A Study on the Safety and Immune Response of Investigatio... | NCT05960097 | Trialant
NCT05960097
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Oct 23, 2025Actual
Enrollment
692Actual
Phase
Phase 2
Conditions
SARS-CoV-2
COVID-19
Interventions
CV0701 mRNA COVID-19 Vaccine (Low dose)
CV0701 mRNA COVID-19 Vaccine (Medium dose)
CV0701 mRNA COVID-19 Vaccine (High dose)
CV0601 mRNA COVID-19 Vaccine
Control vaccine
CV0801 mRNA COVID-19 Vaccine
Countries
United States
Australia
Protocol Section
Identification Module
NCT ID
NCT05960097
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
219075
Secondary IDs
Not provided
Brief Title
A Study on the Safety and Immune Response of Investigational COVID-19 mRNA Vaccines in Healthy Adults
Official Title
A Phase 2 Randomized, Active-controlled, Observer-blind Study to Assess the Safety, Reactogenicity, and Immunogenicity of a Booster Dose of Investigational COVID-19 mRNA Vaccines in Healthy Adults Who Previously Received a Complete Primary Vaccination Series With or Without Booster Dose(s)
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Oct 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 1, 2023Actual
Primary Completion Date
Aug 30, 2024Actual
Completion Date
Aug 30, 2024Actual
First Submitted Date
Jul 24, 2023
First Submission Date that Met QC Criteria
Jul 24, 2023
First Posted Date
Jul 25, 2023Actual
Results Waived
Not provided
Results First Submitted Date
Aug 29, 2025
Results First Submitted that Met QC Criteria
Oct 8, 2025
Results First Posted Date
Oct 23, 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
Oct 8, 2025
Last Update Posted Date
Oct 23, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Name
Class
CureVac
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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 purpose of Part A of this study is to assess the immune response and safety of a booster dose of investigational COVID-19 mRNA vaccines in healthy adults. The study will compare the investigational vaccines to control vaccine.
The purpose of Part B of this study is to assess the immune response and safety of a booster dose of investigational COVID-19 mRNA vaccines in healthy adults. The study will compare the investigational vaccine under three different storage conditions.
Detailed Description
Part A:
This Phase 2 study's Part A evaluates the safety, reactogenicity, and immunogenicity of two candidate vaccines - the bivalent CV0701 and the monovalent CV0601 - in healthy adults who have received a full primary vaccination series (with or without booster doses). By including these candidates, the study will assess whether immune interference occurs between the XY spike protein and the XX spike protein antigens in the bivalent vaccine compared with the XX spike protein antigen in the monovalent vaccine. In Part A, both CV0701 and CV0601 will be compared to the Control Vaccine (that serve as a standard of care control) using a randomized, observer-blinded design.
Part B:
The purpose of Part B is to evaluate the safety and Day 29 immunogenicity of CV0801 under three storage conditions:
Condition 1: Baseline/control
Condition 2: Intermediate storage
Condition 3: Maximum storage
Condition 1 serves as the control against which the performance (safety, reactogenicity, and immunogenicity) of Conditions 2 and 3 will be compared.
mRNA vaccine stability is affected by product-specific factors (e.g., molecular weight, buffer composition, lipid nanoparticle encapsulation), manufacturing factors (such as the duration the vaccine remains in liquid form during production and handling at different temperatures), and storage conditions. The impact of these factors is based on product and process knowledge as well as clinical experience.
Through Part B of this Phase 2 study, GSK and CureVac aim to develop data on how different storage conditions affect the final attributes of the vaccine in a clinical trial setting.
Conditions Module
Conditions
SARS-CoV-2
COVID-19
Keywords
COVID-19
Pandemic
Booster vaccine
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
692Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A: CV0701 mRNA COVID-19 Vaccine (Low dose)
Experimental
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
Biological: CV0601 mRNA COVID-19 Vaccine
Part A: Control Vaccine
Active Comparator
Participants received one dose of the control vaccine at Day 1.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CV0701 mRNA COVID-19 Vaccine (Low dose)
Biological
Study vaccine was administered as a single intramuscular injection.
Part A: CV0701 mRNA COVID-19 Vaccine (Low dose)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part A: Geometric Mean Titer (GMT) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein
At Day 29
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
At Day 29
Part B: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
At Day 29
Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)
Assessed solicited administration site events included injection site redness (erythema), pain, swelling and lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.
Day 1 to Day 7
Part A: Number of Participants Reporting Any Solicited Systemic AEs
Assessed solicited systemic events included fever, chills, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as body temperature is higher than or equal to (>=) 38ºC; preferred location for measuring the temperature is oral. Any = occurrence of the event regardless of intensity grade.
Day 1 to Day 7
Part A: Number of Participants Reporting Any Unsolicited AEs
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs. Any = occurrence of the event regardless of intensity grade.
Secondary Outcomes
Measure
Description
Time Frame
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein
At Day 91 and Day 181
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
At Day 91 and Day 181
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Is at least 18 years old and has achieved legal age according to local regulations in each participating country.
Must provide documented informed consent prior to any study procedures being performed.
Can and will comply with the requirements of the protocol, in the opinion of the investigator.
Is healthy or medically stable as determined by the investigator's judgment based on medical history, vital sign measurements, and physical examination findings. Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.
Prior receipt of an mRNA COVID-19 vaccine. This may be from a completed primary vaccination series or booster dose(s) of an approved or authorized mRNA COVID-19 vaccine. The last vaccination must be an mRNA COVID-19 vaccination received at least 3 months prior to randomization.
If the participant is a woman of childbearing potential, the participant may be enrolled in the study, if they:
have practiced adequate contraception for 30 days prior to study intervention administration; and
have a negative pregnancy test result on the day of study intervention administration; and
have agreed to continue adequate contraception for 2 months after study intervention administration.
Female participants of non-childbearing potential may be enrolled in the study. Nonchildbearing potential is defined as current salpingectomy, hysterectomy, ovariectomy, or postmenopausal.
Participants are excluded from the study if any of the following criteria apply:
Is pregnant or has a positive pregnancy test result at Visit 1.
Is breastfeeding or will (re)start breastfeeding from the study intervention administration to 3 months after study intervention administration.
Has any medical disease or psychiatric condition that, in the opinion of the investigator, precludes study participation because it would place the participant at an unacceptable risk of injury, would render them unable to meet the requirements of the protocol or may interfere with successful completion of the study.
Has any history of an immunosuppressive or immunodeficient condition resulting from disease.
Has used immunosuppressants or other immune-modifying drugs for 14 consecutive days or more within 3 months prior to the study intervention administration. Non-systemic corticosteroids are allowed. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration.
Has an acute medical illness or acute febrile illness with oral temperature ≥38.0°C or ≥100.4°F within 72 hours prior to study intervention administration.
Has participated in another study involving any investigational product, vaccine, or device within 28 days before the study intervention administration and/or planned participation through end of study (EoS).
Has participated in Part A of this study.
Has a history of hypersensitivity or severe allergic reaction including anaphylaxis, generalized urticaria, angioedema, and other significant reactions to any previous mRNA vaccine or any component of the study intervention(s).
Has received or plans to receive immunoglobulins or any blood or blood products within 3 months before study intervention administration through EoS.
Has a bleeding disorder, or prior history of significant bleeding or bruising following intramuscular injections.
Has a history of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
Has a 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 and persistent myocardial infection.
Has received a live vaccine 30 days before the study intervention administration or has a planned administration within 30 days after the study intervention administration.
Has received a non-replicating vaccine 8 days before the study intervention administration or has a planned administration within 14 days after the study intervention administration.
Has a documented history of confirmed SARS-CoV-2 infection within 3 months before study intervention administration.
Has had known close contact with anyone who had a confirmed SARS-CoV-2 infection within 2 weeks before study intervention administration.
Is an employee or family member of the investigator or study site staff.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
GSK Investigational Site
Sacramento
California
95864
United States
GSK Investigational Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Access Criteria
Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
A total of 692 participants were included in enrolled set out of which only 686 were included in exposed set and started the study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
FG001
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
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
Sep 26, 2023
Aug 29, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
This is an observer-blind study.
Who Masked
ParticipantInvestigatorOutcomes Assessor
Biological: Control vaccine
Part B: CV0801 mRNA COVID-19 vaccine (Maximum storage condition)
Experimental
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Maximum storage condition.
Biological: CV0801 mRNA COVID-19 Vaccine
Part B: CV0801 mRNA COVID-19 vaccine (Intermediate storage condition)
Experimental
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Intermediate storage condition.
Biological: CV0801 mRNA COVID-19 Vaccine
Part B: CV0801 mRNA COVID-19 vaccine (Baseline-control storage condition)
Experimental
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Baseline-control storage condition.
Biological: CV0801 mRNA COVID-19 Vaccine
CV0701 mRNA COVID-19 Vaccine (Medium dose)
Biological
Study vaccine was administered as a single intramuscular injection.
Part A: CV0701 mRNA COVID-19 Vaccine (Medium dose)
CV0701 mRNA COVID-19 Vaccine (High dose)
Biological
Study vaccine was administered as a single intramuscular injection.
Part A: CV0701 mRNA COVID-19 Vaccine (High dose)
CV0601 mRNA COVID-19 Vaccine
Biological
Study vaccine was administered as a single intramuscular injection.
Part A: CV0601 mRNA COVID-19 vaccine
Control vaccine
Biological
Study vaccine was administered as a single intramuscular injection.
Part A: Control Vaccine
CV0801 mRNA COVID-19 Vaccine
Biological
Study vaccine was administered as a single intramuscular injection.
Part B: CV0801 mRNA COVID-19 vaccine (Baseline-control storage condition)
Part B: CV0801 mRNA COVID-19 vaccine (Intermediate storage condition)
Part B: CV0801 mRNA COVID-19 vaccine (Maximum storage condition)
Day 1 to Day 28
Part A: Number of Participants Reporting Any Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)
An SAE refers to any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or extends existing hospitalization, causes persistent or significant disability/incapacity, involves a congenital anomaly/birth defect in a participant's offspring, includes an abnormal pregnancy outcome, or occurs in any other situation per the investigator's judgement.
An MAAE results in a visit to a medical professional, such as televisits, physician's office visits, urgent care visits, emergency rooms visits, or hospitalizations.
AESIs are severe or non-severe predefined AEs of scientific and medical concern specific to the product/program. This study noted the following AESIs: potential immune-mediated disease (pIMDs), lab-confirmed moderate to severe COVID-19, myocarditis and pericarditis, anaphylaxis, or severe hypersensitivity within 24 hours post-intervention. "Any" indicates the occurrence of the event regardless of its intensity grade.
Day 1 to Day 181
Part B: Number of Participants Reporting Any Solicited Administration Site AEs
Assessed solicited administration site events included injection site redness (erythema), pain, swelling and lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.
Day 1 to Day 7
Part B: Number of Participants Reporting Any Solicited Systemic AEs
Assessed solicited systemic events included fever, chills, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as body temperature >= 38ºC; preferred location for measuring the temperature is oral. Any = occurrence of the event regardless of intensity grade.
Day 1 to Day 7
Part B: Number of Participants Reporting Any Unsolicited AEs
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs. Any = occurrence of the event regardless of intensity grade.
Day 1 to Day 28
Part B: Number of Participants Reporting Any MAAEs, SAEs and AESIs
Day 1 to Day 181
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein
At Day 29, Day 91 and Day 181
Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein
Seroresponse is defined as post-booster titer greater than or equal to (≥) 4 times the lower limit of quantification (LLOQ) when pre-vaccination titer is below LLOQ or a post-booster titer ≥ 4 times the pre-booster titer when pre-vaccination titer is ≥ LLOQ.
At Day 29 compared to baseline (Day 1)
Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
Seroresponse is defined as post-booster titer ≥ 4 times the lower limit of quantification (LLOQ) when pre-vaccination titer is below LLOQ or a post-booster titer ≥ 4 times the pre-booster titer when pre-vaccination titer is ≥ LLOQ.
At Day 29 compared to baseline (Day 1)
Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein
Seroresponse is defined as post-booster titer ≥ 4 times the LLOQ when pre-vaccination titer is below LLOQ or a post-booster titer ≥ 4 times the pre-booster titer when pre-vaccination titer is ≥ LLOQ.
At Day 29 compared to baseline (Day 1)
Part A: Geometric Mean Increase (GMI) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein
GMI is defined as the the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer.
At Day 29, Day 91 and Day 181 compared to baseline (Day 1)
Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
GMI is defined as the the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer.
At Day 29, Day 91 and Day 181 compared to baseline (Day 1)
Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein
GMI is defined as the the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer.
At Day 29, Day 91 and Day 181 compared to baseline (Day 1)
Hollywood
Florida
33024
United States
GSK Investigational Site
Peoria
Illinois
61614-4896
United States
GSK Investigational Site
Bruce
Australian Capital Territory
2617
Australia
GSK Investigational Site
Blacktown
New South Wales
2148
Australia
GSK Investigational Site
Botany
New South Wales
2019
Australia
GSK Investigational Site
Brookvale
New South Wales
2100
Australia
GSK Investigational Site
Coffs Harbour
New South Wales
2450
Australia
GSK Investigational Site
Darlinghurst
New South Wales
2010
Australia
GSK Investigational Site
Kanwal
New South Wales
2259
Australia
GSK Investigational Site
Maroubra
New South Wales
2035
Australia
GSK Investigational Site
Merewether
New South Wales
2291
Australia
GSK Investigational Site
Blacktown
Queensland
4006
Australia
GSK Investigational Site
Sherwood
Queensland
4068
Australia
GSK Investigational Site
Tarragindi
Queensland
4075
Australia
GSK Investigational Site
Adelaide
South Australia
5000
Australia
GSK Investigational Site
Camberwell
Victoria
3124
Australia
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
FG002
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
FG003
Part A: CV0601 mRNA COVID-19 Vaccine
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
FG004
Part A: Control Vaccine
Participants received one dose of the control vaccine at Day 1.
FG005
Part B: CV0801 mRNA COVID-19 Vaccine (Maximum Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Maximum storage condition.
FG006
Part B: CV0801 mRNA COVID-19 Vaccine (Intermediate Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Intermediate storage condition.
FG007
Part B: CV0801 mRNA COVID-19 Vaccine (Baseline-control Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Baseline-control storage condition.
FG00087 subjects
FG00184 subjects
FG00284 subjects
FG00385 subjects
FG00485 subjects
FG00586 subjects
FG00687 subjects
FG00788 subjects
COMPLETED
FG00083 subjects
FG00183 subjects
FG00282 subjects
FG00382 subjects
FG00483 subjects
FG00585 subjects
FG00684 subjects
FG00785 subjects
NOT COMPLETED
FG0004 subjects
FG0011 subjects
FG0022 subjects
FG0033 subjects
FG0042 subjects
FG0051 subjects
FG0063 subjects
FG0073 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0003 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG0041 subjects
FG0051 subjects
FG0062 subjects
FG0073 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Early Withdrawal: Participant relocated and cannot attend the site
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
BG001
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
BG002
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
BG003
Part A: CV0601 mRNA COVID-19 Vaccine
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
BG004
Part A: Control Vaccine
Participants received one dose of the control vaccine at Day 1.
BG005
Part B: CV0801 mRNA COVID-19 Vaccine (Maximum Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Maximum storage condition.
BG006
Part B: CV0801 mRNA COVID-19 Vaccine (Intermediate Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Intermediate storage condition.
BG007
Part B: CV0801 mRNA COVID-19 Vaccine (Baseline-control Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Baseline-control storage condition.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00087
BG00184
BG00284
BG00385
BG00485
BG00586
BG00687
BG00788
BG008686
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
The Age Continuous analysis is presented separately for Part A and B.
Mean
Standard Deviation
Years
Title
Denominators
Categories
Part A
ParticipantsBG00087
ParticipantsBG00184
ParticipantsBG00284
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00087
ParticipantsBG00184
ParticipantsBG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Aboriginal Australian
ParticipantsBG00087
ParticipantsBG00184
ParticipantsBG002
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
Secondary
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein
Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XX spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 91 and Day 181
ID
Title
Description
OG000
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
OG001
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
OG002
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
OG003
Part A: CV0601 mRNA COVID-19 Vaccine
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
OG004
Part A: Control Vaccine
Participants received one dose of the control vaccine at Day 1.
Units
Counts
Participants
OG00071
OG00166
OG00273
OG003
Title
Denominators
Categories
Day 91
ParticipantsOG00071
ParticipantsOG00166
ParticipantsOG00273
ParticipantsOG003
Secondary
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XY spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 91 and Day 181
ID
Title
Description
OG000
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
OG001
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
OG002
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
OG003
Part A: CV0601 mRNA COVID-19 Vaccine
Secondary
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein
Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XZ spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 29, Day 91 and Day 181
ID
Title
Description
OG000
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
OG001
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
OG002
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
OG003
Part A: CV0601 mRNA COVID-19 Vaccine
Secondary
Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein
Seroresponse is defined as post-booster titer greater than or equal to (≥) 4 times the lower limit of quantification (LLOQ) when pre-vaccination titer is below LLOQ or a post-booster titer ≥ 4 times the pre-booster titer when pre-vaccination titer is ≥ LLOQ.
Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XX spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
Posted
Number
95% Confidence Interval
Percentage of participants
At Day 29 compared to baseline (Day 1)
ID
Title
Description
OG000
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
OG001
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
OG002
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
Secondary
Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
Seroresponse is defined as post-booster titer ≥ 4 times the lower limit of quantification (LLOQ) when pre-vaccination titer is below LLOQ or a post-booster titer ≥ 4 times the pre-booster titer when pre-vaccination titer is ≥ LLOQ.
Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XY spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
Posted
Number
95% Confidence Interval
Percentage of participants
At Day 29 compared to baseline (Day 1)
ID
Title
Description
OG000
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
OG001
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
OG002
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
Secondary
Part A: Percentage of Participants With Seroresponse of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein
Seroresponse is defined as post-booster titer ≥ 4 times the LLOQ when pre-vaccination titer is below LLOQ or a post-booster titer ≥ 4 times the pre-booster titer when pre-vaccination titer is ≥ LLOQ.
Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XZ spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
Posted
Number
95% Confidence Interval
Percentage of participants
At Day 29 compared to baseline (Day 1)
ID
Title
Description
OG000
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
OG001
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
OG002
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
Secondary
Part A: Geometric Mean Increase (GMI) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein
GMI is defined as the the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer.
Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XX spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
Posted
Geometric Mean
95% Confidence Interval
Ratio
At Day 29, Day 91 and Day 181 compared to baseline (Day 1)
ID
Title
Description
OG000
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
OG001
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
OG002
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
Secondary
Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
GMI is defined as the the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer.
Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XY spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
Posted
Geometric Mean
95% Confidence Interval
Ratio
At Day 29, Day 91 and Day 181 compared to baseline (Day 1)
ID
Title
Description
OG000
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
OG001
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
OG002
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
Secondary
Part A: GMI of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XZ Spike Protein
GMI is defined as the the geometric mean of the within participant ratios of the post-dose titer over the pre-dose titer.
Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XZ spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
Posted
Geometric Mean
95% Confidence Interval
Ratio
At Day 29, Day 91 and Day 181 compared to baseline (Day 1)
ID
Title
Description
OG000
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
OG001
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
OG002
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
Primary
Part A: Geometric Mean Titer (GMT) of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XX Spike Protein
Analysis was performed on the Per Protocol Set (PPS) which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XX spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 29
ID
Title
Description
OG000
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
OG001
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
OG002
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
OG003
Part A: CV0601 mRNA COVID-19 Vaccine
Primary
Part A: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XY spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 29
ID
Title
Description
OG000
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
OG001
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
OG002
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
OG003
Part A: CV0601 mRNA COVID-19 Vaccine
Primary
Part B: GMT of Serum Neutralization Titers Against Pseudovirus Bearing SARS-CoV-2 Strain XY Spike Protein
Analysis was performed on the PPS which includes all participants from the Exposed Set who were eligible, complied with vaccination as per protocol, and had anti-neutralizing titer against the SARS-CoV-2 strain XY spike protein. Only participants with data available for the specified analysis at the specified timepoints are included.
Posted
Geometric Mean
95% Confidence Interval
Titers
At Day 29
ID
Title
Description
OG000
Part B: CV0801 mRNA COVID-19 Vaccine (Baseline-control Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Baseline-control storage condition.
OG001
Part B: CV0801 mRNA COVID-19 Vaccine (Intermediate Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Intermediate storage condition.
OG002
Part B: CV0801 mRNA COVID-19 Vaccine (Maximum Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Maximum storage condition.
Primary
Part A: Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)
Assessed solicited administration site events included injection site redness (erythema), pain, swelling and lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.
Analysis was performed on the eDiary Set which includes all participants in the safety analysis set for whom eDiary data are available post-vaccination for the specified duration.
Posted
Count of Participants
Participants
Day 1 to Day 7
ID
Title
Description
OG000
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
OG001
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
OG002
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
Primary
Part A: Number of Participants Reporting Any Solicited Systemic AEs
Assessed solicited systemic events included fever, chills, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as body temperature is higher than or equal to (>=) 38ºC; preferred location for measuring the temperature is oral. Any = occurrence of the event regardless of intensity grade.
Analysis was performed on the eDiary Set which includes all participants in the safety analysis set for whom eDiary data are available post-vaccination for the specified duration.
Posted
Count of Participants
Participants
Day 1 to Day 7
ID
Title
Description
OG000
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
OG001
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
OG002
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
Primary
Part A: Number of Participants Reporting Any Unsolicited AEs
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs. Any = occurrence of the event regardless of intensity grade.
Analysis was performed on the Exposed Set (ES) which includes all participants who received the study intervention and had unsolicited AEs data available post-vaccination for the specified duration.
Posted
Count of Participants
Participants
Day 1 to Day 28
ID
Title
Description
OG000
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
OG001
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
OG002
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
Primary
Part A: Number of Participants Reporting Any Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)
An SAE refers to any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or extends existing hospitalization, causes persistent or significant disability/incapacity, involves a congenital anomaly/birth defect in a participant's offspring, includes an abnormal pregnancy outcome, or occurs in any other situation per the investigator's judgement.
An MAAE results in a visit to a medical professional, such as televisits, physician's office visits, urgent care visits, emergency rooms visits, or hospitalizations.
AESIs are severe or non-severe predefined AEs of scientific and medical concern specific to the product/program. This study noted the following AESIs: potential immune-mediated disease (pIMDs), lab-confirmed moderate to severe COVID-19, myocarditis and pericarditis, anaphylaxis, or severe hypersensitivity within 24 hours post-intervention. "Any" indicates the occurrence of the event regardless of its intensity grade.
Analysis was performed on the ES which includes all participants who received the study intervention and had post-vaccination data available for the specified duration.
Posted
Count of Participants
Participants
Day 1 to Day 181
ID
Title
Description
OG000
Part A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
OG001
Primary
Part B: Number of Participants Reporting Any Solicited Administration Site AEs
Assessed solicited administration site events included injection site redness (erythema), pain, swelling and lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.
Analysis was performed on the eDiary Set which includes all participants in the safety analysis set for whom eDiary data are available post-vaccination for the specified duration.
Posted
Count of Participants
Participants
Day 1 to Day 7
ID
Title
Description
OG000
Part B: CV0801 mRNA COVID-19 Vaccine (Maximum Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Maximum storage condition.
OG001
Part B: CV0801 mRNA COVID-19 Vaccine (Intermediate Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Intermediate storage condition.
OG002
Part B: CV0801 mRNA COVID-19 Vaccine (Baseline-control Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Baseline-control storage condition.
Primary
Part B: Number of Participants Reporting Any Solicited Systemic AEs
Assessed solicited systemic events included fever, chills, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as body temperature >= 38ºC; preferred location for measuring the temperature is oral. Any = occurrence of the event regardless of intensity grade.
Analysis was performed on the eDiary Set which includes all participants in the safety analysis set for whom eDiary data are available post-vaccination for the specified duration.
Posted
Count of Participants
Participants
Day 1 to Day 7
ID
Title
Description
OG000
Part B: CV0801 mRNA COVID-19 Vaccine (Maximum Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Maximum storage condition.
OG001
Part B: CV0801 mRNA COVID-19 Vaccine (Intermediate Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Intermediate storage condition.
OG002
Part B: CV0801 mRNA COVID-19 Vaccine (Baseline-control Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Baseline-control storage condition.
Primary
Part B: Number of Participants Reporting Any Unsolicited AEs
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs. Any = occurrence of the event regardless of intensity grade.
Analysis was performed on the ES which includes all participants who received the study intervention and had unsolicited AEs data available post-vaccination for the specified duration.
Posted
Count of Participants
Participants
Day 1 to Day 28
ID
Title
Description
OG000
Part B: CV0801 mRNA COVID-19 Vaccine (Maximum Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Maximum storage condition.
OG001
Part B: CV0801 mRNA COVID-19 Vaccine (Intermediate Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Intermediate storage condition.
OG002
Part B: CV0801 mRNA COVID-19 Vaccine (Baseline-control Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Baseline-control storage condition.
Primary
Part B: Number of Participants Reporting Any MAAEs, SAEs and AESIs
Analysis was performed on the ES which includes all participants who received the study intervention and had post-vaccination data available for the specified duration.
Posted
Count of Participants
Participants
Day 1 to Day 181
ID
Title
Description
OG000
Part B: CV0801 mRNA COVID-19 Vaccine (Maximum Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Maximum storage condition.
OG001
Part B: CV0801 mRNA COVID-19 Vaccine (Intermediate Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Intermediate storage condition.
OG002
Part B: CV0801 mRNA COVID-19 Vaccine (Baseline-control Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Baseline-control storage condition.
Units
Counts
Participants
Time Frame
Part A and Part B: Solicited AEs from Day 1 to Day 7; Unsolicited AEs from Day 1 to Day 28; SAEs, MAAEs and AESIs from Day 1 to Day 181
Description
Not provided
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 A: CV0701 mRNA COVID-19 Vaccine (Low Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1.
0
87
3
87
64
87
EG001
Part A: CV0701 mRNA COVID-19 Vaccine (Medium Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1.
0
84
0
84
68
84
EG002
Part A: CV0701 mRNA COVID-19 Vaccine (High Dose)
Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1.
0
84
3
84
72
84
EG003
Part A: CV0601 mRNA COVID-19 Vaccine
Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1.
0
85
1
85
62
85
EG004
Part A: Control Vaccine
Participants received one dose of the control vaccine at Day 1.
0
85
3
85
75
85
EG005
Part B: CV0801 mRNA COVID-19 Vaccine (Maximum Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Maximum storage condition.
0
86
2
86
62
86
EG006
Part B: CV0801 mRNA COVID-19 Vaccine (Intermediate Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Intermediate storage condition.
0
87
2
87
55
87
EG007
Part B: CV0801 mRNA COVID-19 Vaccine (Baseline-control Storage Condition)
Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Baseline-control storage condition.
0
88
4
88
65
88
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Coronary artery disease
Cardiac disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0021 events1 affected84 at risk
EG0030 events0 affected85 at risk
EG0040 events0 affected85 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected87 at risk
EG0070 events0 affected88 at risk
Abdominal pain
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Biliary colic
Hepatobiliary disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Hepatic cyst
Hepatobiliary disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Abscess limb
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Endocarditis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Infective exacerbation of chronic obstructive airways disease
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Ophthalmic herpes simplex
Infections and infestations
v27.0
Systematic Assessment
EG0001 events1 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Rhinovirus infection
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0001 events1 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Malignant melanoma in situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0021 events1 affected84 at risk
EG003
Syncope
Nervous system disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Mixed anxiety and depressive disorder
Psychiatric disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Suicidal ideation
Psychiatric disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
v27.0
Systematic Assessment
EG0001 events1 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Endometrial hyperplasia with cellular atypia
Reproductive system and breast disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0021 events1 affected84 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Iron deficiency anaemia
Blood and lymphatic system disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0011 events1 affected84 at risk
EG0020 events0 affected84 at risk
EG0030 events0 affected85 at risk
EG0040 events0 affected85 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected87 at risk
EG0070 events0 affected88 at risk
Lymphadenopathy
Blood and lymphatic system disorders
v27.0
Systematic Assessment
EG0007 events7 affected87 at risk
EG00110 events10 affected84 at risk
EG00215 events15 affected84 at risk
EG003
Palpitations
Cardiac disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Conjunctivitis allergic
Eye disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0011 events1 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Constipation
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Diarrhoea
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0001 events1 affected87 at risk
EG0010 events0 affected84 at risk
EG0021 events1 affected84 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0011 events1 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0011 events1 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0011 events1 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Nausea
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0021 events1 affected84 at risk
EG003
Toothache
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Vomiting
Gastrointestinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Chest discomfort
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0011 events1 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Chills
General disorders
v27.0
Systematic Assessment
EG0005 events5 affected87 at risk
EG0019 events9 affected84 at risk
EG00211 events11 affected84 at risk
EG003
Fatigue
General disorders
v27.0
Systematic Assessment
EG00030 events30 affected87 at risk
EG00127 events27 affected84 at risk
EG00240 events40 affected84 at risk
EG003
Fever
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0011 events1 affected84 at risk
EG0022 events2 affected84 at risk
EG003
Injection site erythema
General disorders
v27.0
Systematic Assessment
EG0002 events2 affected87 at risk
EG0013 events3 affected84 at risk
EG0022 events2 affected84 at risk
EG003
Injection site pain
General disorders
v27.0
Systematic Assessment
EG00034 events34 affected87 at risk
EG00146 events46 affected84 at risk
EG00253 events53 affected84 at risk
EG003
Injection site pruritus
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Injection site swelling
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0011 events1 affected84 at risk
EG0023 events3 affected84 at risk
EG003
Non-cardiac chest pain
General disorders
v27.0
Systematic Assessment
EG0001 events1 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Polyp
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0021 events1 affected84 at risk
EG003
Vessel puncture site bruise
General disorders
v27.0
Systematic Assessment
EG0001 events1 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Vessel puncture site haematoma
General disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0011 events1 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Seasonal allergy
Immune system disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0011 events1 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Bronchitis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
COVID-19
Infections and infestations
v27.0
Systematic Assessment
EG00010 events10 affected87 at risk
EG0015 events5 affected84 at risk
EG0028 events8 affected84 at risk
EG003
Carbuncle
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Conjunctivitis viral
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0011 events1 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Cystitis
Infections and infestations
v27.0
Systematic Assessment
EG0001 events1 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Diverticulitis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Folliculitis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Gastroenteritis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0011 events1 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Gingivitis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Herpes zoster
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Lower respiratory tract infection bacterial
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0021 events1 affected84 at risk
EG003
Nasopharyngitis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Oral herpes
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Respiratory tract infection
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0011 events1 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Respiratory tract infection viral
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0011 events1 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Rhinitis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0022 events2 affected84 at risk
EG003
Rhinovirus infection
Infections and infestations
v27.0
Systematic Assessment
EG0001 events1 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Sinusitis
Infections and infestations
v27.0
Systematic Assessment
EG0001 events1 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Staphylococcal skin infection
Infections and infestations
v27.0
Systematic Assessment
EG0001 events1 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Suspected COVID-19
Infections and infestations
v27.0
Systematic Assessment
EG0001 events1 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Syphilis
Infections and infestations
v27.0
Systematic Assessment
EG0001 events1 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Tonsillitis
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0021 events1 affected84 at risk
EG003
Tooth infection
Infections and infestations
v27.0
Systematic Assessment
EG0001 events1 affected87 at risk
EG0010 events0 affected84 at risk
EG0021 events1 affected84 at risk
EG003
Upper respiratory tract infection
Infections and infestations
v27.0
Systematic Assessment
EG0002 events2 affected87 at risk
EG0016 events5 affected84 at risk
EG0021 events1 affected84 at risk
EG003
Urinary tract infection
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0011 events1 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Wound infection
Infections and infestations
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Contusion
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Fall
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0021 events1 affected84 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0001 events1 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Muscle rupture
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0021 events1 affected84 at risk
EG003
Post-traumatic pain
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Suture related complication
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0021 events1 affected84 at risk
EG003
Tendon injury
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0021 events1 affected84 at risk
EG003
Tooth injury
Injury, poisoning and procedural complications
v27.0
Systematic Assessment
EG0001 events1 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Blood magnesium decreased
Investigations
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Blood pressure systolic increased
Investigations
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Smear cervix abnormal
Investigations
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Vitamin D decreased
Investigations
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0022 events2 affected84 at risk
EG003
Vitamin B12 deficiency
Metabolism and nutrition disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0009 events9 affected87 at risk
EG0017 events7 affected84 at risk
EG00214 events14 affected84 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0011 events1 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0001 events1 affected87 at risk
EG0011 events1 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG00014 events14 affected87 at risk
EG00121 events21 affected84 at risk
EG00235 events35 affected84 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0011 events1 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0021 events1 affected84 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0021 events1 affected84 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0001 events1 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0001 events1 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Tendon pain
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v27.0
Systematic Assessment
EG0001 events1 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Bowen's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Skin cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0011 events1 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Diabetic neuropathy
Nervous system disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Disturbance in attention
Nervous system disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0011 events1 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Dizziness
Nervous system disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0011 events1 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Dysgeusia
Nervous system disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Headache
Nervous system disorders
v27.0
Systematic Assessment
EG00020 events20 affected87 at risk
EG00130 events30 affected84 at risk
EG00237 events37 affected84 at risk
EG003
Lethargy
Nervous system disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0011 events1 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Migraine
Nervous system disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Transient aphasia
Nervous system disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Depression
Psychiatric disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Insomnia
Psychiatric disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0021 events1 affected84 at risk
EG003
Irritability
Psychiatric disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0011 events1 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Nightmare
Psychiatric disorders
v27.0
Systematic Assessment
EG0001 events1 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Panic attack
Psychiatric disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Sleep disorder
Psychiatric disorders
v27.0
Systematic Assessment
EG0001 events1 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Intermenstrual bleeding
Reproductive system and breast disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0011 events1 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0001 events1 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0012 events1 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0002 events2 affected87 at risk
EG0010 events0 affected84 at risk
EG0021 events1 affected84 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
v27.0
Systematic Assessment
EG0001 events1 affected87 at risk
EG0011 events1 affected84 at risk
EG0021 events1 affected84 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0001 events1 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0012 events1 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Miliaria
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0001 events1 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Nail bed bleeding
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0001 events1 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
v27.0
Systematic Assessment
EG0000 events0 affected87 at risk
EG0010 events0 affected84 at risk
EG0021 events1 affected84 at risk
EG003
Hypertension
Vascular disorders
v27.0
Systematic Assessment
EG0001 events1 affected87 at risk
EG0010 events0 affected84 at risk
EG0020 events0 affected84 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.