Study of Recombinant Protein Vaccines With Adjuvant as a... | NCT04762680 | Trialant
NCT04762680
Sponsor
Sanofi Pasteur, a Sanofi Company
Status
Completed
Last Update Posted
Sep 18, 2025Actual
Enrollment
3,159Actual
Phase
Phase 2Phase 3
Conditions
COVID-19
Interventions
SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 1
SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 2
SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 3
SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage A
SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03
SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage B
SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 1
SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 2
SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 3
SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 4
SARS-CoV-2 adjuvanted recombinant protein vaccine, bivalent (D614+B.1.351)-AS03
Countries
United States
Australia
France
Honduras
New Zealand
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT04762680
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
VAT00002
Secondary IDs
ID
Type
Description
Link
U1111-1251-4616
Registry Identifier
ICTRP
2020-003370-41
EudraCT Number
Brief Title
Study of Recombinant Protein Vaccines With Adjuvant as a Primary Series and as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older
Official Title
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)
Acronym
Not provided
Organization
SanofiINDUSTRY
Status Module
Record Verification Date
Sep 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 24, 2021Actual
Primary Completion Date
Jun 29, 2023Actual
Completion Date
Jun 29, 2023Actual
First Submitted Date
Feb 18, 2021
First Submission Date that Met QC Criteria
Feb 18, 2021
First Posted Date
Feb 21, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Mar 6, 2025
Results First Submitted that Met QC Criteria
Sep 2, 2025
Results First Posted Date
Sep 18, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 24, 2024
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Sep 18, 2025Actual
Last Update Submitted Date
Sep 2, 2025
Last Update Posted Date
Sep 18, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Sanofi Pasteur, a Sanofi CompanyINDUSTRY
Collaborators
Name
Class
GlaxoSmithKline
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary objectives of the study are:
To assess the safety profile of the study vaccines in each study intervention group.
To assess the neutralizing antibody profile after primary series vaccination in SARS-CoV-2-naïve adults.
To demonstrate that a booster dose of monovalent or bivalent SARS-CoV-2 vaccine given to adults previously vaccinated with an authorized/approved COVID-19 vaccine induces an immune response that is non-inferior to the response induced by a twodose priming series with the monovalent vaccine, and superior to that observed immediately before booster.
The secondary objectives of the study are:
To assess the neutralizing and binding antibody profiles after primary series vaccination at pre-defined time points during the study.
To assess the neutralizing and binding antibody responses of booster vaccination.
To describe the occurrences of laboratory-confirmed symptomatic COVID19 after primary series and booster vaccination.
To describe the occurrences of serologically-confirmed SARS-CoV-2 infection after primary series vaccination.
Detailed Description
The duration of each participant's participation in the study will be approximately:
Original Phase 2 part: 365 days postinjection 2 (ie, 386 days total). Supplemental Cohorts 1 and 2: 365 days post-booster injection (ie, 366 days total).
Conditions Module
Conditions
COVID-19
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
3,159Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase 2 Cohort -SARS-CoV-2 vaccine Formulation 1
Experimental
2 injections of SARS-CoV-2 vaccine Formulation 1 at Day 1 and Day 22
Biological: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 1
Phase 2 Cohort - SARS-CoV-2 vaccine Formulation 2
Experimental
2 injections of SARS-CoV-2 vaccine Formulation 2 at Day 1 and Day 22
Biological: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 2
Phase 2 Cohort - SARS-CoV-2 vaccine Formulation 3
Experimental
2 injections of SARS-CoV-2 vaccine Formulation 3 Day 1 and Day 22
Biological: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 3
Participants who were previously vaccinated 4 to < 10 months prior with an authorized mRNA or adenovirus-vector COVID-19 vaccine will receive 1 booster injection of monovalent (D614)-AS03 SARS-CoV-2 vaccine
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage A
SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 1
Biological
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
Phase 2 Cohort -SARS-CoV-2 vaccine Formulation 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Immediate Unsolicited Adverse Events (AEs)
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.
Up to 30 minutes after each vaccination (Phase 2: Postdose on Days 1 and 22; Phase 3: Between 4 to 10 months after priming vaccine)
Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
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.
Up to 7 days after each vaccination (Phase 2: Postdose on Days 1 and 22; Phase 3: Between 4 to 10 months after priming vaccine)
Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Unsolicited Adverse Events
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.
Up to 21 days after each vaccination (Phase 2: Postdose on Days 1 and 22; Phase 3: Between 4 to 10 months after priming vaccine)
Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)
Secondary Outcomes
Measure
Description
Time Frame
Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387
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.
Post-vaccination on Days 22, 78, 134, 202, 292, and 387
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
-Aged 18 years or older on the day of inclusion. - -A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: Is of non-childbearing potential. To be considered of non-childbearing potential, a female mut be post-menopausal for at least 1 year or surgically sterile.
OR Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first vaccination until at least 12 weeks after the last vaccination (ie, second dose of primary series or booster injection). A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 4 hours before any dose of study intervention. - -Informed consent form has been signed and dated.
Able to attend all scheduled visits and to comply with all study procedures. SARS-CoV-2 rapid serodiagnostic test performed at the time of enrollment to detect presence of SARS-CoV-2 antibodies (Original Phase 2 Cohort).
For persons living with human immunodeficiency virus (HIV), stable HIV infection determined by participant currently on antiretrovirals with CD4 count > 200/mm3.
Does not intend to receive an authorized/approved COVID-19 vaccine from first vaccination to 3 weeks after the second vaccination despite encouragement by the investigator to receive the authorized vaccine available to them at the time of enrollment.
Supplemental cohorts: for participants originally enrolled in the Phase II cohort of the study, informed consent has to be signed and dated for transitioning to Supplemental Cohort 2.
Supplemental cohorts, Booster arms: received a complete primary vaccination series with an authorized/conditionally approved mRNA COVID-19 vaccine (mRNA-1273 [Moderna] or BNT162b2 [Pfizer/BioNTech]) or adenovirus-vectored COVID-19 vaccine (ChAdOx1 nCoV-19 [Oxford University/AstraZeneca] or Ad26.CoV2.S [J&J/Janssen]), with the last dose administered a minimum of 4 months prior to inclusion but not longer than 10 months prior to inclusion.
Exclusion Criteria:
-Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances.
Dementia or any other cognitive condition at a stage that could interfere with following the trial procedures based on Investigator or designee's judgment.
Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination based on Investigator's judgment.
Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating IM vaccination based on Investigator's judgment.
Unstable acute or chronic illness that in the opinion of the Investigator or designee poses additional risk as a result of participation or that could interfere with the study procedures.
Receipt of solid-organ or bone marrow transplants in the past 180 days. Receipt of anti-cancer chemotherapy in the last 90 days. Receipt of immunoglobulins, blood, or blood-derived products in the past 3 months.
Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]). A prospective participant should not be included in the trial until the condition has resolved or the febrile event has subsided. Receipt of any vaccine in the 30 days preceding or on the day of the first study vaccination or planned receipt of any vaccine between the first study vaccination and in the 30 days following the second study vaccination except for influenza vaccination, which may be received at any time in relation to study intervention.
Applicable to Original Phase II Cohort, Supplemental Cohort 1 and Cohort 2 Comparator Group: Prior administration of a coronavirus vaccine (SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome [MERS-CoV]). Participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study trial period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. Exclusion criterion for the Supplemental Cohort 1 and Cohort 2 comparator group: positive rapid diagnostic test for SARS-CoV-2 antibodies at time of enrollment.
Exclusion criterion for participants in Supplemental Cohort 2 who were primed as participant in the Original Phase II Cohort of the present study: Receipt of authorized/conditionally approved COVID-19 vaccine after enrollment in Original Phase 2 Cohort.
Exclusion criterion for all Booster groups: Documented virologically-confirmed SARS-CoV-2 infection (by NAAT) after first dose of primary immunization.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Sciences & Operations
Sanofi
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Synexus - Clinical Research Advantage, Inc. Site Number : 8400270
de Bruyn G, Wang J, Purvis A, Ruiz MS, Adhikarla H, Alvi S, Bonaparte MI, Brune D, Bueso A, Canter RM, Ceregido MA, Deshmukh S, Diemert D, Finn A, Forrat R, Fu B, Gallais J, Griffin P, Grillet MH, Haney O, Henderson JA, Koutsoukos M, Launay O, Torres FM, Masotti R, Michael NL, Park J, Rivera-Medina DM, Romanyak N, Rook C, Schuerman L, Sher LD, Tavares-Da-Silva F, Whittington A, Chicz RM, Gurunathan S, Savarino S, Sridhar S; VAT00002 booster cohorts study team. Safety and immunogenicity of a variant-adapted SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant as a booster in adults primed with authorized vaccines: a phase 3, parallel-group study. EClinicalMedicine. 2023 Jul 22;62:102109. doi: 10.1016/j.eclinm.2023.102109. eCollection 2023 Aug.
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment 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. Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. To be eligible, participants in the Booster Cohorts were required to have received a primary series, as administered in the Original Cohort.
Recruitment Details
The Phase 2 of study was conducted at 20 centers between 24 February 2021 and 01 May 2021. The Phase 3 of study was conducted at 110 centers between 29 July 2021 and 06 January 2023.
CoV2 preS dTM= Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
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.
FG001
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
Periods
Title
Milestones
Reasons Not Completed
Phase 2
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jan 20, 2022
Mar 6, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Kenya
Mexico
Panama
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
To address the emergence of variant strains, Sanofi Pasteur is developing monovalent and bivalent vaccines for use as universal late booster vaccines which will be studied in additional Phase 3 study cohorts that are added to the initial Phase 2 protocol cohorts. Supplemental Cohorts 1 and 2 will evaluate booster vaccine candidates.
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Quadruple
Masking Description
In the original Phase 2 part, participants, outcome assessors, Investigators, laboratory personnel, and sponsor study staff are blinded to intervention group; and those preparing the study interventions are unblinded to vaccine assignment group.
The supplemental Cohort 1 intervention group and Supplemental Cohorts Comparator Group will be open-label. Supplemental Cohort 2 will involve sequential randomization to main arms then exploratory arms, and the intervention will be modified double-blind (observer-blinded, as described).
Participants who were vaccinated 4 to < 10 months prior with an authorized mRNA or adenovirus-vector COVID-19 vaccine or SARS-Cov-2 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03
Participants who were vaccinated 4 to < 10 months prior with an authorized mRNA or adenovirus-vector COVID-19 vaccine will receive 1 booster injection of bivalent (D614+B.1.351)-AS03 SARS-CoV-2 vaccine
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, bivalent (D614+B.1.351)-AS03
Participants who were vaccinated 4 to < 10 months prior with SARS-Cov-2 vaccine will receive 1 booster injection of monovalent (D614)-AS03 SARS-CoV-2 vaccine
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage A
Supplemental Comparator for Cohort 1 and 2 Boosters - Monovalent (D614)-AS03 SARS-CoV-2 vaccine
Active Comparator
2 injections of monovalent (D614)-AS03 SARS-CoV-2 vaccine at Day 1 and Day 22 in previously unvaccinated, naïve participants
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage B
Cohort 2 - Booster Exploratory 1
Experimental
Participants who were vaccinated 4 to < 10 months prior with an authorized mRNA COVID-19 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 1
Cohort 2 - Booster Exploratory 2
Experimental
Participants who were vaccinated 4 to < 10 months prior with an authorized mRNA COVID-19 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 2
Cohort 2 - Booster Exploratory 3
Experimental
Participants who were vaccinated 4 to < 10 months prior with an authorized mRNA COVID-19 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 3
Cohort 2 - Booster Exploratory 4
Experimental
Participants who were vaccinated 4 to < 10 months prior with an authorized mRNA COVID-19 vaccine will receive 1 booster injection of monovalent (B.1.351)-AS03 SARS-CoV-2 vaccine
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 4
rSP-COVID19
SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 2
Biological
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
Phase 2 Cohort - SARS-CoV-2 vaccine Formulation 2
rSP-COVID19 Formulation 2
SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 3
Biological
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
Phase 2 Cohort - SARS-CoV-2 vaccine Formulation 3
rSP-COVID19 Formulation 3
SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage A
Biological
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
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.
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.
Phase 2: Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) D614G Strain at Day 1
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.
Pre-vaccination on Day 1
Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Day 36
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.
Day 36
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
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.
Day 1 (pre-vaccination) and Day 36
Phase 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Day 36
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.
Day 36
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
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.
Pre-vaccination on Day 1
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
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.
Cohorts 1 and 2: 14 days post-vaccination on Day 1, Day 15; Comparator: 14 days post-vaccination on Day 22, Day 36
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
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. Percentages are rounded off to the tenth decimal place.
Day 36
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
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.
Pre-vaccination on Day 1 and Post-vaccination on Days 22, 78, 134, 202, 292, and 387
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
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).
Post-vaccination on Days 22, 78, 134, 202, 292, and 387
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
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 titers.
Pre-vaccination on Day 1 and post-vaccination on Days 22, 36, 78, 134, 202, 292, and 387
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
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.
Pre-vaccination on Day 1 and Post-vaccination on Days 22, 36, 78, 134, 202, 292, and 387
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
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.
Post-vaccination on Days 22, 36, 78, 134, 202, 292, and 387
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
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.
Post-vaccination on Days 29, 91, 181, and 366
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
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.
Pre-vaccination on Day 1 and Post-vaccination on Days 15, 29, 91, 181, and 366
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
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). Percentages are rounded off to the tenth decimal place.
Cohorts 1 and 2: 14 days post-vaccination on Day 1 (Day 15); Comparator: 14 days post-vaccination on Day 22 (Day 36)
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
Binding antibodies activity against SARS-CoV-2 D614G strain was measured with Nexelis GCN4 S-ELISA and the results were expressed as geometric mean titers.
Pre-vaccination on Day 1 and post-vaccination on Days 15, 29, 91, 181, and 366
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
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.
Pre-vaccination on Day 1 and Post-vaccination on Days 15, 29, 91, 181, and 366
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, and 91
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.
Pre-vaccination on Day 1 and post-vaccination on Days 15, 29, and 91
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, and 91
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.
Pre-vaccination on Day 1 and Post-vaccination on Days 15, 29, and 91
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
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.
Pre-vaccination on Day 1 and post-vaccination on Days 22, 36, 134, 202, 292, and 387
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
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.
Pre-vaccination on Day 1 and Post-vaccination on Days 22, 36, 134, 202, 292, and 387
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
Binding antibodies activity against SARS-CoV-2 D614G strain was measured with Nexelis GCN4 S-ELISA and the results were expressed as geometric mean titers.
Pre-vaccination on Day 1 and post-vaccination on Days 22, 36, 134, 202, 292, and 387
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
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.
Pre-vaccination on Day 1 and Post-vaccination on Days 22, 36, 134, 202, 292, and 387
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
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. Percentages are rounded off to the tenth decimal place.
Post-vaccination on Days 22, 36, 134, 202, 292, and 387
Phase 2: Percentage of Participants With Serologically-Confirmed SARS-CoV-2 Infection
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. Percentages are rounded off to the tenth decimal place.
From first dose of study vaccine administration (Day 1) up to 387 days
Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19
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. Percentages are rounded off to the tenth decimal place.
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.
Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization
Symptomatic COVID-19 was defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness. Percentages are rounded off to the tenth decimal place.
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.
Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Severe Symptomatic COVID-19
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 Ë‚90 millimeter of mercury (mmHg), or diastolic blood pressure Ë‚60 mmHg 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. Percentages are rounded off to the tenth decimal place.
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.
Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Death Associated With Symptomatic COVID-19
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. Percentages are rounded off to the tenth decimal place.
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.
Synexus Chandler Site Number : 8400251
Chandler
Arizona
85225
United States
Synexus - Glendale. Site Number : 8400271
Glendale
Arizona
85306
United States
Baptist Health Center for Clinical Research Site Number : 8400077
Little Rock
Arkansas
72205
United States
Charles R. Drew University of Medicine and Science Site Number : 8400220
Los Angeles
California
90059
United States
Peninsula Research Associates, Inc. Site Number : 8400094
Rolling Hills Estates
California
90274
United States
Optimal Research Site Number : 8400173
San Diego
California
92108
United States
Yale University Site Number : 8400239
New Haven
Connecticut
06510
United States
The George Washington University Site Number : 8400212
Washington D.C.
District of Columbia
20037
United States
Cenexel Research Centers of America Site Number : 8400089
Hollywood
Florida
33024
United States
Optimal Research, LLC Site Number : 8400057
Melbourne
Florida
32934
United States
Synexus Clinical Research US, Inc. - Orlando Site Number : 8400179
Orlando
Florida
32806
United States
Emory University Decatur Site Number : 8400201
Decatur
Georgia
30030
United States
Chicago Clinical Research Institute, Inc. Site Number : 8400269
Chicago
Illinois
60607
United States
Optimal Research Site Number : 8400187
Peoria
Illinois
61614
United States
Synexus Clinical Research Evansville Site Number : 8400272
Evansville
Indiana
47714
United States
Research Works INC Site Number : 8400045
New Orleans
Louisiana
70125
United States
Optimal Research, LLC Rockville Site Number : 8400048
Rockville
Maryland
20850
United States
Brigham and Women's Hospital Site Number : 8400199
Boston
Massachusetts
02115
United States
Synexus St. Louis Site Number : 8400100
St Louis
Missouri
63141
United States
Velocity Clinical Research, Omaha Site Number : 8400030
Omaha
Nebraska
68134
United States
Holy Name Medical Center Site Number : 8400072
Teaneck
New Jersey
07666
United States
NYU VC-Augustana Site Number : 8400267
Brooklyn
New York
11220
United States
New York University Langone Vaccine Center Site Number : 8400230
New York
New York
10016
United States
Columbia University Irving Medical Center Site Number : 8400203
New York
New York
10032
United States
University of Rochester Site Number : 8400207
Rochester
New York
14642
United States
University of Pittsburgh Site Number : 8400233
Pittsburgh
Pennsylvania
15213
United States
Coastal Carolina Research Center Site Number : 8400097
North Charleston
South Carolina
29405
United States
American Indian Clinical Trials Research Network Site Number : 8400204
Sridhar S, Joaquin A, Bonaparte MI, Bueso A, Chabanon AL, Chen A, Chicz RM, Diemert D, Essink BJ, Fu B, Grunenberg NA, Janosczyk H, Keefer MC, Rivera M DM, Meng Y, Michael NL, Munsiff SS, Ogbuagu O, Raabe VN, Severance R, Rivas E, Romanyak N, Rouphael NG, Schuerman L, Sher LD, Walsh SR, White J, von Barbier D, de Bruyn G, Canter R, Grillet MH, Keshtkar-Jahromi M, Koutsoukos M, Lopez D, Masotti R, Mendoza S, Moreau C, Ceregido MA, Ramirez S, Said A, Tavares-Da-Silva F, Shi J, Tong T, Treanor J, Diazgranados CA, Savarino S. Safety and immunogenicity of an AS03-adjuvanted SARS-CoV-2 recombinant protein vaccine (CoV2 preS dTM) in healthy adults: interim findings from a phase 2, randomised, dose-finding, multicentre study. Lancet Infect Dis. 2022 May;22(5):636-648. doi: 10.1016/S1473-3099(21)00764-7. Epub 2022 Jan 25.
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.
FG002
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
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.
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.
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.
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.
FG006
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
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.
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.
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.
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.
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.
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.
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.
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.
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.
FG015
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
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.
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.
FG017
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
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.
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.
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.
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.
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.
FG000241 subjects
FG001239 subjects
FG002242 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
COMPLETED
FG000199 subjects
FG001204 subjects
FG002204 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
NOT COMPLETED
FG00042 subjects
FG00135 subjects
FG00238 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
Protocol Violation
FG0005 subjects
FG0015 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG00023 subjects
FG00121 subjects
FG00228 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG00014 subjects
FG0018 subjects
FG0029 subjects
FG0030 subjects
FG004
Phase 3
Type
Comment
Milestone Data
STARTED
FG0000 subjectsOnly participants started in Phase 3 are reported.
FG0010 subjectsOnly participants started in Phase 3 are reported.
FG0020 subjectsOnly participants started in Phase 3 are reported.
FG003329 subjectsOnly participants started in Phase 3 are reported.
FG004378 subjectsOnly participants started in Phase 3 are reported.
FG005378 subjectsOnly participants started in Phase 3 are reported.
FG006113 subjectsOnly participants started in Phase 3 are reported.
FG007112 subjectsOnly participants started in Phase 3 are reported.
FG008108 subjectsOnly participants started in Phase 3 are reported.
FG009127 subjectsOnly participants started in Phase 3 are reported.
FG010101 subjectsOnly participants started in Phase 3 are reported.
FG011101 subjectsOnly participants started in Phase 3 are reported.
FG012105 subjectsOnly participants started in Phase 3 are reported.
FG01338 subjectsOnly participants started in Phase 3 are reported.
FG01438 subjectsOnly participants started in Phase 3 are reported.
FG015132 subjectsOnly participants started in Phase 3 are reported.
FG01678 subjectsOnly participants started in Phase 3 are reported.
FG017479 subjectsOnly participants started in Phase 3 are reported.
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003302 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00327 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Phase 3 - Exploratory
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjectsOnly participants started in Phase 3 - Exploratory are reported.
FG0040 subjectsOnly participants started in Phase 3 - Exploratory are reported.
FG0050 subjectsOnly participants started in Phase 3 - Exploratory are reported.
FG0060 subjectsOnly participants started in Phase 3 - Exploratory are reported.
FG0070 subjectsOnly participants started in Phase 3 - Exploratory are reported.
FG0080 subjectsOnly participants started in Phase 3 - Exploratory are reported.
FG0090 subjectsOnly participants started in Phase 3 - Exploratory are reported.
FG0100 subjectsOnly participants started in Phase 3 - Exploratory are reported.
FG0110 subjectsOnly participants started in Phase 3 - Exploratory are reported.
FG0120 subjectsOnly participants started in Phase 3 - Exploratory are reported.
FG0130 subjectsOnly participants started in Phase 3 - Exploratory are reported.
FG0140 subjectsOnly participants started in Phase 3 - Exploratory are reported.
FG0150 subjectsOnly participants started in Phase 3 - Exploratory are reported.
FG0160 subjectsOnly participants started in Phase 3 - Exploratory are reported.
FG0170 subjectsOnly participants started in Phase 3 - Exploratory are reported.
FG0184 subjectsOnly participants started in Phase 3 - Exploratory are reported.
FG0198 subjectsOnly participants started in Phase 3 - Exploratory are reported.
FG0209 subjectsOnly participants started in Phase 3 - Exploratory are reported.
FG0219 subjectsOnly participants started in Phase 3 - Exploratory are reported.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
All Randomized set included all participants with a randomized group allocated by interactive response technology. Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. To be eligible, participants in the Booster Cohorts were required to have received a primary series, as administered in the Original Cohort.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
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.
BG001
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
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.
BG002
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
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.
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.
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.
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.
BG006
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
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.
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.
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.
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.
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.
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.
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.
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.
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.
BG015
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
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.
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.
BG017
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
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.
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.
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.
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.
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.
BG022
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000241
BG001239
BG002242
BG003329
BG004378
BG005378
BG006113
BG007112
BG008108
BG009127
BG010101
BG011101
BG012105
BG01338
BG01438
BG015132
BG01678
BG017479
BG0184
BG0198
BG0209
BG0219
BG0223369
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
Count of Participants
Participants
Title
Denominators
Categories
Phase 2
ParticipantsBG000241
ParticipantsBG001239
ParticipantsBG002242
ParticipantsBG003
Sex: Female, Male
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
Count of Participants
Participants
Title
Denominators
Categories
Phase 2
ParticipantsBG000241
ParticipantsBG001239
ParticipantsBG002
Race/Ethnicity, Customized
Participants from the Original Cohort were included in the Booster Cohorts because these assessed separate objectives. Therefore, baseline measure data reported for each Phase separately.
Count of Participants
Participants
Title
Denominators
Categories
Phase 2
ParticipantsBG000241
ParticipantsBG001239
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Secondary
Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387
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. Only participants analyzed at specific timepoint are reported.
Posted
Geometric Mean
95% Confidence Interval
titers
Post-vaccination on Days 22, 78, 134, 202, 292, and 387
ID
Title
Description
OG000
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
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.
OG001
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
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.
OG002
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
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.
Units
Counts
Participants
OG000159
OG001160
OG002160
Title
Denominators
Categories
Day 22
ParticipantsOG000159
ParticipantsOG001160
ParticipantsOG002160
Title
Measurements
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
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. Only participants analyzed at specific timepoint are reported.
Posted
Count of Participants
Participants
Pre-vaccination on Day 1 and Post-vaccination on Days 22, 78, 134, 202, 292, and 387
ID
Title
Description
OG000
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
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.
OG001
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
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.
OG002
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
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.
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
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. Only participants analyzed at specific timepoint are reported.
Posted
Count of Participants
Participants
Post-vaccination on Days 22, 78, 134, 202, 292, and 387
ID
Title
Description
OG000
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
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.
OG001
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
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.
OG002
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
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
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 titers.
The PPAS Naïve-D01+D22 is a subset of the FAS. Only participants analyzed at specific timepoint are reported.
Posted
Geometric Mean
95% Confidence Interval
titers
Pre-vaccination on Day 1 and post-vaccination on Days 22, 36, 78, 134, 202, 292, and 387
ID
Title
Description
OG000
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
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.
OG001
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
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.
OG002
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
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.
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
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. Only participants analyzed at specific timepoint are reported.
Posted
Count of Participants
Participants
Pre-vaccination on Day 1 and Post-vaccination on Days 22, 36, 78, 134, 202, 292, and 387
ID
Title
Description
OG000
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
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.
OG001
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
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.
OG002
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
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.
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
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. Only participants analyzed at specific timepoint are reported.
Posted
Count of Participants
Participants
Post-vaccination on Days 22, 36, 78, 134, 202, 292, and 387
ID
Title
Description
OG000
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
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.
OG001
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
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.
OG002
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
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
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. Only participants analyzed for each parameter at specific timepoint are reported.
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.
OG001
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
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.
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
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. Only participants analyzed for each parameter at specific timepoint are reported.
Posted
Count of Participants
Participants
Pre-vaccination on Day 1 and Post-vaccination on Days 15, 29, 91, 181, and 366
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.
OG001
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
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.
OG002
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
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). Percentages are rounded off to the tenth decimal place.
The PPAS is a subset of the FAS. Only participants analyzed for each parameter at specific timepoint are reported.
Posted
Number
95% Confidence Interval
percentage of participants
Cohorts 1 and 2: 14 days post-vaccination on Day 1 (Day 15); Comparator: 14 days post-vaccination on Day 22 (Day 36)
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.
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.
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
Binding antibodies activity against SARS-CoV-2 D614G strain was measured with Nexelis GCN4 S-ELISA and the results were expressed as geometric mean titers.
The PPAS is a subset of the FAS. Only participants analyzed at specific timepoint are reported. Results data was not collected for 'Phase 3-Exploratory reporting groups' because study vaccine used in exploratory arms were different from booster cohort. No participants were analyzed and thus data was not collected at Day 366 for "Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)" reporting group.
Posted
Geometric Mean
95% Confidence Interval
titers
Pre-vaccination on Day 1 and post-vaccination on Days 15, 29, 91, 181, and 366
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.
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.
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
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. Only participants analyzed for each parameter at specific timepoint are reported. Results data was not collected for 'Phase 3-Exploratory reporting groups' because study vaccine used in exploratory arms were different from booster cohort. No participants were analyzed and thus data was not collected at Day 366 for "Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614)" reporting group.
Posted
Count of Participants
Participants
Pre-vaccination on Day 1 and Post-vaccination on Days 15, 29, 91, 181, and 366
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.
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.
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, and 91
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. Only participants analyzed for each parameter at specific timepoint are reported. Results data was not collected for 'Phase 3-Exploratory reporting groups' because study vaccine used in exploratory arms were different from booster cohort.
Posted
Geometric Mean
95% Confidence Interval
titers
Pre-vaccination on Day 1 and post-vaccination on Days 15, 29, and 91
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.
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.
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, and 91
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. Only participants analyzed for each parameter at specific timepoint are reported. Results data was not collected for 'Phase 3-Exploratory reporting groups' because study vaccine used in exploratory arms were different from booster cohort.
Posted
Count of Participants
Participants
Pre-vaccination on Day 1 and Post-vaccination on Days 15, 29, and 91
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.
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.
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
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. Only participants analyzed for each parameter at specific timepoint are reported.
Posted
Geometric Mean
95% Confidence Interval
titers
Pre-vaccination on Day 1 and post-vaccination on Days 22, 36, 134, 202, 292, and 387
ID
Title
Description
OG000
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
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.
Units
Counts
Participants
OG000
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
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. Only participants analyzed for each parameter at specific timepoint are reported.
Posted
Count of Participants
Participants
Pre-vaccination on Day 1 and Post-vaccination on Days 22, 36, 134, 202, 292, and 387
ID
Title
Description
OG000
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
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.
Units
Counts
Participants
OG000
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
Binding antibodies activity against SARS-CoV-2 D614G strain was measured with Nexelis GCN4 S-ELISA and the results were expressed as geometric mean titers.
The PPAS is a subset of the FAS. Only participants analyzed at specific timepoint are reported.
Posted
Geometric Mean
95% Confidence Interval
titers
Pre-vaccination on Day 1 and post-vaccination on Days 22, 36, 134, 202, 292, and 387
ID
Title
Description
OG000
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
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.
Units
Counts
Participants
OG000
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
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. Only participants analyzed for each parameter at specific timepoint are reported.
Posted
Count of Participants
Participants
Pre-vaccination on Day 1 and Post-vaccination on Days 22, 36, 134, 202, 292, and 387
ID
Title
Description
OG000
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
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.
Units
Counts
Participants
OG000
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
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. Percentages are rounded off to the tenth decimal place.
The PPAS is a subset of the FAS. Only participants analyzed at specific timepoint are reported.
Posted
Number
95% Confidence Interval
percentage of participants
Post-vaccination on Days 22, 36, 134, 202, 292, and 387
ID
Title
Description
OG000
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
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.
Units
Counts
Participants
OG000
Secondary
Phase 2: Percentage of Participants With Serologically-Confirmed SARS-CoV-2 Infection
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. Percentages are rounded off to the tenth decimal place.
The Safety analysis set included participants randomized and who had received at least 1 dose of the study vaccines. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
Posted
Number
95% Confidence Interval
percentage of participants
From first dose of study vaccine administration (Day 1) up to 387 days
ID
Title
Description
OG000
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
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.
OG001
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
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.
Secondary
Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19
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. Percentages are rounded off to the tenth decimal place.
Safety analysis set included participants randomized and who had received at least 1 dose of study vaccines. 1 participant from "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 3" received vaccine formulation of "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". So, number analyzed was 240(N) for "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". Results data was not collected for 'Phase 3-Exploratory reporting groups' because study vaccine used in exploratory arms were different from booster cohort.
Posted
Number
95% Confidence Interval
percentage of participants
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.
ID
Title
Description
OG000
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
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.
OG001
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
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.
Secondary
Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization
Symptomatic COVID-19 was defined as laboratory-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness. Percentages are rounded off to the tenth decimal place.
Safety analysis set included participants randomized and who had received at least 1 dose of study vaccines. 1 participant from "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 3" received vaccine formulation of "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". So, number analyzed was 240(N) for "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". Results data was not collected for 'Phase 3-Exploratory reporting groups' because study vaccine used in exploratory arms were different from booster cohort.
Posted
Number
95% Confidence Interval
percentage of participants
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.
ID
Title
Description
OG000
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
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.
OG001
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
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.
Secondary
Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Severe Symptomatic COVID-19
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 Ë‚90 millimeter of mercury (mmHg), or diastolic blood pressure Ë‚60 mmHg 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. Percentages are rounded off to the tenth decimal place.
Safety analysis set included participants randomized and who had received at least 1 dose of study vaccines. 1 participant from "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 3" received vaccine formulation of "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". So, number analyzed was 240(N) for "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". Results data was not collected for 'Phase 3-Exploratory reporting groups' because study vaccine used in exploratory arms were different from booster cohort.
Posted
Number
95% Confidence Interval
percentage of participants
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.
ID
Title
Description
OG000
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
Secondary
Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Death Associated With Symptomatic COVID-19
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. Percentages are rounded off to the tenth decimal place.
Safety analysis set included participants randomized and who had received at least 1 dose of study vaccines. 1 participant from "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 3" received vaccine formulation of "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". So, number analyzed was 240(N) for "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". Results data was not collected for 'Phase 3-Exploratory reporting groups' because study vaccine used in exploratory arms were different from booster cohort.
Posted
Number
95% Confidence Interval
percentage of participants
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.
ID
Title
Description
OG000
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
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.
OG001
Primary
Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Immediate Unsolicited Adverse Events (AEs)
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.
Safety analysis set included participants randomized and who had received at least 1 dose of study vaccines. 1 participant from "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 3" received vaccine formulation of "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". So, number analyzed was 240(N) for "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". Results data was not collected for 'Phase 3-Exploratory reporting groups' because study vaccine used in exploratory arms were different from booster cohort.
Posted
Count of Participants
Participants
Up to 30 minutes after each vaccination (Phase 2: Postdose on Days 1 and 22; Phase 3: Between 4 to 10 months after priming vaccine)
ID
Title
Description
OG000
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
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.
OG001
Primary
Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
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. Results data was not collected for 'Phase 3-Exploratory reporting groups' because study vaccine used in exploratory arms were different from booster cohort.
Posted
Count of Participants
Participants
Up to 7 days after each vaccination (Phase 2: Postdose on Days 1 and 22; Phase 3: Between 4 to 10 months after priming vaccine)
ID
Title
Description
OG000
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
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.
OG001
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
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
Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Unsolicited Adverse Events
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.
Safety analysis set included participants randomized and who had received at least 1 dose of study vaccines. 1 participant from "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 3" received vaccine formulation of "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". So, number analyzed was 240(N) for "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". Results data was not collected for 'Phase 3-Exploratory reporting groups' because study vaccine used in exploratory arms were different from booster cohort.
Posted
Count of Participants
Participants
Up to 21 days after each vaccination (Phase 2: Postdose on Days 1 and 22; Phase 3: Between 4 to 10 months after priming vaccine)
ID
Title
Description
OG000
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
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.
OG001
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
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
Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)
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.
Safety analysis set included participants randomized and who had received at least 1 dose of study vaccines. 1 participant from "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 3" received vaccine formulation of "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". So, number analyzed was 240(N) for "Phase 2:CoV2 preS dTM-AS03(D614) Formulation 2". Results data was not collected for 'Phase 3-Exploratory reporting groups' because study vaccine used in exploratory arms were different from booster cohort.
Posted
Count of Participants
Participants
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.
ID
Title
Description
OG000
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 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
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 full analysis set (FAS).
Posted
Geometric Mean
95% Confidence Interval
titers
Pre-vaccination on Day 1
ID
Title
Description
OG000
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
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.
OG001
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
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.
OG002
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
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.
Primary
Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Day 36
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. Only participants analyzed at Day 36 are reported.
Posted
Geometric Mean
95% Confidence Interval
titers
Day 36
ID
Title
Description
OG000
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
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.
OG001
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
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.
OG002
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
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.
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
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. Only participants analyzed at specific timepoint are reported.
Posted
Count of Participants
Participants
Day 1 (pre-vaccination) and Day 36
ID
Title
Description
OG000
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
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.
OG001
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
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.
OG002
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
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.
Primary
Phase 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Day 36
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. Only participants analyzed at Day 36 are reported.
Posted
Count of Participants
Participants
Day 36
ID
Title
Description
OG000
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
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.
OG001
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
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.
OG002
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
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.
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
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. Only participants analyzed for each parameter are reported.
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.
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.
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.
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
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. Only participants analyzed for each parameter are reported.
Posted
Geometric Mean
95% Confidence Interval
titers
Cohorts 1 and 2: 14 days post-vaccination on Day 1, Day 15; Comparator: 14 days post-vaccination on Day 22, Day 36
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.
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.
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
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. Percentages are rounded off to the tenth decimal place.
The PPAS is a subset of the FAS. Only participants analyzed for each parameter are reported.
Posted
Number
95% Confidence Interval
percentage of participants
Day 36
ID
Title
Description
OG000
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
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.
Units
Counts
Participants
OG000
Time Frame
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.
Description
Analysis was performed on the safety analysis set. Safety analysis was performed according to the actual study vaccine received by the participants. One participant from "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3" received the vaccine formulation of "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2". So, number of participants analyzed was 240 (N) for "Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2".
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1
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.
0
240
2
240
217
240
EG001
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
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.
0
240
6
240
215
240
EG002
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
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.
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.
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.
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.
0
375
11
375
331
375
EG006
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
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.
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.
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.
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.
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.
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.
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.
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.
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.
0
38
3
38
24
38
EG015
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
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.
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.
0
78
3
78
59
78
EG017
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
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.
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.
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.
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.
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.
0
9
1
9
6
9
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Animal Bite
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG0030 events0 affected328 at risk
EG004
Fall
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Gastrointestinal Stoma Complication
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Hand Fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Head Injury
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Intentional Overdose
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Multiple Fractures
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Multiple Injuries
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Procedural Pain
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Road Traffic Accident
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Spinal Compression Fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Stoma Site Pain
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Acute Myocardial Infarction
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Angina Pectoris
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Supraventricular Tachycardia
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Iron Deficiency Anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Alcoholic Seizure
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Cerebrovascular Accident
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0011 events1 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Cervicobrachial Syndrome
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Loss Of Consciousness
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Motor Neurone Disease
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Trigeminal Neuralgia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Blindness Unilateral
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Pancreatitis Acute
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Small Intestinal Obstruction
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Intervertebral Disc Disorder
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Inappropriate Antidiuretic Hormone Secretion
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Diabetic Ketoacidosis
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0021 events1 affected241 at risk
EG003
Electrolyte Imbalance
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Abscess
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Anal Abscess
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Covid-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0011 events1 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Localised Infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Lung Abscess
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Necrotising Fasciitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Neurological Infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Ovarian Abscess
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Periumbilical Abscess
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Pilonidal Disease
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Pyelonephritis Acute
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Hypertension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Breast Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Malignant Melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Peritoneal Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Prostate Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Serum Sickness-Like Reaction
Immune system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Loss Of Personal Independence In Daily Activities
Social circumstances
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Ectopic Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Antidepressant Discontinuation Syndrome
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Confusional State
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Suicidal Ideation
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Chronic Obstructive Pulmonary Disease
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Cholecystitis Chronic
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Femur Fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0021 events1 affected241 at risk
EG003
Lower Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0021 events1 affected241 at risk
EG003
Acute Kidney Injury
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0011 events1 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Calculus Urinary
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0011 events1 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0011 events1 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Urinary Tract Obstruction
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Intervertebral Disc Degeneration
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0011 events1 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0011 events1 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Invasive Breast Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0011 events1 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0021 events1 affected241 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Foot Fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0002 events1 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG0031 events1 affected328 at risk
EG0041 events1 affected378 at risk
EG0050 events0 affected375 at risk
EG0060 events0 affected113 at risk
EG0070 events0 affected111 at risk
EG0080 events0 affected108 at risk
EG0090 events0 affected127 at risk
EG0100 events0 affected100 at risk
EG0110 events0 affected100 at risk
EG0120 events0 affected103 at risk
EG0130 events0 affected38 at risk
EG0141 events1 affected38 at risk
EG0150 events0 affected132 at risk
EG0160 events0 affected78 at risk
EG0170 events0 affected473 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected8 at risk
EG0200 events0 affected9 at risk
EG0211 events1 affected9 at risk
Muscle Strain
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Skin Laceration
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Lymphadenitis
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0003 events2 affected240 at risk
EG0011 events1 affected240 at risk
EG0023 events3 affected241 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG000195 events141 affected240 at risk
EG001187 events134 affected240 at risk
EG002198 events134 affected241 at risk
EG003
Abdominal Pain Lower
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Dental Caries
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0011 events1 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG00011 events11 affected240 at risk
EG0018 events7 affected240 at risk
EG0029 events8 affected241 at risk
EG003
Tooth Impacted
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Skin Reaction
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG000132 events107 affected240 at risk
EG001134 events102 affected240 at risk
EG002131 events104 affected241 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG000196 events143 affected240 at risk
EG001176 events135 affected240 at risk
EG002166 events123 affected241 at risk
EG003
Breast Abscess
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Covid-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0005 events5 affected240 at risk
EG0013 events3 affected240 at risk
EG0027 events7 affected241 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected240 at risk
EG0011 events1 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Otitis Externa
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected240 at risk
EG0013 events3 affected240 at risk
EG0023 events3 affected241 at risk
EG003
Post-Acute Covid-19 Syndrome
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0011 events1 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected240 at risk
EG0011 events1 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Suspected Covid-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0011 events1 affected240 at risk
EG0023 events3 affected241 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected240 at risk
EG0013 events3 affected240 at risk
EG0022 events2 affected241 at risk
EG003
Viral Upper Respiratory Tract Infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Dust Allergy
Immune system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Chills
General disorders
MedDRA 26.0
Systematic Assessment
EG000113 events97 affected240 at risk
EG001103 events93 affected240 at risk
EG00290 events77 affected241 at risk
EG003
Fatigue
General disorders
MedDRA 26.0
Systematic Assessment
EG00025 events22 affected240 at risk
EG00111 events9 affected240 at risk
EG00219 events17 affected241 at risk
EG003
Injection Site Erythema
General disorders
MedDRA 26.0
Systematic Assessment
EG00031 events28 affected240 at risk
EG00146 events41 affected240 at risk
EG00229 events26 affected241 at risk
EG003
Injection Site Pain
General disorders
MedDRA 26.0
Systematic Assessment
EG000336 events199 affected240 at risk
EG001331 events194 affected240 at risk
EG002339 events200 affected241 at risk
EG003
Injection Site Swelling
General disorders
MedDRA 26.0
Systematic Assessment
EG00042 events40 affected240 at risk
EG00146 events39 affected240 at risk
EG00241 events37 affected241 at risk
EG003
Malaise
General disorders
MedDRA 26.0
Systematic Assessment
EG000189 events138 affected240 at risk
EG001183 events142 affected240 at risk
EG002190 events146 affected241 at risk
EG003
Pyrexia
General disorders
MedDRA 26.0
Systematic Assessment
EG00035 events34 affected240 at risk
EG00136 events35 affected240 at risk
EG00229 events29 affected241 at risk
EG003
Depression
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected240 at risk
EG0010 events0 affected240 at risk
EG0021 events1 affected241 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected240 at risk
EG0014 events3 affected240 at risk
EG0022 events2 affected241 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected240 at risk
EG0012 events2 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0012 events2 affected240 at risk
EG0024 events4 affected241 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected240 at risk
EG0014 events4 affected240 at risk
EG0021 events1 affected241 at risk
EG003
Biliary Colic
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected240 at risk
EG0010 events0 affected240 at risk
EG0020 events0 affected241 at risk
EG003
Injection Site Pruritus
General disorders
MedDRA 26.0
Systematic Assessment
EG0007 events7 affected240 at risk
EG00115 events14 affected240 at risk
EG0028 events6 affected241 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
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.
Units
Counts
Participants
OG000159
OG001160
OG002159
Title
Denominators
Categories
Day 22
ParticipantsOG000159
ParticipantsOG001160
ParticipantsOG002159
Title
Measurements
OG00035
OG00144
OG00253
Day 78
ParticipantsOG000116
ParticipantsOG001123
ParticipantsOG002117
Title
Measurements
OG000
Day 134
ParticipantsOG00098
ParticipantsOG001102
ParticipantsOG00293
Title
Measurements
OG000
Day 202
ParticipantsOG00072
ParticipantsOG00175
ParticipantsOG00277
Title
Measurements
OG000
Day 292
ParticipantsOG00010
ParticipantsOG00111
ParticipantsOG00213
Title
Measurements
OG000
Day 387
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG00212
Title
Measurements
OG000
Units
Counts
Participants
OG000169
OG001172
OG002176
Title
Denominators
Categories
Day 1
ParticipantsOG000166
ParticipantsOG001170
ParticipantsOG002175
Title
Measurements
OG00010.3(9.54 to 11.1)
OG0019.99(9.52 to 10.5)
OG00210.2(9.77 to 10.7)
Day 22
ParticipantsOG000169
ParticipantsOG001172
ParticipantsOG002176
Title
Measurements
OG000
Day 36
ParticipantsOG000165
ParticipantsOG001167
ParticipantsOG002171
Title
Measurements
OG000
Day 78
ParticipantsOG000126
ParticipantsOG001127
ParticipantsOG002127
Title
Measurements
OG000
Day 134
ParticipantsOG000105
ParticipantsOG001111
ParticipantsOG002100
Title
Measurements
OG000
Day 202
ParticipantsOG00087
ParticipantsOG00193
ParticipantsOG00287
Title
Measurements
OG000
Day 292
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00214
Title
Measurements
OG000
Day 387
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG00213
Title
Measurements
OG000
Units
Counts
Participants
OG000166
OG001170
OG002175
Title
Denominators
Categories
Day 22: >=2-fold rise
ParticipantsOG000166
ParticipantsOG001170
ParticipantsOG002175
Title
Measurements
OG000141
OG001155
OG002161
Day 22: >=4-fold rise
ParticipantsOG000166
ParticipantsOG001170
ParticipantsOG002175
Title
Measurements
OG000
Day 36: >=2-fold rise
ParticipantsOG000159
ParticipantsOG001161
ParticipantsOG002166
Title
Measurements
OG000
Day 36: >=4-fold rise
ParticipantsOG000159
ParticipantsOG001161
ParticipantsOG002166
Title
Measurements
OG000
Day 78: >=2-fold rise
ParticipantsOG000121
ParticipantsOG001125
ParticipantsOG002124
Title
Measurements
OG000
Day 78: >=4-fold rise
ParticipantsOG000121
ParticipantsOG001125
ParticipantsOG002124
Title
Measurements
OG000
Day 134: >=2-fold rise
ParticipantsOG000101
ParticipantsOG001110
ParticipantsOG002100
Title
Measurements
OG000
Day 134: >=4-fold rise
ParticipantsOG000101
ParticipantsOG001110
ParticipantsOG002100
Title
Measurements
OG000
Day 202: >=2-fold rise
ParticipantsOG00085
ParticipantsOG00192
ParticipantsOG00287
Title
Measurements
OG000
Day 202: >=4-fold rise
ParticipantsOG00085
ParticipantsOG00192
ParticipantsOG00287
Title
Measurements
OG000
Day 292: >=2-fold rise
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00214
Title
Measurements
OG000
Day 292: >=4-fold rise
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00214
Title
Measurements
OG000
Day 387: >=2-fold rise
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00213
Title
Measurements
OG000
Day 387: >=4-fold rise
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00213
Title
Measurements
OG000
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.
Units
Counts
Participants
OG000166
OG001170
OG002175
Title
Denominators
Categories
Day 22
ParticipantsOG000166
ParticipantsOG001170
ParticipantsOG002175
Title
Measurements
OG000139
OG001154
OG002161
Day 36
ParticipantsOG000159
ParticipantsOG001161
ParticipantsOG002166
Title
Measurements
OG000
Day 78
ParticipantsOG000121
ParticipantsOG001125
ParticipantsOG002124
Title
Measurements
OG000
Day 134
ParticipantsOG000101
ParticipantsOG001110
ParticipantsOG002100
Title
Measurements
OG000
Day 202
ParticipantsOG00085
ParticipantsOG00192
ParticipantsOG00287
Title
Measurements
OG000
Day 292
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00214
Title
Measurements
OG000
Day 387
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00213
Title
Measurements
OG000
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.
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.
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.
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.
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.
OG003
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
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.
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.
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.
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.
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.
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.
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.
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.
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.
OG012
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
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.
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.
OG014
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
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.
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.
OG003
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
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.
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.
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.
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.
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.
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.
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.
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.
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.
OG012
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
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.
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.
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.
OG003
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
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.
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.
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.
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.
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.
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.
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.
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.
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.
OG012
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
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.
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.
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.
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.
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.
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.
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.
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.
OG008
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
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.
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.
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.
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.
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.
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.
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.
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.
OG008
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
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.
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.
Units
Counts
Participants
OG000318
OG001324
OG00299
OG00395
OG00487
OG00591
OG00633
OG00733
OG008103
OG00964
Title
Denominators
Categories
D614G; Day 15: >=2-fold rise
ParticipantsOG000315
ParticipantsOG001320
ParticipantsOG00292
ParticipantsOG00391
ParticipantsOG00487
ParticipantsOG00588
ParticipantsOG00631
ParticipantsOG00733
ParticipantsOG00899
ParticipantsOG00964
Title
Measurements
OG000267
OG001269
OG00279
OG003
D614G; Day 15: >=4-fold rise
ParticipantsOG000315
ParticipantsOG001320
ParticipantsOG00292
ParticipantsOG00391
D614G; Day 29: >=2-fold rise
ParticipantsOG000318
ParticipantsOG001324
ParticipantsOG00299
ParticipantsOG00395
D614G; Day 29: >=4-fold rise
ParticipantsOG000318
ParticipantsOG001324
ParticipantsOG00299
ParticipantsOG00395
D614G; Day 91: >=2-fold rise
ParticipantsOG000251
ParticipantsOG001265
ParticipantsOG00284
ParticipantsOG00386
D614G; Day 91: >=4-fold rise
ParticipantsOG000251
ParticipantsOG001265
ParticipantsOG00284
ParticipantsOG00386
B.1.351; Day 15: >=2-fold rise
ParticipantsOG000299
ParticipantsOG001298
ParticipantsOG00284
ParticipantsOG00385
B.1.351; Day 15: >=4-fold rise
ParticipantsOG000299
ParticipantsOG001298
ParticipantsOG00284
ParticipantsOG00385
B.1.351; Day 29: >=2-fold rise
ParticipantsOG000306
ParticipantsOG001304
ParticipantsOG00290
ParticipantsOG00388
B.1.351; Day 29: >=4-fold rise
ParticipantsOG000306
ParticipantsOG001304
ParticipantsOG00290
ParticipantsOG00388
B.1.351; Day 91: >=2-fold rise
ParticipantsOG000246
ParticipantsOG001252
ParticipantsOG00276
ParticipantsOG00382
B.1.351; Day 91: >=4-fold rise
ParticipantsOG000246
ParticipantsOG001252
ParticipantsOG00276
ParticipantsOG00382
330
Title
Denominators
Categories
D614G: Day 1
ParticipantsOG000330
Title
Measurements
OG00020.3(19.7 to 21.0)
D614G: Day 22
ParticipantsOG000281
Title
Measurements
OG00053.3(44.6 to 63.8)
D614G: Day 36
ParticipantsOG000302
Title
Measurements
OG0003658(3123 to 4286)
D614G: Day 134
ParticipantsOG000143
Title
Measurements
OG0001050(743 to 1486)
D614G: Day 202
ParticipantsOG000128
Title
Measurements
OG0001685(1142 to 2487)
D614G: Day 292
ParticipantsOG000117
Title
Measurements
OG0001943(1294 to 2918)
D614G: Day 387
ParticipantsOG000112
Title
Measurements
OG0001973(1344 to 2897)
B.1.351: Day 1
ParticipantsOG000329
Title
Measurements
OG00020.3(19.7 to 20.8)
B.1.351: Day 22
ParticipantsOG000326
Title
Measurements
OG00029.4(25.7 to 33.5)
B.1.351: Day 36
ParticipantsOG000291
Title
Measurements
OG000413(346 to 493)
B.1.351: Day 134
ParticipantsOG000113
Title
Measurements
OG000496(330 to 745)
B.1.351: Day 202
ParticipantsOG000123
Title
Measurements
OG000671(441 to 1022)
B.1.351: Day 292
ParticipantsOG000120
Title
Measurements
OG000867(560 to 1342)
B.1.351: Day 387
ParticipantsOG000112
Title
Measurements
OG0001033(686 to 1555)
325
Title
Denominators
Categories
D614G; Day 22: >=2-fold rise
ParticipantsOG000281
Title
Measurements
OG00099
D614G; Day 22: >=4-fold rise
ParticipantsOG000281
Title
Measurements
OG00088
D614G; Day 36: >=2-fold rise
ParticipantsOG000301
Title
Measurements
OG000299
D614G; Day 36: >=4-fold rise
ParticipantsOG000301
Title
Measurements
OG000298
D614G; Day 134: >=2-fold rise
ParticipantsOG000143
Title
Measurements
OG000134
D614G; Day 134: >=4-fold rise
ParticipantsOG000143
Title
Measurements
OG000131
D614G; Day 202: >=2-fold rise
ParticipantsOG000127
Title
Measurements
OG000120
D614G; Day 202: >=4-fold rise
ParticipantsOG000127
Title
Measurements
OG000119
D614G; Day 292: >=2-fold rise
ParticipantsOG000117
Title
Measurements
OG000108
D614G; Day 292: >=4-fold rise
ParticipantsOG000117
Title
Measurements
OG000105
D614G; Day 387: >=2-fold rise
ParticipantsOG000111
Title
Measurements
OG000105
D614G; Day 387: >=4-fold rise
ParticipantsOG000111
Title
Measurements
OG000101
B.1.351; Day 22: >=2-fold rise
ParticipantsOG000325
Title
Measurements
OG00039
B.1.351; Day 22: >=4-fold rise
ParticipantsOG000325
Title
Measurements
OG00032
B.1.351; Day 36: >=2-fold rise
ParticipantsOG000290
Title
Measurements
OG000264
B.1.351; Day 36: >=4-fold rise
ParticipantsOG000290
Title
Measurements
OG000251
B.1.351; Day 134: >=2-fold rise
ParticipantsOG000112
Title
Measurements
OG00099
B.1.351; Day 134: >=4-fold rise
ParticipantsOG000112
Title
Measurements
OG00089
B.1.351; Day 202: >=2-fold rise
ParticipantsOG000122
Title
Measurements
OG000100
B.1.351; Day 202: >=4-fold rise
ParticipantsOG000122
Title
Measurements
OG00097
B.1.351; Day 292: >=2-fold rise
ParticipantsOG000119
Title
Measurements
OG00098
B.1.351; Day 292: >=4-fold rise
ParticipantsOG000119
Title
Measurements
OG00091
B.1.351; Day 387: >=2-fold rise
ParticipantsOG000111
Title
Measurements
OG00096
B.1.351; Day 387: >=4-fold rise
ParticipantsOG000111
Title
Measurements
OG00094
330
Title
Denominators
Categories
Day 1
ParticipantsOG000326
Title
Measurements
OG00010.7(9.91 to 11.6)
Day 22
ParticipantsOG000330
Title
Measurements
OG000212(183 to 246)
Day 36
ParticipantsOG000303
Title
Measurements
OG00024278(21681 to 27185)
Day 134
ParticipantsOG000147
Title
Measurements
OG0006593(4952 to 8779)
Day 202
ParticipantsOG000132
Title
Measurements
OG0006667(4833 to 9197)
Day 292
ParticipantsOG000122
Title
Measurements
OG0006868(4919 to 9587)
Day 387
ParticipantsOG000115
Title
Measurements
OG0007112(5216 to 9697)
331
Title
Denominators
Categories
Day 22: >=2-fold rise
ParticipantsOG000331
Title
Measurements
OG000312
Day 22: >=4-fold rise
ParticipantsOG000331
Title
Measurements
OG000290
Day 36: >=2-fold rise
ParticipantsOG000303
Title
Measurements
OG000302
Day 36: >=4-fold rise
ParticipantsOG000303
Title
Measurements
OG000302
Day 134: >=2-fold rise
ParticipantsOG000150
Title
Measurements
OG000149
Day 134: >=4-fold rise
ParticipantsOG000150
Title
Measurements
OG000148
Day 202: >=2-fold rise
ParticipantsOG000134
Title
Measurements
OG000133
Day 202: >=4-fold rise
ParticipantsOG000134
Title
Measurements
OG000133
Day 292: >=2-fold rise
ParticipantsOG000124
Title
Measurements
OG000123
Day 292: >=4-fold rise
ParticipantsOG000124
Title
Measurements
OG000123
Day 387: >=2-fold rise
ParticipantsOG000118
Title
Measurements
OG000117
Day 387: >=4-fold rise
ParticipantsOG000118
Title
Measurements
OG000117
331
Title
Denominators
Categories
Day 22
ParticipantsOG000331
Title
Measurements
OG00094.3(91.2 to 96.5)
Day 36
ParticipantsOG000325
Title
Measurements
OG00099.7(98.3 to 100)
Day 134
ParticipantsOG000159
Title
Measurements
OG00098.7(95.5 to 99.8)
Day 202
ParticipantsOG000141
Title
Measurements
OG00099.3(96.1 to 100)
Day 292
ParticipantsOG000134
Title
Measurements
OG00099.3(95.9 to 100)
Day 387
ParticipantsOG000127
Title
Measurements
OG00099.2(95.7 to 100)
OG002
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
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.
Units
Counts
Participants
OG000240
OG001240
OG002241
Title
Denominators
Categories
Title
Measurements
OG00012.1(8.2 to 16.9)
OG00110.8(7.2 to 15.5)
OG00214.1(10.0 to 19.2)
OG002
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
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.
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.
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.
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.
OG006
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
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.
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.
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.
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.
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.
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.
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.
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.
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.
OG015
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
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.
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.
OG017
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
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.
Units
Counts
Participants
OG000240
OG001240
OG002241
OG003328
OG004378
OG005375
OG006113
OG007111
OG008108
OG009127
OG010100
OG011100
OG012103
OG01338
OG01438
OG015132
OG01678
OG017473
Title
Denominators
Categories
Title
Measurements
OG0003.3(1.4 to 6.5)
OG0011.7(0.5 to 4.2)
OG0025.4(2.9 to 9.0)
OG00314.0(10.5 to 18.3)
OG00420.9(16.9 to 25.4)
OG00523.5(19.3 to 28.1)
OG00612.4(6.9 to 19.9)
OG00710.8(5.7 to 18.1)
OG00810.2(5.2 to 17.5)
OG00924.4(17.2 to 32.8)
OG01025.0(16.9 to 34.7)
OG01129.0(20.4 to 38.9)
OG0129.7(4.8 to 17.1)
OG0130(0 to 9.3)
OG01418.4(7.7 to 34.3)
OG01518.9(12.6 to 26.7)
OG01619.2(11.2 to 29.7)
OG0178.2(5.9 to 11.1)
OG002
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
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.
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.
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.
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.
OG006
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
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.
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.
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.
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.
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.
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.
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.
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.
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.
OG015
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
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.
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.
OG017
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
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.
Units
Counts
Participants
OG000240
OG001240
OG002241
OG003328
OG004378
OG005375
OG006113
OG007111
OG008108
OG009127
OG010100
OG011100
OG012103
OG01338
OG01438
OG015132
OG01678
OG017473
Title
Denominators
Categories
Title
Measurements
OG0000(0 to 1.5)
OG0010(0 to 1.5)
OG0020(0 to 1.5)
OG0030(0 to 1.1)
OG0040(0 to 1.0)
OG0050.3(0 to 1.5)
OG0060(0 to 3.2)
OG0070(0 to 3.3)
OG0080(0 to 3.4)
OG0090.8(0 to 4.3)
OG0100(0 to 3.6)
OG0110(0 to 3.6)
OG0120(0 to 3.5)
OG0130(0 to 9.3)
OG0140(0 to 9.3)
OG0150(0 to 2.8)
OG0160(0 to 4.6)
OG0170(0 to 0.8)
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.
OG001
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
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.
OG002
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
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.
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.
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.
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.
OG006
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
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.
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.
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.
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.
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.
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.
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.
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.
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.
OG015
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
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.
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.
OG017
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
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.
Units
Counts
Participants
OG000240
OG001240
OG002241
OG003328
OG004378
OG005375
OG006113
OG007111
OG008108
OG009127
OG010100
OG011100
OG012103
OG01338
OG01438
OG015132
OG01678
OG017473
Title
Denominators
Categories
Title
Measurements
OG0000(0 to 1.5)
OG0010(0 to 1.5)
OG0020(0 to 1.5)
OG0030(0 to 1.1)
OG0040(0 to 1.0)
OG0050.3(0 to 1.5)
OG0060(0 to 3.2)
OG0070(0 to 3.3)
OG0080(0 to 3.4)
OG0090(0 to 2.9)
OG0100(0 to 3.6)
OG0110(0 to 3.6)
OG0120(0 to 3.5)
OG0130(0 to 9.3)
OG0140(0 to 9.3)
OG0150.8(0 to 4.1)
OG0160(0 to 4.6)
OG0170(0 to 0.8)
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
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.
OG002
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
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.
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.
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.
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.
OG006
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
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.
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.
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.
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.
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.
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.
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.
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.
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.
OG015
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
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.
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.
OG017
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
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.
Units
Counts
Participants
OG000240
OG001240
OG002241
OG003328
OG004378
OG005375
OG006113
OG007111
OG008108
OG009127
OG010100
OG011100
OG012103
OG01338
OG01438
OG015132
OG01678
OG017473
Title
Denominators
Categories
Title
Measurements
OG0000(0 to 1.5)
OG0010(0 to 1.5)
OG0020(0 to 1.5)
OG0030(0 to 1.1)
OG0040(0 to 1.0)
OG0050(0 to 1.0)
OG0060(0 to 3.2)
OG0070(0 to 3.3)
OG0080(0 to 3.4)
OG0090(0 to 2.9)
OG0100(0 to 3.6)
OG0110(0 to 3.6)
OG0120(0 to 3.5)
OG0130(0 to 9.3)
OG0140(0 to 9.3)
OG0150(0 to 2.8)
OG0160(0 to 4.6)
OG0170(0 to 0.8)
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
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.
OG002
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
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.
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.
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.
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.
OG006
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
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.
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.
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.
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.
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.
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.
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.
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.
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.
OG015
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
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.
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.
OG017
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
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.
Units
Counts
Participants
OG000240
OG001240
OG002241
OG003328
OG004378
OG005375
OG006113
OG007111
OG008108
OG009127
OG010100
OG011100
OG012103
OG01338
OG01438
OG015132
OG01678
OG017473
Title
Denominators
Categories
Title
Measurements
OG0002
OG0011
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
OG0130
OG0140
OG0150
OG0160
OG0179
OG002
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
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.
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.
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.
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.
OG006
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
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.
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.
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.
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.
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.
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.
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.
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.
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.
OG015
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
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.
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.
OG017
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
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.
Units
Counts
Participants
OG000238
OG001237
OG002239
OG003326
OG004367
OG005370
OG006113
OG007110
OG008108
OG009127
OG010100
OG011100
OG012102
OG01338
OG01438
OG015132
OG01678
OG017460
Title
Denominators
Categories
Injection site reaction
Title
Measurements
OG000201
OG001196
OG002200
OG003262
OG004300
OG005303
OG00690
OG00782
OG00874
OG009104
OG01087
OG01187
OG01281
OG01319
OG01419
OG01598
OG01646
OG017375
Systemic reaction
Title
Measurements
OG000191
OG001191
OG002185
OG003
OG002
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
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.
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.
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.
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.
OG006
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
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.
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.
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.
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.
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.
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.
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.
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.
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.
OG015
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
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.
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.
OG017
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
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.
Units
Counts
Participants
OG000240
OG001240
OG002241
OG003328
OG004378
OG005375
OG006113
OG007111
OG008108
OG009127
OG010100
OG011100
OG012103
OG01338
OG01438
OG015132
OG01678
OG017473
Title
Denominators
Categories
Title
Measurements
OG00088
OG00181
OG00291
OG00376
OG004106
OG00596
OG00629
OG00718
OG00822
OG00934
OG01027
OG01135
OG01216
OG0137
OG0147
OG01525
OG01611
OG017199
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.
OG001
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2
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.
OG002
Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3
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.
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.
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.
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.
OG006
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
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.
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.
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.
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.
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.
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.
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.
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.
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.
OG015
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
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.
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.
OG017
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
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.
Units
Counts
Participants
OG000240
OG001240
OG002241
OG003328
OG004378
OG005375
OG006113
OG007111
OG008108
OG009127
OG010100
OG011100
OG012103
OG01338
OG01438
OG015132
OG01678
OG017473
Title
Denominators
Categories
SAE
Title
Measurements
OG0002
OG0016
OG0024
OG0038
OG0049
OG00511
OG0063
OG0071
OG0084
OG0093
OG0104
OG0110
OG0121
OG0132
OG0143
OG0153
OG0163
OG01714
AESI
Title
Measurements
OG0000
OG0010
OG0020
OG003
MAAE
Title
Measurements
OG00042
OG00148
OG00259
OG003
Units
Counts
Participants
OG000167
OG001170
OG002171
Title
Denominators
Categories
Title
Measurements
OG00020.0(NA to NA)Since all participants have 20 titers at Day 1, leading to a zero standard error, this makes it impossible to calculate a meaningful confidence interval.
OG00120.0(NA to NA)Since all participants have 20 titers at Day 1, leading to a zero standard error, this makes it impossible to calculate a meaningful confidence interval.
OG00220.0(NA to NA)Since all participants have 20 titers at Day 1, leading to a zero standard error, this makes it impossible to calculate a meaningful confidence interval.
Units
Counts
Participants
OG000162
OG001163
OG002167
Title
Denominators
Categories
Title
Measurements
OG0002132(1690 to 2688)
OG0012376(1873 to 3015)
OG0022903(2289 to 3683)
Units
Counts
Participants
OG000159
OG001158
OG002161
Title
Denominators
Categories
>=2-fold rise
Title
Measurements
OG000155
OG001156
OG002158
>=4-fold rise
Title
Measurements
OG000154
OG001154
OG002157
Units
Counts
Participants
OG000159
OG001158
OG002161
Title
Denominators
Categories
Title
Measurements
OG000155
OG001156
OG002158
OG003
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
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.
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.
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.
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.
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.
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.
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.
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.
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.
OG012
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
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.
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.
Units
Counts
Participants
OG000301
OG001348
OG002345
OG003107
OG004107
OG005101
OG006120
OG00790
OG00897
OG00989
OG01036
OG01136
OG012108
OG01368
Title
Denominators
Categories
D614G
ParticipantsOG000301
ParticipantsOG001348
ParticipantsOG002345
ParticipantsOG003107
ParticipantsOG004107
ParticipantsOG005101
ParticipantsOG006107
ParticipantsOG00789
ParticipantsOG00893
ParticipantsOG00982
ParticipantsOG01036
ParticipantsOG01136
ParticipantsOG012107
ParticipantsOG01367
Title
Measurements
OG000320(275 to 373)
OG001678(558 to 824)
OG002579(478 to 701)
OG003
B.1.351
ParticipantsOG000290
ParticipantsOG001336
ParticipantsOG002324
ParticipantsOG00388
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.
OG003
Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614)
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.
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.
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.
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.
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.
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.
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.
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.
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.
OG012
Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614)
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.
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.
OG014
Phase 3: Comparator: CoV2 preS dTM-AS03 (D614)
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.