A Phase 3 interventional study of SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent D614) (primary series) and SARS-CoV-2 adjuvanted recombinant protein vaccine (bivalent D614 + B.1.351) (primary series) in COVID-19, sponsored by Sanofi Pasteur, a Sanofi Company. Terminated at 86 sites in 11 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by Sanofi Pasteur, a Sanofi Company (part of Sanofi) · Phase 3, Interventional, and Prevention
The purpose of this Phase III study is to assess the efficacy, safety, and immunogenicity of two CoV2 preS dTM-AS03 vaccines (monovalent and bivalent) as part of primary series vaccinations in a multi-stage approach, as well as a booster injection of a CoV2 preS dTM-AS03 vaccine, in adults 18 years of age and older.
A total of approximately 21 046 participants are planned to be enrolled (5080 per study intervention group in Stage 1 and 5443 per study intervention group in Stage 2).
Initial, double-blind, primary series study design is planned for 365 days post-last Initial injection (ie, approximately 386 days total) for each participant.
Based on decisions of the Study Oversight Group, Stage 1 and Stage 2 participants will be invited to participate in an unblinded Crossover / Booster study design with duration as follows:
The duration of participation in the initial, double-blind, primary series design of the study will be approximately 365 days post-last injection (ie, approximately 386 days total) for each participant.
Based on decisions of the Study OG, Stage 1 and Stage 2 participants will be invited to participate in an unblinded Crossover / Booster study design with duration as follows:
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 23,670 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Sanofi Pasteur, a Sanofi Company is the lead sponsor of 374 studies on the registry; 4 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.
First submitted after Sanofi Pasteur became part of Sanofi.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 25 hours before any dose of study intervention.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
2 injections of monovalent SARS-CoV-2 vaccine at Day 1 and Day 22
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent D614) (primary series) · Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent B.1.351) (booster dose) >= 4 months after last vaccination
2 injections of placebo at Day 1 and Day 22
Biological: Placebo · Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent D614)(primary series)& SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent B.1.351)(booster dose)>=4 months after last vaccination
2 injections of bivalent SARS-CoV-2 vaccine at Day 1 and Day 22
Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine (bivalent D614 + B.1.351) (primary series) · Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent B.1.351) (booster dose) >= 4 months after last vaccination
2 injections of placebo at Day 1 and Day 22
Biological: Placebo · Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent D614)(primary series)& SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent B.1.351)(booster dose)>=4 months after last vaccination
Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection
Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection.
Pharmaceutical form: liquid. Route of administration: intramuscular administration.
Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection.
Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection.
Stage 1 and Stage 2: Number of Participants With Onset of Symptomatic Coronavirus Disease 2019 (COVID-19) Episode
Symptomatic COVID-19 was defined as virologically-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness (CLI).
Time frame: From Day 36 up to Day 387
Stage 1 and Stage 2: Number of Participants With Solicited Injection Site and Systemic Reactions
A solicited reaction was defined as an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and case report form (CRF) collected within 7 days after each injection and considered to be related to the corresponding 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 and included systemic manifestations such as headache, fever, as well as localized or topical manifestations that are not associated with the injection site.
Time frame: Up to 7 days after each vaccination (post-dose on Days 1 and 22)
Stage 1 and Stage 2: Number of Participants With Unsolicited Non-Serious 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. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that was pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.
Time frame: Up to 21 days after each vaccination (post-dose on Days 1 and 22)
Stage 1 and Stage 2: Number of Participants With Immediate 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. Immediate events were recorded to capture medically relevant unsolicited injection site and systemic AEs which occurred within the first 30 minutes after vaccination.
Time frame: Up to 30 minutes after each vaccination (post-dose on Days 1 and 22)
Stage 1 and Stage 2: Number of Participants With Medically Attended Adverse Events (MAAE), Serious Adverse Events (SAE), and Adverse Events of Special Interest (AESI)
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: From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Percentage of Participants With Virologically-Confirmed SARS-CoV-2 Infection and/or Symptomatic COVID-19
Virologically-confirmed SARS-CoV-2 infection was defined as a positive result for SARS CoV-2 by nucleic acid amplification test (NAAT) on at least 1 respiratory sample. This included positive results by any NAAT that included tests performed outside the trial protocol if confirmed by the adjudication committee. Symptomatic COVID-19 was defined as virologically-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness. Percentages are rounded off to the tenth decimal place. Here, percentage of participants with virologically-confirmed SARS-CoV-2 infection and/or symptomatic COVID-19 (regardless of adjudication) are reported.
Time frame: From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Number of Participants With SARS-CoV-2 Infection
SARS-CoV-2 infection was defined as a serologically-confirmed SARS-CoV-2 infection or virologically-confirmed SARS-CoV-2 infection.
Time frame: From Day 36 up to Day 387
Stage 1 and Stage 2: Number of Participants With Occurrence of Severe COVID-19
Severe COVID-19 was defined as COVID-19 with any 1 of the following: 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. Admission to an intensive care unit. Death.
Time frame: From Day 36 up to Day 387
Stage 1 and Stage 2: Number of Participants With Asymptomatic SARS-CoV-2 Infection
Asymptomatic SARS-CoV-2 infection was defined as SARS-CoV-2 infection, with no reported COVID-19-like illness episodes between enrollment and 14 days after the timepoint at which SARS-CoV-2 infection was ascertained.
Time frame: From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Number of Swabs With Positive Nucleic Acid Amplification Test (NAAT)
The viral copies were collected as protocol-defined respiratory swabs during participant's illness episode and reported as positive continuous values. Here, duration between two consecutive positive NAAT results was calculated as: (the date of last swab tested positive) - (the date of first tested positive) + 1.
Time frame: From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Number of Participants With Respective Number of Days Between Two Consecutive Positive Nucleic Acid Amplification Test
Duration between two consecutive positive NAAT results was calculated as: the date of last swab tested positive - the date of first swab tested positive + 1.
Time frame: From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Number of Participants With Positive NAAT for SARS-CoV-2
Virologically-confirmed SARS-CoV-2 infection was defined as a positive result for SARS-CoV-2 by NAAT on at least 1 respiratory sample. Respiratory samples for NAAT testing were collected in participants with CLI through the study.
Time frame: From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Number of Participants With Centers for Disease Control and Prevention (CDC)-Defined COVID-19
CDC-defined COVID-19 included virologically-confirmed SARS-CoV-2 infection with at least 1 of: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.
Time frame: From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Number of Participants With Occurrences of Hospitalized COVID-19
Hospitalized COVID-19 was defined as an episode of symptomatic COVID-19 that required inpatient hospitalization.
Time frame: From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Number of Participants With Symptomatic COVID-19 With Severity of Moderate or Worse
Symptomatic COVID-19 was defined as virologically-confirmed SARS-CoV-2 infection accompanied by protocol-defined CLI. Moderate COVID-19 was defined as symptomatic COVID-19 with either shortness of breath that persisted for at least 12 hours or clinical signs of moderate illness measured at least on 2 occasions separated by 30 minutes and no clinical signs indicative of severe COVID-19.
Time frame: From first dose of study vaccine administration (Day 1) up to 387 days
Stage 1 and Stage 2: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G Strain at Days 1, 22, and 43
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 and post-vaccination on Days 22, and 43
Crossover: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G and B.1.351 Strains at Days 1, 43, 142, 163, and 322
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 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 and post-vaccination on Days 43, 142, 163 and 322
Booster: Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 D614G and B.1.351 Strains at Days 1, 22, and 202
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 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 and post-vaccination on Days 22, and 202
Stage 1 and Stage 2: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22 and 43
Responders are participants who had baseline values below lower limit of quantification (LLOQ) with quantifiable neutralization titer above assay LLOQ at each pre-defined post-vaccination timepoint and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination timepoint.
Time frame: Post-vaccination on Days 22 and 43
Crossover: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G and B.1.351 Strains at Days 43, 142, 163, and 322
Responders are participants who had baseline values below LLOQ with quantifiable neutralization titer above assay LLOQ at each pre-defined post-vaccination timepoint and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination timepoint.
Time frame: Post-vaccination on Days 43, 142, 163 and 322
Booster: Number of Responders as Determined by Neutralizing Antibody Titers Against SARS-CoV-2 D614G and B.1.351 Strains at Days 22 and 202
Responders are participants who had baseline values below LLOQ with quantifiable neutralization titer above assay LLOQ at each pre-defined post-vaccination timepoint and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination timepoint.
Time frame: Post-vaccination on Days 22, and 202
Stage 1: Number of Participants With >=2-Fold and >=4-Fold Rise in Neutralizing Antibody Titers Against SARS-CoV-2 D614G Strain at Days 22 and 43
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) are reported.
Time frame: Pre-vaccination on Day 1 and post-vaccination on Days 22 and 43
Crossover: Number of Participants With >=2-Fold and >=4-Fold Rise in Neutralizing Antibody Titers Against SARS-CoV-2 D614G and B.1.351 Strains at Days 43, 142, 163, and 322
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 strain was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers \>=2-fold and \>=4-fold increase from baseline (pre-vaccination) are reported.
Time frame: Pre-vaccination on Day 1 and post-vaccination on Days 43, 142, 163, and 322
Booster: Number of Participants With >=2-Fold and >=4-Fold Rise in Neutralizing Antibody Titers Against SARS-CoV-2 D614G and B.1.351 Strains at Days 22 and 202
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 strain was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers \>=2-fold and \>=4-fold increase from baseline (pre-vaccination) are reported.
Time frame: Pre-vaccination on Day 1 and post-vaccination on Days 22, and 202
Number of Participants With Symptomatic COVID-19 Episodes
Symptomatic COVID-19 is defined as virologically-confirmed SARS-CoV-2 infection accompanied by protocol-defined CLI. Grade 1: A type of AE that was usually transient and required only minimal treatment or therapeutic intervention and did not generally interfere with usual activities of daily living. Grade 2: A type of AE that was usually alleviated with additional therapeutic intervention and interfered with usual activities of daily living, causing discomfort but posed no significant or permanent risk of harm to the research participant. Grade 3: A type of AE that interrupted usual activities of daily living, or significantly affects clinical status, or required intensive therapeutic intervention.
Time frame: Stages 1 and 2: From first dose of study vaccine administration (Day 1) up to Day 387. Crossover and Booster: From first dose of study vaccine administration (Day 1) up to Day 487
Number of Participants With COVID-19 Severity Using a 7-Point Ordinal Scale
The COVID-19 severity scale was based on the 7-point ordinal scale of clinical assessments: 1: death; 2: hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 3: hospitalized, on non-invasive ventilation or high flow oxygen devices; 4: hospitalized, that required supplemental oxygen; 5: hospitalized, that did not require supplemental oxygen- discharged but required ongoing medical care (COVID-19 related or otherwise); 6: hospitalized, that did not require supplemental oxygen discharged without ongoing medical care; 7: not hospitalized.
Time frame: Stages 1 and 2: From first dose of study vaccine administration (Day 1) up to Day 387. Crossover and Booster: From first dose of study vaccine administration (Day 1) up to Day 487
Number of Deaths Associated With 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 who 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.
Time frame: Stages 1 and 2: From first dose of study vaccine administration (Day 1) up to Day 387. Crossover and Booster: From first dose of study vaccine administration (Day 1) up to Day 487
The study was conducted at 87 centers in 11 countries from 26 May 2021 to 31 August 2024.
| Milestone | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo | Crossover: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Booster: CoV2 preS dTM-AS03 Monovalent (B.1.351) Vaccine |
|---|---|---|---|---|---|---|
| Started | 5061 | 5078 | 6776 | 6755 | 0 | 0 |
| Completed | 4236 | 3989 | 5757 | 5400 | 0 | 0 |
| Not completed | 825 | 1089 | 1019 | 1355 | 0 | 0 |
| Withdrew: Lost to follow-up | 220 | 275 | 259 | 298 | 0 | 0 |
| Withdrew: Withdrawal by subject | 509 | 649 | 616 | 749 | 0 | 0 |
| Withdrew: Protocol violation | 79 | 105 | 102 | 219 | 0 | 0 |
| Withdrew: Adverse event | 12 | 33 | 34 | 48 | 0 | 0 |
| Withdrew: Study terminated by sponsor | 1 | 19 | 0 | 40 | 0 | 0 |
| Withdrew: Other | 4 | 8 | 8 | 1 | 0 | 0 |
| Milestone | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo | Crossover: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Booster: CoV2 preS dTM-AS03 Monovalent (B.1.351) Vaccine |
|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 6801 | 0 |
| Completed | 0 | 0 | 0 | 0 | 6115 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 686 | 0 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 18 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 0 | 173 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 278 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 161 | 0 |
| Withdrew: Other | 0 | 0 | 0 | 0 | 56 | 0 |
| Milestone | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo | Crossover: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Booster: CoV2 preS dTM-AS03 Monovalent (B.1.351) Vaccine |
|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 14237 |
| Completed | 0 | 0 | 0 | 0 | 0 | 13695 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 542 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 17 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 0 | 0 | 139 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 183 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 180 |
| Withdrew: Other | 0 | 0 | 0 | 0 | 0 | 23 |
Symptomatic COVID-19 was defined as virologically-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness (CLI).
| Participants | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo |
|---|---|---|---|---|
| Stage 1 and Stage 2: Number of Participants With Onset of Symptomatic Coronavirus Disease 2019 (COVID-19) Episode | 120 | 121 | 151 | 209 |
A solicited reaction was defined as an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and case report form (CRF) collected within 7 days after each injection and considered to be related to the corresponding 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 and included systemic manifestations such as headache, fever, as well as localized or topical manifestations that are not associated with the injection site.
| Participants | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo |
|---|---|---|---|---|
| Solicited injection site reactions | 1020 | 490 | 1147 | 661 |
| Solicited systemic reactions | 1053 | 663 | 1117 | 844 |
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 was pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.
| Participants | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo |
|---|---|---|---|---|
| Stage 1 and Stage 2: Number of Participants With Unsolicited Non-Serious Adverse Events (AEs) | 197 | 259 | 349 | 470 |
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 injection site and systemic AEs which occurred within the first 30 minutes after vaccination.
| Participants | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo |
|---|---|---|---|---|
| Stage 1 and Stage 2: Number of Participants With Immediate Adverse Events | 9 | 6 | 5 | 12 |
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.
| Participants | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo |
|---|---|---|---|---|
| MAAE | 708 | 704 | 1094 | 1101 |
| SAE | 100 | 135 | 149 | 160 |
| AESI | 5 | 11 | 4 | 3 |
Virologically-confirmed SARS-CoV-2 infection was defined as a positive result for SARS CoV-2 by nucleic acid amplification test (NAAT) on at least 1 respiratory sample. This included positive results by any NAAT that included tests performed outside the trial protocol if confirmed by the adjudication committee. Symptomatic COVID-19 was defined as virologically-confirmed SARS-CoV-2 infection accompanied by protocol-defined COVID-19-like illness. Percentages are rounded off to the tenth decimal place. Here, percentage of participants with virologically-confirmed SARS-CoV-2 infection and/or symptomatic COVID-19 (regardless of adjudication) are reported.
| percentage of participants | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo |
|---|---|---|---|---|
| Stage 1 and Stage 2: Percentage of Participants With Virologically-Confirmed SARS-CoV-2 Infection and/or Symptomatic COVID-19 | 8.3 (7.5 to 9.1) | 10.2 (9.3 to 11.0) | 16.5 (15.6 to 17.4) | 20.5 (19.5 to 21.4) |
SARS-CoV-2 infection was defined as a serologically-confirmed SARS-CoV-2 infection or virologically-confirmed SARS-CoV-2 infection.
| Participants | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo |
|---|---|---|---|---|
| Stage 1 and Stage 2: Number of Participants With SARS-CoV-2 Infection | 612 | 615 | 286 | 346 |
Severe COVID-19 was defined as COVID-19 with any 1 of the following: 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. Admission to an intensive care unit. Death.
| Participants | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo |
|---|---|---|---|---|
| Stage 1 and Stage 2: Number of Participants With Occurrence of Severe COVID-19 | 1 | 6 | 10 | 6 |
Asymptomatic SARS-CoV-2 infection was defined as SARS-CoV-2 infection, with no reported COVID-19-like illness episodes between enrollment and 14 days after the timepoint at which SARS-CoV-2 infection was ascertained.
| Participants | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo |
|---|---|---|---|---|
| Stage 1 and Stage 2: Number of Participants With Asymptomatic SARS-CoV-2 Infection | 377 | 427 | 188 | 222 |
The viral copies were collected as protocol-defined respiratory swabs during participant's illness episode and reported as positive continuous values. Here, duration between two consecutive positive NAAT results was calculated as: (the date of last swab tested positive) - (the date of first tested positive) + 1.
| number of swabs | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo |
|---|---|---|---|---|
| Stage 1 and Stage 2: Number of Swabs With Positive Nucleic Acid Amplification Test (NAAT) | 174 | 154 | 37 | 61 |
Duration between two consecutive positive NAAT results was calculated as: the date of last swab tested positive - the date of first swab tested positive + 1.
| Participants | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo |
|---|---|---|---|---|
| 1-3 days | 65 | 53 | 8 | 10 |
| 4-6 days | 14 | 12 | 3 | 8 |
| 7-9 days | 38 | 38 | 10 | 19 |
| 10-30 days | 42 | 38 | 10 | 15 |
| > 30 days | 15 | 13 | 6 | 9 |
Virologically-confirmed SARS-CoV-2 infection was defined as a positive result for SARS-CoV-2 by NAAT on at least 1 respiratory sample. Respiratory samples for NAAT testing were collected in participants with CLI through the study.
| Participants | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo |
|---|---|---|---|---|
| Stage 1 and Stage 2: Number of Participants With Positive NAAT for SARS-CoV-2 | 336 | 405 | 279 | 411 |
CDC-defined COVID-19 included virologically-confirmed SARS-CoV-2 infection with at least 1 of: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.
| Participants | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo |
|---|---|---|---|---|
| Stage 1 and Stage 2: Number of Participants With Centers for Disease Control and Prevention (CDC)-Defined COVID-19 | 203 | 256 | 154 | 210 |
Hospitalized COVID-19 was defined as an episode of symptomatic COVID-19 that required inpatient hospitalization.
| Participants | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo |
|---|---|---|---|---|
| Stage 1 and Stage 2: Number of Participants With Occurrences of Hospitalized COVID-19 | 3 | 7 | 2 | 3 |
Symptomatic COVID-19 was defined as virologically-confirmed SARS-CoV-2 infection accompanied by protocol-defined CLI. Moderate COVID-19 was defined as symptomatic COVID-19 with either shortness of breath that persisted for at least 12 hours or clinical signs of moderate illness measured at least on 2 occasions separated by 30 minutes and no clinical signs indicative of severe COVID-19.
| Participants | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo |
|---|---|---|---|---|
| Stage 1 and Stage 2: Number of Participants With Symptomatic COVID-19 With Severity of Moderate or Worse | 18 | 31 | 25 | 24 |
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.
| titers | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo |
|---|---|---|---|---|
| Day 1 | 124 (103 to 150) | 303 (232 to 395) | — | — |
| Day 22 | 1890 (1385 to 2578) | 378 (283 to 505) | — | — |
| Day 43 | 5619 (4541 to 6953) | 493 (362 to 671) | — | — |
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 strain was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers.
| titers | Crossover: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine |
|---|---|
| D614G: Day 1 | 2074 (1606 to 2679) |
| D614G: Day 43 | 11654 (9547 to 14227) |
| D614G: Day 142 | 5134 (4008 to 6575) |
| D614G: Day 163 | 7220 (5738 to 9084) |
| D614G: Day 322 | 9010 (6928 to 11717) |
| B.1.351: Day 1 | 1228 (950 to 1586) |
| B.1.351: Day 43 | 6974 (5576 to 8723) |
| B.1.351: Day 142 | 3187 (2485 to 4088) |
| B.1.351: Day 163 | 5118 (4025 to 6507) |
| B.1.351: Day 322 | 6659 (5053 to 8774) |
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 strain was measured with the neutralization assay (monogram assay) and the results were expressed as geometric mean titers.
| titers | Booster: CoV2 preS dTM-AS03 Monovalent (B.1.351) Vaccine |
|---|---|
| D614G: Day 1 | 4387 (3763 to 5115) |
| D614G: Day 22 | 9075 (7822 to 10529) |
| D614G: Day 202 | 6155 (5349 to 7083) |
| B.1.351: Day 1 | 2751 (2349 to 3222) |
| B.1.351: Day 22 | 6620 (5624 to 7794) |
| B.1.351: Day 202 | 4349 (3727 to 5076) |
Responders are participants who had baseline values below lower limit of quantification (LLOQ) with quantifiable neutralization titer above assay LLOQ at each pre-defined post-vaccination timepoint and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination timepoint.
| Participants | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo |
|---|---|---|---|---|
| Day 22 | 247 | 26 | — | — |
| Day 43 | 316 | 34 | — | — |
Responders are participants who had baseline values below LLOQ with quantifiable neutralization titer above assay LLOQ at each pre-defined post-vaccination timepoint and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination timepoint.
| Participants | Crossover: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine |
|---|---|
| D614G: Day 43 | 113 |
| D614G: Day 142 | 85 |
| D614G: Day 163 | 94 |
| D614G: Day 322 | 25 |
| B.1.351: Day 43 | 124 |
| B.1.351: Day 142 | 76 |
| B.1.351: Day 163 | 103 |
| B.1.351: Day 322 | 25 |
Responders are participants who had baseline values below LLOQ with quantifiable neutralization titer above assay LLOQ at each pre-defined post-vaccination timepoint and participants with baseline values above LLOQ with a 4-fold increase in neutralizing antibody titers at each pre-defined post-vaccination timepoint.
| Participants | Booster: CoV2 preS dTM-AS03 Monovalent (B.1.351) Vaccine |
|---|---|
| D614G: Day 22 | 129 |
| D614G: Day 202 | 42 |
| B.1.351: Day 22 | 153 |
| B.1.351: Day 202 | 56 |
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) are reported.
| Participants | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo |
|---|---|---|
| >=2 fold rise: Day 22 | 260 | 38 |
| >=4 fold rise: Day 22 | 240 | 26 |
| >=2 fold rise: Day 43 | 331 | 39 |
| >=4 fold rise: Day 43 | 315 | 33 |
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 strain was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers \>=2-fold and \>=4-fold increase from baseline (pre-vaccination) are reported.
| Participants | Crossover: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine |
|---|---|
| D614G; >=2-fold rise: Day 43 | 149 |
| D614G; >=4-fold rise: Day 43 | 113 |
| D614G; >=2-fold rise: Day 142 | 111 |
| D614G; >=4-fold rise: Day 142 | 85 |
| D614G; >=2-fold rise: Day 163 | 116 |
| D614G; >=4-fold rise: Day 163 | 94 |
| D614G; >=2-fold rise: Day 322 | 32 |
| D614G; >=4-fold rise: Day 322 | 25 |
| B.1.351; >=2-fold rise: Day 43 | 147 |
| B.1.351; >=4-fold rise: Day 43 | 124 |
| B.1.351; >=2-fold rise: Day 142 | 112 |
| B.1.351; >=4-fold rise: Day 142 | 76 |
| B.1.351; >=2-fold rise: Day 163 | 127 |
| B.1.351; >=4-fold rise: Day 163 | 103 |
| B.1.351; >=2-fold rise: Day 322 | 35 |
| B.1.351; >=4-fold rise: Day 322 | 25 |
Neutralizing antibodies activity against SARS-CoV-2 D614G strain and B.1.351 strain was measured with serum neutralization assay (monogram assay). Participants with neutralization antibody titers \>=2-fold and \>=4-fold increase from baseline (pre-vaccination) are reported.
| Participants | Booster: CoV2 preS dTM-AS03 Monovalent (B.1.351) Vaccine |
|---|---|
| D614G; >=2-fold rise: Day 22 | 207 |
| D614G; >=4-fold rise: Day 22 | 127 |
| D614G; >=2-fold rise: Day 202 | 87 |
| D614G; >=4-fold rise: Day 202 | 42 |
| B.1.351; >=2-fold rise: Day 22 | 228 |
| B.1.351; >=4-fold rise: Day 22 | 152 |
| B.1.351; >=2-fold rise: Day 202 | 105 |
| B.1.351; >=4-fold rise: Day 202 | 54 |
Symptomatic COVID-19 is defined as virologically-confirmed SARS-CoV-2 infection accompanied by protocol-defined CLI. Grade 1: A type of AE that was usually transient and required only minimal treatment or therapeutic intervention and did not generally interfere with usual activities of daily living. Grade 2: A type of AE that was usually alleviated with additional therapeutic intervention and interfered with usual activities of daily living, causing discomfort but posed no significant or permanent risk of harm to the research participant. Grade 3: A type of AE that interrupted usual activities of daily living, or significantly affects clinical status, or required intensive therapeutic intervention.
| Participants | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo | Crossover: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Booster: CoV2 preS dTM-AS03 Monovalent (B.1.351) Vaccine |
|---|---|---|---|---|---|---|
| Grade 1 | 23 | 41 | 58 | 80 | 21 | 62 |
| Grade 2 | 56 | 100 | 89 | 142 | 8 | 46 |
| Grade 3 | 25 | 23 | 37 | 50 | 1 | 11 |
The COVID-19 severity scale was based on the 7-point ordinal scale of clinical assessments: 1: death; 2: hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation; 3: hospitalized, on non-invasive ventilation or high flow oxygen devices; 4: hospitalized, that required supplemental oxygen; 5: hospitalized, that did not require supplemental oxygen- discharged but required ongoing medical care (COVID-19 related or otherwise); 6: hospitalized, that did not require supplemental oxygen discharged without ongoing medical care; 7: not hospitalized.
| Participants | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo | Crossover: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Booster: CoV2 preS dTM-AS03 Monovalent (B.1.351) Vaccine |
|---|---|---|---|---|---|---|
| Ordinal scale 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Ordinal scale 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Ordinal scale 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Ordinal scale 4 | 0 | 0 | 0 | 0 | 0 | 0 |
| Ordinal scale 5 | 0 | 0 | 1 | 1 | 0 | 1 |
| Ordinal scale 6 | 0 | 1 | 0 | 1 | 0 | 1 |
| Ordinal scale 7 | 86 | 146 | 150 | 248 | 30 | 122 |
| Missing | 12 | 11 | 20 | 14 | 2 | 2 |
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 who 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.
| Participants | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo | Crossover: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Booster: CoV2 preS dTM-AS03 Monovalent (B.1.351) Vaccine |
|---|---|---|---|---|---|---|
| Number of Deaths Associated With COVID-19 | 0 | 0 | 0 | 0 | 0 | 0 |
Collected over Stages 1 and 2: From first dose of study vaccine administration (Day 1) up to end of follow-up, 387 days. Crossover and Booster: From first dose of study vaccine administration (Day 1) up to end of follow-up 487 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | 9/5,049 (0.2%) | 100/5,049 (2%) | 1,321/5,049 (26.2%) |
| Stage 1: CoV2 preS dTM-AS03 Placebo | 26/5,064 (0.5%) | 135/5,064 (2.7%) | 845/5,064 (16.7%) |
| Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | 29/6,733 (0.4%) | 149/6,733 (2.2%) | 1,610/6,733 (23.9%) |
| Stage 2: CoV2 preS dTM-AS03 Placebo | 40/6,714 (0.6%) | 160/6,714 (2.4%) | 1,200/6,714 (17.9%) |
| Crossover: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | 6/6,529 (0.1%) | 53/6,529 (0.8%) | 133/6,529 (2%) |
| Booster: CoV2 preS dTM-AS03 Monovalent (B.1.351) Vaccine | 21/14,237 (0.1%) | 125/14,237 (0.9%) | 261/14,237 (1.8%) |
| Event | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo | Crossover: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Booster: CoV2 preS dTM-AS03 Monovalent (B.1.351) Vaccine |
|---|---|---|---|---|---|---|
| MalariaInfections and infestations | 7/5049 | 7/5064 | 13/6733 | 16/6714 | 9/6529 | 14/14237 |
| Covid-19Infections and infestations | 4/5049 | 11/5064 | 0/6733 | 7/6714 | 0/6529 | 0/14237 |
| Urinary Tract InfectionInfections and infestations | 6/5049 | 11/5064 | 8/6733 | 6/6714 | 2/6529 | 9/14237 |
| PneumoniaInfections and infestations | 7/5049 | 4/5064 | 3/6733 | 11/6714 | 3/6529 | 8/14237 |
| Abortion SpontaneousPregnancy, puerperium and perinatal conditions | 0/5049 | 7/5064 | 5/6733 | 11/6714 | 0/6529 | 3/14237 |
| GastroenteritisInfections and infestations | 8/5049 | 4/5064 | 2/6733 | 9/6714 | 7/6529 | 5/14237 |
| AnaemiaBlood and lymphatic system disorders | 2/5049 | 8/5064 | 4/6733 | 5/6714 | 4/6529 | 1/14237 |
| Covid-19 PneumoniaInfections and infestations | 0/5049 | 6/5064 | 1/6733 | 1/6714 | 0/6529 | 0/14237 |
| Peptic UlcerGastrointestinal disorders | 2/5049 | 4/5064 | 7/6733 | 1/6714 | 1/6529 | 2/14237 |
| CellulitisInfections and infestations | 3/5049 | 4/5064 | 2/6733 | 3/6714 | 3/6529 | 5/14237 |
| Event | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo | Crossover: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Booster: CoV2 preS dTM-AS03 Monovalent (B.1.351) Vaccine |
|---|---|---|---|---|---|---|
| Injection Site PainGeneral disorders | 1018/5049 | 483/5064 | 1206/6733 | 686/6714 | 35/6529 | 33/14237 |
| HeadacheNervous system disorders | 700/5049 | 470/5064 | 950/6733 | 775/6714 | 53/6529 | 147/14237 |
| MyalgiaMusculoskeletal and connective tissue disorders | 653/5049 | 339/5064 | 683/6733 | 490/6714 | 25/6529 | 33/14237 |
| MalaiseGeneral disorders | 624/5049 | 354/5064 | 713/6733 | 553/6714 | 6/6529 | 4/14237 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 492/5049 | 273/5064 | 631/6733 | 472/6714 | 27/6529 | 62/14237 |
| ChillsGeneral disorders | 354/5049 | 164/5064 | 470/6733 | 328/6714 | 1/6529 | 13/14237 |
| PyrexiaGeneral disorders | 279/5049 | 100/5064 | 209/6733 | 178/6714 | 5/6529 | 16/14237 |
Stages 1 and 2: The full analysis set (FAS) consisted of all randomized participants who received at least 1 study injection.
| Age, Continuous(year) | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo | Total |
|---|---|---|---|---|---|
| Mean | 37.9 ± 13.8 | 37.8 ± 13.9 | 36.2 ± 13.0 | 36.1 ± 13.0 | 36.9 ± 13.4 |
| Sex: Female, Male(Participants) | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo | Total |
|---|---|---|---|---|---|
| Female | 2213 | 2174 | 2754 | 2764 | 9905 |
| Male | 2836 | 2891 | 3980 | 3952 | 13659 |
| Race/Ethnicity, Customized(Participants) | Stage 1: CoV2 preS dTM-AS03 Monovalent (D614) Vaccine | Stage 1: CoV2 preS dTM-AS03 Placebo | Stage 2: CoV2 preS dTM-AS03 Bivalent (D614 + B.1.351) Vaccine | Stage 2: CoV2 preS dTM-AS03 Placebo | Total |
|---|---|---|---|---|---|
| White | 114 | 116 | 297 | 301 | 828 |
| Asian | 2219 | 2226 | 2562 | 2567 | 9574 |
| Black or African American | 1056 | 1053 | 2873 | 2854 | 7836 |
| American Indian or Alaska Native | 1641 | 1645 | 408 | 404 | 4098 |
| Native Hawaiian or Other Pacific Islander | 1 | 3 | 2 | 3 | 9 |
| Multiple | 8 | 6 | 5 | 5 | 24 |
| Not Reported | 1 | 3 | 95 | 82 | 181 |
| Unknown | 9 | 13 | 492 | 500 | 1014 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
This study is terminated, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sanofi Pasteur, a Sanofi Company →