase 3: Cohort 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366

Secondary: Phase 3: Cohort 2: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366

Secondary: Phase 3: Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 22, 36, 134, 202, 292, and 387

Secondary: Phase 3: Comparator: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 1, 22, 36, 134, 202, 292, and 387

Secondary: Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387

Secondary: Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 22, 36, 134, 202, 292, and 387

Secondary: Phase 3: Comparator: Geometric Mean Concentration of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 134, 202, 292, and 387

Secondary: Phase 3: Comparator: Geometric Mean Concentration of Binding Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, 36, 134, 202, 292, and 387

Secondary: Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387

Secondary: Phase 3: Comparator: Number of Participants With >=2-Fold and >=4-Fold Rise in Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387

Secondary: Phase 3: Comparator: Percentage of Responders as Determined by Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387

Secondary: Phase 3: Comparator: Percentage of Responders as Determined by Binding Antibody Concentration Against SARS-CoV-2 D614G Strain at Days 22, 36, 134, 202, 292, and 387

Secondary: Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19

Secondary: Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19

Secondary: Phase 2: Percentage of Participants With Serologically-Confirmed SARS-CoV-2 Infection

Secondary: Phase 2: Percentage of Participants With Serologically-Confirmed SARS-CoV-2 Infection

Secondary: Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization

Secondary: Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization

Secondary: Percentage of Participants With Severe Symptomatic COVID-19

Secondary: Percentage of Participants With Severe Symptomatic COVID-19

Secondary: Percentage of Participants With Death Associated With Symptomatic COVID-19

Secondary: Percentage of Participants With Death Associated With Symptomatic COVID-19

Adverse events

Adverse events

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