Study of Recombinant Protein Vaccine Formulations Against COVID-19 in Healthy Adults 18 Years of Age and Older

Immunogenicity and Safety of SARS-CoV-2 Recombinant Protein Vaccine Formulations (With or Without Adjuvant) in Healthy Adults 18 Years of Age and Older

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04537208

Enrollment

441

Registered

2020-09-03

Start date

2020-09-03

Completion date

2021-11-19

Last updated

2025-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 (Healthy Volunteers)

Brief summary

The primary objectives of the study were: * To describe the neutralizing antibody profile at Day 1, Day 22, and Day 36 of each study intervention group. * To describe the safety profile of all participants in each age group and each study intervention group up to 12 months post-last injection. The secondary objectives of the study are: * To describe binding antibody profile at Day 1, Day 22, Day 36, Day 181 (Cohort 1) or Day 202 (Cohort 2), and Day 366 (Cohort 1) or Day 387 (Cohort 2) of each study intervention group. * To describe the neutralizing antibody profile at Day 181 (Cohort 1) or Day 202 (Cohort 2) and at Day 366 (Cohort 1) and Day 387 (Cohort 2) of each study intervention group. * To describe the occurrence of virologically-confirmed coronavirus disease (COVID-19)-like illness and serologically-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. * To evaluate the correlation / association between antibody responses to SARS-CoV-2 Recombinant Protein and the risk of virologically-confirmed COVID-19-like illness and/or serologically-confirmed SARS-CoV-2 infection.

Detailed description

The duration of each participant's participation in the study was approximately 365 days (Cohort 1) and 386 days (Cohort 2) post last injection.

Interventions

BIOLOGICALCoV2 preS dTM-AF03 (low-dose)

Pharmaceutical form: liquid; route of administration: intramuscular injection

BIOLOGICALCoV2 preS dTM-AF03 (high-dose)

Pharmaceutical form: liquid; route of administration: intramuscular injection

BIOLOGICALCoV2 preS dTM-AS03 (low-dose)

Pharmaceutical form: liquid; route of administration: intramuscular injection

BIOLOGICALCoV2 preS dTM-AS03 (high-dose)

Pharmaceutical form: liquid; route of administration: intramuscular injection

BIOLOGICALCoV2 preS dTM (high-dose) without adjuvant

Pharmaceutical form: liquid; route of administration: intramuscular injection

BIOLOGICALPlacebo (0.9% normal saline)

Pharmaceutical form: liquid; route of administration: intramuscular injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Participants, outcome assessors, Investigators, laboratory personnel, and the majority of Sponsor study staff will be blinded to vaccine group assignment; injection schedule will be unblinded and those preparing/administering the study interventions will be unblinded.

Intervention model description

This was a parallel group prevention study. Participants from 2 age groups (adults 18 through 49 years of age and adults 50 years of age and older) received either 1 injection (Cohort 1) or 2 injections (Cohort 2) of study vaccine or placebo control. As a precautionary step, a sentinel safety cohort of 6 participants (younger adults only) within each dosing group from Cohort 1 was enrolled. An early safety data review was performed, including evaluation of safety data and laboratory measures to Day 9. Upon acceptable safety demonstrated from unblinded data review by limited members of the Sponsor Study Team, the remaining participants were enrolled simultaneously.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Aged 18 years of age or older on the day of inclusion. * Informed consent form had been signed and dated. * Able to attend all scheduled visits and complied with all study procedures.

Exclusion criteria

* Participant was pregnant, or lactating, or of childbearing potential and not used an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 12 weeks after the last vaccination. To be considered of non-childbearing potential, a female was post-menopausal for at least 1 year or surgically sterile. * Receipt of any vaccine in the 30 days preceding the first study vaccination or planned receipt of any vaccine in the 30 days following the last study vaccination except for influenza vaccination, which might be received at least 2 weeks before and a minimum of 2 weeks after study vaccines. * Prior administration of a coronavirus vaccine SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome). * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * History of SARS-CoV-2 infection, confirmed either clinically, serologically, or microbiologically * Chronic illness or condition considered to potentially increase the risk for severe COVID illness or that, in the opinion of the Investigator, was at a stage where it might interfere with study conduct or completion. * Receipt of any therapy known to had in-vitro antiviral activity against SARS-CoV-2 within 72 hours prior to the first blood drew. * Health care workers provided direct participant care for COVID-19 participants. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	From Day 1 up to 8 days post last dose (i.e., up to Day 9 for Cohort 1 and up to Day 30 for Cohort 2)	Laboratory tests included hemoglobin (male and female), above and below normal white blood cell, lymphocytes, neutrophils & eosinophils, platelet count, creatinine and 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 in LFT), amylase & lipase, Urine: protein, glucose & blood. The US FDA Guidance for Industry Toxicity Grading Scale for Healthy Adults and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials was used for grading. As per the guidance, Grade 1 = mild, Grade 2 = moderate and Grade 3 = severe.
Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36	Day 1 (pre-vaccination) and Day 36 (post-vaccination)	SARS-CoV-2 neutralizing antibodies 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.
Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22	Day 22 (post-vaccination)	Seroconversion was defined as participants with a Baseline (Day 1) titer value below lower limit of quantification (LLOQ) with a detectable neutralization antibody titer above assay LLOQ post vaccination (at Day 22). LLOQ of the neutralization assay was a titer of 10.
Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36	Day 36 (post-vaccination)	Seroconversion was defined as participants with a Baseline (Day 1) titer value below LLOQ with a detectable neutralization antibody titer above assay LLOQ post vaccination (at Day 36). LLOQ of the neutralization assay was a titer of 10.
Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Within 30 minutes post any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])	An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessary had to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions prelisted in the case report form (CRF) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF. Reported AEs for each arm were presented as pre-specified in the study protocol.
Number of Participants With Solicited Injection Site Reactions	Within 7 days post any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])	A solicited reaction (SR) was defined as an expected adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRF and considered as related to vaccination. Solicited injection site reactions included pain, erythema and swelling. Reported AEs for each arm were presented as pre-specified in the study protocol.
Number of Participants With Solicited Systemic Reactions	Within 7 days post any and each vaccination (Vaccination 1 [i.e., Day 1] and 2 [i.e., Day 22])	An SR was defined as an expected AR (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRF and considered as related to vaccination. Solicited systemic reactions included fever, headache, malaise and myalgia. Reported AEs for each arm were presented as pre-specified in the study protocol.
Number of Participants With Unsolicited Adverse Events	Within 21 days post any and each vaccination (Vaccination 1 [i.e., Day 1] and 2 [i.e., Day 22])	An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessary had to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset post-vaccination. Reported AEs for each arm were presented as pre-specified in the study protocol.
Number of Participants With Medically Attended Adverse Events (MAAE)	From Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)	A MAAE were AEs with a new onset or a worsening of a condition that prompted the participant to seek unplanned medical advice at a physician's office (including phone contact or email) or emergency department. An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessarily had to have a causal relationship with treatment. Reported AEs for each arm were presented as pre-specified in the study protocol.
Number of Participants With Serious Adverse Events (SAE)	From Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)	An SAE was 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. Reported AEs for each arm were presented as pre-specified in the study protocol.
Number of Participants With Adverse Events of Special Interest (AESIs)	From Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)	An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. Reported AEs for each arm were presented as pre-specified in the study protocol.
Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 1	Day 1 (pre-vaccination)	GMTs of SARS-CoV-2 neutralizing antibodies was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.
Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 22	Day 22 (post-vaccination)	GMTs of SARS-CoV-2 neutralizing antibodies was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.
Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 36	Day 36 (post-vaccination)	GMTs of SARS-CoV-2 neutralizing antibodies was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.
Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22	Day 1 (pre-vaccination) and Day 22 (post-vaccination)	SARS-CoV-2 neutralizing antibodies 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.
Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36	Day 1 (pre-vaccination) and Day 36 (post-vaccination)	SARS-CoV-2 neutralizing antibodies 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.
Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22	Day 1 (pre-vaccination) and Day 22 (post-vaccination)	SARS-CoV-2 neutralizing antibodies 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.

Secondary

Measure	Time frame	Description
Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 181 (only for Cohort 1), Day 202 (only for Cohort 2), Day 366 (only for Cohort 1), and Day 387 (only for Cohort 2)	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 01, Day 36/Day 01, Day 181/Day 1, Day 202/Day 1, Day 366/Day 1, and Day 387/Day 1.
Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 181 (only for Cohort 1), Day 202 (only for Cohort 2), Day 366 (only for Cohort 1), and Day 387 (only for Cohort 2)	Binding Antibody Titers were evaluated by ELISA. Fold rise (2-fold and 4-fold) was calculated as the ratio of titer values for binding antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 22/Day 1 and Day 36/Day 1, Day 181/Day 1, Day 202/Day 1, Day 366/Day 1, and Day 387/Day 1.
Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387	Cohort 1: Day 181 and Day 366 and Cohort 2: Day 202 and Day 387 (post-vaccination)	GMTs of SARS-CoV-2 neutralizing antibodies was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.
Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 1 (pre-vaccination), Cohort 1: Day 181 and Day 366 and Cohort 2: Day 202 and Day 387 (post-vaccination)	SARS-CoV-2 neutralizing antibodies 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 181/Day 1 and Day 366/Day 1; Cohort 2: Day 202/Day 1 and Day 387/Day 1.
Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 1 (pre-vaccination), Cohort 1: Day 181 and Day 366 and Cohort 2: Day 202 and Day 387 (post-vaccination)	SARS-CoV-2 neutralizing antibodies was measured using a neutralization assay. The fold rise (2-fold and 4-fold) was calculated as the ratio of titer values of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Cohort 1: Day 181/Day 1 and Day 366/Day 1 and Cohort 2: Day 202/Day 1 and Day 387/Day 1.
Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387	Cohort 1: Day 181 and Day 366 and Cohort 2: Day 202 and Day 387 (post-vaccination)	Seroconversion was defined as participants with a Baseline (Day 1) titer value below LLOQ with a detectable neutralization antibody titer above assay LLOQ post vaccination (Cohort 1: Day 181 and Day 366 and Cohort 2: Day 202 and Day 387). LLOQ of the neutralization assay was a titer of 10.
Number of Participants With Virologically-confirmed Coronavirus Disease (COVID-19)-Like Illness	Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)	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. The various COVID-19-like illness symptoms were cough, fever, anosmia, ageusia, chillblains, difficulty breathing, shortness of breath, pneumonia, stroke, myocarditis, myocardial infarction, thromboembolic event, purpura fulminans, pharyngitis, chills, myalgia, headache, rhinorrhea, abdominal pain, nausea, diarrhea and vomiting.
Number of Participants With Serologically-confirmed SARS-CoV-2 Infection	Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)	Serologically-confirmed SARS-CoV-2 infection was defined as a change from negative to positive result in serum for presence of antibodies specific to non-Spike protein of SARS-CoV-2 detected by ELISA assay from any post-baseline sampling time point compared to the Baseline value.
Correlates of Risk / Protection Based on Antibody Responses to SARS-CoV-2	From Day 1 up to Day 366 for Cohort 1 and up to Day 387 for Cohort 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.
Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 181 (only for Cohort 1), Day 202 (only for Cohort 2), Day 366 (only for Cohort 1), and Day 387 (only for Cohort 2)	GMC of Anti-S binding antibodies were assessed using enzyme-linked immunosorbent assay (ELISA) and were measured in binding antibody units/milliliter (BAU/mL).

Countries

United States

Participant flow

Recruitment details

The study was conducted at 10 active sites in the United States between 03 September 2020 to 19 November 2021.

Pre-assignment details

A total of 441 participants were enrolled, of which 439 were vaccinated in the study.

Participants by arm

Arm	Count
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03 Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.	34
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03 Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.	34
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03 Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.	34
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03 Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.	34
Cohort 1: Group 5: Placebo Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.	34
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03 Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.	28
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03 Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.	84
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03 Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.	27
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03 Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.	85
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.	18
Cohort 2: Group 11: Placebo Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.	29
Total	441

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006	FG007	FG008	FG009	FG010
Overall Study	Adverse Event	0	0	0	0	0	0	0	0	1	0	0
Overall Study	Lost to Follow-up	4	1	3	4	3	2	3	2	7	2	2
Overall Study	Protocol deviation	0	0	2	0	0	2	4	0	1	0	2
Overall Study	Withdrawal by Subject	4	2	1	3	5	1	6	1	7	2	4

Baseline characteristics

Characteristic	Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Total	Cohort 2: Group 11: Placebo	Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Cohort 1: Group 5: Placebo	Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
Age, Continuous	42.8 years STANDARD_DEVIATION 14.2	42.1 years STANDARD_DEVIATION 15	43.2 years STANDARD_DEVIATION 16.2	34.8 years STANDARD_DEVIATION 10.2	44.7 years STANDARD_DEVIATION 15.5	42.2 years STANDARD_DEVIATION 15.5	42.9 years STANDARD_DEVIATION 14.9	43.7 years STANDARD_DEVIATION 14.1	39.6 years STANDARD_DEVIATION 15.7	39.0 years STANDARD_DEVIATION 17.2	39.8 years STANDARD_DEVIATION 15.5	41.9 years STANDARD_DEVIATION 12.8
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	2 Participants	28 Participants	1 Participants	1 Participants	4 Participants	0 Participants	7 Participants	3 Participants	1 Participants	5 Participants	1 Participants	3 Participants
Race (NIH/OMB) Black or African American	1 Participants	15 Participants	2 Participants	1 Participants	3 Participants	1 Participants	4 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) More than one race	0 Participants	5 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants	6 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants	0 Participants
Race (NIH/OMB) White	29 Participants	383 Participants	26 Participants	16 Participants	78 Participants	25 Participants	72 Participants	24 Participants	30 Participants	25 Participants	30 Participants	28 Participants
Sex: Female, Male Female	22 Participants	229 Participants	14 Participants	10 Participants	44 Participants	18 Participants	36 Participants	14 Participants	18 Participants	21 Participants	17 Participants	15 Participants
Sex: Female, Male Male	12 Participants	212 Participants	15 Participants	8 Participants	41 Participants	9 Participants	48 Participants	14 Participants	16 Participants	13 Participants	17 Participants	19 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk	EG010 affected / at risk
deaths Total, all-cause mortality	0 / 36	0 / 36	0 / 35	0 / 34	0 / 34	0 / 26	0 / 80	0 / 26	0 / 85	0 / 18	0 / 29
other Total, other adverse events	22 / 36	31 / 36	23 / 35	31 / 34	15 / 34	21 / 26	75 / 80	25 / 26	84 / 85	10 / 18	14 / 29
serious Total, serious adverse events	2 / 36	1 / 36	1 / 35	0 / 34	0 / 34	1 / 26	1 / 80	0 / 26	2 / 85	0 / 18	0 / 29

Outcome results

Primary

Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22

SARS-CoV-2 neutralizing antibodies 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.

Time frame: Day 1 (pre-vaccination) and Day 22 (post-vaccination)

Population: Analysis was performed on PPAS-IAS population. Here, overall number of participants analyzed signifies participants with available data for this OM.

Arm	Measure	Value (GEOMETRIC_MEAN)
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22	1.00 ratio
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22	1.00 ratio
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22	1.00 ratio
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22	1.05 ratio
Cohort 1: Group 5: Placebo	Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22	1.00 ratio
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22	1.00 ratio
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22	1.06 ratio
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22	1.00 ratio
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22	1.12 ratio
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22	1.07 ratio
Cohort 2: Group 11: Placebo	Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22	1.00 ratio

Primary

Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36

SARS-CoV-2 neutralizing antibodies 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.

Time frame: Day 1 (pre-vaccination) and Day 36 (post-vaccination)

Population: Analysis was performed on PPAS-IAS population. Here, overall number of participants analyzed signifies participants with available data for this OM.

Arm	Measure	Value (GEOMETRIC_MEAN)
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36	1.00 ratio
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36	1.00 ratio
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36	1.00 ratio
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36	1.06 ratio
Cohort 1: Group 5: Placebo	Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36	1.03 ratio
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36	2.42 ratio
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36	3.36 ratio
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36	6.24 ratio
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36	14.0 ratio
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36	1.00 ratio
Cohort 2: Group 11: Placebo	Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36	1.00 ratio

Primary

Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 1

GMTs of SARS-CoV-2 neutralizing antibodies was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.

Time frame: Day 1 (pre-vaccination)

Population: Analysis was performed on Per-protocol analysis set for immunogenicity (PPAS-IAS) population which included all participants who received at least one injection of study intervention and had evaluable immunogenicity data, with no major protocol violations. Here, overall number of participants analyzed signifies participants with available data for this outcome measure (OM).

Arm	Measure	Value (GEOMETRIC_MEAN)
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 1	5.00 titers
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 1	5.00 titers
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 1	5.00 titers
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 1	5.00 titers
Cohort 1: Group 5: Placebo	Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 1	5.00 titers
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 1	5.00 titers
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 1	5.00 titers
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 1	5.00 titers
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 1	5.00 titers
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 1	5.00 titers
Cohort 2: Group 11: Placebo	Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 1	5.00 titers

Primary

Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 22

GMTs of SARS-CoV-2 neutralizing antibodies was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.

Time frame: Day 22 (post-vaccination)

Population: Analysis was performed on PPAS-IAS population. Here, overall number of participants analyzed signifies participants with available data for this OM.

Arm	Measure	Value (GEOMETRIC_MEAN)
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 22	5.00 titers
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 22	5.00 titers
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 22	5.00 titers
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 22	5.27 titers
Cohort 1: Group 5: Placebo	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 22	5.00 titers
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 22	5.00 titers
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 22	5.29 titers
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 22	5.00 titers
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 22	5.59 titers
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 22	5.35 titers
Cohort 2: Group 11: Placebo	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 22	5.00 titers

Primary

Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 36

GMTs of SARS-CoV-2 neutralizing antibodies was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.

Time frame: Day 36 (post-vaccination)

Population: Analysis was performed on PPAS-IAS population. Here, overall number of participants analyzed signifies participants with available data for this OM.

Arm	Measure	Value (GEOMETRIC_MEAN)
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 36	5.00 titers
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 36	5.00 titers
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 36	5.00 titers
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 36	5.31 titers
Cohort 1: Group 5: Placebo	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 36	5.17 titers
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 36	11.5 titers
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 36	17.4 titers
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 36	31.2 titers
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 36	69.0 titers
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 36	5.00 titers
Cohort 2: Group 11: Placebo	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 36	5.00 titers

Primary

Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36

SARS-CoV-2 neutralizing antibodies 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.

Time frame: Day 1 (pre-vaccination) and Day 36 (post-vaccination)

Population: Analysis was performed on PPAS-IAS population. Here, overall number of participants analyzed signifies participants with available data for this OM.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36	>=2-fold rise	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36	>=4-fold rise	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36	>=2-fold rise	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36	>=4-fold rise	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36	>=2-fold rise	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36	>=4-fold rise	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36	>=2-fold rise	1 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36	>=4-fold rise	1 Participants
Cohort 1: Group 5: Placebo	Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36	>=2-fold rise	1 Participants
Cohort 1: Group 5: Placebo	Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36	>=4-fold rise	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36	>=4-fold rise	5 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36	>=2-fold rise	7 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36	>=4-fold rise	22 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36	>=2-fold rise	31 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36	>=2-fold rise	14 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36	>=4-fold rise	14 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36	>=2-fold rise	57 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36	>=4-fold rise	49 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36	>=2-fold rise	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36	>=4-fold rise	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36	>=2-fold rise	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36	>=4-fold rise	0 Participants

Primary

Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22

SARS-CoV-2 neutralizing antibodies 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.

Time frame: Day 1 (pre-vaccination) and Day 22 (post-vaccination)

Population: Analysis was performed on PPAS-IAS population. Here, overall number of participants analyzed signifies participants with available data for this OM.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22	>=2-fold rise	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22	>=4-fold rise	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22	>=2-fold rise	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22	>=4-fold rise	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22	>=2-fold rise	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22	>=4-fold rise	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22	>=2-fold rise	1 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22	>=4-fold rise	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22	>=2-fold rise	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22	>=4-fold rise	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22	>=4-fold rise	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22	>=2-fold rise	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22	>=4-fold rise	2 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22	>=2-fold rise	2 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22	>=2-fold rise	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22	>=4-fold rise	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22	>=2-fold rise	4 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22	>=4-fold rise	2 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22	>=2-fold rise	1 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22	>=4-fold rise	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22	>=2-fold rise	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22	>=4-fold rise	0 Participants

Primary

Number of Participants With Adverse Events of Special Interest (AESIs)

An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. Reported AEs for each arm were presented as pre-specified in the study protocol.

Time frame: From Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)

Population: Analysis was performed on SafAS population.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Adverse Events of Special Interest (AESIs)	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Adverse Events of Special Interest (AESIs)	1 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Adverse Events of Special Interest (AESIs)	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Adverse Events of Special Interest (AESIs)	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Adverse Events of Special Interest (AESIs)	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Adverse Events of Special Interest (AESIs)	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Adverse Events of Special Interest (AESIs)	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Adverse Events of Special Interest (AESIs)	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Adverse Events of Special Interest (AESIs)	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Adverse Events of Special Interest (AESIs)	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Adverse Events of Special Interest (AESIs)	0 Participants

Primary

Number of Participants With Immediate Unsolicited Adverse Events (AEs)

An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessary had to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions prelisted in the case report form (CRF) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF. Reported AEs for each arm were presented as pre-specified in the study protocol.

Time frame: Within 30 minutes post any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])

Population: Analyzed on safety analysis set (SafAS) population which included randomized participants who had received at least one injection of study intervention and were analyzed according to study intervention they actually received. Here, '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 for the specified Group, as there was only 1 vaccination administered to Cohort 1.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post vaccination 1	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post any vaccination	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post vaccination 1	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post any vaccination	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post any vaccination	1 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post vaccination 1	1 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post vaccination 1	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post any vaccination	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post any vaccination	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post vaccination 1	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post vaccination 1	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post vaccination 2	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post any vaccination	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post vaccination 1	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post vaccination 2	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post any vaccination	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post vaccination 1	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post any vaccination	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post vaccination 2	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post any vaccination	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post vaccination 1	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post vaccination 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post vaccination 1	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post any vaccination	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post vaccination 2	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post any vaccination	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post vaccination 2	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Immediate Unsolicited Adverse Events (AEs)	Post vaccination 1	0 Participants

Primary

Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance

Laboratory tests included hemoglobin (male and female), above and below normal white blood cell, lymphocytes, neutrophils & eosinophils, platelet count, creatinine and 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 in LFT), amylase & lipase, Urine: protein, glucose & blood. The US FDA Guidance for Industry Toxicity Grading Scale for Healthy Adults and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials was used for grading. As per the guidance, Grade 1 = mild, Grade 2 = moderate and Grade 3 = severe.

Time frame: From Day 1 up to 8 days post last dose (i.e., up to Day 9 for Cohort 1 and up to Day 30 for Cohort 2)

Population: Analysis was performed on SafAS 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. Reported data for each arm were presented as pre-specified in the study protocol.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 1	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 3	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 1	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 1	2 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 2	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 2	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 3	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 3	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 1	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 3	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 3	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 3	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 1	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 3	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 1	2 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 1	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 1	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 2	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 2	1 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 2	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 3	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 1	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 2	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 2	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 2	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 2	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 3	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 2	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 3	1 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 1	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 3	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 2	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 1	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 3	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 1	1 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 3	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 2	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 2	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 3	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 1	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 2	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 1	2 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 2	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 2	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 2	2 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 1	2 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 1	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 1	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 1	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 3	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 1	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 3	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 2	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 3	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 1	1 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 3	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 2	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 3	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 2	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 1	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 1	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 3	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 2	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 1	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 3	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 3	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 3	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 1	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 3	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 2	1 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 3	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 2	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 1	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 2	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 2	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 2	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 1	2 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 3	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 2	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 3	1 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 1	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 1	1 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 3	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 3	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 2	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 1	1 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 1	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 3	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 2	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 1	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 1	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 3	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 3	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 2	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 2	1 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 1	1 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 3	1 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 3	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 2	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 1	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 1	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 2	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 3	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 2	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 2	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 1	3 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 3	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 2	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 3	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 1	1 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 3	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 1	1 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 2	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 2	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 1	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 3	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 2	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 2	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 1	1 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 3	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 3	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 2	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 1	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 1	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 1	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 3	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 2	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 2	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 1	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 3	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 3	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 2	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 1	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 1	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 3	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 3	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 2	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 1	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 2	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 3	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 2	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 3	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 3	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 1	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 3	1 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 1	1 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 2	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 1	3 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 3	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 2	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 3	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 2	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 1	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 3	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 3	1 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 2	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 1	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 1	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 1	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 2	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 2	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 2	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 1	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 1	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 3	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 3	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 2	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 3	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 2	1 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 1	1 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 2	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 2	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 3	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 2	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 1	4 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 2	1 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 3	1 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 2	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 3	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 2	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 1	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 1	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 1	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 2	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 3	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 3	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 1	1 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 1	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 2	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 3	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 1	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 3	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 2	1 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 3	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 3	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 1	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 3	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 2	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 1	2 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 1	1 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 1	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 3	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 2	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 1	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 3	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 3	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 1	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 2	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 1	1 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 2	1 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 1	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 1	1 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 2	1 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 3	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 2	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 2	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 2	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 1	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 3	1 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 1	1 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 2	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 2	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 2	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 1	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 2	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 1	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 3	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 1	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 2	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 3	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 1	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 3	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 3	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 3	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 2	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 1	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 3	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 1	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 2	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 3	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 3	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 2	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 3	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 3	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 2	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 3	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 1	1 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 2	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 3	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 1	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 2	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 3	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 1	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 2	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 3	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 1	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 2	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 3	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 1	2 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 2	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 3	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 1	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 2	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 3	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 1	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 2	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 3	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 1	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 2	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 3	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 1	1 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 2	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 3	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 1	1 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 1	1 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 1	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 2	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 3	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 1	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 2	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 3	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 1	1 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 2	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 3	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 1	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 2	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 3	1 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 1	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 2	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 3	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 1	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 2	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 3	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 1	1 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 2	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 3	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 1	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 2	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 3	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 1	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 2	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 3	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 1	3 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 2	1 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 1	1 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 2	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 3	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 1	1 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 2	3 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 3	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 1	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 2	1 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 3	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 1	1 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 2	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 3	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 2	1 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 3	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 1	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 2	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 3	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 1	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 2	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 2	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 1	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 2	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 2	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 2	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 1	2 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 2	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 1	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 1	1 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 1	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 1	1 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 2	1 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 2	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 2	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 2	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 2	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 2	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 1	1 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 2	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 1	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 2	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 2	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 2	1 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 1	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 1	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 2	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 2	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 1	1 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 2	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 1	2 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 2	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 1	2 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 1	6 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 1	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 2	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 2	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 1	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 1	1 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 2	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 1	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 1	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 1	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 1	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 2	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 2	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 2	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 1	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 1	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 3	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 2	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 2	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 1	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 1	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 1	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 1	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 3	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 1	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 2	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 3	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 1	1 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 2	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 2	1 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 1	1 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 2	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 2	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 1	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 2	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 3	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 1	1 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 1	1 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 1	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 2	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 1	1 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 3	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 3	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 1	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 3	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 3	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 3	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 1	1 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 1	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 1	1 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 1	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 3	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 2	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 3	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 3	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 2	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 1	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 2	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 2	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 2	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 1	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 2	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 3	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 3	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 1	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 2	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 2	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 3	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 3	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 2	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 3	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 3	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 3	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 1	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 2	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 2	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 1	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 1	1 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 2	1 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 3	1 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 1	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 3	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 3	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 1	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 3	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 2	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 2	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 2	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 1	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 3	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 1	1 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 2	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 3	1 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 2	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 2	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 1	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 1	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 3	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 3	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 1	1 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 1	3 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 2	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 3	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 2	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 3	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 2	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 1	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 3	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 1	1 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 3	1 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 2	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 3	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 3	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 1	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 2	1 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 2	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 3	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 1	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 2	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 1	2 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 2	5 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 3	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 3	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 1	1 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 2	1 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 2	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 3	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 1	3 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 1	1 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 2	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 3	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 1	3 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 3	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 2	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 3	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 3	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 2	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 1	2 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 2	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 1	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 3	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 1	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 2	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 3	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 2	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 3	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 1	1 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 2	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 2	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 3	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 1	3 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 1	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 1	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 2	1 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 1	5 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 3	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 3	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 1	3 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 2	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 2	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 1	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 3	1 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 1	9 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 2	1 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 1	3 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 3	1 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 1	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 3	1 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 2	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 3	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 2	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 1	1 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 2	1 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 2	3 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 3	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 2	1 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 1	2 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 3	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 1	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 2	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 3	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 1	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 3	0 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 1	3 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 2	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 1	4 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 2	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 1	1 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 1	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 1	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 1	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 1	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 3	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 1	3 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 2	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 3	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 1	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 2	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 2	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 3	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 1	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 2	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 2	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 1	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 1	2 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 3	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 3	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 3	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 3	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 3	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 2	1 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 1	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 3	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 2	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 3	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 3	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 3	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 1	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 2	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 3	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 2	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 2	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 2	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 1	1 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 3	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 1	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 1	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 2	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 3	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 1	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 3	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 2	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 2	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 2	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 3	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 1	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 3	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 2	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 3	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 2	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 3	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 1	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 1	1 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 3	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 2	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 2	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 2	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 1	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 2	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 3	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 1	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 1	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 2	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 3	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 3	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 2	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 3	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 3	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 2	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 2	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 2	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 3	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 1	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 1	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 1	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 1	1 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 3	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 2	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 1	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 3	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 1	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 3	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 2	1 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 2	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 3	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 3	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 2	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 2	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 1	1 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 2	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 2	1 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 1	1 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 3	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 1	2 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 1	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 3	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 1	1 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 3	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 2	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 2	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 3	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 3	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 3	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 3	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 1	1 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 1	2 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 2	3 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 1	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 2	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 2	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 1	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 3	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 1	4 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 3	1 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 1	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 1	10 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 1	1 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 3	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 2	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 3	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 3	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 2	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 1	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 1	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 2	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 2	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 3	1 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 2	1 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 2	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 1	1 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 3	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 2	1 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 1	4 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 2	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 3	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 2	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 3	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 1	3 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 2	1 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 1	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 3	1 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 3	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 3	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 1	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 1	3 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 3	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 1	5 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 2	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 2	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 3	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 2	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 2	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 1	2 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 1	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 3	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 1	5 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 3	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 1	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 3	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 1	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 1	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 3	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 3	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 1	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 1	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 1	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 1	1 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 1	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 1	1 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 1	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 1	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 3	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 1	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 3	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 1	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 3	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 2	1 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 1	1 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 3	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 3	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 3	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 3	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 1	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 3	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 1	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 3	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 3	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 3	1 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 3	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 1	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 3	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 3	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 2	1 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 3	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 3	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 3	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 1	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 3	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 3	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 1	1 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 1	2 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 1	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 1	1 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 1	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 1	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 3	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 3	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 3	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 3	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 1	1 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 1	2 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 1	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 2	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 3	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 3	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 3	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 2	1 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 2	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 2	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 1	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 2	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 3	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 1	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 2	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 3	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 2	1 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 1	2 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 1	2 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 1	2 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - protein: Grade 3	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 3	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 2	1 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 3	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 1	4 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 3	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 1	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 1	2 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Neutrophils Decreased: Grade 2	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 2	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 1	2 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 1	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 2	1 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 3	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 1	1 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 1	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 1	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 2	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 3	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 1	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 1	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 2	1 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 2	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 2	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 2	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Blood Urea Nitrogen: Grade 3	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin: Grade 3	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Male): Grade 1	3 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 1	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 1	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with normal in LFT: Grade 1	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 2	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 3	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - glucose: Grade 3	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyponatremia: Grade 3	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 1	2 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 3	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Eosinophils: Grade 2	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 3	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Amylase: Grade 3	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 2	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypernatremia: Grade 1	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 1	2 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 1	1 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 1	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 2	2 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 2	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hemoglobin (Female): Grade 1	1 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypokalemia: Grade 3	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperkalemia: Grade 2	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 1	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Above normal white blood cell: Grade 2	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 3	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Below normal white blood cell: Grade 3	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hyperglycemia: Grade 3	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Urine - blood: Grade 2	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Creatinine: Grade 2	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Aspartate aminotransferase: Grade 2	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Absolute Lymphocytes Decreased: Grade 3	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Hypoproteinemia: Grade 2	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Lipase: Grade 1	1 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Platelets Decreased: Grade 3	1 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alkaline phosphate: Grade 3	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Bilirubin - with any increase in LFT: Grade 2	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance	Alanine aminotransferase: Grade 3	0 Participants

Primary

Number of Participants With Medically Attended Adverse Events (MAAE)

A MAAE were AEs with a new onset or a worsening of a condition that prompted the participant to seek unplanned medical advice at a physician's office (including phone contact or email) or emergency department. An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessarily had to have a causal relationship with treatment. Reported AEs for each arm were presented as pre-specified in the study protocol.

Time frame: From Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)

Population: Analysis was performed on SafAS population.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Medically Attended Adverse Events (MAAE)	5 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Medically Attended Adverse Events (MAAE)	3 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Medically Attended Adverse Events (MAAE)	4 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Medically Attended Adverse Events (MAAE)	5 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Medically Attended Adverse Events (MAAE)	4 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Medically Attended Adverse Events (MAAE)	8 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Medically Attended Adverse Events (MAAE)	11 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Medically Attended Adverse Events (MAAE)	6 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Medically Attended Adverse Events (MAAE)	7 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Medically Attended Adverse Events (MAAE)	1 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Medically Attended Adverse Events (MAAE)	2 Participants

Primary

Number of Participants With Serious Adverse Events (SAE)

An SAE was 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. Reported AEs for each arm were presented as pre-specified in the study protocol.

Time frame: From Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)

Population: Analysis was performed on SafAS population.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Serious Adverse Events (SAE)	2 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Serious Adverse Events (SAE)	1 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Serious Adverse Events (SAE)	1 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Serious Adverse Events (SAE)	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Serious Adverse Events (SAE)	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Serious Adverse Events (SAE)	1 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Serious Adverse Events (SAE)	1 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Serious Adverse Events (SAE)	0 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Serious Adverse Events (SAE)	2 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Serious Adverse Events (SAE)	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Serious Adverse Events (SAE)	0 Participants

Primary

Number of Participants With Solicited Injection Site Reactions

A solicited reaction (SR) was defined as an expected adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRF and considered as related to vaccination. Solicited injection site reactions included pain, erythema and swelling. Reported AEs for each arm were presented as pre-specified in the study protocol.

Time frame: Within 7 days post any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])

Population: Analysis was performed on SafAS 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 available for assessment for the specified Group, as there was only 1 vaccination administered to Cohort 1.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Injection Site Reactions	Swelling post-vaccination 1	1 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Injection Site Reactions	Pain post-any vaccination	18 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Injection Site Reactions	Swelling post-any vaccination	1 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Injection Site Reactions	Erythema post-any vaccination	2 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Injection Site Reactions	Pain post-vaccination 1	18 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Injection Site Reactions	Erythema post-vaccination 1	2 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Injection Site Reactions	Erythema post-any vaccination	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Injection Site Reactions	Pain post-any vaccination	30 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Injection Site Reactions	Swelling post-vaccination 1	2 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Injection Site Reactions	Pain post-vaccination 1	30 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Injection Site Reactions	Erythema post-vaccination 1	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Injection Site Reactions	Swelling post-any vaccination	2 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Injection Site Reactions	Pain post-any vaccination	21 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Injection Site Reactions	Erythema post-vaccination 1	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Injection Site Reactions	Erythema post-any vaccination	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Injection Site Reactions	Swelling post-any vaccination	1 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Injection Site Reactions	Pain post-vaccination 1	21 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Injection Site Reactions	Swelling post-vaccination 1	1 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Injection Site Reactions	Swelling post-vaccination 1	2 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Injection Site Reactions	Swelling post-any vaccination	2 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Injection Site Reactions	Pain post-vaccination 1	28 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Injection Site Reactions	Erythema post-vaccination 1	3 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Injection Site Reactions	Pain post-any vaccination	28 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Injection Site Reactions	Erythema post-any vaccination	3 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Solicited Injection Site Reactions	Pain post-vaccination 1	5 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Solicited Injection Site Reactions	Pain post-any vaccination	5 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Solicited Injection Site Reactions	Erythema post-vaccination 1	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Solicited Injection Site Reactions	Swelling post-vaccination 1	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Solicited Injection Site Reactions	Swelling post-any vaccination	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Solicited Injection Site Reactions	Erythema post-any vaccination	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Injection Site Reactions	Erythema post-vaccination 2	2 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Injection Site Reactions	Erythema post-vaccination 1	1 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Injection Site Reactions	Swelling post-any vaccination	3 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Injection Site Reactions	Swelling post-vaccination 2	3 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Injection Site Reactions	Pain post-vaccination 1	16 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Injection Site Reactions	Swelling post-vaccination 1	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Injection Site Reactions	Pain post-any vaccination	19 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Injection Site Reactions	Erythema post-any vaccination	3 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Injection Site Reactions	Pain post-vaccination 2	19 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Injection Site Reactions	Pain post-any vaccination	73 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Injection Site Reactions	Swelling post-vaccination 1	1 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Injection Site Reactions	Pain post-vaccination 1	53 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Injection Site Reactions	Pain post-vaccination 2	70 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Injection Site Reactions	Erythema post-any vaccination	19 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Injection Site Reactions	Erythema post-vaccination 1	1 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Injection Site Reactions	Erythema post-vaccination 2	19 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Injection Site Reactions	Swelling post-vaccination 2	15 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Injection Site Reactions	Swelling post-any vaccination	16 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Injection Site Reactions	Erythema post-vaccination 1	1 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Injection Site Reactions	Pain post-vaccination 1	13 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Injection Site Reactions	Swelling post-vaccination 2	4 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Injection Site Reactions	Erythema post-any vaccination	4 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Injection Site Reactions	Pain post-vaccination 2	19 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Injection Site Reactions	Swelling post-any vaccination	4 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Injection Site Reactions	Swelling post-vaccination 1	0 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Injection Site Reactions	Pain post-any vaccination	20 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Injection Site Reactions	Erythema post-vaccination 2	4 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Injection Site Reactions	Pain post-vaccination 1	64 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Injection Site Reactions	Pain post-any vaccination	80 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Injection Site Reactions	Erythema post-vaccination 1	4 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Injection Site Reactions	Erythema post-vaccination 2	37 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Injection Site Reactions	Pain post-vaccination 2	78 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Injection Site Reactions	Swelling post-vaccination 1	5 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Injection Site Reactions	Swelling post-vaccination 2	26 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Injection Site Reactions	Swelling post-any vaccination	27 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Injection Site Reactions	Erythema post-any vaccination	39 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Solicited Injection Site Reactions	Erythema post-vaccination 1	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Solicited Injection Site Reactions	Swelling post-any vaccination	1 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Solicited Injection Site Reactions	Erythema post-any vaccination	1 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Solicited Injection Site Reactions	Erythema post-vaccination 2	1 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Solicited Injection Site Reactions	Pain post-any vaccination	4 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Solicited Injection Site Reactions	Pain post-vaccination 2	2 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Solicited Injection Site Reactions	Pain post-vaccination 1	2 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Solicited Injection Site Reactions	Swelling post-vaccination 1	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Solicited Injection Site Reactions	Swelling post-vaccination 2	1 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Solicited Injection Site Reactions	Swelling post-vaccination 1	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Solicited Injection Site Reactions	Erythema post-any vaccination	1 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Solicited Injection Site Reactions	Erythema post-vaccination 2	1 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Solicited Injection Site Reactions	Swelling post-vaccination 2	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Solicited Injection Site Reactions	Erythema post-vaccination 1	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Solicited Injection Site Reactions	Swelling post-any vaccination	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Solicited Injection Site Reactions	Pain post-any vaccination	6 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Solicited Injection Site Reactions	Pain post-vaccination 1	4 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Solicited Injection Site Reactions	Pain post-vaccination 2	3 Participants

Primary

Number of Participants With Solicited Systemic Reactions

An SR was defined as an expected AR (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRF and considered as related to vaccination. Solicited systemic reactions included fever, headache, malaise and myalgia. Reported AEs for each arm were presented as pre-specified in the study protocol.

Time frame: Within 7 days post any and each vaccination (Vaccination 1 [i.e., Day 1] and 2 [i.e., Day 22])

Population: Analysis was performed on SafAS 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 available for assessment for the specified Group, as there was only 1 vaccination administered to Cohort 1.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Systemic Reactions	Myalgia post-any vaccination	6 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Systemic Reactions	Myalgia post-vaccination 1	6 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Systemic Reactions	Malaise post-any vaccination	6 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Systemic Reactions	Malaise post-vaccination 1	6 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Systemic Reactions	Fever post-any vaccination	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Systemic Reactions	Fever post-vaccination 1	0 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Systemic Reactions	Headache post-any vaccination	10 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Systemic Reactions	Headache post-vaccination 1	10 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Systemic Reactions	Headache post-vaccination 1	13 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Systemic Reactions	Fever post-vaccination 1	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Systemic Reactions	Headache post-any vaccination	13 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Systemic Reactions	Myalgia post-vaccination 1	12 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Systemic Reactions	Myalgia post-any vaccination	12 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Systemic Reactions	Malaise post-any vaccination	11 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Systemic Reactions	Fever post-any vaccination	0 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Systemic Reactions	Malaise post-vaccination 1	11 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Systemic Reactions	Fever post-vaccination 1	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Systemic Reactions	Headache post-vaccination 1	4 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Systemic Reactions	Myalgia post-any vaccination	13 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Systemic Reactions	Malaise post-any vaccination	9 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Systemic Reactions	Malaise post-vaccination 1	9 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Systemic Reactions	Myalgia post-vaccination 1	13 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Systemic Reactions	Headache post-any vaccination	4 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Systemic Reactions	Fever post-any vaccination	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Systemic Reactions	Malaise post-vaccination 1	8 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Systemic Reactions	Headache post-any vaccination	11 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Systemic Reactions	Myalgia post-vaccination 1	15 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Systemic Reactions	Fever post-any vaccination	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Systemic Reactions	Malaise post-any vaccination	8 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Systemic Reactions	Myalgia post-any vaccination	15 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Systemic Reactions	Fever post-vaccination 1	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Systemic Reactions	Headache post-vaccination 1	11 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Solicited Systemic Reactions	Malaise post-vaccination 1	5 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Solicited Systemic Reactions	Fever post-vaccination 1	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Solicited Systemic Reactions	Myalgia post-vaccination 1	6 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Solicited Systemic Reactions	Headache post-any vaccination	6 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Solicited Systemic Reactions	Myalgia post-any vaccination	6 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Solicited Systemic Reactions	Fever post-any vaccination	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Solicited Systemic Reactions	Malaise post-any vaccination	5 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Solicited Systemic Reactions	Headache post-vaccination 1	6 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Systemic Reactions	Malaise post-any vaccination	15 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Systemic Reactions	Headache post-vaccination 2	13 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Systemic Reactions	Fever post-any vaccination	4 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Systemic Reactions	Myalgia post-vaccination 1	5 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Systemic Reactions	Myalgia post-vaccination 2	12 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Systemic Reactions	Malaise post-vaccination 2	13 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Systemic Reactions	Fever post-vaccination 1	1 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Systemic Reactions	Malaise post-vaccination 1	4 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Systemic Reactions	Fever post-vaccination 2	4 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Systemic Reactions	Headache post-any vaccination	14 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Systemic Reactions	Myalgia post-any vaccination	15 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Solicited Systemic Reactions	Headache post-vaccination 1	3 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Systemic Reactions	Headache post-any vaccination	60 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Systemic Reactions	Headache post-vaccination 1	20 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Systemic Reactions	Malaise post-any vaccination	61 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Systemic Reactions	Myalgia post-any vaccination	63 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Systemic Reactions	Malaise post-vaccination 1	16 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Systemic Reactions	Malaise post-vaccination 2	59 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Systemic Reactions	Myalgia post-vaccination 2	60 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Systemic Reactions	Myalgia post-vaccination 1	22 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Systemic Reactions	Fever post-any vaccination	28 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Systemic Reactions	Fever post-vaccination 2	28 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Systemic Reactions	Fever post-vaccination 1	1 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Solicited Systemic Reactions	Headache post-vaccination 2	57 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Systemic Reactions	Fever post-vaccination 2	5 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Systemic Reactions	Myalgia post-any vaccination	19 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Systemic Reactions	Myalgia post-vaccination 1	9 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Systemic Reactions	Myalgia post-vaccination 2	18 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Systemic Reactions	Fever post-vaccination 1	1 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Systemic Reactions	Headache post-any vaccination	17 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Systemic Reactions	Headache post-vaccination 1	7 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Systemic Reactions	Headache post-vaccination 2	16 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Systemic Reactions	Malaise post-any vaccination	19 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Systemic Reactions	Malaise post-vaccination 1	6 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Systemic Reactions	Malaise post-vaccination 2	18 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Solicited Systemic Reactions	Fever post-any vaccination	5 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Systemic Reactions	Malaise post-vaccination 2	64 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Systemic Reactions	Headache post-any vaccination	59 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Systemic Reactions	Fever post-vaccination 1	2 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Systemic Reactions	Fever post-any vaccination	25 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Systemic Reactions	Myalgia post-any vaccination	69 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Systemic Reactions	Malaise post-vaccination 1	24 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Systemic Reactions	Malaise post-any vaccination	68 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Systemic Reactions	Headache post-vaccination 2	53 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Systemic Reactions	Myalgia post-vaccination 1	32 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Systemic Reactions	Myalgia post-vaccination 2	65 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Systemic Reactions	Headache post-vaccination 1	34 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Solicited Systemic Reactions	Fever post-vaccination 2	23 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Solicited Systemic Reactions	Headache post-vaccination 1	4 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Solicited Systemic Reactions	Headache post-any vaccination	5 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Solicited Systemic Reactions	Malaise post-any vaccination	1 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Solicited Systemic Reactions	Fever post-vaccination 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Solicited Systemic Reactions	Fever post-vaccination 1	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Solicited Systemic Reactions	Fever post-any vaccination	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Solicited Systemic Reactions	Malaise post-vaccination 1	1 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Solicited Systemic Reactions	Myalgia post-vaccination 2	2 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Solicited Systemic Reactions	Malaise post-vaccination 2	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Solicited Systemic Reactions	Myalgia post-vaccination 1	2 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Solicited Systemic Reactions	Myalgia post-any vaccination	3 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Solicited Systemic Reactions	Headache post-vaccination 2	3 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Solicited Systemic Reactions	Headache post-vaccination 1	7 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Solicited Systemic Reactions	Malaise post-vaccination 2	3 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Solicited Systemic Reactions	Fever post-vaccination 2	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Solicited Systemic Reactions	Myalgia post-vaccination 1	2 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Solicited Systemic Reactions	Headache post-vaccination 2	3 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Solicited Systemic Reactions	Malaise post-any vaccination	6 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Solicited Systemic Reactions	Myalgia post-any vaccination	3 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Solicited Systemic Reactions	Malaise post-vaccination 1	5 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Solicited Systemic Reactions	Myalgia post-vaccination 2	3 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Solicited Systemic Reactions	Headache post-any vaccination	7 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Solicited Systemic Reactions	Fever post-any vaccination	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Solicited Systemic Reactions	Fever post-vaccination 1	0 Participants

Primary

Number of Participants With Unsolicited Adverse Events

Time frame: Within 21 days post any and each vaccination (Vaccination 1 [i.e., Day 1] and 2 [i.e., Day 22])

Population: Analysis was performed on SafAS population. Here, 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were available for assessment for the specified Group, as there was only 1 vaccination administered to Cohort 1.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Unsolicited Adverse Events	Post vaccination 1	10 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Unsolicited Adverse Events	Post any vaccination	10 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Unsolicited Adverse Events	Post vaccination 1	9 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Unsolicited Adverse Events	Post any vaccination	9 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Unsolicited Adverse Events	Post vaccination 1	9 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Unsolicited Adverse Events	Post any vaccination	9 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Unsolicited Adverse Events	Post vaccination 1	10 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Unsolicited Adverse Events	Post any vaccination	10 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Unsolicited Adverse Events	Post any vaccination	8 Participants
Cohort 1: Group 5: Placebo	Number of Participants With Unsolicited Adverse Events	Post vaccination 1	8 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Unsolicited Adverse Events	Post vaccination 2	11 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Unsolicited Adverse Events	Post any vaccination	13 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With Unsolicited Adverse Events	Post vaccination 1	3 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Unsolicited Adverse Events	Post any vaccination	34 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Unsolicited Adverse Events	Post vaccination 1	13 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With Unsolicited Adverse Events	Post vaccination 2	29 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Unsolicited Adverse Events	Post any vaccination	11 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Unsolicited Adverse Events	Post vaccination 2	5 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With Unsolicited Adverse Events	Post vaccination 1	8 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Unsolicited Adverse Events	Post vaccination 1	26 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Unsolicited Adverse Events	Post vaccination 2	39 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With Unsolicited Adverse Events	Post any vaccination	50 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Unsolicited Adverse Events	Post any vaccination	5 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Unsolicited Adverse Events	Post vaccination 1	3 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With Unsolicited Adverse Events	Post vaccination 2	4 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Unsolicited Adverse Events	Post any vaccination	9 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Unsolicited Adverse Events	Post vaccination 2	3 Participants
Cohort 2: Group 11: Placebo	Number of Participants With Unsolicited Adverse Events	Post vaccination 1	7 Participants

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 value below lower limit of quantification (LLOQ) with a detectable neutralization antibody titer above assay LLOQ post vaccination (at Day 22). LLOQ of the neutralization assay was a titer of 10.

Time frame: Day 22 (post-vaccination)

Population: Analysis was performed on PPAS-IAS population. Here, overall number of participants analyzed signifies participants with available data for this OM.

Arm	Measure	Value (NUMBER)
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22	0 percentage of participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22	0 percentage of participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22	0 percentage of participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22	4.2 percentage of participants
Cohort 1: Group 5: Placebo	Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22	0 percentage of participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22	0 percentage of participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22	3.0 percentage of participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22	0 percentage of participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22	5.9 percentage of participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22	7.7 percentage of participants
Cohort 2: Group 11: Placebo	Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22	0 percentage of participants

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 value below LLOQ with a detectable neutralization antibody titer above assay LLOQ post vaccination (at Day 36). LLOQ of the neutralization assay was a titer of 10.

Time frame: Day 36 (post-vaccination)

Population: Analysis was performed on PPAS-IAS population. Here, overall number of participants analyzed signifies participants with available data for this OM.

Arm	Measure	Value (NUMBER)
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36	0 percentage of participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36	0 percentage of participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36	0 percentage of participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36	4.2 percentage of participants
Cohort 1: Group 5: Placebo	Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36	4.2 percentage of participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36	43.8 percentage of participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36	52.5 percentage of participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36	70.0 percentage of participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36	87.7 percentage of participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36	0 percentage of participants
Cohort 2: Group 11: Placebo	Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36	0 percentage of participants

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.

Time frame: From Day 1 up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2

Population: Data for this OM (Correlates of Risk / Protection Based on Antibody Responses to SARS-CoV-2) was not collected and analyzed because of the limited number of COVID-19 cases before receiving an authorized/approved COVID-19 vaccine, and thus the corresponding anti-nucleoprotein testing was not conducted, and the planned efficacy analysis was not performed.

Secondary

Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387

GMC of Anti-S binding antibodies were assessed using enzyme-linked immunosorbent assay (ELISA) and were measured in binding antibody units/milliliter (BAU/mL).

Time frame: Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 181 (only for Cohort 1), Day 202 (only for Cohort 2), Day 366 (only for Cohort 1), and Day 387 (only for Cohort 2)

Population: Analysis was performed on PPAS-IAS population. Here, '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 Group for the specified time point.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 366	2161 BAU/mL
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 22	34.7 BAU/mL
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 1	9.45 BAU/mL
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 36	26.0 BAU/mL
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 181	50.9 BAU/mL
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 1	9.80 BAU/mL
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 181	145 BAU/mL
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 22	61.8 BAU/mL
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 36	73.7 BAU/mL
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 366	7355 BAU/mL
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 36	41.0 BAU/mL
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 366	1250 BAU/mL
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 22	46.1 BAU/mL
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 1	9.45 BAU/mL
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 181	21.7 BAU/mL
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 181	127 BAU/mL
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 36	136 BAU/mL
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 366	12580 BAU/mL
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 1	10.1 BAU/mL
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 22	160 BAU/mL
Cohort 1: Group 5: Placebo	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 366	6265 BAU/mL
Cohort 1: Group 5: Placebo	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 36	9.45 BAU/mL
Cohort 1: Group 5: Placebo	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 181	44.6 BAU/mL
Cohort 1: Group 5: Placebo	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 22	9.45 BAU/mL
Cohort 1: Group 5: Placebo	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 1	9.45 BAU/mL
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 36	1049 BAU/mL
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 1	11.7 BAU/mL
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 22	45.2 BAU/mL
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 202	925 BAU/mL
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 387	3439 BAU/mL
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 36	3571 BAU/mL
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 387	9009 BAU/mL
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 22	88.4 BAU/mL
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 1	9.66 BAU/mL
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 202	828 BAU/mL
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 36	3086 BAU/mL
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 1	9.45 BAU/mL
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 387	24115 BAU/mL
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 202	1338 BAU/mL
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 22	50.2 BAU/mL
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 36	7842 BAU/mL
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 22	136 BAU/mL
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 202	3451 BAU/mL
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 1	9.73 BAU/mL
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 387	37532 BAU/mL
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 1	10.5 BAU/mL
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 202	28070 BAU/mL
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 387	4114 BAU/mL
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 22	10.4 BAU/mL
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 36	29.8 BAU/mL
Cohort 2: Group 11: Placebo	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 202	217 BAU/mL
Cohort 2: Group 11: Placebo	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 36	9.45 BAU/mL
Cohort 2: Group 11: Placebo	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 22	9.45 BAU/mL
Cohort 2: Group 11: Placebo	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 1	9.45 BAU/mL
Cohort 2: Group 11: Placebo	Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387	Day 387	1126 BAU/mL

Secondary

Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387

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 01, Day 36/Day 01, Day 181/Day 1, Day 202/Day 1, Day 366/Day 1, and Day 387/Day 1.

Population: Analysis was performed on PPAS-IAS population. Here, overall number of participants analyzed signifies participants with available data for this OM, '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 Group for the specified time point.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 181/Day 1	5.39 ratio
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 366/Day 1	229 ratio
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1	3.67 ratio
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1	2.75 ratio
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1	7.52 ratio
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 181/Day 1	14.5 ratio
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 366/Day 1	685 ratio
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1	6.30 ratio
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 181/Day 1	2.30 ratio
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 366/Day 1	132 ratio
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1	4.34 ratio
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1	4.88 ratio
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 181/Day 1	13.4 ratio
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1	15.8 ratio
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 366/Day 1	1331 ratio
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1	13.4 ratio
Cohort 1: Group 5: Placebo	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 366/Day 1	663 ratio
Cohort 1: Group 5: Placebo	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 181/Day 1	4.72 ratio
Cohort 1: Group 5: Placebo	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1	1.00 ratio
Cohort 1: Group 5: Placebo	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1	1.00 ratio
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 387/Day 1	364 ratio
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1	3.67 ratio
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1	91.0 ratio
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 202/Day 1	58.2 ratio
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 202/Day 1	68.9 ratio
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 387/Day 1	933 ratio
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1	9.12 ratio
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1	367 ratio
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1	327 ratio
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 202/Day 1	142 ratio
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 387/Day 1	2552 ratio
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1	5.32 ratio
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1	13.8 ratio
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 387/Day 1	3972 ratio
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 202/Day 1	387 ratio
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1	812 ratio
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 202/Day 1	2970 ratio
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1	2.78 ratio
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1	0.989 ratio
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 387/Day 1	435 ratio
Cohort 2: Group 11: Placebo	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1	1.00 ratio
Cohort 2: Group 11: Placebo	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 387/Day 1	119 ratio
Cohort 2: Group 11: Placebo	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 202/Day 1	23.0 ratio
Cohort 2: Group 11: Placebo	Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1	1.00 ratio

Secondary

Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387

SARS-CoV-2 neutralizing antibodies 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 181/Day 1 and Day 366/Day 1; Cohort 2: Day 202/Day 1 and Day 387/Day 1.

Time frame: Day 1 (pre-vaccination), Cohort 1: Day 181 and Day 366 and Cohort 2: Day 202 and Day 387 (post-vaccination)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 181/Day 1	1.38 ratio
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 366/Day 1	7.12 ratio
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 181/Day 1	1.76 ratio
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 366/Day 1	31.9 ratio
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 181/Day 1	1.00 ratio
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 366/Day 1	7.26 ratio
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 181/Day 1	2.00 ratio
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 366/Day 1	25.4 ratio
Cohort 1: Group 5: Placebo	Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 181/Day 1	2.19 ratio
Cohort 1: Group 5: Placebo	Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 366/Day 1	48.5 ratio
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 387/Day 1	6.02 ratio
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 202/Day 1	6.34 ratio
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 387/Day 1	49.5 ratio
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 202/Day 1	2.38 ratio
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 202/Day 1	6.16 ratio
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 387/Day 1	145 ratio
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 202/Day 1	11.7 ratio
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 387/Day 1	209 ratio
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 202/Day 1	71.0 ratio
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 387/Day 1	7.95 ratio
Cohort 2: Group 11: Placebo	Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 202/Day 1	3.20 ratio
Cohort 2: Group 11: Placebo	Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 387/Day 1	4.60 ratio

Secondary

Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387

GMTs of SARS-CoV-2 neutralizing antibodies was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.

Time frame: Cohort 1: Day 181 and Day 366 and Cohort 2: Day 202 and Day 387 (post-vaccination)

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387	Day 181	6.89 titers
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387	Day 366	35.6 titers
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387	Day 181	8.81 titers
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387	Day 366	159 titers
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387	Day 181	5.00 titers
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387	Day 366	36.3 titers
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387	Day 181	9.99 titers
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387	Day 366	127 titers
Cohort 1: Group 5: Placebo	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387	Day 181	10.9 titers
Cohort 1: Group 5: Placebo	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387	Day 366	242 titers
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387	Day 387	30.1 titers
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387	Day 202	31.7 titers
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387	Day 387	235 titers
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387	Day 202	14.5 titers
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387	Day 202	30.8 titers
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387	Day 387	727 titers
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387	Day 202	53.6 titers
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387	Day 387	1043 titers
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387	Day 202	355 titers
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387	Day 387	39.7 titers
Cohort 2: Group 11: Placebo	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387	Day 202	16.0 titers
Cohort 2: Group 11: Placebo	Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387	Day 387	23.0 titers

Secondary

Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387

Binding Antibody Titers were evaluated by ELISA. Fold rise (2-fold and 4-fold) was calculated as the ratio of titer values for binding antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 22/Day 1 and Day 36/Day 1, Day 181/Day 1, Day 202/Day 1, Day 366/Day 1, and Day 387/Day 1.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1: >=2-fold rise	9 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1: >=4-fold rise	10 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1: >=2-fold rise	14 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1: >=4-fold rise	8 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 181/Day 1: >=2-fold rise	10 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 181/Day 1: >=4-fold rise	6 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 366/Day 1: >=2-fold rise	5 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 366/Day 1: >=4-fold rise	5 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 366/Day 1: >=4-fold rise	5 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1: >=4-fold rise	15 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 181/Day 1: >=4-fold rise	10 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1: >=4-fold rise	12 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1: >=2-fold rise	17 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 181/Day 1: >=2-fold rise	11 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 366/Day 1: >=2-fold rise	5 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1: >=2-fold rise	18 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 366/Day 1: >=2-fold rise	6 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 181/Day 1: >=2-fold rise	6 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1: >=2-fold rise	15 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1: >=4-fold rise	9 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 181/Day 1: >=4-fold rise	3 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 366/Day 1: >=4-fold rise	6 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1: >=2-fold rise	14 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1: >=4-fold rise	9 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 366/Day 1: >=2-fold rise	7 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1: >=2-fold rise	21 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1: >=2-fold rise	21 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 181/Day 1: >=2-fold rise	11 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 366/Day 1: >=4-fold rise	7 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1: >=4-fold rise	20 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 181/Day 1: >=4-fold rise	7 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1: >=4-fold rise	18 Participants
Cohort 1: Group 5: Placebo	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1: >=2-fold rise	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 181/Day 1: >=4-fold rise	4 Participants
Cohort 1: Group 5: Placebo	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1: >=4-fold rise	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 366/Day 1: >=4-fold rise	6 Participants
Cohort 1: Group 5: Placebo	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1: >=2-fold rise	0 Participants
Cohort 1: Group 5: Placebo	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 181/Day 1: >=2-fold rise	4 Participants
Cohort 1: Group 5: Placebo	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 366/Day 1: >=2-fold rise	6 Participants
Cohort 1: Group 5: Placebo	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1: >=4-fold rise	0 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1: >=4-fold rise	15 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1: >=2-fold rise	15 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 387/Day 1: >=4-fold rise	2 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 202/Day 1: >=4-fold rise	4 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 202/Day 1: >=2-fold rise	4 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 387/Day 1: >=2-fold rise	2 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1: >=2-fold rise	10 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1: >=4-fold rise	8 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 387/Day 1: >=2-fold rise	9 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1: >=4-fold rise	46 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1: >=2-fold rise	59 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 387/Day 1: >=4-fold rise	8 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1: >=4-fold rise	58 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 202/Day 1: >=2-fold rise	25 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 202/Day 1: >=4-fold rise	25 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1: >=2-fold rise	55 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1: >=2-fold rise	20 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 387/Day 1: >=2-fold rise	6 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 202/Day 1: >=2-fold rise	8 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 387/Day 1: >=4-fold rise	6 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 202/Day 1: >=4-fold rise	8 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1: >=4-fold rise	20 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1: >=4-fold rise	13 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1: >=2-fold rise	17 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1: >=4-fold rise	56 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1: >=2-fold rise	65 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 387/Day 1: >=2-fold rise	10 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1: >=2-fold rise	66 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 202/Day 1: >=4-fold rise	26 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 202/Day 1: >=2-fold rise	26 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 387/Day 1: >=4-fold rise	10 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1: >=4-fold rise	65 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1: >=2-fold rise	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 202/Day 1: >=2-fold rise	4 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 202/Day 1: >=4-fold rise	4 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 387/Day 1: >=4-fold rise	2 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1: >=4-fold rise	3 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1: >=2-fold rise	7 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1: >=4-fold rise	0 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 387/Day 1: >=2-fold rise	2 Participants
Cohort 2: Group 11: Placebo	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 202/Day 1: >=2-fold rise	3 Participants
Cohort 2: Group 11: Placebo	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 387/Day 1: >=4-fold rise	1 Participants
Cohort 2: Group 11: Placebo	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1: >=2-fold rise	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 387/Day 1: >=2-fold rise	1 Participants
Cohort 2: Group 11: Placebo	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1: >=2-fold rise	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 202/Day 1: >=4-fold rise	3 Participants
Cohort 2: Group 11: Placebo	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 36/Day 1: >=4-fold rise	0 Participants
Cohort 2: Group 11: Placebo	Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387	Day 22/Day 1: >=4-fold rise	0 Participants

Secondary

Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387

SARS-CoV-2 neutralizing antibodies was measured using a neutralization assay. The fold rise (2-fold and 4-fold) was calculated as the ratio of titer values of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Cohort 1: Day 181/Day 1 and Day 366/Day 1 and Cohort 2: Day 202/Day 1 and Day 387/Day 1.

Time frame: Day 1 (pre-vaccination), Cohort 1: Day 181 and Day 366 and Cohort 2: Day 202 and Day 387 (post-vaccination)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 366/Day 1: >=2-fold rise	4 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 366/Day 1: >=4-fold rise	3 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 181/Day 1: >=2-fold rise	2 Participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 181/Day 1: >=4-fold rise	1 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 181/Day 1: >=4-fold rise	2 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 366/Day 1: >=2-fold rise	5 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 366/Day 1: >=4-fold rise	5 Participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 181/Day 1: >=2-fold rise	2 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 366/Day 1: >=2-fold rise	3 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 366/Day 1: >=4-fold rise	3 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 181/Day 1: >=4-fold rise	0 Participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 181/Day 1: >=2-fold rise	0 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 366/Day 1: >=2-fold rise	6 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 181/Day 1: >=2-fold rise	2 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 366/Day 1: >=4-fold rise	6 Participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 181/Day 1: >=4-fold rise	2 Participants
Cohort 1: Group 5: Placebo	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 366/Day 1: >=4-fold rise	6 Participants
Cohort 1: Group 5: Placebo	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 366/Day 1: >=2-fold rise	6 Participants
Cohort 1: Group 5: Placebo	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 181/Day 1: >=4-fold rise	3 Participants
Cohort 1: Group 5: Placebo	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 181/Day 1: >=2-fold rise	4 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 387/Day 1: >=4-fold rise	1 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 202/Day 1: >=2-fold rise	1 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 202/Day 1: >=4-fold rise	1 Participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 387/Day 1: >=2-fold rise	1 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 387/Day 1: >=2-fold rise	7 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 387/Day 1: >=4-fold rise	6 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 202/Day 1: >=2-fold rise	6 Participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 202/Day 1: >=4-fold rise	5 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 202/Day 1: >=4-fold rise	3 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 387/Day 1: >=2-fold rise	6 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 387/Day 1: >=4-fold rise	6 Participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 202/Day 1: >=2-fold rise	3 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 202/Day 1: >=2-fold rise	19 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 387/Day 1: >=4-fold rise	10 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 387/Day 1: >=2-fold rise	10 Participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 202/Day 1: >=4-fold rise	14 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 387/Day 1: >=2-fold rise	2 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 202/Day 1: >=4-fold rise	4 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 202/Day 1: >=2-fold rise	4 Participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 387/Day 1: >=4-fold rise	2 Participants
Cohort 2: Group 11: Placebo	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 202/Day 1: >=4-fold rise	2 Participants
Cohort 2: Group 11: Placebo	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 387/Day 1: >=4-fold rise	1 Participants
Cohort 2: Group 11: Placebo	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 387/Day 1: >=2-fold rise	1 Participants
Cohort 2: Group 11: Placebo	Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387	Day 202/Day 1: >=2-fold rise	2 Participants

Secondary

Number of Participants With Serologically-confirmed SARS-CoV-2 Infection

Serologically-confirmed SARS-CoV-2 infection was defined as a change from negative to positive result in serum for presence of antibodies specific to non-Spike protein of SARS-CoV-2 detected by ELISA assay from any post-baseline sampling time point compared to the Baseline value.

Time frame: Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)

Population: Data for this OM (serologically confirmed SARS-CoV2 infection) was not collected and analyzed because of the limited number of COVID-19 cases before receiving an authorized/approved COVID-19 vaccine, and thus the corresponding anti-nucleoprotein testing was not conducted, and the planned efficacy analysis was not performed.

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. The various COVID-19-like illness symptoms were cough, fever, anosmia, ageusia, chillblains, difficulty breathing, shortness of breath, pneumonia, stroke, myocarditis, myocardial infarction, thromboembolic event, purpura fulminans, pharyngitis, chills, myalgia, headache, rhinorrhea, abdominal pain, nausea, diarrhea and vomiting.

Time frame: Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)

Population: Data for this OM (virologically confirmed COVID-19 like illness) was not collected and analyzed because of the limited number of COVID-19 cases before receiving an authorized/approved COVID-19 vaccine, and thus the corresponding anti-nucleoprotein testing was not conducted, and the planned efficacy analysis was not performed.

Secondary

Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387

Seroconversion was defined as participants with a Baseline (Day 1) titer value below LLOQ with a detectable neutralization antibody titer above assay LLOQ post vaccination (Cohort 1: Day 181 and Day 366 and Cohort 2: Day 202 and Day 387). LLOQ of the neutralization assay was a titer of 10.

Time frame: Cohort 1: Day 181 and Day 366 and Cohort 2: Day 202 and Day 387 (post-vaccination)

Arm	Measure	Group	Value (NUMBER)
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387	Day 181	13.3 percentage of participants
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03	Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387	Day 366	80.0 percentage of participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387	Day 181	14.3 percentage of participants
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03	Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387	Day 366	83.3 percentage of participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387	Day 181	0 percentage of participants
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03	Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387	Day 366	50.0 percentage of participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387	Day 181	13.3 percentage of participants
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03	Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387	Day 366	85.7 percentage of participants
Cohort 1: Group 5: Placebo	Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387	Day 181	25.0 percentage of participants
Cohort 1: Group 5: Placebo	Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387	Day 366	85.7 percentage of participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387	Day 387	50.0 percentage of participants
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03	Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387	Day 202	25.0 percentage of participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387	Day 387	77.8 percentage of participants
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03	Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387	Day 202	24.0 percentage of participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387	Day 202	37.5 percentage of participants
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03	Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387	Day 387	100 percentage of participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387	Day 202	73.1 percentage of participants
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03	Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387	Day 387	100 percentage of participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387	Day 202	100 percentage of participants
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD	Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387	Day 387	100 percentage of participants
Cohort 2: Group 11: Placebo	Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387	Day 202	40.0 percentage of participants
Cohort 2: Group 11: Placebo	Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387	Day 387	100 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026

Study of Recombinant Protein Vaccine Formulations Against COVID-19 in Healthy Adults 18 Years of Age and Older

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Masking description

Intervention model description

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22

Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36

Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 1

Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 22

Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 36

Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36

Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22

Number of Participants With Adverse Events of Special Interest (AESIs)

Number of Participants With Immediate Unsolicited Adverse Events (AEs)

Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance

Number of Participants With Medically Attended Adverse Events (MAAE)

Number of Participants With Serious Adverse Events (SAE)

Number of Participants With Solicited Injection Site Reactions

Number of Participants With Solicited Systemic Reactions

Number of Participants With Unsolicited Adverse Events

Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22

Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36

Correlates of Risk / Protection Based on Antibody Responses to SARS-CoV-2

Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387

Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387

Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387

Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387

Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387

Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387

Number of Participants With Serologically-confirmed SARS-CoV-2 Infection

Number of Participants With Virologically-confirmed Coronavirus Disease (COVID-19)-Like Illness

Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387