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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1251-5486 | Registry Identifier | ICTRP |
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Sponsor's decision not to pursue further development of this product given the wide availability of authorized/approved mRNA COVID-19 vaccines
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The primary objectives of the study are:
The secondary objectives of the study are:
The duration of each participant's participation in the study was approximately 365 days post-last injection: approximately 386 days duration for participants receiving 2 injections and approximately 365 days duration total for participants receiving a single injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sentinel Cohort: SARS-CoV-2 Vaccine Ultra Low dose | Experimental | Participants received two intramuscular (IM) injections of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
|
| Sentinel Cohort: SARS-CoV-2 Vaccine Low dose | Experimental | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
|
| Sentinel Cohort: SARS-CoV-2 Vaccine Medium dose | Experimental | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. |
|
| FEC Cohort 1: SARS-CoV-2 Vaccine Ultra Low dose | Experimental | Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1. |
|
| FEC Cohort 1: SARS-CoV-2 Vaccine Low dose | Experimental | Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 mRNA vaccine formulation 1 | Biological | Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | AE: any untoward medical occurrence in clinical investigation participant administered medicinal product & which did not have any causal relationship with the treatment. Unsolicited AE: observed AE that did not fulfill conditions prelisted in case report form (CRF) in terms of diagnosis &/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, & any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in CRF. Reported AEs were presented as pre-specified in protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2. | Within 30 minutes post any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22]) |
| Number of Participants With Solicited Injection Site Reactions | Solicited reaction (SR): expected adverse reaction (sign or symptom) observed & reported under conditions (nature & onset) prelisted (i.e., solicited) in CRF and considered as related to product administered. Solicited injection site reactions included pain, erythema, & swelling. Reported AEs for each arm were presented as pre-specified in study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2. | Within 7 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22]) |
| Number of Participants With Solicited Systemic Reactions | SR was an expected adverse reaction (sign or symptom) observed & reported under conditions (nature & onset) prelisted (i.e., solicited) in CRF & considered as related to product administered. Solicited systemic reactions included fever, headache, malaise, myalgia, arthralgia & chills. Reported AEs for each arm were presented as pre-specified in study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2. | Within 7 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22]) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | GMC of Anti-S binding antibodies were assessed using enzyme-linked immunosorbent assay (ELISA) and were measured in ELISA unit/mL (ELU/mL). Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. |
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Inclusion criteria:
OR
A participant of childbearing potential must had a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 8 hours before the study intervention.
Exclusion criteria:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number :8400003 | Rolling Hills Estates | California | 90274 | United States | ||
| Investigational Site Number :8400002 |
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| Label | URL |
|---|---|
| VAW00001 Plain Language Results Summary | View source |
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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
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Participants (aged 18-49 years) in Sentinel Cohort received two vaccinations, 21 days apart. FEC participants were stratified into 2 age groups: younger adult group (18-49 years) and the older adult group (greater than or equal to [>=] 50 years). FEC Cohort 1 participants received a single injection of study vaccine or placebo, while participants in Cohort 2 received two vaccinations (21 days apart). A total of 182 participants were enrolled, of which 180 were vaccinated in the study.
The study was conducted at 17 active sites in 4 countries between 12 Mar 2021 and 27 Jun 2022. Study consisted of 2 cohorts: Sentinel Cohort and Full Enrollment Cohort (FEC). For analysis purpose, Baseline, safety and outcome measure data was planned to be collected, analyzed and reported for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sentinel Cohort: SARS-CoV-2 Vaccine Ultra Low Dose | Participants received two intramuscular (IM) injections of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
| FG001 | Sentinel Cohort: SARS-CoV-2 Vaccine Low Dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 8, 2021 | Sep 28, 2023 |
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This was a sequential group prevention study consisting of a sentinel cohort followed by the Full Enrollment Cohort. There were 3 dose levels (up to 25 participants 18-49 years of age for each dose level) in the Sentinel Cohort, which were done in an open-label fashion with stepwise safety evaluation for each dose level and each vaccination. All sentinel participants received 2 vaccinations, 21 days apart. For the Full Enrollment Cohort (FEC), which was done in a double-blind design participants were stratified into 2 groups based on age at enrollment: the younger adult age group (140 planned participants 18-49 years of age) and the older adult age group (168 planned participants greater than or equal to [>=] 50 years of age). The FEC Cohort 1 (Groups 1 to 3) received a single injection of study intervention while participants in Cohort 2 (Groups 4 to 6) received 2 vaccinations (to be given 21 days apart).
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In the FEC: blinding for vaccine group assignment (formulation) of participants, outcome assessors, Investigators, laboratory personnel, and Sponsor study staff. Only study site staff who prepare and administer the vaccine and were not involved with the safety evaluations were unblinded to vaccine group assignment. There was no blinding for injection schedule.
The Sentinel Cohort was open-label (no blinding).
|
| FEC Cohort 1: Placebo | Placebo Comparator | Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1. |
|
| FEC Cohort 2: SARS-CoV-2 Vaccine Ultra Low dose | Experimental | Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
|
| FEC Cohort 2: SARS-CoV-2 Vaccine Low dose | Experimental | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
|
| FEC Cohort 2: Placebo | Placebo Comparator | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. |
|
| SARS-CoV-2 mRNA vaccine formulation 2 | Biological | Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection |
|
| SARS-CoV-2 mRNA vaccine formulation 3 | Biological | Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection |
|
| Placebo (0.9% normal saline) | Biological | Pharmaceutical form: Liquid Route of administration: Intramuscular injection |
|
| Number of Participants With Unsolicited Adverse Events | An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which did not have any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Reported AEs for each arm were presented as pre-specified in the study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2. | Within 21 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22]) |
| Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | SAEs: any untoward medical occurrence 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. AESIs: event for which ongoing monitoring & rapid communication by investigator to the sponsor was done. MAAE was a new onset or worsening of a condition that prompted participant or participant's parent/legally acceptable representative to seek unplanned medical advice at physician's office or emergency department. Reported AEs for each arm were presented as pre-specified in study protocol. | From Day 1 until 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) |
| Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Laboratory tests: hemoglobin (male & female), above & below normal white blood cell, lymphocytes, neutrophils & eosinophils, platelet count, creatinine & blood urea nitrogen, hyponatremia & hypernatremia, hyperkalemia & hypokalemia, hyperglycemia (non-fasting), hypoproteinemia, alkaline phosphate, alanine aminotransferase, aspartate aminotransferase, bilirubin (with any increase in liver function test [LFT], bilirubin (normal LFT), prothrombin & partial thromboplastin time (seconds), Urine: protein, glucose & blood. US FDA "Toxicity Grading Scale for Healthy Adults & Adolescent Volunteers" was used for grading; Grade 1=mild, Grade 2=moderate & Grade 3=severe. In the data table, 'number analyzed'=participants with available data for each specified category & '0'=none of participants were available for assessment for specified Group. | From Day 1 up to up to 8 days post last vaccination (i.e., up to Day 9 for Cohort 1 groups; up to Day 30 for Cohort 2 groups) |
| Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 1 | GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution. Data for this OM was planned to be collected and analyzed for combined population (FEC+ Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. | Day 1 (pre-vaccination) |
| Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 22 | GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution. | Day 22 (post-vaccination) |
| Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 36 | GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution. | Day 36 (post-vaccination) |
| Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22 | SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 1. | Day 1 (pre-vaccination) and Day 22 (post-vaccination) |
| Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36 | SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (Day 36) and pre-vaccination (on Day 1) i.e., Day 36/Day 1. | Day 1 (pre-vaccination) and Day 36 (post-vaccination) |
| Percentage of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22 | SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. The fold rise (2-fold and 4-fold) was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (on Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 1. | Day 1 (pre-vaccination) and Day 22 (post-vaccination) |
| Percentage of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36 | SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. The fold rise (2-fold and 4-fold) was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (on Day 36) and pre-vaccination (on Day 1) i.e., Day 36/Day 1. | Day 1 (pre-vaccination) and Day 36 (post-vaccination) |
| Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22 | Seroconversion was defined as participants with a Baseline (Day 1) titer values below lower limit of quantification (LLOQ) with a detectable neutralization antibody titer above assay LLOQ post injection (at Day 22). LLOQ of the neutralization assay was a titer of 10. | Day 22 (post-vaccination) |
| Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36 | Seroconversion was defined as participants with a Baseline (Day 1) titer values below LLOQ with a detectable neutralization antibody titer above assay LLOQ post injection (at Day 36). LLOQ of the neutralization assay was a titer of 10. | Day 36 (post-vaccination) |
| Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 91 (only for Cohort 1), Day 112 (only for Cohort 2), Day 181 (only for Cohort 1), and Day 202 (only for Cohort 2) |
| Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Binding antibody titers were evaluated by ELISA. Fold-rise was calculated as the ratio of geometric mean concentrations of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 22/Day 1, Day 36/Day 1, Day 91/Day 1, Day 112/Day 1, Day 181/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. | Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 91 (only for Cohort 1), Day 112 (only for Cohort 2), Day 181 (only for Cohort 1), and Day 202 (only for Cohort 2) |
| Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Binding antibody titers were evaluated by ELISA. Fold-rise (2-fold and 4-fold) was calculated as the ratio of geometric mean concentrations of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 22/Day 1, Day 36/Day 1, Day 91/Day 1, Day 112/Day 1, Day 181/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. | Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 91 (only for Cohort 1), Day 112 (only for Cohort 2), Day 181 (only for Cohort 1), and Day 202 (only for Cohort 2) |
| Geometric Mean Titers of Neutralizing Antibody Titer Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 91, 112, 181, and 202 | GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. | Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination) |
| Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., for Cohort 1: Day 91/Day 1, Day 181/Day 1; Cohort 2: Day 112/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. | Day 1 (pre-vaccination), Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination) |
| Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise (2-fold and 4-fold) was calculated as the ratio of geometric mean concentrations of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 91/Day 1, Day 112/Day 1, Day 181/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. | Day 1 (pre-vaccination), Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination) |
| Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens | Seroconversion was defined as participants with a Baseline (Day 1) titer values below lower limit of quantification (LLOQ) with a detectable neutralization antibody titer above assay LLOQ post injection. LLOQ of the neutralization assay was a titer of 10. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. | Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination) |
| Number of Participants With Virologically-confirmed Coronavirus Disease (COVID-19)-Like Illness | Virologically-confirmed COVID-19-like illness was defined by specified clinical symptoms and signs and confirmed by positive result for SARS-CoV-2 by nucleic acid amplification test (NAAT) on a respiratory sample in association with a COVID-19-like illness. | Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination) |
| Number of Participants With Serologically-confirmed SARS-CoV-2 Infection | Serologically-confirmed SARS-CoV-2 infection as defined by SARS-CoV-2 Nucleoprotein specific antibody detection immunoassay was reported in this outcome measure. | Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination) |
| Correlates of Risk/Protection Based on Antibody Responses to SARS-CoV-2 | Correlate of risk / protection based on antibody responses to SARS-CoV-2 was evaluated using virus neutralization or ELISA, considering virologically-confirmed COVID-19-like illness and/or serologically-confirmed SARS-CoV-2 infection. | Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination) |
| Hollywood |
| Florida |
| 33024 |
| United States |
| Investigational Site Number :8400006 | Miami | Florida | 33135 | United States |
| Investigational Site Number :8400017 | Iowa City | Iowa | 52242 | United States |
| Investigational Site Number :8400007 | Kansas City | Missouri | 64114 | United States |
| Investigational Site Number :8400008 | Omaha | Nebraska | 68134 | United States |
| Investigational Site Number :8400001 | Rochester | New York | 14609 | United States |
| Investigational Site Number :8400010 | Philadelphia | Pennsylvania | 19104 | United States |
| Investigational Site Number :8400004 | North Charleston | South Carolina | 29405 | United States |
| Investigational Site Number :8400015 | Knoxville | Tennessee | 37920 | United States |
| Investigational Site Number :8400009 | Houston | Texas | 77081 | United States |
| Investigational Site Number :8400005 | Salt Lake City | Utah | 84107 | United States |
| Investigational Site Number :0360003 | Morayfield | Queensland | 4506 | Australia |
| Investigational Site Number :0360005 | South Brisbane | Queensland | 4101 | Australia |
| Investigational Site Number :0360001 | Melbourne | Victoria | 3010 | Australia |
| Investigational Site Number :0360002 | Nedlands | Western Australia | 6009 | Australia |
| Investigational Site Number :0760001 | Salvador | Estado de Bahia | 40415-006 | Brazil |
| Investigational Site Number :0760004 | Campo Grande | Mato Grosso do Sul | 79070-900 | Brazil |
| Investigational Site Number :0760003 | Belo Horizonte | Minas Gerais | 30110-063 | Brazil |
| Investigational Site Number :3400002 | Barrio del Centro | 11101 | Honduras |
| Investigational Site Number :3400001 | San Pedro Sula | 21104 | Honduras |
Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
| FG002 | Sentinel Cohort: SARS-CoV-2 Vaccine Medium Dose | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. |
| FG003 | FEC Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1. |
| FG004 | FEC Cohort 1: SARS-CoV-2 Vaccine Low Dose | Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1. |
| FG005 | FEC Cohort 1: Placebo | Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1. |
| FG006 | FEC Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
| FG007 | FEC Cohort 2: SARS-CoV-2 Vaccine Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
| FG008 | FEC Cohort 2: Placebo | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. |
| Vaccinated on Day 1 |
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| Vaccinated on Day 22 |
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| Safety Analysis Set (SafAS) | Participants who had received at least one injection of study intervention and were analyzed according to the study intervention they actually received. |
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| COMPLETED |
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| NOT COMPLETED |
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Analysis was performed on all enrolled participants according to the intervention to which they were randomized. Data for baseline characteristics was planned to be collected and analyzed for combined population (Full Enrollment Cohort + Sentinel Cohort) in which the same dose-level groups in Sentinel Cohort and Full Enrollment Cohort were pooled for the analysis. Since Sentinel Cohort: SARS-CoV-2 Vaccine Medium Dose group received 2 injections; they were presented under Cohort 2 for analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1. |
| BG001 | Cohort 1: SARS-CoV-2 Vaccine Low Dose | Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1. |
| BG002 | Cohort 1: Placebo | Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1. |
| BG003 | Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
| BG004 | Cohort 2: SARS-CoV-2 Vaccine Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
| BG005 | Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. |
| BG006 | Cohort 2: Placebo | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) | AE: any untoward medical occurrence in clinical investigation participant administered medicinal product & which did not have any causal relationship with the treatment. Unsolicited AE: observed AE that did not fulfill conditions prelisted in case report form (CRF) in terms of diagnosis &/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, & any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in CRF. Reported AEs were presented as pre-specified in protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2. | SafAS: participants who received at least one injection of study vaccine were analyzed by the intervention they actually received. Data were collected & analyzed for the combined population in which same dose-level groups in Sentinel Cohort and FEC were pooled. One ultra-low dose Sentinel Cohort participant who was supposed to receive 2 doses received only 1 & was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme. | Posted | Count of Participants | Participants | Within 30 minutes post any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22]) |
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| Primary | Number of Participants With Solicited Injection Site Reactions | Solicited reaction (SR): expected adverse reaction (sign or symptom) observed & reported under conditions (nature & onset) prelisted (i.e., solicited) in CRF and considered as related to product administered. Solicited injection site reactions included pain, erythema, & swelling. Reported AEs for each arm were presented as pre-specified in study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2. | SafAS population. Here, "overall number of participants analyzed" = participants with available data for this outcome measure (OM). Data were collected & analyzed for the combined population in which same dose-level groups in Sentinel Cohort and FEC were pooled. | Posted | Count of Participants | Participants | Within 7 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22]) |
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| Primary | Number of Participants With Solicited Systemic Reactions | SR was an expected adverse reaction (sign or symptom) observed & reported under conditions (nature & onset) prelisted (i.e., solicited) in CRF & considered as related to product administered. Solicited systemic reactions included fever, headache, malaise, myalgia, arthralgia & chills. Reported AEs for each arm were presented as pre-specified in study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2. | SafAS population. Here, "overall number of participants analyzed" = participants with available data for this OM. Data were collected & analyzed for the combined population in which same dose-level groups in Sentinel Cohort and FEC were pooled. | Posted | Count of Participants | Participants | Within 7 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22]) |
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| Primary | Number of Participants With Unsolicited Adverse Events | An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which did not have any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Reported AEs for each arm were presented as pre-specified in the study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2. | Analyzed on SafAS population. Data were collected & analyzed for the combined population in which same dose-level groups in Sentinel Cohort and FEC were pooled. One ultra-low dose Sentinel Cohort participant who was supposed to receive 2 doses received only 1 & was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme. | Posted | Count of Participants | Participants | Within 21 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22]) |
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| Primary | Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) | SAEs: any untoward medical occurrence 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. AESIs: event for which ongoing monitoring & rapid communication by investigator to the sponsor was done. MAAE was a new onset or worsening of a condition that prompted participant or participant's parent/legally acceptable representative to seek unplanned medical advice at physician's office or emergency department. Reported AEs for each arm were presented as pre-specified in study protocol. | Analysis was performed on SafAS population. Data were collected & analyzed for the combined population in which same dose-level groups in Sentinel Cohort and FEC were pooled. One ultra-low dose Sentinel Cohort participant who was supposed to receive 2 doses received only 1 & was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme. | Posted | Count of Participants | Participants | From Day 1 until 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) |
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| Primary | Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance | Laboratory tests: hemoglobin (male & female), above & below normal white blood cell, lymphocytes, neutrophils & eosinophils, platelet count, creatinine & blood urea nitrogen, hyponatremia & hypernatremia, hyperkalemia & hypokalemia, hyperglycemia (non-fasting), hypoproteinemia, alkaline phosphate, alanine aminotransferase, aspartate aminotransferase, bilirubin (with any increase in liver function test [LFT], bilirubin (normal LFT), prothrombin & partial thromboplastin time (seconds), Urine: protein, glucose & blood. US FDA "Toxicity Grading Scale for Healthy Adults & Adolescent Volunteers" was used for grading; Grade 1=mild, Grade 2=moderate & Grade 3=severe. In the data table, 'number analyzed'=participants with available data for each specified category & '0'=none of participants were available for assessment for specified Group. | SafAS. "Overall number of participants analyzed" = participants with available data for this OM. Data were collected & analyzed for the combined population in which same dose-level groups in Sentinel Cohort and FEC were pooled. | Posted | Count of Participants | Participants | From Day 1 up to up to 8 days post last vaccination (i.e., up to Day 9 for Cohort 1 groups; up to Day 30 for Cohort 2 groups) |
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| Primary | Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 1 | GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution. Data for this OM was planned to be collected and analyzed for combined population (FEC+ Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. | Analyzed on modified full analysis set (mFAS) population that included all participants who received at least one injection of study intervention, analyzed according to the intervention they actually received, and excludes participants with positive pseudovirus neutralization test results against SARS-CoV-2 D614G variant at Baseline (Day 1). Here, "overall number of participants analyzed" signifies participants with available data for this OM. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 1 (pre-vaccination) |
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| Primary | Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 22 | GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution. | Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC+ Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 22 (post-vaccination) |
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| Primary | Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 36 | GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution. | Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC+ Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 36 (post-vaccination) |
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| Primary | Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22 | SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 1. | Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Day 1 (pre-vaccination) and Day 22 (post-vaccination) |
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| Primary | Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36 | SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (Day 36) and pre-vaccination (on Day 1) i.e., Day 36/Day 1. | Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Day 1 (pre-vaccination) and Day 36 (post-vaccination) |
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| Primary | Percentage of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22 | SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. The fold rise (2-fold and 4-fold) was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (on Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 1. | Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 (pre-vaccination) and Day 22 (post-vaccination) |
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| Primary | Percentage of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36 | SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. The fold rise (2-fold and 4-fold) was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (on Day 36) and pre-vaccination (on Day 1) i.e., Day 36/Day 1. | Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 (pre-vaccination) and Day 36 (post-vaccination) |
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| Primary | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22 | Seroconversion was defined as participants with a Baseline (Day 1) titer values below lower limit of quantification (LLOQ) with a detectable neutralization antibody titer above assay LLOQ post injection (at Day 22). LLOQ of the neutralization assay was a titer of 10. | Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 22 (post-vaccination) |
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| Primary | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36 | Seroconversion was defined as participants with a Baseline (Day 1) titer values below LLOQ with a detectable neutralization antibody titer above assay LLOQ post injection (at Day 36). LLOQ of the neutralization assay was a titer of 10. | Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 36 (post-vaccination) |
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| Secondary | Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 | GMC of Anti-S binding antibodies were assessed using enzyme-linked immunosorbent assay (ELISA) and were measured in ELISA unit/mL (ELU/mL). Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. | Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM and 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were evaluable for assessment in specified Groups for the specified time point. | Posted | Geometric Mean | 95% Confidence Interval | ELU/mL | Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 91 (only for Cohort 1), Day 112 (only for Cohort 2), Day 181 (only for Cohort 1), and Day 202 (only for Cohort 2) |
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| Secondary | Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Binding antibody titers were evaluated by ELISA. Fold-rise was calculated as the ratio of geometric mean concentrations of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 22/Day 1, Day 36/Day 1, Day 91/Day 1, Day 112/Day 1, Day 181/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. | Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM and, 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were evaluable for assessment in the specified Groups for the specified time point. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 91 (only for Cohort 1), Day 112 (only for Cohort 2), Day 181 (only for Cohort 1), and Day 202 (only for Cohort 2) |
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| Secondary | Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 | Binding antibody titers were evaluated by ELISA. Fold-rise (2-fold and 4-fold) was calculated as the ratio of geometric mean concentrations of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 22/Day 1, Day 36/Day 1, Day 91/Day 1, Day 112/Day 1, Day 181/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. | Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM, and 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were evaluable for assessment in the specified Groups for the specified time point. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 91 (only for Cohort 1), Day 112 (only for Cohort 2), Day 181 (only for Cohort 1), and Day 202 (only for Cohort 2) |
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| Secondary | Geometric Mean Titers of Neutralizing Antibody Titer Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 91, 112, 181, and 202 | GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. | Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM, and 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were evaluable for assessment in the specified Groups for the specified time point. | Posted | Geometric Mean | 95% Confidence Interval | titers | Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination) |
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| Secondary | Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., for Cohort 1: Day 91/Day 1, Day 181/Day 1; Cohort 2: Day 112/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. | Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM, and 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were evaluable for assessment in the specified Groups for the specified time point. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Day 1 (pre-vaccination), Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination) |
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| Secondary | Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 | SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise (2-fold and 4-fold) was calculated as the ratio of geometric mean concentrations of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 91/Day 1, Day 112/Day 1, Day 181/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. | Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM, and 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were evaluable for assessment in the specified Groups for the specified time point. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 (pre-vaccination), Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination) |
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| Secondary | Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens | Seroconversion was defined as participants with a Baseline (Day 1) titer values below lower limit of quantification (LLOQ) with a detectable neutralization antibody titer above assay LLOQ post injection. LLOQ of the neutralization assay was a titer of 10. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis. | Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM, and 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were evaluable for assessment in the specified Groups for the specified time point. | Posted | Number | 95% Confidence Interval | percentage of participants | Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination) |
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| Secondary | Number of Participants With Virologically-confirmed Coronavirus Disease (COVID-19)-Like Illness | Virologically-confirmed COVID-19-like illness was defined by specified clinical symptoms and signs and confirmed by positive result for SARS-CoV-2 by nucleic acid amplification test (NAAT) on a respiratory sample in association with a COVID-19-like illness. | Data was not collected and analyzed for this OM (virologically confirmed COVID-19 like illness) due to discontinuation of the development of the messenger ribonucleic acid (mRNA) COVID-19 vaccine by Sponsor. Hence, no further corresponding testing was conducted, and the planned efficacy analysis was not performed. | Posted | Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination) |
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| Secondary | Number of Participants With Serologically-confirmed SARS-CoV-2 Infection | Serologically-confirmed SARS-CoV-2 infection as defined by SARS-CoV-2 Nucleoprotein specific antibody detection immunoassay was reported in this outcome measure. | Data was not collected and analyzed for this OM (serologically confirmed SARS-CoV-2 infection) due to discontinuation of the development of the mRNA COVID-19 vaccine by Sponsor. Hence, no further corresponding testing was conducted, and the planned efficacy analysis was not performed. | Posted | Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination) |
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| Secondary | Correlates of Risk/Protection Based on Antibody Responses to SARS-CoV-2 | Correlate of risk / protection based on antibody responses to SARS-CoV-2 was evaluated using virus neutralization or ELISA, considering virologically-confirmed COVID-19-like illness and/or serologically-confirmed SARS-CoV-2 infection. | Data was not collected and analyzed for this OM (Correlates of Risk / Protection Based on Antibody Responses to SARS-CoV-2) due to discontinuation of the development of the mRNA COVID-19 vaccine by Sponsor. Hence, no further corresponding testing was conducted, and the planned efficacy analysis was not performed. | Posted | Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination) |
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Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups)
SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected & analyzed for combined population in which the same dose-level groups in Sentinel & FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose | Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1. | 0 | 37 | 0 | 37 | 31 | 37 |
| EG001 | Cohort 1: SARS-CoV-2 Vaccine Low Dose | Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1. | 0 | 34 | 0 | 34 | 30 | 34 |
| EG002 | Cohort 1: Placebo | Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1. | 0 | 18 | 1 | 18 | 11 | 18 |
| EG003 | Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. | 0 | 36 | 0 | 36 | 34 | 36 |
| EG004 | Cohort 2: SARS-CoV-2 Vaccine Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. | 0 | 36 | 0 | 36 | 35 | 36 |
| EG005 | Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. | 0 | 10 | 1 | 10 | 10 | 10 |
| EG006 | Cohort 2: Placebo | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. | 0 | 9 | 0 | 9 | 7 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Cystitis Haemorrhagic | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Pain | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Axillary Pain | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Injection Site Swelling | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment | Fever/Pyrexia events which occurred 7 days post-vaccination was considered as an unsolicited AE. |
|
| Covid-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Tooth Infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Tooth Fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Sars-Cov-2 Test Positive | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Muscle Tightness | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment | Headache events which occurred 7 days post-vaccination was considered as an unsolicited AE. |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Sinus Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
Due to early termination of this study by the Sponsor prior to full enrollment, the corresponding testing was not conducted, and few planned efficacy outcome measures data were not collected and analysis was not performed.
The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi Pasteur | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 2, 2022 | Sep 28, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Post vaccination 1 |
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| Post vaccination 2 |
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| Cohort 1: Placebo |
Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1. |
| OG003 | Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
| OG004 | Cohort 2: SARS-CoV-2 Vaccine Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
| OG005 | Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. |
| OG006 | Cohort 2: Placebo | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. |
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Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1. |
| OG003 | Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
| OG004 | Cohort 2: SARS-CoV-2 Vaccine Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
| OG005 | Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. |
| OG006 | Cohort 2: Placebo | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. |
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| OG002 | Cohort 1: Placebo | Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1. |
| OG003 | Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
| OG004 | Cohort 2: SARS-CoV-2 Vaccine Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
| OG005 | Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. |
| OG006 | Cohort 2: Placebo | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. |
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| Cohort 1: SARS-CoV-2 Vaccine Low Dose |
Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1. |
| OG002 | Cohort 1: Placebo | Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1. |
| OG003 | Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
| OG004 | Cohort 2: SARS-CoV-2 Vaccine Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
| OG005 | Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. |
| OG006 | Cohort 2: Placebo | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. |
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Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1. |
| OG002 | Cohort 1: Placebo | Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1. |
| OG003 | Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
| OG004 | Cohort 2: SARS-CoV-2 Vaccine Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
| OG005 | Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. |
| OG006 | Cohort 2: Placebo | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. |
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Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1. |
| OG003 | Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
| OG004 | Cohort 2: SARS-CoV-2 Vaccine Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
| OG005 | Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. |
| OG006 | Cohort 2: Placebo | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. |
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| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose |
Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
| OG004 | Cohort 2: SARS-CoV-2 Vaccine Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
| OG005 | Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. |
| OG006 | Cohort 2: Placebo | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. |
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| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose |
Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
| OG004 | Cohort 2: SARS-CoV-2 Vaccine Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
| OG005 | Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. |
| OG006 | Cohort 2: Placebo | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. |
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| OG003 | Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
| OG004 | Cohort 2: SARS-CoV-2 Vaccine Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
| OG005 | Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. |
| OG006 | Cohort 2: Placebo | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. |
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| OG003 | Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
| OG004 | Cohort 2: SARS-CoV-2 Vaccine Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
| OG005 | Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. |
| OG006 | Cohort 2: Placebo | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. |
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| OG003 | Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
| OG004 | Cohort 2: SARS-CoV-2 Vaccine Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
| OG005 | Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. |
| OG006 | Cohort 2: Placebo | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. |
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| OG003 | Cohort 2: Group 4: SARS-CoV-2 Vaccine Ultra Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
| OG004 | Cohort 2: Group 5: SARS-CoV-2 Vaccine Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
| OG005 | Cohort 2: Group 6: SARS-CoV-2 Vaccine Medium Dose | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. |
| OG006 | Cohort 2: Group 7: Placebo | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. |
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| OG003 | Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
| OG004 | Cohort 2: SARS-CoV-2 Vaccine Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
| OG005 | Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. |
| OG006 | Cohort 2: Placebo | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. |
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| OG003 | Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
| OG004 | Cohort 2: SARS-CoV-2 Vaccine Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
| OG005 | Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. |
| OG006 | Cohort 2: Placebo | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. |
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| OG002 |
| Cohort 1: Placebo |
Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1. |
| OG003 | Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
| OG004 | Cohort 2: SARS-CoV-2 Vaccine Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
| OG005 | Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. |
| OG006 | Cohort 2: Placebo | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. |
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| OG002 | Cohort 1: Placebo | Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1. |
| OG003 | Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
| OG004 | Cohort 2: SARS-CoV-2 Vaccine Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
| OG005 | Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. |
| OG006 | Cohort 2: Placebo | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. |
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Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.
| OG002 | Cohort 1: Placebo | Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1. |
| OG003 | Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
| OG004 | Cohort 2: SARS-CoV-2 Vaccine Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
| OG005 | Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. |
| OG006 | Cohort 2: Placebo | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. |
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Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1. |
| OG003 | Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
| OG004 | Cohort 2: SARS-CoV-2 Vaccine Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
| OG005 | Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. |
| OG006 | Cohort 2: Placebo | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. |
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| OG002 | Cohort 1: Placebo | Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1. |
| OG003 | Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
| OG004 | Cohort 2: SARS-CoV-2 Vaccine Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
| OG005 | Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. |
| OG006 | Cohort 2: Placebo | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. |
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| OG002 | Cohort 1: Group 3: Placebo | Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1. |
| OG003 | Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
| OG004 | Cohort 2: SARS-CoV-2 Vaccine Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
| OG005 | Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. |
| OG006 | Cohort 2: Placebo | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. |
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| OG002 |
| Cohort 1: Placebo |
Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1. |
| OG003 | Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
| OG004 | Cohort 2: SARS-CoV-2 Vaccine Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
| OG005 | Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. |
| OG006 | Cohort 2: Placebo | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. |
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| OG003 | Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
| OG004 | Cohort 2: SARS-CoV-2 Vaccine Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
| OG005 | Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. |
| OG006 | Cohort 2: Placebo | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. |
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Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
| OG004 | Cohort 2: SARS-CoV-2 Vaccine Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
| OG005 | Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. |
| OG006 | Cohort 2: Placebo | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. |
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| OG003 |
| Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose |
Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively. |
| OG004 | Cohort 2: Group 5: SARS-CoV-2 Vaccine Low Dose | Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively. |
| OG005 | Cohort 2: SARS-CoV-2 Vaccine Medium Dose | Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively. |
| OG006 | Cohort 2: Placebo | Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively. |
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