COVID-19
Conditions
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).
Interventions
BIOLOGICALSARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 1
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
BIOLOGICALSARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 2
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
BIOLOGICALSARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 3
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
BIOLOGICALSARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage A
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
BIOLOGICALSARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
BIOLOGICALSARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage B
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
BIOLOGICALSARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 1
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
BIOLOGICALSARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 2
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
BIOLOGICALSARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 3
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
BIOLOGICALSARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 4
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
BIOLOGICALSARS-CoV-2 adjuvanted recombinant protein vaccine, bivalent (D614+B.1.351)-AS03
Pharmaceutical form: Emulsion for injection Route of administration: Intramuscular injection
Sponsors
GlaxoSmithKline
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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).
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Cohorts 1 and 2: 14 days post-vaccination on Day 1, Day 15; Comparator: 14 days post-vaccination on Day 22, Day 36 | 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. |
| 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 | 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. |
| Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 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) | 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. |
| Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic 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) | 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. |
| Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Unsolicited Adverse Events | 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) | 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. |
| 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) | 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. | 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: Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) D614G Strain at Day 1 | Pre-vaccination on 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. |
| Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Day 36 | 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. |
| 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 | Day 1 (pre-vaccination) and 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. |
| Phase 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Day 36 | 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. |
| 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 | Pre-vaccination on 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Pre-vaccination on Day 1 and post-vaccination on Days 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. |
| 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 | Pre-vaccination on Day 1 and Post-vaccination on 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. |
| 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 | Pre-vaccination on Day 1 and post-vaccination on 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 the neutralization assay (monogram assay) and the results were expressed as geometric mean titers. |
| 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 | Pre-vaccination on Day 1 and Post-vaccination on 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. |
| 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 | Pre-vaccination on Day 1 and post-vaccination on Days 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. |
| 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 | Pre-vaccination on Day 1 and Post-vaccination on 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. |
| Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387 | Post-vaccination on 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. |
| Phase 2: Percentage of Participants With Serologically-Confirmed SARS-CoV-2 Infection | From first dose of study vaccine administration (Day 1) up to 387 days | 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. |
| Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19 | 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. | 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 (Cohorts 1, 2 and Comparator): Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization | 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. | 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 (Cohorts 1, 2 and Comparator): Percentage of Participants With Severe Symptomatic COVID-19 | 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. | Severe COVID-19 was defined as COVID-19 with any 1: Any clinical signs of severe illness measured at least on 2 occasions separated by 30 minutes, supplemental oxygen administration for \>1 hour, use of invasive or non-invasive ventilation or Extracorporeal Membrane Oxygenation, clinical diagnosis of respiratory failure, significant acute renal, hepatic, or neurologic dysfunction, shock (defined by systolic blood pressure ˂90 millimeter of mercury (mmHg), or diastolic blood pressure ˂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 (Cohorts 1, 2 and Comparator): Percentage of Participants With Death Associated With Symptomatic COVID-19 | 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. | 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 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 | Post-vaccination on 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. |
| 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 | Pre-vaccination on Day 1 and Post-vaccination on 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. |
| 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 | Post-vaccination on 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). |
| 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 | Pre-vaccination on Day 1 and post-vaccination on Days 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. |
| 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 | Pre-vaccination on Day 1 and Post-vaccination on 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. |
| 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 | Post-vaccination on 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. |
| 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 | Post-vaccination on 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. |
| 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 | Pre-vaccination on Day 1 and Post-vaccination on 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. |
| 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 | Cohorts 1 and 2: 14 days post-vaccination on Day 1 (Day 15); Comparator: 14 days post-vaccination on Day 22 (Day 36) | 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. |
| 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 | Pre-vaccination on Day 1 and post-vaccination on Days 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. |
| 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 | Pre-vaccination on Day 1 and Post-vaccination on 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. |
Countries
Australia, France, Honduras, New Zealand, Spain, United Kingdom, United States
Participant flow
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.
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 241 |
| 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. | 239 |
| 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. | 242 |
| Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614) 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. | 329 |
| Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351) 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. | 378 |
| Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351) 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. | 378 |
| 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. | 113 |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) 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. | 112 |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) 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. | 108 |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) 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. | 127 |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) 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. | 101 |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) 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. | 101 |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) 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. | 105 |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) 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. | 38 |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) 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. | 38 |
| 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. | 132 |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) 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. | 78 |
| 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. | 479 |
| Phase 3: Exploratory 1: PBP - CoV2 preS dTM (B.1.351) 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. | 4 |
| Phase 3: Exploratory 2: PBP - CoV2 preS dTM (B.1.351) 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. | 8 |
| Phase 3: Exploratory 3: PBP - CoV2 preS dTM (B.1.351) 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. | 9 |
| Phase 3: Exploratory 4: PBP - CoV2 preS dTM (B.1.351) 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. | 9 |
| Total | 3,369 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 | FG020 | FG021 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 2 | Adverse Event | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Phase 2 | Lost to Follow-up | 14 | 8 | 9 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Phase 2 | Protocol Violation | 5 | 5 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Phase 2 | Withdrawal by Subject | 23 | 21 | 28 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Phase 3 | Adverse Event | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 |
| Phase 3 | Lost to Follow-up | 0 | 0 | 0 | 9 | 22 | 24 | 2 | 4 | 6 | 4 | 3 | 0 | 5 | 4 | 6 | 1 | 1 | 66 | 0 | 0 | 0 | 0 |
| Phase 3 | Protocol Violation | 0 | 0 | 0 | 4 | 1 | 5 | 1 | 0 | 0 | 0 | 0 | 2 | 3 | 0 | 0 | 1 | 0 | 10 | 0 | 0 | 0 | 0 |
| Phase 3 | Withdrawal by Subject | 0 | 0 | 0 | 13 | 17 | 12 | 8 | 3 | 2 | 4 | 3 | 1 | 3 | 2 | 1 | 4 | 6 | 32 | 0 | 0 | 0 | 0 |
| Phase 3 - Exploratory | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Phase 3 - Exploratory | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | Phase 3: Cohort 1: PBP - CoV2 preS dTM-AS03 (D614) | Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (B.1.351) | Phase 3: Cohort 2: PBP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 3: Cohort 1: MP - CoV2 preS dTM-AS03 (D614) | Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) | Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | Phase 3: Exploratory 1: PBP - CoV2 preS dTM (B.1.351) | Phase 3: Exploratory 2: PBP - CoV2 preS dTM (B.1.351) | Phase 3: Exploratory 3: PBP - CoV2 preS dTM (B.1.351) | Phase 3: Exploratory 4: PBP - CoV2 preS dTM (B.1.351) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical Phase 2 <=18 years | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical Phase 2 >=65 years | 42 Participants | 46 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 46 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 134 Participants |
| Age, Categorical Phase 2 Between 18 and 65 years | 196 Participants | 196 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 195 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 587 Participants |
| Age, Categorical Phase 3 <=18 years | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 9 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 17 Participants |
| Age, Categorical Phase 3 >=65 years | 0 Participants | 0 Participants | 63 Participants | 17 Participants | 23 Participants | 25 Participants | 15 Participants | 13 Participants | 32 Participants | 15 Participants | 14 Participants | 6 Participants | 3 Participants | 2 Participants | 40 Participants | 38 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 309 Participants |
| Age, Categorical Phase 3 Between 18 and 65 years | 0 Participants | 0 Participants | 266 Participants | 357 Participants | 353 Participants | 88 Participants | 97 Participants | 94 Participants | 95 Participants | 86 Participants | 87 Participants | 98 Participants | 35 Participants | 36 Participants | 92 Participants | 40 Participants | 467 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2291 Participants |
| Age, Categorical Phase 3 - Exploratory <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Phase 3 - Exploratory >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Age, Categorical Phase 3 - Exploratory Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 7 Participants | 9 Participants | 8 Participants | 28 Participants |
| Race/Ethnicity, Customized Phase 2 American Indian or Alaska Native | 24 Participants | 20 Participants | 5 Participants | 5 Participants | 6 Participants | 2 Participants | 6 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants | 2 Participants | 20 Participants | 14 Participants | 15 Participants | 22 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 148 Participants |
| Race/Ethnicity, Customized Phase 2 Asian | 10 Participants | 10 Participants | 19 Participants | 12 Participants | 13 Participants | 7 Participants | 1 Participants | 3 Participants | 11 Participants | 4 Participants | 7 Participants | 0 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 18 Participants | 13 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 136 Participants |
| Race/Ethnicity, Customized Phase 2 Black or African American | 23 Participants | 20 Participants | 15 Participants | 54 Participants | 61 Participants | 3 Participants | 16 Participants | 32 Participants | 2 Participants | 3 Participants | 2 Participants | 5 Participants | 16 Participants | 10 Participants | 7 Participants | 2 Participants | 52 Participants | 14 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 337 Participants |
| Race/Ethnicity, Customized Phase 2 Missing | 30 Participants | 30 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 29 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 89 Participants |
| Race/Ethnicity, Customized Phase 2 Multiple | 2 Participants | 4 Participants | 1 Participants | 6 Participants | 6 Participants | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 8 Participants | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 39 Participants |
| Race/Ethnicity, Customized Phase 2 Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 10 Participants |
| Race/Ethnicity, Customized Phase 2 Not Reported | 0 Participants | 0 Participants | 33 Participants | 44 Participants | 49 Participants | 0 Participants | 1 Participants | 6 Participants | 10 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 4 Participants | 7 Participants | 8 Participants | 9 Participants | 179 Participants |
| Race/Ethnicity, Customized Phase 2 Unknown | 0 Participants | 0 Participants | 4 Participants | 8 Participants | 2 Participants | 0 Participants | 6 Participants | 3 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 23 Participants | 22 Participants | 10 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 84 Participants |
| Race/Ethnicity, Customized Phase 2 White | 149 Participants | 156 Participants | 252 Participants | 247 Participants | 240 Participants | 100 Participants | 79 Participants | 61 Participants | 104 Participants | 92 Participants | 87 Participants | 99 Participants | 15 Participants | 21 Participants | 80 Participants | 37 Participants | 372 Participants | 156 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2347 Participants |
| Race/Ethnicity, Customized Phase 3 American Indian or Alaska Native | 0 Participants | 0 Participants | 5 Participants | 5 Participants | 6 Participants | 2 Participants | 6 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants | 2 Participants | 20 Participants | 14 Participants | 15 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 82 Participants |
| Race/Ethnicity, Customized Phase 3 Asian | 0 Participants | 0 Participants | 19 Participants | 12 Participants | 13 Participants | 7 Participants | 1 Participants | 3 Participants | 11 Participants | 4 Participants | 7 Participants | 0 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 18 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 103 Participants |
| Race/Ethnicity, Customized Phase 3 Black or African American | 0 Participants | 0 Participants | 15 Participants | 54 Participants | 61 Participants | 3 Participants | 16 Participants | 32 Participants | 2 Participants | 3 Participants | 2 Participants | 5 Participants | 16 Participants | 10 Participants | 7 Participants | 2 Participants | 52 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 280 Participants |
| Race/Ethnicity, Customized Phase 3 Missing | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Phase 3 Multiple | 0 Participants | 0 Participants | 1 Participants | 6 Participants | 6 Participants | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 8 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 28 Participants |
| Race/Ethnicity, Customized Phase 3 Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized Phase 3 Not Reported | 0 Participants | 0 Participants | 33 Participants | 44 Participants | 49 Participants | 0 Participants | 1 Participants | 6 Participants | 10 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 151 Participants |
| Race/Ethnicity, Customized Phase 3 Unknown | 0 Participants | 0 Participants | 4 Participants | 8 Participants | 2 Participants | 0 Participants | 6 Participants | 3 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 23 Participants | 22 Participants | 10 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 82 Participants |
| Race/Ethnicity, Customized Phase 3 White | 0 Participants | 0 Participants | 252 Participants | 247 Participants | 240 Participants | 100 Participants | 79 Participants | 61 Participants | 104 Participants | 92 Participants | 87 Participants | 99 Participants | 15 Participants | 21 Participants | 80 Participants | 37 Participants | 372 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1886 Participants |
| Race/Ethnicity, Customized Phase 3 - Exploratory American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Phase 3 - Exploratory Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Phase 3 - Exploratory Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Phase 3 - Exploratory Missing | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Phase 3 - Exploratory Multiple | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Phase 3 - Exploratory Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Phase 3 - Exploratory Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 7 Participants | 8 Participants | 9 Participants | 28 Participants |
| Race/Ethnicity, Customized Phase 3 - Exploratory Unknown | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Phase 3 - Exploratory White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Phase 2 Female | 114 Participants | 122 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 123 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 359 Participants |
| Sex: Female, Male Phase 2 Male | 125 Participants | 120 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 118 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 363 Participants |
| Sex: Female, Male Phase 3 Female | 0 Participants | 0 Participants | 181 Participants | 208 Participants | 199 Participants | 68 Participants | 60 Participants | 64 Participants | 59 Participants | 42 Participants | 48 Participants | 63 Participants | 19 Participants | 20 Participants | 64 Participants | 38 Participants | 215 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1348 Participants |
| Sex: Female, Male Phase 3 Male | 0 Participants | 0 Participants | 148 Participants | 170 Participants | 179 Participants | 45 Participants | 52 Participants | 44 Participants | 68 Participants | 59 Participants | 53 Participants | 42 Participants | 19 Participants | 18 Participants | 68 Participants | 40 Participants | 264 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1269 Participants |
| Sex: Female, Male Phase 3 - Exploratory Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 3 Participants | 8 Participants | 6 Participants | 20 Participants |
| Sex: Female, Male Phase 3 - Exploratory Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 5 Participants | 1 Participants | 3 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 240 | 0 / 240 | 0 / 241 | 0 / 328 | 0 / 378 | 0 / 375 | 0 / 113 | 0 / 111 | 0 / 108 | 0 / 127 | 0 / 100 | 0 / 100 | 0 / 103 | 0 / 38 | 0 / 38 | 0 / 132 | 0 / 78 | 1 / 473 | 0 / 4 | 0 / 8 | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 217 / 240 | 215 / 240 | 219 / 241 | 281 / 328 | 328 / 378 | 331 / 375 | 97 / 113 | 88 / 111 | 83 / 108 | 115 / 127 | 92 / 100 | 97 / 100 | 89 / 103 | 21 / 38 | 24 / 38 | 112 / 132 | 59 / 78 | 421 / 473 | 4 / 4 | 7 / 8 | 8 / 9 | 6 / 9 |
| serious Total, serious adverse events | 2 / 240 | 6 / 240 | 4 / 241 | 8 / 328 | 9 / 378 | 11 / 375 | 3 / 113 | 1 / 111 | 4 / 108 | 3 / 127 | 4 / 100 | 0 / 100 | 1 / 103 | 2 / 38 | 3 / 38 | 3 / 132 | 3 / 78 | 14 / 473 | 2 / 4 | 0 / 8 | 1 / 9 | 1 / 9 |
Outcome results
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 2 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 1 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 1 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 0 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 0 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 0 Participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 0 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 0 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 0 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 0 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 0 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 0 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 0 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 0 Participants |
| Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 0 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 0 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 0 Participants |
| Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Immediate Unsolicited Adverse Events (AEs) | 9 Participants |
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.
Time frame: 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.
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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) | MAAE | 42 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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) | SAE | 2 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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) | AESI | 0 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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) | SAE | 6 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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) | AESI | 0 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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) | MAAE | 48 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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) | AESI | 0 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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) | SAE | 4 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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) | MAAE | 59 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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) | MAAE | 80 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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) | SAE | 8 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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) | AESI | 2 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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) | AESI | 0 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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) | SAE | 9 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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) | MAAE | 106 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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) | MAAE | 117 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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) | SAE | 11 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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) | AESI | 1 Participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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) | MAAE | 28 Participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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) | SAE | 3 Participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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) | AESI | 1 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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) | SAE | 1 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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) | AESI | 0 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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) | MAAE | 25 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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) | AESI | 0 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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) | MAAE | 19 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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) | SAE | 4 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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) | AESI | 0 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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) | SAE | 3 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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) | MAAE | 31 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | 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) | AESI | 0 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | 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) | MAAE | 24 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | 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) | SAE | 4 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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) | AESI | 1 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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) | MAAE | 29 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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) | SAE | 0 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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) | SAE | 1 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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) | AESI | 0 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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) | MAAE | 19 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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) | SAE | 2 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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) | MAAE | 7 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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) | AESI | 0 Participants |
| Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) | 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) | AESI | 0 Participants |
| Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) | 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) | SAE | 3 Participants |
| Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) | 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) | MAAE | 7 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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) | SAE | 3 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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) | AESI | 0 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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) | MAAE | 42 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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) | AESI | 1 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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) | MAAE | 32 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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) | SAE | 3 Participants |
| Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) | 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) | AESI | 1 Participants |
| Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) | 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) | SAE | 14 Participants |
| Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) | 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) | MAAE | 110 Participants |
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Injection site reaction | 201 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Systemic reaction | 191 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Injection site reaction | 196 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Systemic reaction | 191 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Injection site reaction | 200 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Systemic reaction | 185 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Injection site reaction | 262 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Systemic reaction | 198 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Systemic reaction | 238 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Injection site reaction | 300 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Systemic reaction | 242 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Injection site reaction | 303 Participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Injection site reaction | 90 Participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Systemic reaction | 67 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Injection site reaction | 82 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Systemic reaction | 67 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Systemic reaction | 65 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Injection site reaction | 74 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Systemic reaction | 75 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Injection site reaction | 104 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Systemic reaction | 61 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Injection site reaction | 87 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Systemic reaction | 75 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Injection site reaction | 87 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Injection site reaction | 81 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Systemic reaction | 62 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Injection site reaction | 19 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Systemic reaction | 14 Participants |
| Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Injection site reaction | 19 Participants |
| Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Systemic reaction | 17 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Injection site reaction | 98 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Systemic reaction | 88 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Injection site reaction | 46 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Systemic reaction | 36 Participants |
| Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Injection site reaction | 375 Participants |
| Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Systemic reaction | 359 Participants |
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Unsolicited Adverse Events | 88 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Unsolicited Adverse Events | 81 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Unsolicited Adverse Events | 91 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Unsolicited Adverse Events | 76 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Unsolicited Adverse Events | 106 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Unsolicited Adverse Events | 96 Participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Unsolicited Adverse Events | 29 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Unsolicited Adverse Events | 18 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Unsolicited Adverse Events | 22 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Unsolicited Adverse Events | 34 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Unsolicited Adverse Events | 27 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Unsolicited Adverse Events | 35 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Unsolicited Adverse Events | 16 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Unsolicited Adverse Events | 7 Participants |
| Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Unsolicited Adverse Events | 7 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Unsolicited Adverse Events | 25 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Unsolicited Adverse Events | 11 Participants |
| Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Number of Participants With Unsolicited Adverse Events | 199 Participants |
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.
Time frame: Pre-vaccination on Day 1
Population: The per-protocol analysis set (PPAS) Naïve-D01+D22 is a subset of the full analysis set (FAS).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | Phase 2: Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) D614G Strain at Day 1 | 20.0 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | Phase 2: Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) D614G Strain at Day 1 | 20.0 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | Phase 2: Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) D614G Strain at Day 1 | 20.0 titers |
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.
Time frame: Day 36
Population: The PPAS Naïve-D01+D22 is a subset of the FAS. Only participants analyzed at Day 36 are reported.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Day 36 | 2132 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Day 36 | 2376 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Day 36 | 2903 titers |
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.
Time frame: Day 1 (pre-vaccination) and Day 36
Population: The PPAS Naïve-D01+D22 is a subset of the FAS. Only participants analyzed at specific timepoint are reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | >=2-fold rise | 155 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | >=4-fold rise | 154 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | >=2-fold rise | 156 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | >=4-fold rise | 154 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | >=2-fold rise | 158 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | >=4-fold rise | 157 Participants |
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.
Time frame: Day 36
Population: The PPAS Naïve-D01+D22 is a subset of the FAS. Only participants analyzed at Day 36 are reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | Phase 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Day 36 | 155 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | Phase 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Day 36 | 156 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | Phase 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Day 36 | 158 Participants |
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.
Time frame: Cohorts 1 and 2: 14 days post-vaccination on Day 1, Day 15; Comparator: 14 days post-vaccination on Day 22, Day 36
Population: The PPAS is a subset of the FAS. Only participants analyzed for each parameter are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 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 | D614G | 6964 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 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 | B.1.351 | 2610 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | D614G | 9995 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | B.1.351 | 7021 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | D614G | 8430 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | B.1.351 | 4900 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G | 6347 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351 | 2222 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | B.1.351 | 9449 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | D614G | 14240 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | B.1.351 | 6581 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | D614G | 12522 titers |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | D614G | 6257 titers |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351 | 2062 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | D614G | 5536 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | B.1.351 | 4610 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | D614G | 5855 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | B.1.351 | 3099 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351 | 2054 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G | 6875 titers |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | 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 | D614G | 11005 titers |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | 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 | B.1.351 | 6872 titers |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | B.1.351 | 5057 titers |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | D614G | 11624 titers |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351 | 7452 titers |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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 | D614G | 22457 titers |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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 | D614G | 25002 titers |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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 | B.1.351 | 13300 titers |
| Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) | 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 | B.1.351 | 413 titers |
| Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) | 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 | D614G | 3611 titers |
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.
Time frame: Pre-vaccination on Day 1
Population: The PPAS is a subset of the FAS. Only participants analyzed for each parameter are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G | 320 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351 | 70.1 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | D614G | 678 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | B.1.351 | 176 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | B.1.351 | 149 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | D614G | 579 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351 | 122 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G | 668 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | B.1.351 | 258 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | D614G | 1107 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | B.1.351 | 296 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | D614G | 1347 titers |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351 | 54.1 titers |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | D614G | 265 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | D614G | 137 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | B.1.351 | 43.3 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | B.1.351 | 36.8 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | D614G | 134 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351 | 42.6 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G | 222 titers |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | 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 | B.1.351 | 345 titers |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | 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 | D614G | 1188 titers |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | D614G | 447 titers |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | B.1.351 | 122 titers |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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 | D614G | 274 titers |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351 | 97.7 titers |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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 | B.1.351 | 70.3 titers |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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 | D614G | 159 titers |
Primary
Phase 3: Comparator: Percentage of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Day 36
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.
Time frame: Day 36
Population: The PPAS is a subset of the FAS. Only participants analyzed for each parameter are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G | 99.3 percentage of participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351 | 91.0 percentage of participants |
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.
Time frame: 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.
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Death Associated With Symptomatic COVID-19 | 0 percentage of participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Death Associated With Symptomatic COVID-19 | 0 percentage of participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Death Associated With Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Death Associated With Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Death Associated With Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Death Associated With Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Death Associated With Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Death Associated With Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Death Associated With Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Death Associated With Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Death Associated With Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Death Associated With Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Death Associated With Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Death Associated With Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Death Associated With Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Death Associated With Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Death Associated With Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Death Associated With Symptomatic COVID-19 | 0 percentage of participants |
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.
Time frame: 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.
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19 | 3.3 percentage of participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19 | 1.7 percentage of participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19 | 5.4 percentage of participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19 | 14.0 percentage of participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19 | 20.9 percentage of participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19 | 23.5 percentage of participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19 | 12.4 percentage of participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19 | 10.8 percentage of participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19 | 10.2 percentage of participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19 | 24.4 percentage of participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19 | 25.0 percentage of participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19 | 29.0 percentage of participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19 | 9.7 percentage of participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19 | 18.4 percentage of participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19 | 18.9 percentage of participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19 | 19.2 percentage of participants |
| Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Laboratory-Confirmed Symptomatic COVID-19 | 8.2 percentage of participants |
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 ˂90 millimeter of mercury (mmHg), or diastolic blood pressure ˂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.
Time frame: 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.
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Severe Symptomatic COVID-19 | 0 percentage of participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Severe Symptomatic COVID-19 | 0 percentage of participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Severe Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Severe Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Severe Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Severe Symptomatic COVID-19 | 0.3 percentage of participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Severe Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Severe Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Severe Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Severe Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Severe Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Severe Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Severe Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Severe Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Severe Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Severe Symptomatic COVID-19 | 0.8 percentage of participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Severe Symptomatic COVID-19 | 0 percentage of participants |
| Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Severe Symptomatic COVID-19 | 0 percentage of participants |
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.
Time frame: 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.
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization | 0 percentage of participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization | 0 percentage of participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization | 0 percentage of participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization | 0 percentage of participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization | 0 percentage of participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization | 0.3 percentage of participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization | 0 percentage of participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization | 0 percentage of participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization | 0 percentage of participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization | 0.8 percentage of participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization | 0 percentage of participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization | 0 percentage of participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization | 0 percentage of participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization | 0 percentage of participants |
| Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization | 0 percentage of participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization | 0 percentage of participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization | 0 percentage of participants |
| Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) | Phase 2 and Phase 3 (Cohorts 1, 2 and Comparator): Percentage of Participants With Symptomatic COVID-19 Episodes Associated With Hospitalization | 0 percentage of participants |
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.
Time frame: Pre-vaccination on Day 1 and post-vaccination on Days 22, 36, 78, 134, 202, 292, and 387
Population: The PPAS Naïve-D01+D22 is a subset of the FAS. Only participants analyzed at specific timepoint are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 1 | 10.3 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 22 | 103 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 36 | 15533 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 78 | 6572 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 134 | 2750 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 202 | 1414 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 292 | 40589 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 387 | 61087 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 36 | 17176 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 292 | 9247 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 78 | 7526 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 134 | 2977 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 202 | 1961 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 1 | 9.99 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 22 | 149 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 387 | 58674 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 36 | 18003 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 22 | 228 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 1 | 10.2 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 78 | 7133 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 292 | 5557 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 202 | 1438 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 134 | 2696 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 387 | 16234 titers |
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.
Time frame: Post-vaccination on Days 22, 78, 134, 202, 292, and 387
Population: The PPAS Naïve-D01+D22 is a subset of the FAS. Only participants analyzed at specific timepoint are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387 | Day 22 | 36.0 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387 | Day 78 | 467 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387 | Day 134 | 225 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387 | Day 202 | 254 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387 | Day 292 | 12145 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387 | Day 387 | 17837 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387 | Day 387 | 46305 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387 | Day 22 | 39.6 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387 | Day 202 | 344 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387 | Day 292 | 2518 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387 | Day 78 | 558 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387 | Day 134 | 249 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387 | Day 78 | 569 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387 | Day 134 | 260 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387 | Day 387 | 8353 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387 | Day 202 | 259 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387 | Day 22 | 47.3 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | Phase 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 22, 78, 134, 202, 292, and 387 | Day 292 | 804 titers |
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.
Time frame: Pre-vaccination on Day 1 and Post-vaccination on Days 22, 36, 78, 134, 202, 292, and 387
Population: The PPAS Naïve-D01+D22 is a subset of the FAS. Only participants analyzed at specific timepoint are reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 292: >=2-fold rise | 11 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 78: >=4-fold rise | 121 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 36: >=2-fold rise | 159 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 202: >=4-fold rise | 85 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 134: >=2-fold rise | 101 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 22: >=4-fold rise | 117 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 202: >=2-fold rise | 85 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 134: >=4-fold rise | 101 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 292: >=4-fold rise | 11 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 36: >=4-fold rise | 158 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 387: >=4-fold rise | 10 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 22: >=2-fold rise | 141 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 78: >=2-fold rise | 121 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 387: >=2-fold rise | 10 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 292: >=2-fold rise | 12 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 22: >=2-fold rise | 155 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 22: >=4-fold rise | 136 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 36: >=2-fold rise | 160 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 36: >=4-fold rise | 160 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 78: >=2-fold rise | 124 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 78: >=4-fold rise | 124 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 134: >=2-fold rise | 109 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 134: >=4-fold rise | 109 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 202: >=2-fold rise | 91 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 202: >=4-fold rise | 91 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 292: >=4-fold rise | 12 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 387: >=2-fold rise | 10 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 387: >=4-fold rise | 10 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 387: >=2-fold rise | 13 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 202: >=4-fold rise | 85 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 78: >=2-fold rise | 124 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 36: >=4-fold rise | 165 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 292: >=2-fold rise | 14 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 36: >=2-fold rise | 165 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 22: >=2-fold rise | 161 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 292: >=4-fold rise | 14 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 22: >=4-fold rise | 156 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 134: >=4-fold rise | 100 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 134: >=2-fold rise | 100 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 387: >=4-fold rise | 13 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 202: >=2-fold rise | 86 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 78: >=4-fold rise | 124 Participants |
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.
Time frame: Pre-vaccination on Day 1 and Post-vaccination on Days 22, 78, 134, 202, 292, and 387
Population: The PPAS Naïve-D01+D22 is a subset of the FAS. Only participants analyzed at specific timepoint are reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 22: >=4-fold rise | 28 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 134: >=2-fold rise | 85 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 78: >=4-fold rise | 105 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 387: >=2-fold rise | 10 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 134: >=4-fold rise | 75 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 22: >=2-fold rise | 35 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 292: >=4-fold rise | 10 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 202: >=2-fold rise | 57 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 292: >=2-fold rise | 10 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 78: >=2-fold rise | 108 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 202: >=4-fold rise | 53 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 387: >=4-fold rise | 10 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 202: >=4-fold rise | 57 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 292: >=2-fold rise | 10 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 292: >=4-fold rise | 9 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 387: >=2-fold rise | 9 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 78: >=4-fold rise | 115 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 387: >=4-fold rise | 9 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 134: >=2-fold rise | 87 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 22: >=4-fold rise | 36 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 134: >=4-fold rise | 83 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 22: >=2-fold rise | 44 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 202: >=2-fold rise | 62 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 78: >=2-fold rise | 116 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 387: >=4-fold rise | 11 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 22: >=2-fold rise | 53 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 22: >=4-fold rise | 44 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 78: >=2-fold rise | 113 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 78: >=4-fold rise | 110 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 134: >=2-fold rise | 82 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 134: >=4-fold rise | 76 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 202: >=2-fold rise | 62 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 202: >=4-fold rise | 60 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 292: >=2-fold rise | 11 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 292: >=4-fold rise | 8 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 387: >=2-fold rise | 11 Participants |
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.
Time frame: Post-vaccination on Days 22, 36, 78, 134, 202, 292, and 387
Population: The PPAS Naïve-D01+D22 is a subset of the FAS. Only participants analyzed at specific timepoint are reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 36 | 159 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 202 | 85 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 134 | 101 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 22 | 139 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 387 | 10 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 292 | 11 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 78 | 121 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 134 | 109 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 22 | 154 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 36 | 160 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 78 | 124 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 202 | 91 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 292 | 12 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 387 | 10 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 202 | 86 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 36 | 165 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 387 | 13 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 292 | 14 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 134 | 100 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 78 | 124 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 22 | 161 Participants |
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).
Time frame: Post-vaccination on Days 22, 78, 134, 202, 292, and 387
Population: The PPAS Naïve-D01+D22 is a subset of the FAS. Only participants analyzed at specific timepoint are reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 22 | 35 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 78 | 108 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 134 | 85 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 202 | 57 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 292 | 10 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 387 | 10 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 387 | 9 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 22 | 44 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 202 | 62 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 292 | 10 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 78 | 116 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 134 | 87 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 78 | 113 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 134 | 82 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 387 | 11 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 202 | 62 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 22 | 53 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 292 | 11 Participants |
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.
Time frame: From first dose of study vaccine administration (Day 1) up to 387 days
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | Phase 2: Percentage of Participants With Serologically-Confirmed SARS-CoV-2 Infection | 12.1 percentage of participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | Phase 2: Percentage of Participants With Serologically-Confirmed SARS-CoV-2 Infection | 10.8 percentage of participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | Phase 2: Percentage of Participants With Serologically-Confirmed SARS-CoV-2 Infection | 14.1 percentage of participants |
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.
Time frame: Post-vaccination on Days 29, 91, 181, and 366
Population: The PPAS is a subset of the FAS. Only participants analyzed for each parameter at specific timepoint are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 29: D614G | 5795 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 29: B.1.351 | 2078 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 91: D614G | 4623 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 91: B.1.351 | 1522 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 181: D614G | 7502 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 181: B.1.351 | 2328 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 366: D614G | 10224 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 366: B.1.351 | 3419 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 181: B.1.351 | 3217 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 181: D614G | 10068 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 29: B.1.351 | 1726 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 366: B.1.351 | 3349 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 366: D614G | 10567 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 91: B.1.351 | 1254 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 91: D614G | 4879 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 29: D614G | 5743 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 366: D614G | 2940 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 91: D614G | 2704 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 91: B.1.351 | 949 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 181: D614G | 2658 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 181: B.1.351 | 1035 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 366: B.1.351 | 942 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 29: D614G | 4869 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 29: B.1.351 | 1790 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 91: D614G | 2509 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 91: B.1.351 | 711 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 29: B.1.351 | 1390 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 29: D614G | 4400 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 181: D614G | 5649 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 366: B.1.351 | 2233 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 366: D614G | 6314 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 181: B.1.351 | 1853 titers |
Secondary
Phase 3: Cohort 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titers Against SARS-CoV-2 D614G Strain and B.1.351 Variant at Days 15, 29, 91, 181, and 366
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.
Time frame: Pre-vaccination on Day 1 and Post-vaccination on Days 15, 29, 91, 181, and 366
Population: The PPAS is a subset of the FAS. Only participants analyzed for each parameter at specific timepoint are reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 91: >=4-fold rise | 189 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 15: >=4-fold rise | 246 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 29: >=4-fold rise | 250 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 91: >=2-fold rise | 203 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 29: >=2-fold rise | 261 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 15: >=2-fold rise | 263 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 29: >=4-fold rise | 245 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 15: >=4-fold rise | 252 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 366: >=2-fold rise | 137 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 91: >=2-fold rise | 208 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 91: >=4-fold rise | 187 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 181: >=4-fold rise | 145 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 181: >=2-fold rise | 167 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 366: >=4-fold rise | 127 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 181: >=4-fold rise | 149 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 29: >=2-fold rise | 266 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 181: >=2-fold rise | 162 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 366: >=2-fold rise | 141 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 366: >=4-fold rise | 129 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 15: >=2-fold rise | 258 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | B.1.351; Day 91: >=4-fold rise | 54 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | B.1.351; Day 15: >=2-fold rise | 76 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | B.1.351; Day 366: >=2-fold rise | 32 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | B.1.351; Day 91: >=2-fold rise | 64 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | D614G; Day 91: >=4-fold rise | 57 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | B.1.351; Day 15: >=4-fold rise | 67 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | D614G; Day 15: >=2-fold rise | 86 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | B.1.351; Day 366: >=4-fold rise | 30 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | D614G; Day 366: >=4-fold rise | 34 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | B.1.351; Day 29: >=2-fold rise | 79 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | D614G; Day 181: >=2-fold rise | 50 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | B.1.351; Day 29: >=4-fold rise | 70 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | D614G; Day 366: >=2-fold rise | 38 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | D614G; Day 29: >=4-fold rise | 79 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | B.1.351; Day 181: >=2-fold rise | 38 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | D614G; Day 29: >=2-fold rise | 91 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | D614G; Day 181: >=4-fold rise | 44 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | D614G; Day 91: >=2-fold rise | 74 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | D614G; Day 15: >=4-fold rise | 70 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | B.1.351; Day 181: >=4-fold rise | 38 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | B.1.351; Day 29: >=2-fold rise | 109 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | D614G; Day 15: >=2-fold rise | 95 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | D614G; Day 15: >=4-fold rise | 87 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | D614G; Day 29: >=2-fold rise | 97 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | D614G; Day 29: >=4-fold rise | 87 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | D614G; Day 91: >=2-fold rise | 67 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | D614G; Day 91: >=4-fold rise | 58 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | D614G; Day 181: >=2-fold rise | 54 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | D614G; Day 181: >=4-fold rise | 42 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | D614G; Day 366: >=2-fold rise | 33 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | D614G; Day 366: >=4-fold rise | 28 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | B.1.351; Day 15: >=2-fold rise | 109 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | B.1.351; Day 15: >=4-fold rise | 103 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | B.1.351; Day 29: >=4-fold rise | 103 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | B.1.351; Day 91: >=2-fold rise | 75 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | B.1.351; Day 91: >=4-fold rise | 67 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | B.1.351; Day 181: >=2-fold rise | 59 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | B.1.351; Day 181: >=4-fold rise | 51 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | B.1.351; Day 366: >=2-fold rise | 36 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | B.1.351; Day 366: >=4-fold rise | 34 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 366: >=4-fold rise | 31 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 366: >=2-fold rise | 31 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 366: >=2-fold rise | 34 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 91: >=4-fold rise | 66 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 181: >=4-fold rise | 41 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 181: >=2-fold rise | 51 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 15: >=4-fold rise | 66 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 181: >=2-fold rise | 54 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 91: >=4-fold rise | 56 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 91: >=2-fold rise | 62 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 15: >=2-fold rise | 70 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 181: >=4-fold rise | 46 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 29: >=4-fold rise | 68 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 29: >=2-fold rise | 83 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 29: >=2-fold rise | 73 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 29: >=4-fold rise | 80 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 15: >=4-fold rise | 76 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 15: >=2-fold rise | 78 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 366: >=4-fold rise | 30 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 91: >=2-fold rise | 68 Participants |
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.
Time frame: Pre-vaccination on Day 1 and post-vaccination on Days 15, 29, and 91
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 15: D614G | 9995 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 1: B.1.351 | 176 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 1: D614G | 678 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 15: B.1.351 | 7021 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 29: D614G | 14065 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 29: B.1.351 | 8947 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 91: D614G | 11037 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 91: B.1.351 | 6557 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 29: B.1.351 | 6045 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 29: D614G | 10885 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 91: B.1.351 | 4359 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 15: D614G | 8430 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 1: D614G | 579 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 1: B.1.351 | 149 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 91: D614G | 8523 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 15: B.1.351 | 4900 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 1: B.1.351 | 258 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 91: B.1.351 | 8141 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 91: D614G | 13701 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 29: B.1.351 | 10264 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 15: B.1.351 | 9449 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 15: D614G | 14240 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 29: D614G | 16286 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 1: D614G | 1107 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 91: D614G | 12424 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 29: D614G | 16874 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 1: B.1.351 | 296 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 91: B.1.351 | 5474 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 1: D614G | 1347 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 29: B.1.351 | 8139 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 15: B.1.351 | 6581 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 15: D614G | 12522 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 91: B.1.351 | 2456 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 1: B.1.351 | 43.3 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 91: D614G | 3620 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 1: D614G | 137 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 15: D614G | 5536 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 15: B.1.351 | 4610 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 29: D614G | 6320 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 29: B.1.351 | 4736 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 15: B.1.351 | 3099 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 91: B.1.351 | 2029 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 15: D614G | 5855 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 29: B.1.351 | 3103 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 29: D614G | 6370 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 1: D614G | 134 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 1: B.1.351 | 36.8 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 91: D614G | 3981 titers |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | Day 91: B.1.351 | 3374 titers |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | Day 91: D614G | 5797 titers |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | Day 15: D614G | 11005 titers |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | Day 1: D614G | 1188 titers |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | Day 1: B.1.351 | 345 titers |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | Day 15: B.1.351 | 6872 titers |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | Day 29: D614G | 9711 titers |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | Day 29: B.1.351 | 6028 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 1: D614G | 447 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 1: B.1.351 | 122 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 15: D614G | 11624 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 15: B.1.351 | 5057 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 29: D614G | 9521 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 91: B.1.351 | 2405 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 29: B.1.351 | 4007 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 91: D614G | 5880 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 91: D614G | 14498 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 15: B.1.351 | 7452 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 29: B.1.351 | 7185 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 15: D614G | 22457 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 1: D614G | 274 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 1: B.1.351 | 97.7 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 29: D614G | 16032 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 91: B.1.351 | 6455 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 15: B.1.351 | 13300 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 29: D614G | 16425 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 91: D614G | 13641 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 91: B.1.351 | 8990 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 29: B.1.351 | 12712 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 15: D614G | 25002 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 1: B.1.351 | 70.3 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 1: D614G | 159 titers |
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.
Time frame: Pre-vaccination on Day 1 and Post-vaccination on Days 15, 29, and 91
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 15: >=2-fold rise | 275 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 29: >=4-fold rise | 240 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 91: >=2-fold rise | 212 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 29: >=2-fold rise | 272 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 91: >=4-fold rise | 195 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 91: >=2-fold rise | 199 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 15: >=2-fold rise | 267 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 15: >=4-fold rise | 249 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 29: >=4-fold rise | 258 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 91: >=4-fold rise | 175 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 15: >=4-fold rise | 232 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 29: >=2-fold rise | 278 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | B.1.351; Day 29: >=4-fold rise | 261 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | B.1.351; Day 15: >=2-fold rise | 269 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | B.1.351; Day 15: >=4-fold rise | 247 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | B.1.351; Day 91: >=4-fold rise | 197 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | D614G; Day 15: >=4-fold rise | 242 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | D614G; Day 29: >=2-fold rise | 283 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | B.1.351; Day 91: >=2-fold rise | 207 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | D614G; Day 29: >=4-fold rise | 251 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | D614G; Day 91: >=2-fold rise | 208 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | D614G; Day 15: >=2-fold rise | 269 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | B.1.351; Day 29: >=2-fold rise | 277 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | D614G; Day 91: >=4-fold rise | 187 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | B.1.351; Day 29: >=4-fold rise | 75 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | D614G; Day 15: >=4-fold rise | 67 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | B.1.351; Day 91: >=4-fold rise | 62 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | D614G; Day 91: >=2-fold rise | 69 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | D614G; Day 29: >=2-fold rise | 83 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | B.1.351; Day 15: >=2-fold rise | 77 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | D614G; Day 15: >=2-fold rise | 79 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | D614G; Day 91: >=4-fold rise | 57 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | D614G; Day 29: >=4-fold rise | 74 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | B.1.351; Day 91: >=2-fold rise | 69 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | B.1.351; Day 15: >=4-fold rise | 70 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | B.1.351; Day 29: >=2-fold rise | 81 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 29: >=2-fold rise | 76 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 15: >=2-fold rise | 77 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 29: >=4-fold rise | 70 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 15: >=4-fold rise | 58 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 29: >=4-fold rise | 67 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 91: >=4-fold rise | 60 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 91: >=2-fold rise | 70 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 29: >=2-fold rise | 79 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 15: >=4-fold rise | 68 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 15: >=2-fold rise | 79 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 91: >=2-fold rise | 68 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 91: >=4-fold rise | 54 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | D614G; Day 15: >=4-fold rise | 78 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | B.1.351; Day 15: >=2-fold rise | 85 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | D614G; Day 29: >=2-fold rise | 84 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | D614G; Day 29: >=4-fold rise | 80 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | B.1.351; Day 91: >=4-fold rise | 56 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | B.1.351; Day 91: >=2-fold rise | 56 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | B.1.351; Day 29: >=2-fold rise | 86 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | D614G; Day 91: >=4-fold rise | 55 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | D614G; Day 91: >=2-fold rise | 57 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | B.1.351; Day 15: >=4-fold rise | 83 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | B.1.351; Day 29: >=4-fold rise | 84 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | D614G; Day 15: >=2-fold rise | 85 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | B.1.351; Day 15: >=4-fold rise | 88 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | D614G; Day 15: >=2-fold rise | 84 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | D614G; Day 15: >=4-fold rise | 79 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | D614G; Day 29: >=2-fold rise | 83 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | D614G; Day 29: >=4-fold rise | 80 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | D614G; Day 91: >=2-fold rise | 51 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | D614G; Day 91: >=4-fold rise | 48 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | B.1.351; Day 15: >=2-fold rise | 88 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | B.1.351; Day 29: >=2-fold rise | 87 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | B.1.351; Day 29: >=4-fold rise | 87 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | B.1.351; Day 91: >=2-fold rise | 56 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | B.1.351; Day 91: >=4-fold rise | 53 Participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 29: >=4-fold rise | 20 Participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 91: >=2-fold rise | 22 Participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 29: >=2-fold rise | 22 Participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 15: >=2-fold rise | 28 Participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 91: >=4-fold rise | 12 Participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 91: >=2-fold rise | 16 Participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 15: >=2-fold rise | 26 Participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 91: >=4-fold rise | 16 Participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 29: >=2-fold rise | 28 Participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 15: >=4-fold rise | 22 Participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 15: >=4-fold rise | 18 Participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 29: >=4-fold rise | 15 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | B.1.351; Day 15: >=4-fold rise | 24 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | B.1.351; Day 29: >=4-fold rise | 25 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | D614G; Day 91: >=4-fold rise | 16 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | D614G; Day 29: >=4-fold rise | 23 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | D614G; Day 29: >=2-fold rise | 28 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | B.1.351; Day 91: >=4-fold rise | 17 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | D614G; Day 15: >=4-fold rise | 26 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | B.1.351; Day 29: >=2-fold rise | 26 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | B.1.351; Day 15: >=2-fold rise | 28 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | B.1.351; Day 91: >=2-fold rise | 21 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | D614G; Day 91: >=2-fold rise | 20 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | D614G; Day 15: >=2-fold rise | 30 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | D614G; Day 29: >=4-fold rise | 85 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | D614G; Day 91: >=4-fold rise | 78 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | B.1.351; Day 15: >=4-fold rise | 85 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | D614G; Day 91: >=2-fold rise | 81 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | B.1.351; Day 29: >=2-fold rise | 95 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | D614G; Day 29: >=2-fold rise | 89 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | B.1.351; Day 29: >=4-fold rise | 92 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | D614G; Day 15: >=4-fold rise | 84 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | B.1.351; Day 91: >=4-fold rise | 80 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | B.1.351; Day 91: >=2-fold rise | 87 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | D614G; Day 15: >=2-fold rise | 86 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | B.1.351; Day 15: >=2-fold rise | 88 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 15: >=2-fold rise | 62 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 91: >=2-fold rise | 58 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 91: >=4-fold rise | 53 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 15: >=2-fold rise | 60 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 91: >=2-fold rise | 57 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 29: >=2-fold rise | 62 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 29: >=4-fold rise | 56 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 91: >=4-fold rise | 55 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 15: >=4-fold rise | 58 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 15: >=4-fold rise | 58 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351; Day 29: >=4-fold rise | 58 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G; Day 29: >=2-fold rise | 58 Participants |
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.
Time frame: Cohorts 1 and 2: 14 days post-vaccination on Day 1 (Day 15); Comparator: 14 days post-vaccination on Day 22 (Day 36)
Population: The PPAS is a subset of the FAS. Only participants analyzed for each parameter at specific timepoint are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G | 90.6 percentage of participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351 | 92.5 percentage of participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | D614G | 73.7 percentage of participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | B.1.351 | 83.3 percentage of participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | D614G | 75.6 percentage of participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | B.1.351 | 82.9 percentage of participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G | 71.4 percentage of participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351 | 84.8 percentage of participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | B.1.351 | 83.3 percentage of participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | D614G | 72.8 percentage of participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | B.1.351 | 80.0 percentage of participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | D614G | 63.7 percentage of participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | D614G | 86.1 percentage of participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351 | 90.4 percentage of participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | D614G | 89.7 percentage of participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | B.1.351 | 95.4 percentage of participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | D614G | 89.8 percentage of participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | B.1.351 | 96.7 percentage of participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351 | 93.8 percentage of participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | D614G | 88.0 percentage of participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | 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 | D614G | 58.1 percentage of participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | 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 | B.1.351 | 75.9 percentage of participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | B.1.351 | 77.4 percentage of participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | D614G | 78.8 percentage of participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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 | B.1.351 | 85.9 percentage of participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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 | D614G | 84.8 percentage of participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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 | D614G | 90.6 percentage of participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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 | B.1.351 | 90.6 percentage of participants |
| Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) | 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 | B.1.351 | 86.6 percentage of participants |
| Phase 3: Comparator: CoV2 preS dTM-AS03 (D614) | 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 | D614G | 99.0 percentage of participants |
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.
Time frame: Pre-vaccination on Day 1 and post-vaccination on Days 15, 29, 91, 181, and 366
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 181 | 20073 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 1 | 1888 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 91 | 18845 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 366 | 41232 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 29 | 20212 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 15 | 26710 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 1 | 3032 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 29 | 33416 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 91 | 29384 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 366 | 19545 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 15 | 36428 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 181 | 20450 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 91 | 23908 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 29 | 27083 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 1 | 2580 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 15 | 30892 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 366 | 19989 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 181 | 18628 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 91 | 20758 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 1 | 3236 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 366 | 32368 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 15 | 27390 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 181 | 25701 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 29 | 23079 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 91 | 37791 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 1 | 3285 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 29 | 48428 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 15 | 43611 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 366 | 25800 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 181 | 25615 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 366 | 19848 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 91 | 35363 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 181 | 24500 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 15 | 34704 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 29 | 41018 titers |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 1 | 3505 titers |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | Day 15 | 21654 titers |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | Day 1 | 993 titers |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | Day 29 | 13305 titers |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | Day 91 | 9792 titers |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | Day 181 | 7281 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 366 | 10382 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 29 | 16401 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 91 | 10365 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 1 | 564 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 181 | 8665 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 15 | 23775 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 181 | 10649 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 29 | 17729 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 1 | 537 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 15 | 28783 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 366 | 10937 titers |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 91 | 13189 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 181 | 12342 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 366 | 14545 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 91 | 9032 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 29 | 14014 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 15 | 21758 titers |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 1 | 608 titers |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 29 | 29315 titers |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 91 | 18463 titers |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 366 | 12176 titers |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 181 | 11275 titers |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 15 | 31067 titers |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 1 | 2290 titers |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 181 | 19231 titers |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 91 | 16236 titers |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 15 | 34534 titers |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 1 | 996 titers |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 366 | 12002 titers |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 29 | 24388 titers |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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 | Day 1 | 1357 titers |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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 | Day 91 | 41282 titers |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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 | Day 366 | 32168 titers |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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 | Day 15 | 65824 titers |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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 | Day 181 | 21387 titers |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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 | Day 29 | 60707 titers |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 15 | 77057 titers |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 29 | 65974 titers |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 366 | 33194 titers |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 1 | 969 titers |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 91 | 40566 titers |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 181 | 20803 titers |
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.
Time frame: Pre-vaccination on Day 1 and Post-vaccination on Days 15, 29, 91, 181, and 366
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 29: >=4-fold rise | 253 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 181: >=2-fold rise | 175 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 15: >=2-fold rise | 287 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 366: >=2-fold rise | 27 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 15: >=4-fold rise | 265 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 91: >=2-fold rise | 227 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 366: >=4-fold rise | 26 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 91: >=4-fold rise | 197 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 29: >=2-fold rise | 285 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 181: >=4-fold rise | 146 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 91: >=2-fold rise | 210 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 29: >=2-fold rise | 278 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 366: >=2-fold rise | 174 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 366: >=4-fold rise | 147 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 181: >=4-fold rise | 160 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 15: >=2-fold rise | 276 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 15: >=4-fold rise | 234 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 29: >=4-fold rise | 243 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 91: >=4-fold rise | 183 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 2 | 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 | Day 181: >=2-fold rise | 189 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 91: >=2-fold rise | 217 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 366: >=2-fold rise | 184 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 181: >=4-fold rise | 167 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 15: >=4-fold rise | 265 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 181: >=2-fold rise | 193 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 91: >=4-fold rise | 184 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 15: >=2-fold rise | 292 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 366: >=4-fold rise | 165 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 29: >=2-fold rise | 285 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 3 | 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 | Day 29: >=4-fold rise | 254 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 91: >=2-fold rise | 73 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 29: >=2-fold rise | 93 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 15: >=4-fold rise | 72 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 15: >=2-fold rise | 94 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 181: >=2-fold rise | 43 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 181: >=4-fold rise | 38 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 366: >=2-fold rise | 15 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 29: >=4-fold rise | 71 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 366: >=4-fold rise | 13 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 91: >=4-fold rise | 60 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 91: >=2-fold rise | 70 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 181: >=4-fold rise | 55 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 29: >=2-fold rise | 87 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 91: >=4-fold rise | 62 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 15: >=4-fold rise | 73 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 366: >=2-fold rise | 62 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 366: >=4-fold rise | 56 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 29: >=4-fold rise | 75 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 15: >=2-fold rise | 84 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 181: >=2-fold rise | 63 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 15: >=2-fold rise | 87 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 181: >=2-fold rise | 59 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 366: >=4-fold rise | 37 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 15: >=4-fold rise | 69 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 29: >=2-fold rise | 87 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 366: >=2-fold rise | 49 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 29: >=4-fold rise | 74 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 91: >=2-fold rise | 76 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 91: >=4-fold rise | 58 Participants |
| Phase 3: Cohort 2: MP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 181: >=4-fold rise | 48 Participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | Day 29: >=4-fold rise | 96 Participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | Day 91: >=2-fold rise | 82 Participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | Day 181: >=4-fold rise | 45 Participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | Day 29: >=2-fold rise | 111 Participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | Day 15: >=4-fold rise | 106 Participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | Day 91: >=4-fold rise | 69 Participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | Day 15: >=2-fold rise | 114 Participants |
| Phase 3: Cohort 1: OUAP - CoV2 preS dTM-AS03 (D614) | 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 | Day 181: >=2-fold rise | 59 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 15: >=4-fold rise | 85 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 29: >=4-fold rise | 85 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 366: >=2-fold rise | 26 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 15: >=2-fold rise | 92 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 366: >=4-fold rise | 23 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 91: >=2-fold rise | 61 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 181: >=2-fold rise | 53 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 29: >=2-fold rise | 92 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 91: >=4-fold rise | 57 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 181: >=4-fold rise | 45 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 181: >=4-fold rise | 40 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 366: >=4-fold rise | 23 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 15: >=2-fold rise | 92 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 15: >=4-fold rise | 90 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 29: >=4-fold rise | 86 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 91: >=4-fold rise | 56 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 181: >=2-fold rise | 49 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 91: >=2-fold rise | 59 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 366: >=2-fold rise | 27 Participants |
| Phase 3: Cohort 2: OUAP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 29: >=2-fold rise | 90 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 366: >=2-fold rise | 9 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 15: >=2-fold rise | 88 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 15: >=4-fold rise | 84 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 29: >=2-fold rise | 91 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 29: >=4-fold rise | 84 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 91: >=2-fold rise | 79 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 91: >=4-fold rise | 72 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 181: >=2-fold rise | 56 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 181: >=4-fold rise | 51 Participants |
| Phase 3: Cohort 1: JJJP - CoV2 preS dTM-AS03 (D614) | 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 | Day 366: >=4-fold rise | 7 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 15: >=4-fold rise | 19 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 29: >=2-fold rise | 24 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 366: >=2-fold rise | 12 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 366: >=4-fold rise | 11 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 181: >=2-fold rise | 14 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 181: >=4-fold rise | 11 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 15: >=2-fold rise | 24 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 91: >=2-fold rise | 17 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 91: >=4-fold rise | 14 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 29: >=4-fold rise | 19 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 15: >=2-fold rise | 29 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 29: >=2-fold rise | 27 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 181: >=4-fold rise | 17 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 91: >=4-fold rise | 22 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 366: >=2-fold rise | 17 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 181: >=2-fold rise | 20 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 15: >=4-fold rise | 28 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 366: >=4-fold rise | 14 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 91: >=2-fold rise | 23 Participants |
| Phase 3: Cohort 2: JJJP - CoV2 preS dTM-AS03 (D614 + B.1.351) | 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 | Day 29: >=4-fold rise | 27 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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 | Day 29: >=2-fold rise | 115 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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 | Day 91: >=4-fold rise | 98 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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 | Day 91: >=2-fold rise | 105 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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 | Day 366: >=4-fold rise | 77 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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 | Day 181: >=4-fold rise | 89 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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 | Day 29: >=4-fold rise | 109 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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 | Day 366: >=2-fold rise | 83 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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 | Day 15: >=4-fold rise | 103 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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 | Day 15: >=2-fold rise | 108 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (D614) | 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 | Day 181: >=2-fold rise | 98 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 29: >=2-fold rise | 69 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 15: >=2-fold rise | 69 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 181: >=2-fold rise | 62 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 29: >=4-fold rise | 66 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 181: >=4-fold rise | 59 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 366: >=4-fold rise | 52 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 91: >=2-fold rise | 65 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 15: >=4-fold rise | 67 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 91: >=4-fold rise | 62 Participants |
| Phase 3: Cohort 2: PP - CoV2 preS dTM-AS03 (B.1.351) | 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 | Day 366: >=2-fold rise | 53 Participants |
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.
Time frame: Pre-vaccination on Day 1 and post-vaccination on Days 22, 36, 134, 202, 292, and 387
Population: The PPAS is a subset of the FAS. Only participants analyzed at specific timepoint are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 1 | 10.7 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 22 | 212 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 36 | 24278 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 134 | 6593 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 202 | 6667 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 292 | 6868 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 387 | 7112 titers |
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.
Time frame: Pre-vaccination on Day 1 and post-vaccination on Days 22, 36, 134, 202, 292, and 387
Population: The PPAS is a subset of the FAS. Only participants analyzed for each parameter at specific timepoint are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351: Day 134 | 496 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G: Day 1 | 20.3 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G: Day 22 | 53.3 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G: Day 36 | 3658 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G: Day 134 | 1050 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G: Day 202 | 1685 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G: Day 292 | 1943 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G: Day 387 | 1973 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351: Day 1 | 20.3 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351: Day 22 | 29.4 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351: Day 36 | 413 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351: Day 202 | 671 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351: Day 292 | 867 titers |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351: Day 387 | 1033 titers |
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.
Time frame: Pre-vaccination on Day 1 and Post-vaccination on Days 22, 36, 134, 202, 292, and 387
Population: The PPAS is a subset of the FAS. Only participants analyzed for each parameter at specific timepoint are reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 22: >=2-fold rise | 312 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 22: >=4-fold rise | 290 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 36: >=2-fold rise | 302 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 36: >=4-fold rise | 302 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 134: >=2-fold rise | 149 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 134: >=4-fold rise | 148 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 202: >=2-fold rise | 133 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 202: >=4-fold rise | 133 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 292: >=2-fold rise | 123 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 292: >=4-fold rise | 123 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 387: >=2-fold rise | 117 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 387: >=4-fold rise | 117 Participants |
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.
Time frame: Pre-vaccination on Day 1 and Post-vaccination on Days 22, 36, 134, 202, 292, and 387
Population: The PPAS is a subset of the FAS. Only participants analyzed for each parameter at specific timepoint are reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 22: >=2-fold rise | 99 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 22: >=4-fold rise | 88 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 36: >=2-fold rise | 299 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 36: >=4-fold rise | 298 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 134: >=2-fold rise | 134 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 134: >=4-fold rise | 131 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 202: >=2-fold rise | 120 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 202: >=4-fold rise | 119 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 292: >=2-fold rise | 108 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 292: >=4-fold rise | 105 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 387: >=2-fold rise | 105 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | D614G; Day 387: >=4-fold rise | 101 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 22: >=2-fold rise | 39 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 22: >=4-fold rise | 32 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 36: >=2-fold rise | 264 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 36: >=4-fold rise | 251 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 134: >=2-fold rise | 99 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 134: >=4-fold rise | 89 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 202: >=2-fold rise | 100 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 202: >=4-fold rise | 97 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 292: >=2-fold rise | 98 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 292: >=4-fold rise | 91 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 387: >=2-fold rise | 96 Participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | B.1.351; Day 387: >=4-fold rise | 94 Participants |
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.
Time frame: Post-vaccination on Days 22, 36, 134, 202, 292, and 387
Population: The PPAS is a subset of the FAS. Only participants analyzed at specific timepoint are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 22 | 94.3 percentage of participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 36 | 99.7 percentage of participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 134 | 98.7 percentage of participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 202 | 99.3 percentage of participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 292 | 99.3 percentage of participants |
| Phase 2: CoV2 preS dTM-AS03 (D614) Formulation 1 | 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 | Day 387 | 99.2 percentage of participants |