Safety and Immunogenicity Study of a Booster Dose of the... | NCT05477186 | Trialant
NCT05477186
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Feb 21, 2025Actual
Enrollment
185Actual
Phase
Phase 1
Conditions
COVID-19
SARS-CoV-2
Interventions
CV0501 (3 μg)
CV0501 (6 μg)
CV0501 (12 μg)
CV0501 (25 μg)
CV0501 (50 μg)
CV0501 (100 μg)
CV0501 (200 μg)
Countries
United States
Australia
Philippines
Protocol Section
Identification Module
NCT ID
NCT05477186
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
218595
Secondary IDs
Not provided
Brief Title
Safety and Immunogenicity Study of a Booster Dose of the Investigational CV0501 mRNA COVID-19 Vaccine in Adults at Least 18 Years Old
Official Title
A Phase 1, Open-label, Safety and Immunogenicity Study of a Booster Dose of the Investigational CV0501 mRNA COVID-19 Vaccine in Adults at Least 18 Years Old
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Jan 2025
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
Aug 12, 2022Actual
Primary Completion Date
Aug 18, 2023Actual
Completion Date
Aug 18, 2023Actual
First Submitted Date
Jul 27, 2022
First Submission Date that Met QC Criteria
Jul 27, 2022
First Posted Date
Jul 28, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Aug 16, 2024
Results First Submitted that Met QC Criteria
Jan 31, 2025
Results First Posted Date
Feb 21, 2025Actual
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
Jan 31, 2025
Last Update Posted Date
Feb 21, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
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
Prevention of COVID-19 caused by SARS-CoV-2.
Detailed Description
Not provided
Conditions Module
Conditions
COVID-19
SARS-CoV-2
Keywords
COVID-19
Pandemic
Booster vaccination
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
185Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A: CV0501 Dose Cohort 1 (12 μg)
Experimental
Healthy participants received a single dose of 12 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
Biological: CV0501 (12 μg)
Part A: CV0501 Dose Cohort 2 (25 μg)
Experimental
Healthy participants received a single dose of 25 μg CV0501 vaccine intramuscularly at Day 1.
Biological: CV0501 (25 μg)
Part A: CV0501 Dose Cohort 3 (50 μg)
Experimental
Healthy participants received a single dose of 50 μg CV0501 vaccine intramuscularly at Day 1.
Biological: CV0501 (50 μg)
Part A: CV0501 Dose Cohort 4 (100 μg)
Experimental
Healthy participants received a single dose of 100 μg CV0501 vaccine intramuscularly at Day 1.
Biological: CV0501 (100 μg)
Part A: CV0501 Dose Cohort 5 (200 μg)
Experimental
Healthy participants received a single dose of 200 μg CV0501 vaccine intramuscularly at Day 1.
Biological: CV0501 (200 μg)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CV0501 (3 μg)
Biological
Study vaccine was administered as a single intramuscular injection.
Part B: CV0501 Dose Cohort 7 (6 μg)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination
Assessed solicited local adverse events were injection site pain, redness, swelling, and Lymphadenopathy.
From Day 1 to Day 7 (including Day 7)
Number of Participants With Solicited Systemic AE During 7 Days After Vaccination
Assessed solicited systemic AEs were fever, headache, fatigue, myalgia, arthralgia, and chills.
From Day 1 to Day 7 (including Day 7)
Number of Participants With Unsolicited AEs for 28 Days After Study Vaccination
An unsolicited AE is defined as any AE that is volunteered from the participant and occurs within 28 days after vaccination.
From Day 1 to day 28 (including day 28)
Number of Participants With Medically Attended Adverse Events (MAAEs) From Study Vaccination Through the End of the Study
An MAAE is defined as an AE that results in a visit to a medical professional. Medically attended visits are defined as a telemedicine visit, physician's office visit, urgent care visit, emergency room visit, hospitalization, or death.
From Day 1 up to Day 180 (including Day 180)
Number of Participants With Adverse Events of Special Interest (AESIs) From Study Vaccination Through the End of the Study
An AESI (serious or nonserious) is defined as an AE or serious adverse event (SAE) 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 could be appropriate.
From Day 1 up to Day 180 (including Day 180)
Number of Participants With Serious Adverse Events (SAEs) From Study Vaccination Through the End of the Study
Secondary Outcomes
Measure
Description
Time Frame
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
At Day 1, Day 15, Day 29, Day 91, and Day 181
Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Must provide documented informed consent prior to any study procedures being performed
Is capable of understanding and agrees to comply with planned study procedures and to be available for all study visits
Has received at least 2 doses of Comirnaty or Moderna COVID-19 Vaccine (Spikevax®\), with the last dose of vaccine received at least 6 months prior to screening
Negative for SARS-CoV-2 infection by RT-PCR test at screening
Is a male or nonpregnant female >= 18 years old
If the participant is a woman of childbearing potential, the participant agrees to use at least 1 highly effective form of contraception for at least 30 days prior to the study vaccination up to 3 months after study vaccination.
Agrees to refrain from blood or plasma donation from the first study vaccination through end of study.
Has a body mass index of 18 to 40 kg/m^2, inclusive, at screening.
Is healthy or medically stable as determined by investigator judgment based on medical history, clinical laboratory tests, vital sign measurements, and physical examination findings
Exclusion Criteria:
Participant is female and has a positive pregnancy test result at screening.
Participant is female and is breastfeeding or will (re)start breastfeeding from the study vaccination to 3 months after vaccination.
Has an acute febrile illness with temperature >=38.0°C or >=100.4°F within 72 hours before study vaccination. Individuals with suspected COVID-19 symptoms should be excluded and referred for medical care.
Has a history of documented SARS-CoV-2 infection or COVID-19 within 6 months before screening.
Has a documented medical history of HIV, hepatitis B or hepatitis C infection prior to screening, or a positive test for these conditions at screening.
Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (eg, malignancy) or immunosuppressive/cytotoxic therapy (eg, medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders). Chronic use (more than 14 continuous days) of any medication that may be associated with changes in immune function including, but not limited to, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy immunotherapy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar or toxic drugs within 6 months of the first study vaccination. Inclusion of persons who use low dose topical, ophthalmic, inhaled, or intranasal steroid preparations is permitted.
History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or presence of any medical condition that increases risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis, persistent myocardial viral infection (eg, due to enterovirus or adenovirus), and celiac disease.
Has a new onset, clinically significant, abnormal biochemistry or hematology finding (defined as >= Grade 1) at screening (adults with Grade 1 laboratory abnormalities that have been stable for at least 6 months before enrollment may be included in the study).
Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to: systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain- Barré syndrome, multiple sclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), Takayasu arteritis, granulomatosis with polyangiitis, psoriasis, and insulin-dependent diabetes mellitus (Type 1).
Has an unstable chronic medical condition. This refers to a condition requiring a new medication or increase in dose of current medication(s) or a condition requiring hospitalization within 6 months prior to screening.
Has a history of hypersensitivity or severe allergic reaction, including anaphylaxis, generalized urticaria, angioedema, and other significant reactions, to vaccines or to any component of the investigational product.
Has received or plans to receive any licensed vaccine, within 4 weeks before or 4 weeks after study vaccination. Inactivated vaccines for influenza are permitted during the study if they are administered at least 14 days before or after study vaccination.
Has had known close contact with anyone who had a confirmed SARS-CoV-2 infection within 2 weeks before study vaccination. Rescreening of these participants permitted after quarantine period is complete.
Has participated or plans to participate in another investigational study involving any investigational product or device within 6 months or 5 half-lives, whichever is longer, before the study vaccination through end of study.
Has received or plans to receive immunoglobulins or any blood or blood products within 3 months before the first study vaccination through end of study.
Has a bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
Has a history of alcohol abuse or other recreational drug use (excluding cannabis) within 6 months before study vaccination.
Has any abnormal skin condition or permanent body art (eg, tattoo) that would interfere with the ability to observe local reactions at the injection site.
Has a medical disease or psychiatric condition that, in the opinion of the investigator, precludes study participation because it would place the individual at an unacceptable risk of injury, render the individual unable to meet the requirements of the protocol or interfere with the individual's successful completion of the trial.
Participant is an employee or family member of the investigator or study site personnel.
Essink BJ, Shapiro C, Isidro MGD, Bradley P, Pragalos A, Bloch M, Santiaguel J, Frias MV, Miyakis S, Alves de Mesquita M, Berre S, Servais C, Waugh N, Hoffmann C, Baba E, Schonborn-Kellenberger O, Wolz OO, Koch SD, Ganyani T, Boutet P, Mann P, Mueller SO, Ramanathan R, Gaudinski MR, Vanhoutte N. Safety and immunogenicity of a modified mRNA-lipid nanoparticle vaccine candidate against COVID-19: Results from a phase 1, dose-escalation study. Hum Vaccin Immunother. 2024 Dec 31;20(1):2408863. doi: 10.1080/21645515.2024.2408863. Epub 2024 Oct 18.
GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Escalation to the next higher dose cohorts was based on the Safety Review Team (SRT) review of safety data from the same age group.
Recruitment Details
The study was conducted at 20 centers in Australia, Philippines and United States.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part B: CV0501 Dose Cohort 6 (3 μg)
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
FG001
Part B: CV0501 Dose Cohort 7 (6 μg)
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
0
More Info Module
Limitations and Caveats
Not provided
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
Jul 26, 2022
Aug 16, 2024
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
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Part B: CV0501 Dose Cohort 6 (3 μg)
Experimental
Healthy participants received a single dose of 3 μg CV0501 vaccine intramuscularly at Day 1.
Biological: CV0501 (6 μg)
Part B: CV0501 Dose Cohort 7 (6 μg)
Experimental
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
Biological: CV0501 (3 μg)
CV0501 (6 μg)
Biological
Study vaccine was administered as a single intramuscular injection.
Part B: CV0501 Dose Cohort 6 (3 μg)
CV0501 (12 μg)
Biological
Study vaccine was administered as a single intramuscular injection.
Part A: CV0501 Dose Cohort 1 (12 μg)
CV0501 (25 μg)
Biological
Study vaccine was administered as a single intramuscular injection.
Part A: CV0501 Dose Cohort 2 (25 μg)
CV0501 (50 μg)
Biological
Study vaccine was administered as a single intramuscular injection.
Part A: CV0501 Dose Cohort 3 (50 μg)
CV0501 (100 μg)
Biological
Study vaccine was administered as a single intramuscular injection.
Part A: CV0501 Dose Cohort 4 (100 μg)
CV0501 (200 μg)
Biological
Study vaccine was administered as a single intramuscular injection.
Part A: CV0501 Dose Cohort 5 (200 μg)
An SAE is defined as any event that: Results in death Is immediately life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is a spontaneous miscarriage Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered SAEs when, based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.
From Day 1 up to Day 180 (including Day 180)
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
An abnormal laboratory is defined as any value outside of the normal range. Normal ranges were: Alanine Aminotransferase: (Female: 10-32 micro (u)/ liter (L); Male: 10-40 u/L); Alkaline Phosphatase: (Female: 30-115 u/L; Male: 43-115 u/L); Aspartate Aminotransferase: (Female: 10-36 u/L; Male: 10-43 u/L); Bilirubin total: 0.1-1.1 milligram (mg)/deciliter (dL); Bilirubin, Direct: 0-0.4 mg/dL ;Creatinine:0.7-1.4 mg/dL; Eosinophils: 0%-7%; Eosinophils/Leukocytes: 0.00-0.80 x 10^3/uL ; Erythrocytes: (Female: 3.70-5.20 x 10^6/uL; Male: 4.63-6.08x 10^6/uL); Hemoglobin: (Female: 11.0-15.5 gram (g)/dL; Male: 12.5-17.0 g/dL); Leukocytes: 3.70-11.00 x 10^3/uL; Lymphocytes 12.0%-46.0%; Lymphocytes/Leukocytes: 0.90-3.60 x 10^3/uL; Monocytes/Leukocytes: 0.00-1.20 x 10^3/uL; Neutrophils: 4.0% - 71.0%; Neutrophils/Leukocytes:1.70-7.90x 10^3/uL; Platelets: 163-375 x 10^3/uL; Urea Nitrogen: 5-20 mg/dL.
8 days from vaccination at Day 1
At Day 15, Day 29, Day 91, and Day 181
Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29
Seroresponse was defined as post-boost titers >= 4 times pre-boost (baseline) titers for participants with titer >= LLOQ at pre-vaccination and as post-booster titer >= 4 times LLOQ for participants with titer < LLOQ at pre vaccination.
At day 29 (28 days after the booster dose)
Hollywood
Florida
33024
United States
GSK Investigational Site
Melbourne
Florida
32934
United States
GSK Investigational Site
Savannah
Georgia
31406
United States
GSK Investigational Site
Peoria
Illinois
61614-4896
United States
GSK Investigational Site
Metairie
Louisiana
70006-5322
United States
GSK Investigational Site
Rockville
Maryland
20854
United States
GSK Investigational Site
Omaha
Nebraska
68134
United States
GSK Investigational Site
Binghamton
New York
13760
United States
GSK Investigational Site
Cincinnati
Ohio
45212
United States
GSK Investigational Site
Norfolk
Virginia
68701
United States
GSK Investigational Site
Brookvale
New South Wales
2100
Australia
GSK Investigational Site
Merewether
New South Wales
2291
Australia
GSK Investigational Site
Sydney
New South Wales
2010
Australia
GSK Investigational Site
Wollongong
New South Wales
2500
Australia
GSK Investigational Site
Cavite
4114
Philippines
GSK Investigational Site
Iloilo City
5000
Philippines
Derived
Roth N, Gergen J, Kovacikova K, Mueller SO, Ulrich L, Schon J, Halwe NJ, Fricke C, Corleis B, Dorhoi A, Hoffmann D, Beer M, Maione D, Petsch B, Rauch S. Assessment of Immunogenicity and Efficacy of CV0501 mRNA-Based Omicron COVID-19 Vaccination in Small Animal Models. Vaccines (Basel). 2023 Jan 31;11(2):318. doi: 10.3390/vaccines11020318.
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
FG002
Part A: CV0501 Dose Cohort 1 (12 μg)
Healthy participants received a single dose of 12 μg CV0501 vaccine intramuscularly at Day 1.
FG003
Part A: CV0501 Dose Cohort 2 (25 μg)
Healthy participants received a single dose of 25 μg CV0501 vaccine intramuscularly at Day 1.
FG004
Part A: CV0501 Dose Cohort 3 (50 μg)
Healthy participants received a single dose of 50 μg CV0501 vaccine intramuscularly at Day 1.
FG005
Part A: CV0501 Dose Cohort 4 (100 μg)
Healthy participants received a single dose of 100 μg CV0501 vaccine intramuscularly at Day 1.
FG006
Part A: CV0501 Dose Cohort 5 (200 μg)
Healthy participants received a single dose of 200 μg CV0501 vaccine intramuscularly at Day 1.
FG00015 subjects
FG00117 subjects
FG00231 subjects
FG00330 subjects
FG00431 subjects
FG00531 subjects
FG00630 subjects
Safety Set
FG00015 subjects
FG00115 subjects
FG00230 subjects
FG00330 subjects
FG00430 subjects
FG00530 subjects
FG00630 subjects
Per Protocol Immunogenicity (PPI)
FG00015 subjects
FG00114 subjects
FG00228 subjects
FG00327 subjects
FG00428 subjects
FG00529 subjects
FG00626 subjects
COMPLETED
FG00013 subjects
FG00115 subjects
FG00228 subjects
FG00329 subjects
FG00429 subjects
FG00530 subjects
FG00628 subjects
NOT COMPLETED
FG0002 subjects
FG0012 subjects
FG0023 subjects
FG0031 subjects
FG0042 subjects
FG0051 subjects
FG0062 subjects
Type
Comment
Reasons
Vaccine not administered
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG004
Analysis was performed on enrolled set which includes all participants who have a signed Informed Consent Form and were assigned to a group, vaccinated, or had an immunogenicity blood draw.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part B: CV0501 Dose Cohort 6 (3 μg)
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
BG001
Part B: CV0501 Dose Cohort 7 (6 μg)
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
BG002
Part A: CV0501 Dose Cohort 1 (12 μg)
Healthy participants received a single dose of 12 μg CV0501 vaccine intramuscularly at Day 1.
BG003
Part A: CV0501 Dose Cohort 2 (25 μg)
Healthy participants received a single dose of 25 μg CV0501 vaccine intramuscularly at Day 1.
BG004
Part A: CV0501 Dose Cohort 3 (50 μg)
Healthy participants received a single dose of 50 μg CV0501 vaccine intramuscularly at Day 1.
BG005
Part A: CV0501 Dose Cohort 4 (100 μg)
Healthy participants received a single dose of 100 μg CV0501 vaccine intramuscularly at Day 1.
BG006
Part A: CV0501 Dose Cohort 5 (200 μg)
Healthy participants received a single dose of 200 μg CV0501 vaccine intramuscularly at Day 1.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00015
BG00117
BG00231
BG00330
BG00431
BG00531
BG00630
BG007185
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
BG00036.8± 12.18
BG00135.8± 12.66
BG00250.9± 16.43
BG003
Sex/Gender, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Male
BG00011
BG0017
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0003
BG0012
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
Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination
Assessed solicited local adverse events were injection site pain, redness, swelling, and Lymphadenopathy.
Analysis was performed on the Safety set who received 1 dose of investigational product. Only participants in the Safety Set with at least one day of eDiary entry within each dose group and at each level of summarization were included in this analysis; one participant in the 25 μg group did not complete the eDiary and was excluded from the summary.
Posted
Count of Participants
Participants
From Day 1 to Day 7 (including Day 7)
ID
Title
Description
OG000
Part B: CV0501 Dose Cohort 6 (3 μg)
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
OG001
Part B: CV0501 Dose Cohort 7 (6 μg)
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
OG002
Part A: CV0501 Dose Cohort 1 (12 μg)
Healthy participants received a single dose of 12 μg CV0501 vaccine intramuscularly at Day 1.
OG003
Part A: CV0501 Dose Cohort 2 (25 μg)
Healthy participants received a single dose of 25 μg CV0501 vaccine intramuscularly at Day 1.
OG004
Part A: CV0501 Dose Cohort 3 (50 μg)
Healthy participants received a single dose of 50 μg CV0501 vaccine intramuscularly at Day 1.
OG005
Part A: CV0501 Dose Cohort 4 (100 μg)
Healthy participants received a single dose of 100 μg CV0501 vaccine intramuscularly at Day 1.
OG006
Part A: CV0501 Dose Cohort 5 (200 μg)
Healthy participants received a single dose of 200 μg CV0501 vaccine intramuscularly at Day 1.
Units
Counts
Participants
OG00015
OG00115
OG00230
OG003
Title
Denominators
Categories
Overall
Title
Measurements
OG0005
OG0019
OG00216
OG003
Primary
Number of Participants With Solicited Systemic AE During 7 Days After Vaccination
Assessed solicited systemic AEs were fever, headache, fatigue, myalgia, arthralgia, and chills.
Analysis was performed on the Safety set who received 1 dose of investigational product. Only participants in the Safety Set with at least one day of eDiary entry within each dose group and at each level of summarization were included in this analysis; one participant in the 25 μg group did not complete the eDiary and was excluded from the summary.
Posted
Count of Participants
Participants
From Day 1 to Day 7 (including Day 7)
ID
Title
Description
OG000
Part B: CV0501 Dose Cohort 6 (3 μg)
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
OG001
Part B: CV0501 Dose Cohort 7 (6 μg)
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
OG002
Part A: CV0501 Dose Cohort 1 (12 μg)
Healthy participants received a single dose of 12 μg CV0501 vaccine intramuscularly at Day 1.
OG003
Primary
Number of Participants With Unsolicited AEs for 28 Days After Study Vaccination
An unsolicited AE is defined as any AE that is volunteered from the participant and occurs within 28 days after vaccination.
Analysis was performed on the Safety set who received 1 dose of investigational product.
Posted
Count of Participants
Participants
From Day 1 to day 28 (including day 28)
ID
Title
Description
OG000
Part B: CV0501 Dose Cohort 6 (3 μg)
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
OG001
Part B: CV0501 Dose Cohort 7 (6 μg)
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
OG002
Part A: CV0501 Dose Cohort 1 (12 μg)
Healthy participants received a single dose of 12 μg CV0501 vaccine intramuscularly at Day 1.
OG003
Part A: CV0501 Dose Cohort 2 (25 μg)
Healthy participants received a single dose of 25 μg CV0501 vaccine intramuscularly at Day 1.
Primary
Number of Participants With Medically Attended Adverse Events (MAAEs) From Study Vaccination Through the End of the Study
An MAAE is defined as an AE that results in a visit to a medical professional. Medically attended visits are defined as a telemedicine visit, physician's office visit, urgent care visit, emergency room visit, hospitalization, or death.
Analysis was performed on the Safety set who received 1 dose of investigational product.
Posted
Count of Participants
Participants
From Day 1 up to Day 180 (including Day 180)
ID
Title
Description
OG000
Part B: CV0501 Dose Cohort 6 (3 μg)
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
OG001
Part B: CV0501 Dose Cohort 7 (6 μg)
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
OG002
Part A: CV0501 Dose Cohort 1 (12 μg)
Healthy participants received a single dose of 12 μg CV0501 vaccine intramuscularly at Day 1.
OG003
Part A: CV0501 Dose Cohort 2 (25 μg)
Primary
Number of Participants With Adverse Events of Special Interest (AESIs) From Study Vaccination Through the End of the Study
An AESI (serious or nonserious) is defined as an AE or serious adverse event (SAE) 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 could be appropriate.
Analysis was performed on the Safety set who received 1 dose of investigational product.
Posted
Count of Participants
Participants
From Day 1 up to Day 180 (including Day 180)
ID
Title
Description
OG000
Part B: CV0501 Dose Cohort 6 (3 μg)
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
OG001
Part B: CV0501 Dose Cohort 7 (6 μg)
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
OG002
Part A: CV0501 Dose Cohort 1 (12 μg)
Healthy participants received a single dose of 12 μg CV0501 vaccine intramuscularly at Day 1.
OG003
Part A: CV0501 Dose Cohort 2 (25 μg)
Primary
Number of Participants With Serious Adverse Events (SAEs) From Study Vaccination Through the End of the Study
An SAE is defined as any event that: Results in death Is immediately life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is a spontaneous miscarriage Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered SAEs when, based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.
Analysis was performed on the Safety set who received 1 dose of investigational product.
Posted
Count of Participants
Participants
From Day 1 up to Day 180 (including Day 180)
ID
Title
Description
OG000
Part B: CV0501 Dose Cohort 6 (3 μg)
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
OG001
Part B: CV0501 Dose Cohort 7 (6 μg)
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
Secondary
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
The Per Protocol Immunogenicity (PPI) Set includes all eligible participants who received a dose of investigational product per protocol and who have values at specific timepoint for neutralizing Ab titers against pseudovirus bearing S protein from the Omicron variant of SARS-CoV-2.
Posted
Geometric Mean
Standard Deviation
Titers
At Day 1, Day 15, Day 29, Day 91, and Day 181
ID
Title
Description
OG000
Part B: CV0501 Dose Cohort 6 (3 μg)
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
OG001
Part B: CV0501 Dose Cohort 7 (6 μg)
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
OG002
Part A: CV0501 Dose Cohort 1 (12 μg)
Healthy participants received a single dose of 12 μg CV0501 vaccine intramuscularly at Day 1.
OG003
Part A: CV0501 Dose Cohort 2 (25 μg)
Secondary
Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point
The Per Protocol Immunogenicity (PPI) Set includes all eligible participants who received a dose of investigational product per protocol and who have values at specific timepoint for neutralizing Ab titers against pseudovirus bearing S protein from the Omicron variant of SARS-CoV-2.
Posted
Geometric Mean
Standard Deviation
Fold increase
At Day 15, Day 29, Day 91, and Day 181
ID
Title
Description
OG000
Part B: CV0501 Dose Cohort 6 (3 μg)
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
OG001
Part B: CV0501 Dose Cohort 7 (6 μg)
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
OG002
Part A: CV0501 Dose Cohort 1 (12 μg)
Healthy participants received a single dose of 12 μg CV0501 vaccine intramuscularly at Day 1.
OG003
Part A: CV0501 Dose Cohort 2 (25 μg)
Secondary
Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29
Seroresponse was defined as post-boost titers >= 4 times pre-boost (baseline) titers for participants with titer >= LLOQ at pre-vaccination and as post-booster titer >= 4 times LLOQ for participants with titer < LLOQ at pre vaccination.
The Per Protocol Immunogenicity (PPI) Set includes all eligible participants who received a dose of investigational product per protocol and who have values at specific timepoint for neutralizing Ab titers against pseudovirus bearing S protein from the Omicron variant of SARS-CoV-2.
Posted
Number
95% Confidence Interval
Percentage of participants
At day 29 (28 days after the booster dose)
ID
Title
Description
OG000
Part B: CV0501 Dose Cohort 6 (3 μg)
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
OG001
Part B: CV0501 Dose Cohort 7 (6 μg)
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
OG002
Part A: CV0501 Dose Cohort 1 (12 μg)
Healthy participants received a single dose of 12 μg CV0501 vaccine intramuscularly at Day 1.
Primary
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
An abnormal laboratory is defined as any value outside of the normal range. Normal ranges were: Alanine Aminotransferase: (Female: 10-32 micro (u)/ liter (L); Male: 10-40 u/L); Alkaline Phosphatase: (Female: 30-115 u/L; Male: 43-115 u/L); Aspartate Aminotransferase: (Female: 10-36 u/L; Male: 10-43 u/L); Bilirubin total: 0.1-1.1 milligram (mg)/deciliter (dL); Bilirubin, Direct: 0-0.4 mg/dL ;Creatinine:0.7-1.4 mg/dL; Eosinophils: 0%-7%; Eosinophils/Leukocytes: 0.00-0.80 x 10^3/uL ; Erythrocytes: (Female: 3.70-5.20 x 10^6/uL; Male: 4.63-6.08x 10^6/uL); Hemoglobin: (Female: 11.0-15.5 gram (g)/dL; Male: 12.5-17.0 g/dL); Leukocytes: 3.70-11.00 x 10^3/uL; Lymphocytes 12.0%-46.0%; Lymphocytes/Leukocytes: 0.90-3.60 x 10^3/uL; Monocytes/Leukocytes: 0.00-1.20 x 10^3/uL; Neutrophils: 4.0% - 71.0%; Neutrophils/Leukocytes:1.70-7.90x 10^3/uL; Platelets: 163-375 x 10^3/uL; Urea Nitrogen: 5-20 mg/dL.
Analysis was performed on the Safety set who received 1 dose of investigational product.
Posted
Count of Participants
Participants
8 days from vaccination at Day 1
ID
Title
Description
OG000
Part B: CV0501 Dose Cohort 6 (3 μg)
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
OG001
Part B: CV0501 Dose Cohort 7 (6 μg)
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
Time Frame
Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), and Adverse Events of Special Interest (AESIs) were collected through the entire period of the study (from Day 1 up to study end [Day 180]). Solicited adverse events were collected from Day 1-7. Unsolicited adverse events from Day 1-28. Abnormal Clinical Safety Laboratory Findings from Day 1-8. Non-Serious Covid-19 Adverse Events from Day 1 up to Study End [Day 180] after Study Vaccination.
Description
Adverse events were assessed in safety set which included all participants that received the study intervention administration.
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
Part B: CV0501 Dose Cohort 6 (3 μg)
Healthy participants received a single dose of 3 microgram (μg) CV0501 vaccine intramuscularly at Day 1.
0
15
0
15
11
15
EG001
Part B: CV0501 Dose Cohort 7 (6 μg)
Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1.
0
15
0
15
10
15
EG002
Part A: CV0501 Dose Cohort 1 (12 μg)
Healthy participants received a single dose of 12 μg CV0501 vaccine intramuscularly at Day 1.
0
30
0
30
18
30
EG003
Part A: CV0501 Dose Cohort 2 (25 μg)
Healthy participants received a single dose of 25 μg CV0501 vaccine intramuscularly at Day 1.
0
30
0
30
22
30
EG004
Part A: CV0501 Dose Cohort 3 (50 μg)
Healthy participants received a single dose of 50 μg CV0501 vaccine intramuscularly at Day 1.
0
30
1
30
19
30
EG005
Part A: CV0501 Dose Cohort 4 (100 μg)
Healthy participants received a single dose of 100 μg CV0501 vaccine intramuscularly at Day 1.
0
30
2
30
22
30
EG006
Part A: CV0501 Dose Cohort 5 (200 μg)
Healthy participants received a single dose of 200 μg CV0501 vaccine intramuscularly at Day 1.
0
30
0
30
24
30
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA, Version 26.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected30 at risk
EG0030 events0 affected30 at risk
EG0040 events0 affected30 at risk
EG0051 events1 affected30 at risk
EG0060 events0 affected30 at risk
Cholecystitis
Hepatobiliary disorders
MedDRA, Version 26.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected30 at risk
EG003
Syncope
Nervous system disorders
MedDRA, Version 26.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected30 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Injection site pain
General disorders
MedDRA, Version 26.0
Systematic Assessment
EG0005 events5 affected15 at risk
EG0019 events9 affected15 at risk
EG00214 events14 affected30 at risk
EG00319 events19 affected30 at risk
EG00415 events15 affected30 at risk
EG00519 events19 affected30 at risk
EG00622 events22 affected30 at risk
Fatigue
General disorders
MedDRA, Version 26.0
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected15 at risk
EG0025 events5 affected30 at risk
EG003
Chills
General disorders
MedDRA, Version 26.0
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected15 at risk
EG0023 events3 affected30 at risk
EG003
Injection site erythema
General disorders
MedDRA, Version 26.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected30 at risk
EG003
Injection site swelling
General disorders
MedDRA, Version 26.0
Systematic Assessment
EG0001 events1 affected15 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected30 at risk
EG003
Fever
General disorders
MedDRA, Version 26.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected30 at risk
EG003
Administration site pain
General disorders
MedDRA, Version 26.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected30 at risk
EG003
Chest pain
General disorders
MedDRA, Version 26.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected30 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA, Version 26.0
Systematic Assessment
EG0002 events2 affected15 at risk
EG0013 events3 affected15 at risk
EG0028 events8 affected30 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA, Version 26.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected15 at risk
EG0022 events2 affected30 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA, Version 26.0
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected30 at risk
EG003
Headache
Nervous system disorders
MedDRA, Version 26.0
Systematic Assessment
EG0004 events4 affected15 at risk
EG0014 events4 affected15 at risk
EG0025 events5 affected30 at risk
EG003
COVID-19
Infections and infestations
MedDRA, Version 26.0
Systematic Assessment
EG0002 events2 affected15 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected30 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA, Version 26.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected15 at risk
EG0020 events0 affected30 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA, Version 26.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected30 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA, Version 26.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected30 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA, Version 26.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected30 at risk
EG003
Tooth infection
Infections and infestations
MedDRA, Version 26.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected30 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA, Version 26.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected15 at risk
EG0021 events1 affected30 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA, Version 26.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected15 at risk
EG0024 events4 affected30 at risk
EG003
Burns second degree
Injury, poisoning and procedural complications
MedDRA, Version 26.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected30 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA, Version 26.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected30 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA, Version 26.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected30 at risk
EG003
Tonsillar hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA, Version 26.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected30 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA, Version 26.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected30 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA, Version 26.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected30 at risk
EG003
Hypertension
Vascular disorders
MedDRA, Version 26.0
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected15 at risk
EG0020 events0 affected30 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.