Study of Recombinant Protein Vaccine Formulations Against... | NCT04537208 | Trialant
NCT04537208
Sponsor
Sanofi Pasteur, a Sanofi Company
Status
Completed
Last Update Posted
Sep 17, 2025Actual
Enrollment
441Actual
Phase
Phase 1Phase 2
Conditions
COVID-19 (Healthy Volunteers)
Interventions
CoV2 preS dTM-AF03 (low-dose)
CoV2 preS dTM-AF03 (high-dose)
CoV2 preS dTM-AS03 (low-dose)
CoV2 preS dTM-AS03 (high-dose)
CoV2 preS dTM (high-dose) without adjuvant
Placebo (0.9% normal saline)
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT04537208
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
VAT00001
Secondary IDs
ID
Type
Description
Link
U1111-1250-4757
Other Identifier
UTN
Brief Title
Study of Recombinant Protein Vaccine Formulations Against COVID-19 in Healthy Adults 18 Years of Age and Older
Official Title
Immunogenicity and Safety of SARS-CoV-2 Recombinant Protein Vaccine Formulations (With or Without Adjuvant) in Healthy Adults 18 Years of Age and Older
Acronym
Not provided
Organization
SanofiINDUSTRY
Status Module
Record Verification Date
May 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 3, 2020Actual
Primary Completion Date
Nov 19, 2021Actual
Completion Date
Nov 19, 2021Actual
First Submitted Date
Sep 2, 2020
First Submission Date that Met QC Criteria
Sep 2, 2020
First Posted Date
Sep 3, 2020Actual
Results Waived
Not provided
Results First Submitted Date
May 24, 2023
Results First Submitted that Met QC Criteria
May 24, 2023
Results First Posted Date
Jun 22, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 15, 2025
Last Update Posted Date
Sep 17, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Sanofi Pasteur, a Sanofi CompanyINDUSTRY
Collaborators
Name
Class
GlaxoSmithKline
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary objectives of the study 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.
Conditions Module
Conditions
COVID-19 (Healthy Volunteers)
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
441Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1: Group 1: SARS-CoV-2 vaccine LD + AF03
Experimental
Participants received a single intramuscular (IM) injection of SARS-CoV2 vaccine low-dose (LD) formulation along with adjuvant AF03 on Day 1.
Biological: CoV2 preS dTM-AF03 (low-dose)
Cohort 1: Group 2: SARS-CoV-2 vaccine LD + AS03
Experimental
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
Biological: CoV2 preS dTM-AS03 (low-dose)
Cohort 1: Group 3: SARS-CoV-2 vaccine HD + AF03
Experimental
Participants received a single IM injection of SARS-CoV2 vaccine high-dose (HD) formulation along with adjuvant AF03 on Day 1.
Biological: CoV2 preS dTM-AF03 (high-dose)
Cohort 1: Group 4: SARS-CoV-2 vaccine HD + AS03
Experimental
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
Biological: CoV2 preS dTM-AS03 (high-dose)
Cohort 1: Group 5: Placebo
Placebo Comparator
Participants received an IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CoV2 preS dTM-AF03 (low-dose)
Biological
Pharmaceutical form: liquid; route of administration: intramuscular injection
Cohort 1: Group 1: SARS-CoV-2 vaccine LD + AF03
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
Day 1 (pre-vaccination)
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.
Day 22 (post-vaccination)
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.
Day 36 (post-vaccination)
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.
Day 1 (pre-vaccination) and Day 22 (post-vaccination)
Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36
SARS-CoV-2 neutralizing antibodies was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (Day 36) and pre-vaccination (on Day 1) i.e., Day 36/Day 1.
Day 1 (pre-vaccination) and Day 36 (post-vaccination)
Secondary Outcomes
Measure
Description
Time Frame
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).
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)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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.
De Rosa SC, Cohen KW, Bonaparte M, Fu B, Garg S, Gerard C, Goepfert PA, Huang Y, Larocque D, McElrath MJ, Morris D, Van der Most R, de Bruyn G, Pagnon A. Whole-blood cytokine secretion assay as a high-throughput alternative for assessing the cell-mediated immunity profile after two doses of an adjuvanted SARS-CoV-2 recombinant protein vaccine candidate. Clin Transl Immunology. 2022 Jan 11;11(1):e1360. doi: 10.1002/cti2.1360. eCollection 2022.
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
A total of 441 participants were enrolled, of which 439 were vaccinated in the study.
Recruitment Details
The study was conducted at 10 active sites in the United States between 03 September 2020 to 19 November 2021.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
Participants received a single intramuscular (IM) injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine low-dose (LD) formulation along with adjuvant AF03 on Day 1.
FG001
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Feb 5, 2021
May 24, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
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.
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Quadruple
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.
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
Biological: CoV2 preS dTM-AF03 (low-dose)
Cohort 2: Group 7: SARS-CoV-2 vaccine LD + AS03
Experimental
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
Biological: CoV2 preS dTM-AS03 (low-dose)
Cohort 2: Group 8: SARS-CoV-2 vaccine HD + AF03
Experimental
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
Biological: CoV2 preS dTM-AF03 (high-dose)
Cohort 2: Group 9: SARS-CoV-2 vaccine HD + AS03
Experimental
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
Biological: CoV2 preS dTM-AS03 (high-dose)
Cohort 2: Group 10: SARS-CoV-2 vaccine HD
Experimental
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
Biological: CoV2 preS dTM (high-dose) without adjuvant
Cohort 2: Group 11: Placebo
Placebo Comparator
Participants received an IM injection of placebo matching to SARS-CoV2 on Day 1 and Day 22, respectively.
Biological: Placebo (0.9% normal saline)
Cohort 2: Group 6: SARS-CoV-2 vaccine LD + AF03
CoV2 preS dTM-AF03 (high-dose)
Biological
Pharmaceutical form: liquid; route of administration: intramuscular injection
Cohort 1: Group 3: SARS-CoV-2 vaccine HD + AF03
Cohort 2: Group 8: SARS-CoV-2 vaccine HD + AF03
CoV2 preS dTM-AS03 (low-dose)
Biological
Pharmaceutical form: liquid; route of administration: intramuscular injection
Cohort 1: Group 2: SARS-CoV-2 vaccine LD + AS03
Cohort 2: Group 7: SARS-CoV-2 vaccine LD + AS03
CoV2 preS dTM-AS03 (high-dose)
Biological
Pharmaceutical form: liquid; route of administration: intramuscular injection
Cohort 1: Group 4: SARS-CoV-2 vaccine HD + AS03
Cohort 2: Group 9: SARS-CoV-2 vaccine HD + AS03
CoV2 preS dTM (high-dose) without adjuvant
Biological
Pharmaceutical form: liquid; route of administration: intramuscular injection
Cohort 2: Group 10: SARS-CoV-2 vaccine HD
Placebo (0.9% normal saline)
Biological
Pharmaceutical form: liquid; route of administration: intramuscular injection
Cohort 1: Group 5: Placebo
Cohort 2: Group 11: Placebo
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.
Day 1 (pre-vaccination) and Day 22 (post-vaccination)
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.
Day 1 (pre-vaccination) and Day 36 (post-vaccination)
Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22
Seroconversion was defined as participants with a Baseline (Day 1) titer 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.
Day 22 (post-vaccination)
Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36
Seroconversion was defined as participants with a Baseline (Day 1) titer 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.
Day 36 (post-vaccination)
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.
Within 30 minutes post any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])
Number of Participants With Solicited Injection Site Reactions
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.
Within 7 days post any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])
Number of Participants With Solicited Systemic Reactions
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.
Within 7 days post any and each vaccination (Vaccination 1 [i.e., Day 1] and 2 [i.e., Day 22])
Number of Participants With Unsolicited Adverse Events
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.
Within 21 days post any and each vaccination (Vaccination 1 [i.e., Day 1] and 2 [i.e., Day 22])
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
Cohort 1: Day 181 and Day 366 and Cohort 2: Day 202 and Day 387 (post-vaccination)
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.
Day 1 (pre-vaccination), Cohort 1: Day 181 and Day 366 and Cohort 2: Day 202 and Day 387 (post-vaccination)
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.
Day 1 (pre-vaccination), Cohort 1: Day 181 and Day 366 and Cohort 2: Day 202 and Day 387 (post-vaccination)
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.
Cohort 1: Day 181 and Day 366 and Cohort 2: Day 202 and Day 387 (post-vaccination)
Number of Participants With Virologically-confirmed Coronavirus Disease (COVID-19)-Like Illness
Virologically-confirmed COVID-19-like illness was defined by specified clinical symptoms and signs and confirmed by positive result for SARS-CoV-2 by nucleic acid amplification test (NAAT) on a respiratory sample in association with a COVID-19-like illness. 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.
Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)
Number of Participants With Serologically-confirmed SARS-CoV-2 Infection
Serologically-confirmed SARS-CoV-2 infection 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.
Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)
Correlates of Risk / Protection Based on Antibody Responses to SARS-CoV-2
Correlate of risk / protection based on antibody responses to SARS-CoV-2 was evaluated using virus neutralization or ELISA, considering virologically-confirmed COVID-19-like illness and/or serologically-confirmed SARS-CoV-2 infection.
From Day 1 up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2
Rolling Hills Estates
California
90274
United States
Investigational Site Number 8400011
Hollywood
Florida
33024
United States
Investigational Site Number 8400019
Melbourne
Florida
32934
United States
Investigational Site Number 8400016
Boston
Massachusetts
02115
United States
Investigational Site Number 8400002
Omaha
Nebraska
68134
United States
Investigational Site Number 8400001
Rochester
New York
14609
United States
Investigational Site Number 8400007
Rochester
New York
14642
United States
Investigational Site Number 8400008
Cleveland
Ohio
44122
United States
Investigational Site Number 8400003
Philadelphia
Pennsylvania
19104
United States
Investigational Site Number 8400014
Mt. Pleasant
South Carolina
29464
United States
Derived
Goepfert PA, Fu B, Chabanon AL, Bonaparte MI, Davis MG, Essink BJ, Frank I, Haney O, Janosczyk H, Keefer MC, Koutsoukos M, Kimmel MA, Masotti R, Savarino SJ, Schuerman L, Schwartz H, Sher LD, Smith J, Tavares-Da-Silva F, Gurunathan S, DiazGranados CA, de Bruyn G. Safety and immunogenicity of SARS-CoV-2 recombinant protein vaccine formulations in healthy adults: interim results of a randomised, placebo-controlled, phase 1-2, dose-ranging study. Lancet Infect Dis. 2021 Sep;21(9):1257-1270. doi: 10.1016/S1473-3099(21)00147-X. Epub 2021 Apr 19.
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
FG002
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
Participants received a single IM injection of SARS-CoV2 vaccine high-dose (HD) formulation along with adjuvant AF03 on Day 1.
FG003
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.
FG004
Cohort 1: Group 5: Placebo
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
FG005
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.
FG006
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.
FG007
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.
FG008
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.
FG009
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.
FG010
Cohort 2: Group 11: Placebo
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
FG00034 subjects
FG00134 subjects
FG00234 subjects
FG00334 subjects
FG00434 subjects
FG00528 subjects
FG00684 subjects
FG00727 subjects
FG00885 subjects
FG00918 subjects
FG01029 subjects
Vaccinated on Day 1
FG00034 subjects
FG00134 subjects
FG00234 subjects
FG00334 subjects
FG00434 subjects
FG00528 subjects
FG00682 subjects
FG00727 subjects
FG00885 subjects
FG00918 subjects
FG01029 subjects
Vaccinated on Day 22
Only Cohort 2 participants received second dose of vaccine at Day 22.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00526 subjects
FG00680 subjects
FG00726 subjects
FG00885 subjects
FG00917 subjects
FG01029 subjects
Safety Analysis Set (SafAS)
Participants who had received at least one injection of study intervention and were analyzed according to the study intervention they actually received.
FG00036 subjects2 participants randomized to 'Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03' received only one injection in Cohort 2 and thus included in arm 'Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03' for safety analysis.
FG00136 subjects2 participants randomized to 'Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03' received only one injection in Cohort 2 and thus included in arm 'Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03' for safety analysis.
FG00235 subjects1 participant randomized to 'Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03' received only one injection in Cohort 2 and thus included in arm 'Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03' for safety analysis.
FG00334 subjects
FG00434 subjects
FG00526 subjects2 participants randomized to 'Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03' received only one injection in Cohort 2 and thus included in arm 'Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03' for safety analysis.
FG00680 subjects2 participants randomized to 'Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03' received only one injection in Cohort 2 and thus included in arm 'Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03' for safety analysis.
FG00726 subjects1 participant randomized to 'Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03' received only one injection in Cohort 2 and thus included in arm 'Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03' for safety analysis.
FG00885 subjects
FG00918 subjects
FG01029 subjects
COMPLETED
FG00026 subjects
FG00131 subjects
FG00228 subjects
FG00327 subjects
FG00426 subjects
FG00523 subjects
FG00671 subjects
FG00724 subjects
FG00869 subjects
FG00914 subjects
FG01021 subjects
NOT COMPLETED
FG0008 subjects
FG0013 subjects
FG0026 subjects
FG0037 subjects
FG0048 subjects
FG0055 subjects
FG00613 subjects
FG0073 subjects
FG00816 subjects
FG0094 subjects
FG0108 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
Protocol deviation
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0004 subjects
FG0012 subjects
FG0021 subjects
FG0033 subjects
FG004
Lost to Follow-up
FG0004 subjects
FG0011 subjects
FG0023 subjects
FG0034 subjects
FG004
Analysis was performed on all randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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.
BG001
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.
BG002
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.
BG003
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.
BG004
Cohort 1: Group 5: Placebo
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
BG005
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.
BG006
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.
BG007
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.
BG008
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.
BG009
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.
BG010
Cohort 2: Group 11: Placebo
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
BG011
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00034
BG00134
BG00234
BG00334
BG00434
BG00528
BG00684
BG00727
BG00885
BG00918
BG01029
BG011441
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00042.8± 14.2
BG00141.9± 12.8
BG00239.8± 15.5
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00022
BG00115
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
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).
Posted
Geometric Mean
95% Confidence Interval
titers
Day 1 (pre-vaccination)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
Cohort 1: Group 5: Placebo
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
OG009
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.
OG010
Cohort 2: Group 11: Placebo
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
Units
Counts
Participants
OG00024
OG00121
OG00220
OG003
Title
Denominators
Categories
Title
Measurements
OG0005.00(NA to NA)95% confidence interval (CI) was not computable as the standard deviation (SD) of the sample was 0, since all participants had the same value.
OG0015.00(NA to NA)95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
OG002
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.
Analysis was performed on PPAS-IAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM.
Posted
Geometric Mean
95% Confidence Interval
titers
Day 22 (post-vaccination)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
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.
Analysis was performed on PPAS-IAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM.
Posted
Geometric Mean
95% Confidence Interval
titers
Day 36 (post-vaccination)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
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.
Analysis was performed on PPAS-IAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM.
Posted
Geometric Mean
95% Confidence Interval
ratio
Day 1 (pre-vaccination) and Day 22 (post-vaccination)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
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.
Analysis was performed on PPAS-IAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM.
Posted
Geometric Mean
95% Confidence Interval
ratio
Day 1 (pre-vaccination) and Day 36 (post-vaccination)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
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.
Analysis was performed on PPAS-IAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM.
Posted
Count of Participants
Participants
Day 1 (pre-vaccination) and Day 22 (post-vaccination)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
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.
Analysis was performed on PPAS-IAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM.
Posted
Count of Participants
Participants
Day 1 (pre-vaccination) and Day 36 (post-vaccination)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
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.
Analysis was performed on PPAS-IAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM.
Posted
Number
95% Confidence Interval
percentage of participants
Day 22 (post-vaccination)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
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.
Analysis was performed on PPAS-IAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM.
Posted
Number
95% Confidence Interval
percentage of participants
Day 36 (post-vaccination)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
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.
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.
Posted
Count of Participants
Participants
Within 30 minutes post any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])
ID
Title
Description
OG000
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.
OG001
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
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.
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.
Posted
Count of Participants
Participants
Within 7 days post any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])
ID
Title
Description
OG000
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.
OG001
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.
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.
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.
Posted
Count of Participants
Participants
Within 7 days post any and each vaccination (Vaccination 1 [i.e., Day 1] and 2 [i.e., Day 22])
ID
Title
Description
OG000
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.
OG001
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.
OG002
Primary
Number of Participants With Unsolicited Adverse Events
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.
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.
Posted
Count of Participants
Participants
Within 21 days post any and each vaccination (Vaccination 1 [i.e., Day 1] and 2 [i.e., Day 22])
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
Analysis was performed on SafAS population.
Posted
Count of Participants
Participants
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)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
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.
Analysis was performed on SafAS population.
Posted
Count of Participants
Participants
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)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
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.
Analysis was performed on SafAS population.
Posted
Count of Participants
Participants
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)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
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.
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.
Posted
Count of Participants
Participants
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)
ID
Title
Description
OG000
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.
OG001
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
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).
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.
Posted
Geometric Mean
95% Confidence Interval
BAU/mL
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)
ID
Title
Description
OG000
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.
OG001
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.
OG002
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
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.
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.
Posted
Geometric Mean
95% Confidence Interval
ratio
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)
ID
Title
Description
OG000
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.
OG001
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.
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.
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.
Posted
Count of Participants
Participants
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)
ID
Title
Description
OG000
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.
OG001
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.
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.
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.
Posted
Geometric Mean
95% Confidence Interval
titers
Cohort 1: Day 181 and Day 366 and Cohort 2: Day 202 and Day 387 (post-vaccination)
ID
Title
Description
OG000
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.
OG001
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.
OG002
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
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.
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.
Posted
Geometric Mean
95% Confidence Interval
ratio
Day 1 (pre-vaccination), Cohort 1: Day 181 and Day 366 and Cohort 2: Day 202 and Day 387 (post-vaccination)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
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.
Posted
Count of Participants
Participants
Day 1 (pre-vaccination), Cohort 1: Day 181 and Day 366 and Cohort 2: Day 202 and Day 387 (post-vaccination)
ID
Title
Description
OG000
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.
OG001
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.
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
Cohort 1: Day 181 and Day 366 and Cohort 2: Day 202 and Day 387 (post-vaccination)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
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.
Posted
Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)
ID
Title
Description
OG000
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.
OG001
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.
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.
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.
Posted
Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
Secondary
Correlates of Risk / Protection Based on Antibody Responses to SARS-CoV-2
Correlate of risk / protection based on antibody responses to SARS-CoV-2 was evaluated using virus neutralization or ELISA, considering virologically-confirmed COVID-19-like illness and/or serologically-confirmed SARS-CoV-2 infection.
Data 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.
Posted
From Day 1 up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
Time Frame
Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
Description
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
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.
0
36
2
36
22
36
EG001
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.
0
36
1
36
31
36
EG002
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.
0
35
1
35
23
35
EG003
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.
0
34
0
34
31
34
EG004
Cohort 1: Group 5: Placebo
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
0
34
0
34
15
34
EG005
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.
0
26
1
26
21
26
EG006
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.
0
80
1
80
75
80
EG007
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.
0
26
0
26
25
26
EG008
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.
0
85
2
85
84
85
EG009
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.
0
18
0
18
10
18
EG010
Cohort 2: Group 11: Placebo
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
0
29
0
29
14
29
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nipple Infection
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected36 at risk
EG0020 events0 affected35 at risk
EG0030 events0 affected34 at risk
EG0040 events0 affected34 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected80 at risk
EG0070 events0 affected26 at risk
EG0080 events0 affected85 at risk
EG0090 events0 affected18 at risk
EG0100 events0 affected29 at risk
Pelvic Abscess
Infections and infestations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected36 at risk
EG0020 events0 affected35 at risk
EG003
Craniocerebral Injury
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected36 at risk
EG0020 events0 affected35 at risk
EG003
Femoral Neck Fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected36 at risk
EG0020 events0 affected35 at risk
EG003
Breast Cancer Recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected36 at risk
EG0020 events0 affected35 at risk
EG003
Intraductal Proliferative Breast Lesion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected36 at risk
EG0020 events0 affected35 at risk
EG003
Transient Ischaemic Attack
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected36 at risk
EG0021 events1 affected35 at risk
EG003
Abortion Missed
Pregnancy, puerperium and perinatal conditions
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected36 at risk
EG0020 events0 affected35 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected36 at risk
EG0020 events0 affected35 at risk
EG0031 events1 affected34 at risk
EG0040 events0 affected34 at risk
EG0050 events0 affected26 at risk
EG0060 events0 affected80 at risk
EG0070 events0 affected26 at risk
EG0081 events1 affected85 at risk
EG0091 events1 affected18 at risk
EG0100 events0 affected29 at risk
Constipation
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0012 events2 affected36 at risk
EG0020 events0 affected35 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected36 at risk
EG0011 events1 affected36 at risk
EG0021 events1 affected35 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0012 events1 affected36 at risk
EG0021 events1 affected35 at risk
EG003
Chest Discomfort
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected36 at risk
EG0020 events0 affected35 at risk
EG003
Chills
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected36 at risk
EG0020 events0 affected35 at risk
EG003
Fatigue
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0011 events1 affected36 at risk
EG0022 events2 affected35 at risk
EG003
Injection Site Discomfort
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected36 at risk
EG0020 events0 affected35 at risk
EG003
Injection Site Erythema
General disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected36 at risk
EG0010 events0 affected36 at risk
EG0020 events0 affected35 at risk
EG003
Injection Site Pain
General disorders
MedDRA 25.0
Systematic Assessment
EG00018 events18 affected36 at risk
EG00130 events30 affected36 at risk
EG00221 events21 affected35 at risk
EG003
Injection Site Pruritus
General disorders
MedDRA 25.0
Systematic Assessment
EG0002 events1 affected36 at risk
EG0010 events0 affected36 at risk
EG0021 events1 affected35 at risk
EG003
Injection Site Swelling
General disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected36 at risk
EG0012 events2 affected36 at risk
EG0021 events1 affected35 at risk
EG003
Malaise
General disorders
MedDRA 25.0
Systematic Assessment
Malaise event which occurred 7 days post-vaccination was considered as an unsolicited AE.
EG0006 events6 affected36 at risk
EG00112 events12 affected36 at risk
EG0029 events9 affected35 at risk
EG003
Pyrexia
General disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected36 at risk
EG0020 events0 affected35 at risk
EG003
Blood Potassium Increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected36 at risk
EG0020 events0 affected35 at risk
EG003
Blood Urea Increased
Investigations
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected36 at risk
EG0020 events0 affected35 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0002 events2 affected36 at risk
EG0010 events0 affected36 at risk
EG0020 events0 affected35 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
Myalgia events which occurred 7 days post-vaccination was considered as an unsolicited AE.
EG0007 events6 affected36 at risk
EG00112 events12 affected36 at risk
EG00213 events13 affected35 at risk
EG003
Pain In Extremity
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected36 at risk
EG0020 events0 affected35 at risk
EG003
Ageusia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected36 at risk
EG0020 events0 affected35 at risk
EG003
Anosmia
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected36 at risk
EG0020 events0 affected35 at risk
EG003
Headache
Nervous system disorders
MedDRA 25.0
Systematic Assessment
Headache events which occurred 7 days post-vaccination was considered as an unsolicited AE.
EG00010 events10 affected36 at risk
EG00113 events13 affected36 at risk
EG0024 events4 affected35 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0001 events1 affected36 at risk
EG0010 events0 affected36 at risk
EG0020 events0 affected35 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected36 at risk
EG0020 events0 affected35 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected36 at risk
EG0021 events1 affected35 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Systematic Assessment
EG0000 events0 affected36 at risk
EG0010 events0 affected36 at risk
EG0020 events0 affected35 at risk
EG003
Due to the limited number of COVID-19 cases before receiving an authorized/approved COVID-19 vaccine, the corresponding anti-nucleoprotein testing was not conducted, the planned few efficacy outcome measures data were not collected and analysis was not performed.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.