Dose-Finding Trial to Evaluate the Safety and Immunogenic... | NCT04232280 | Trialant
NCT04232280
Sponsor
ModernaTX, Inc.
Status
Completed
Last Update Posted
May 5, 2026Actual
Enrollment
315Actual
Phase
Phase 2
Conditions
Cytomegalovirus Infection
Interventions
mRNA-1647
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT04232280
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
mRNA-1647-P202
Secondary IDs
Not provided
Brief Title
Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 in Healthy Adults
Official Title
A Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus Vaccine mRNA-1647 in Healthy Adults
Acronym
Not provided
Organization
ModernaTX, Inc.INDUSTRY
Status Module
Record Verification Date
May 2026
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
Jan 9, 2020Actual
Primary Completion Date
Jan 4, 2023Actual
Completion Date
Jan 4, 2023Actual
First Submitted Date
Jan 9, 2020
First Submission Date that Met QC Criteria
Jan 14, 2020
First Posted Date
Jan 18, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Dec 18, 2025
Results First Submitted that Met QC Criteria
May 1, 2026
Results First Posted Date
May 5, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Dec 29, 2023
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
May 5, 2026Actual
Last Update Submitted Date
May 1, 2026
Last Update Posted Date
May 5, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ModernaTX, Inc.INDUSTRY
Collaborators
Not provided
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
This clinical study will assess the safety and immunogenicity of 3 dose levels of mRNA-1647 cytomegalovirus vaccine in CMV-seronegative and CMV-seropositive healthy adults 18-40 years of age.
Detailed Description
mRNA-1647-P202 is a 2-part study. Part 1 of the study evaluates the safety and immunogenicity of 3 dose levels of mRNA-1647 vaccine or placebo, administered on a 0, 2, 6-month schedule in healthy CMV-seronegative and CMV-seropositive males and females, 18 to 40 years of age. A planned interim analysis of safety and immunogenicity through Month 3 (1 month after the second dose) of Part 1 of the study informed the selection of the middle dose level for further development. Part 2 of the study is designed to further evaluate the safety and immunogenicity of the middle dose level of mRNA-1647 vaccine or placebo on a 0, 2, 6-month schedule in approximately 200 healthy participants 18 to 40 years of age, comprised of CMV-seronegative and CMV-seropositive female population, which includes the target population for the pivotal Phase 3 efficacy trial.
Conditions Module
Conditions
Cytomegalovirus Infection
Keywords
Moderna
mRNA-1647
Cytomegalovirus
CMV
Cytomegalovirus Vaccine
Cytomegalovirus Infections
Cytomegalovirus Congenital
Virus Diseases
Infection Viral
DNA Virus Infections
Messenger RNA
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
315Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
mRNA-1647 Dose Level A
Experimental
Participants will receive mRNA-1647 vaccine at Dose Level A by intramuscular (IM) injection on Day 1, Day 56, and Day 168.
Biological: mRNA-1647
mRNA-1647 Dose Level B
Experimental
Participants will receive mRNA-1647 vaccine at Dose Level B by IM injection on Day 1, Day 56, and Day 168.
Biological: mRNA-1647
mRNA-1647 Dose Level C
Experimental
Participants will receive mRNA-1647 vaccine at Dose Level C by IM injection on Day 1, Day 56, and Day 168.
Biological: mRNA-1647
Placebo
Placebo Comparator
Participants will receive placebo matching to the mRNA-1647 vaccine dose by IM injection on Day 1, Day 56, and Day 168.
Other: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
mRNA-1647
Biological
Lyophilized product that is reconstituted with saline then diluted with a special diluent to reach the desired concentration
mRNA-1647 Dose Level A
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Solicited ARs were selected signs and symptoms occurring after vaccination administration during a specified post-vaccination follow-up period. The occurrence and intensity of the selected signs and symptoms was actively solicited from the participant during a specified post-vaccination follow-up period (day of vaccination and 6 subsequent days), using a predefined checklist in the electronic diary. The following local ARs were solicited: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the vaccination arm. The following systemic ARs were solicited: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, fever, and chills. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Up to Day 175 (7 days following last dose administration)
Number of Participants With Unsolicited Adverse Events (AEs)
An unsolicited AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The treatment-emergent AEs are defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section."
Up to Day 196 (28 days following last dose administration)
Number of Participants With Medically Attended Adverse Events (MAAEs)
An MAAE is an AE that lead to a visit to a healthcare practitioner (HCP). This would include visits to study clinic for unscheduled assessments (for example, rash assessment, abnormal laboratory follow-up), and visits to HCPs external to the clinical site (for example, urgent care, primary care physician). A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section."
Secondary Outcomes
Measure
Description
Time Frame
GMT of Anti-Glycoprotein B (gB)-Specific Immunoglobulin G (IgG) and Anti-Pentamer-specific IgG as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) of Post-Baseline/Baseline Titers
Blood samples for antibody-mediated immunogenicity were collected during protocol-specified study visits. Serological assessment for anti-gB-specific IgG and anti-pentameric gH/gL/UL128/UL130/UL131A glycoprotein complex (Pentamer)-specific IgG binding was measured with ELISA. The GMT measures the level of inhibition of anti-gB-specific IgG (anti-gB) and anti-Pentamer-specific IgG (anti-Pentamer) against cytomegalovirus. Results are reported as fold dilution (titer). GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female 18-40 years of age (Part 1); Female 18-40 years of age (Part 2)
Understands and agrees to comply with the trial procedures and provides written informed consent
According to the assessment of the Investigator, is in good general health and is capable of complying with trial procedures
Body mass index (BMI) 18-35 kilograms/meter (kg/m^2)
Female participants must either be of non-childbearing potential or use acceptable methods of contraception from at least 28 days prior to the first vaccination and through 3 months following last vaccination and is not breastfeeding.
Male participants must agree to practice adequate contraception from the time of the first vaccination and through 3 months after the last vaccination.
Exclusion Criteria:
Acutely ill or febrile on the day of the first vaccination
Prior receipt of any CMV vaccine
Abnormal screening safety laboratory test results
Diagnosis or condition that, in the judgment of Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to trial procedures
Has received or plans to receive a vaccine ≤28 days prior to the first vaccination or plans to receive a non-study vaccine within 28 days prior to or after any study vaccination, except for any licensed influenza vaccine which can be administered >14 days before or after any study vaccination. COVID-19 vaccines (regardless of manufacturer) may be administered >7 days but preferably >14 days before or after any study vaccination, with the intention of prioritizing COVID-19 vaccination over all other considerations.
Prior receipt of chronic systemic immunosuppressants or immune-modifying drugs
Receipt of intravenous immunoglobulins or plasma products within 3 months prior to the day of the first study vaccination
Previous receipt of medications in lipid nanoparticle (LNP) formulation (Part 1 participants only)
Has donated ≥450 milliliters (mL) of blood products within 28 days of the Screening visit
Participated in an interventional clinical trial within 28 days prior to the day of enrollment
Is an immediate family member or household member of trial personnel
Galiza EP, Khalil A, Heath PT. Update on Vaccines in Antenatal Care. Pediatr Infect Dis J. 2024 Feb 1;43(2):e60-e62. doi: 10.1097/INF.0000000000004183. Epub 2023 Dec 27. No abstract available.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Data were collected based on participant serostatus and the treatment group to which the participant was randomized regardless of the part of the study.
Recruitment Details
mRNA-1647-P202 was a 2-part study. For Part 1, participants were randomized to receive 1 of 3 dose levels (50, 100, 150 micrograms [ug]) of the mRNA-1647 vaccine and placebo in CMV-seronegative and CMV-seropositive male and female participants.
For Part 2, new female participants (that is, did not participate in Part 1) who were either CMV-seronegative or CMV-seropositive were randomized to receive either the mRNA-1647 vaccine (100 ug) or placebo.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Seronegative mRNA-1647 (50 ug)
Cytomegalovirus (CMV)-seronegative participants received mRNA-1647 (50 ug) by intramuscular (IM) injection on Day 1, Day 56, and Day 168.
FG001
Seronegative mRNA-1647 (100 ug)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Randomized Set: all participants who were randomized in the study, regardless of the participant's treatment status in the study. Participants were included in the treatment group to which they were randomized.
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
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
May 27, 2021
Dec 18, 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
MeSH Terms
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Observer-Blind
Who Masked
ParticipantInvestigator
mRNA-1647 Dose Level B
mRNA-1647 Dose Level C
Placebo
Other
0.9% sodium chloride (normal saline) injection
Placebo
Up to Day 336 (6 months following last dose administration)
Number of Participants With Serious Adverse Events (SAEs)
An SAE was defined as any untoward medical occurrence that, in the view of either the Investigator or the Sponsor, resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization (hospitalization or prolongation of hospitalization in the absence of a precipitating event was not in itself an SAE), resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section."
Up to Day 504 (1 year following last dose administration)
Geometric Mean Titer (GMT) of Serum Neutralizing Anti-CMV Antibodies Against Epithelial Cell Infection and Against Fibroblast Infection
Blood samples for antibody-mediated immunogenicity (AMI) analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV neutralizing antibody titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. Results are reported as fold dilution (titer). GMT 95% confidence interval (CI) was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Baseline (Day 1), Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
Geometric Mean Ratio (GMR) of Serum Neutralizing Anti-CMV Antibodies Against Epithelial Cell Infection and Against Fibroblast Infection
Blood samples for antibody-mediated immunogenicity analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV neutralizing antibody titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. The GMR measures the changes in immunogenicity titers within participants. Results are reported as a ratio (post-baseline/baseline titers). GMR 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
Percentage of Participants With ≥2-Fold, 3-Fold, and 4-Fold Increases in Neutralizing Antibodies (nAb) Over Baseline Against Epithelial Cell Infection and Against Fibroblast Infection
Blood samples for antibody-mediated immunogenicity analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV nAb titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. A ≥z-fold increase from baseline at participant level was defined as a ≥z * the lower limit of quantification (LLOQ) for participants with baseline antibody level below the LLOQ, or a z-times or higher-level ratio in participants with baseline antibody level equal to or above the LLOQ. LLOQ=16. Results are reported as percentage of participants with ≥2-fold, 3-fold, and 4-fold increases in serum anti-CMV nAb titers from baseline. 95% CI for percentage is calculated using the Clopper-Pearson method.
Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
Baseline (Day 1), Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
GMR of Anti-gB-specific IgG and Anti-Pentamer-specific IgG as Measured by ELISA of Post-Baseline/Baseline Titers
Blood samples for antibody-mediated immunogenicity were collected during protocol-specified study visits. Serological assessment for anti-gB-specific IgG and anti-Pentamer-specific IgG binding was measured with ELISA. The GMR measures the changes in immunogenicity titers within participants. Results are reported as a ratio (post-baseline/baseline titers). GMR 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation. Number Analyzed = participants who were evaluable at specified timepoints.
Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
GMT of Serum nAb Against Epithelial Cell Infection and Against Fibroblast Infection at Each Timepoint, in the CMV-Seropositive Group and in the CMV-Seronegative Group
Blood samples for antibody-mediated immunogenicity analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV nAb titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. Results are reported as fold dilution (titer). GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Baseline (Day 1), Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
GMR of Serum nAb Against Epithelial Cell Infection and Against Fibroblast Infection at Each Timepoint, in the CMV-Seropositive Group and in the CMV-Seronegative Group
Blood samples for antibody-mediated immunogenicity analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV nAb titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. The GMR measures the changes in immunogenicity titers within participants. Results are reported as a ratio (post-baseline/baseline titers). GMR 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
Percentage of Participants With ≥2-Fold, 3-Fold, and 4-Fold Increases Over Baseline of Serum nAb Against Epithelial Cell Infection and Against Fibroblast Infection in the CMV-Seropositive and CMV-Seronegative Groups
Blood samples for antibody-mediated immunogenicity analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV nAb titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. A ≥z-fold increase from baseline at participant level was defined as a ≥z * the LLOQ for participants with baseline antibody level below the LLOQ, or a z-times or higher-level ratio in participants with baseline antibody level equal to or above the LLOQ. LLOQ=16. Results are reported as percentage of participants with ≥2-fold, 3-fold, and 4-fold increases in serum anti-CMV nAb titers from baseline. 95% CI for percentage is calculated using the Clopper-Pearson method.
Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
GMT of Antigen-Specific IgG (ELISA) at Each Timepoint in the CMV-Seropositive and CMV-Seronegative Groups
Blood samples for antibody-mediated immunogenicity were collected during protocol-specified study visits. Serological assessment for anti-gB-specific IgG and anti-Pentamer-specific IgG binding was measured with ELISA. Results are reported as fold dilution (titer). GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Baseline (Day 1), Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
GMR of Antigen-Specific IgG (ELISA) at Each Timepoint in the CMV-Seropositive and CMV-Seronegative Groups
Blood samples for antibody-mediated immunogenicity were collected during protocol-specified study visits. Serological assessment for anti-gB-specific IgG and anti-Pentamer-specific IgG binding was measured with ELISA. The GMR measures the changes in immunogenicity titers within participants. Results are reported as a ratio (post-baseline/baseline titers). GMR 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
Peoria
Illinois
61614
United States
Johnson County Clin-Trials
Lenexa
Kansas
66219
United States
Alliance for Multispecialty Research
Lexington
Kentucky
40509
United States
Aventiv Research Inc
Columbus
Ohio
43213-6523
United States
Tekton Research Inc
Austin
Texas
78745
United States
Crossroads Clinical Research
Victoria
Texas
77901
United States
Foothill Family Clinic
Salt Lake City
Utah
84109
United States
Foothill Family Clinic-South Clinic
Salt Lake City
Utah
84121
United States
CMV-seronegative participants received mRNA-1647 (100 ug) by IM injection on Day 1, Day 56, and Day 168.
FG002
Seronegative mRNA-1647 (150 ug)
CMV-seronegative participants received mRNA-1647 (150 ug) by IM injection on Day 1, Day 56, and Day 168.
FG003
Seronegative Placebo
CMV-seronegative participants received a placebo-matching IM injection on Day 1, Day 56, and Day 168.
FG004
Seropositive mRNA-1647 (50 ug)
CMV-seropositive participants received mRNA-1647 (50 ug) by IM injection on Day 1, Day 56, and Day 168.
FG005
Seropositive mRNA-1647 (100 ug)
CMV-seropositive participants received mRNA-1647 (100 ug) by IM injection on Day 1, Day 56, and Day 168.
FG006
Seropositive mRNA-1647 (150 ug)
CMV-seropositive participants received mRNA-1647 (150 ug) by IM injection on Day 1, Day 56, and Day 168.
FG007
Seropositive Placebo
CMV-seropositive participants received a placebo-matching IM injection on Day 1, Day 56, and Day 168.
FG00045 subjects
FG00173 subjects
FG00245 subjects
FG00355 subjects
FG00418 subjects
FG00536 subjects
FG00618 subjects
FG00725 subjects
Received At Least 1 Dose Of Study Drug
FG00045 subjects
FG00173 subjects
FG00245 subjects
FG00355 subjects
FG00418 subjects
FG00536 subjects
FG00618 subjects
FG00725 subjects
Safety Set
All randomized participants who received any study vaccination. Safety data were collected based on the treatment a participant received, regardless of the part of the study.
FG00045 subjects
FG00172 subjects
FG00245 subjects
FG00353 subjects
FG00418 subjects
FG00537 subjects
FG00618 subjects
FG00727 subjects
Full Analysis Set (FAS)
Participants who a) received any study injection, b) had baseline (Day 1) data available for those analyses that required baseline data, and c) had at least 1 post-injection assessment for the analysis endpoint. Participants were included in the injection group to which they were randomized.
FG00045 subjects
FG00168 subjects
FG00245 subjects
FG00355 subjects
FG00415 subjects
FG00534 subjects
FG00617 subjects
FG00723 subjects
Part 1 Participants
FG00045 subjects
FG00145 subjects
FG00245 subjects
FG00345 subjects
FG00418 subjects
FG00518 subjects
FG00618 subjects
FG00718 subjects
Part 2 (Female Participants Only)
FG0000 subjects
FG00128 subjects
FG0020 subjects
FG00310 subjects
FG0040 subjects
FG00518 subjects
FG0060 subjects
FG0077 subjects
COMPLETED
FG00034 subjects
FG00152 subjects
FG00235 subjects
FG00347 subjects
FG00415 subjects
FG00528 subjects
FG00613 subjects
FG00718 subjects
NOT COMPLETED
FG00011 subjects
FG00121 subjects
FG00210 subjects
FG0038 subjects
FG0043 subjects
FG0058 subjects
FG0065 subjects
FG0077 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0006 subjects
FG00114 subjects
FG0026 subjects
FG0034 subjects
FG0040 subjects
FG0055 subjects
FG0063 subjects
FG0074 subjects
Lost to Follow-up
FG0004 subjects
FG0016 subjects
FG0023 subjects
FG0034 subjects
FG004
Participant No Longer Eligible
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Non-compliance
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Randomized Set: all participants who were randomized in the study, regardless of the participant's treatment status in the study. Participants were included in the treatment group to which they were randomized.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Seronegative mRNA-1647 (50 ug)
CMV-seronegative participants received mRNA-1647 (50 ug) by IM injection on Day 1, Day 56, and Day 168.
BG001
Seronegative mRNA-1647 (100 ug)
CMV-seronegative participants received mRNA-1647 (100 ug) by IM injection on Day 1, Day 56, and Day 168.
BG002
Seronegative mRNA-1647 (150 ug)
CMV-seronegative participants received mRNA-1647 (150 ug) by IM injection on Day 1, Day 56, and Day 168.
BG003
Seronegative Placebo
CMV-seronegative participants received a placebo-matching IM injection on Day 1, Day 56, and Day 168.
BG004
Seropositive mRNA-1647 (50 ug)
CMV-seropositive participants received mRNA-1647 (50 ug) by IM injection on Day 1, Day 56, and Day 168.
BG005
Seropositive mRNA-1647 (100 ug)
CMV-seropositive participants received mRNA-1647 (100 ug) by IM injection on Day 1, Day 56, and Day 168.
BG006
Seropositive mRNA-1647 (150 ug)
CMV-seropositive participants received mRNA-1647 (150 ug) by IM injection on Day 1, Day 56, and Day 168.
BG007
Seropositive Placebo
CMV-seropositive participants received a placebo-matching IM injection on Day 1, Day 56, and Day 168.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00045
BG00173
BG00245
BG00355
BG00418
BG00536
BG00618
BG00725
BG008315
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
BG00029.6± 7.07
BG00128.6± 6.88
BG00228.7± 6.10
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00021
BG00150
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0005
BG00112
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Solicited ARs were selected signs and symptoms occurring after vaccination administration during a specified post-vaccination follow-up period. The occurrence and intensity of the selected signs and symptoms was actively solicited from the participant during a specified post-vaccination follow-up period (day of vaccination and 6 subsequent days), using a predefined checklist in the electronic diary. The following local ARs were solicited: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the vaccination arm. The following systemic ARs were solicited: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, fever, and chills. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Solicited Safety Set: All participants who were randomized, received any study vaccination, and contributed any solicited AR data. Safety data were collected based on the treatment a participant received, regardless of the part of the study.
Posted
Count of Participants
Participants
Up to Day 175 (7 days following last dose administration)
ID
Title
Description
OG000
Seronegative mRNA-1647 (50 ug)
CMV-seronegative participants received mRNA-1647 (50 ug) by IM injection on Day 1, Day 56, and Day 168.
OG001
Seronegative mRNA-1647 (100 ug)
CMV-seronegative participants received mRNA-1647 (100 ug) by IM injection on Day 1, Day 56, and Day 168.
OG002
Seronegative mRNA-1647 (150 ug)
CMV-seronegative participants received mRNA-1647 (150 ug) by IM injection on Day 1, Day 56, and Day 168.
OG003
Seronegative Placebo
CMV-seronegative participants received a placebo-matching IM injection on Day 1, Day 56, and Day 168.
OG004
Seropositive mRNA-1647 (50 ug)
CMV-seropositive participants received mRNA-1647 (50 ug) by IM injection on Day 1, Day 56, and Day 168.
OG005
Seropositive mRNA-1647 (100 ug)
CMV-seropositive participants received mRNA-1647 (100 ug) by IM injection on Day 1, Day 56, and Day 168.
OG006
Seropositive mRNA-1647 (150 ug)
CMV-seropositive participants received mRNA-1647 (150 ug) by IM injection on Day 1, Day 56, and Day 168.
OG007
Seropositive Placebo
Units
Counts
Participants
OG00045
OG00172
OG00245
OG003
Title
Denominators
Categories
After First Vaccination: Solicited Local ARs
ParticipantsOG00045
ParticipantsOG00172
ParticipantsOG00245
ParticipantsOG003
Primary
Number of Participants With Unsolicited Adverse Events (AEs)
An unsolicited AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. The treatment-emergent AEs are defined as any event not present before exposure to study drug or any event already present that worsened in intensity or frequency after exposure. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section."
Safety Set: All randomized participants who received any study vaccination. Safety data were collected based on the treatment a participant received, regardless of the part of the study.
Posted
Count of Participants
Participants
Up to Day 196 (28 days following last dose administration)
ID
Title
Description
OG000
Seronegative mRNA-1647 (50 ug)
CMV-seronegative participants received mRNA-1647 (50 ug) by IM injection on Day 1, Day 56, and Day 168.
OG001
Seronegative mRNA-1647 (100 ug)
CMV-seronegative participants received mRNA-1647 (100 ug) by IM injection on Day 1, Day 56, and Day 168.
OG002
Seronegative mRNA-1647 (150 ug)
CMV-seronegative participants received mRNA-1647 (150 ug) by IM injection on Day 1, Day 56, and Day 168.
Primary
Number of Participants With Medically Attended Adverse Events (MAAEs)
An MAAE is an AE that lead to a visit to a healthcare practitioner (HCP). This would include visits to study clinic for unscheduled assessments (for example, rash assessment, abnormal laboratory follow-up), and visits to HCPs external to the clinical site (for example, urgent care, primary care physician). A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section."
Safety Set: All randomized participants who received any study vaccination. Safety data were collected based on the treatment a participant received, regardless of the part of the study.
Posted
Count of Participants
Participants
Up to Day 336 (6 months following last dose administration)
ID
Title
Description
OG000
Seronegative mRNA-1647 (50 ug)
CMV-seronegative participants received mRNA-1647 (50 ug) by IM injection on Day 1, Day 56, and Day 168.
OG001
Seronegative mRNA-1647 (100 ug)
CMV-seronegative participants received mRNA-1647 (100 ug) by IM injection on Day 1, Day 56, and Day 168.
OG002
Seronegative mRNA-1647 (150 ug)
CMV-seronegative participants received mRNA-1647 (150 ug) by IM injection on Day 1, Day 56, and Day 168.
Primary
Number of Participants With Serious Adverse Events (SAEs)
An SAE was defined as any untoward medical occurrence that, in the view of either the Investigator or the Sponsor, resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization (hospitalization or prolongation of hospitalization in the absence of a precipitating event was not in itself an SAE), resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section."
Safety Set: All randomized participants who received any study vaccination. Safety data were collected based on the treatment a participant received, regardless of the part of the study.
Posted
Count of Participants
Participants
Up to Day 504 (1 year following last dose administration)
ID
Title
Description
OG000
Seronegative mRNA-1647 (50 ug)
CMV-seronegative participants received mRNA-1647 (50 ug) by IM injection on Day 1, Day 56, and Day 168.
OG001
Seronegative mRNA-1647 (100 ug)
CMV-seronegative participants received mRNA-1647 (100 ug) by IM injection on Day 1, Day 56, and Day 168.
OG002
Seronegative mRNA-1647 (150 ug)
Primary
Geometric Mean Titer (GMT) of Serum Neutralizing Anti-CMV Antibodies Against Epithelial Cell Infection and Against Fibroblast Infection
Blood samples for antibody-mediated immunogenicity (AMI) analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV neutralizing antibody titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. Results are reported as fold dilution (titer). GMT 95% confidence interval (CI) was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Per-Protocol Set for AMI: All FAS for AMI participants who a) complied with vaccination schedule, b) complied with timings of blood sampling to have post-vaccination results available for at least 1 assay component, c) had no major protocol deviations that impacted immune response. Number Analyzed=participants evaluable at specified timepoints. Data collected based on participant serostatus and the treatment group to which the participant was randomized regardless of the part of the study.
Posted
Geometric Mean
95% Confidence Interval
titer
Baseline (Day 1), Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
ID
Title
Description
OG000
Seronegative mRNA-1647 (50 ug)
CMV-seronegative participants received mRNA-1647 (50 ug) by IM injection on Day 1, Day 56, and Day 168.
OG001
Seronegative mRNA-1647 (100 ug)
Primary
Geometric Mean Ratio (GMR) of Serum Neutralizing Anti-CMV Antibodies Against Epithelial Cell Infection and Against Fibroblast Infection
Blood samples for antibody-mediated immunogenicity analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV neutralizing antibody titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. The GMR measures the changes in immunogenicity titers within participants. Results are reported as a ratio (post-baseline/baseline titers). GMR 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Per-Protocol Set for AMI: All FAS for AMI participants who a) complied with vaccination schedule, b) complied with timings of blood sampling to have post-vaccination results available for at least 1 assay component, c) had no major protocol deviations that impacted immune response. Number Analyzed=participants evaluable at specified timepoints. Data collected based on participant serostatus and the treatment group to which the participant was randomized regardless of the part of the study.
Posted
Geometric Mean
95% Confidence Interval
Ratio
Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
ID
Title
Description
OG000
Seronegative mRNA-1647 (50 ug)
CMV-seronegative participants received mRNA-1647 (50 ug) by IM injection on Day 1, Day 56, and Day 168.
OG001
Seronegative mRNA-1647 (100 ug)
Primary
Percentage of Participants With ≥2-Fold, 3-Fold, and 4-Fold Increases in Neutralizing Antibodies (nAb) Over Baseline Against Epithelial Cell Infection and Against Fibroblast Infection
Blood samples for antibody-mediated immunogenicity analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV nAb titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. A ≥z-fold increase from baseline at participant level was defined as a ≥z * the lower limit of quantification (LLOQ) for participants with baseline antibody level below the LLOQ, or a z-times or higher-level ratio in participants with baseline antibody level equal to or above the LLOQ. LLOQ=16. Results are reported as percentage of participants with ≥2-fold, 3-fold, and 4-fold increases in serum anti-CMV nAb titers from baseline. 95% CI for percentage is calculated using the Clopper-Pearson method.
Per-Protocol Set for AMI: All FAS for AMI participants who a) complied with vaccination schedule, b) complied with timings of blood sampling to have post-vaccination results available for at least 1 assay component, c) had no major protocol deviations that impacted immune response. Number Analyzed=participants evaluable at specified timepoints. Data collected based on participant serostatus and the treatment group to which the participant was randomized regardless of the part of the study.
Posted
Number
95% Confidence Interval
percentage of participants
Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
ID
Title
Description
OG000
Seronegative mRNA-1647 (50 ug)
CMV-seronegative participants received mRNA-1647 (50 ug) by IM injection on Day 1, Day 56, and Day 168.
Secondary
GMT of Anti-Glycoprotein B (gB)-Specific Immunoglobulin G (IgG) and Anti-Pentamer-specific IgG as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) of Post-Baseline/Baseline Titers
Blood samples for antibody-mediated immunogenicity were collected during protocol-specified study visits. Serological assessment for anti-gB-specific IgG and anti-pentameric gH/gL/UL128/UL130/UL131A glycoprotein complex (Pentamer)-specific IgG binding was measured with ELISA. The GMT measures the level of inhibition of anti-gB-specific IgG (anti-gB) and anti-Pentamer-specific IgG (anti-Pentamer) against cytomegalovirus. Results are reported as fold dilution (titer). GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Per-Protocol Set for AMI: All FAS for AMI participants who a) complied with vaccination schedule, b) complied with timings of blood sampling to have post-vaccination results available for at least 1 assay component, c) had no major protocol deviations that impacted immune response. Number Analyzed=participants evaluable at specified timepoints. Data collected based on participant serostatus and the treatment group to which the participant was randomized regardless of the part of the study.
Posted
Geometric Mean
95% Confidence Interval
titer
Baseline (Day 1), Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
ID
Title
Description
OG000
Seronegative mRNA-1647 (50 ug)
CMV-seronegative participants received mRNA-1647 (50 ug) by IM injection on Day 1, Day 56, and Day 168.
OG001
Secondary
GMR of Anti-gB-specific IgG and Anti-Pentamer-specific IgG as Measured by ELISA of Post-Baseline/Baseline Titers
Blood samples for antibody-mediated immunogenicity were collected during protocol-specified study visits. Serological assessment for anti-gB-specific IgG and anti-Pentamer-specific IgG binding was measured with ELISA. The GMR measures the changes in immunogenicity titers within participants. Results are reported as a ratio (post-baseline/baseline titers). GMR 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation. Number Analyzed = participants who were evaluable at specified timepoints.
Per-Protocol Set for AMI: All FAS for AMI participants who a) complied with vaccination schedule, b) complied with timings of blood sampling to have post-vaccination results available for at least 1 assay component, c) had no major protocol deviations that impacted immune response. Number Analyzed=participants evaluable at specified timepoints. Data collected based on participant serostatus and the treatment group to which the participant was randomized regardless of the part of the study.
Posted
Geometric Mean
95% Confidence Interval
Ratio
Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
ID
Title
Description
OG000
Seronegative mRNA-1647 (50 ug)
CMV-seronegative participants received mRNA-1647 (50 ug) by IM injection on Day 1, Day 56, and Day 168.
OG001
Seronegative mRNA-1647 (100 ug)
Secondary
GMT of Serum nAb Against Epithelial Cell Infection and Against Fibroblast Infection at Each Timepoint, in the CMV-Seropositive Group and in the CMV-Seronegative Group
Blood samples for antibody-mediated immunogenicity analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV nAb titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. Results are reported as fold dilution (titer). GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Per-Protocol Set for AMI: All FAS for AMI participants who a) complied with vaccination schedule, b) complied with timings of blood sampling to have post-vaccination results available for at least 1 assay component, c) had no major protocol deviations that impacted immune response. Number Analyzed=participants evaluable at specified timepoints. Data collected based on participant serostatus and the treatment group to which the participant was randomized regardless of the part of the study.
Posted
Geometric Mean
95% Confidence Interval
titer
Baseline (Day 1), Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
ID
Title
Description
OG000
Seronegative mRNA-1647 - Total
CMV-seronegative participants received mRNA-1647 (50, 100, and 150 ug) by IM injection on Day 1, Day 56, and Day 168.
OG001
Seropositive mRNA-1647 - Total
Secondary
GMR of Serum nAb Against Epithelial Cell Infection and Against Fibroblast Infection at Each Timepoint, in the CMV-Seropositive Group and in the CMV-Seronegative Group
Blood samples for antibody-mediated immunogenicity analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV nAb titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. The GMR measures the changes in immunogenicity titers within participants. Results are reported as a ratio (post-baseline/baseline titers). GMR 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Per-Protocol Set for AMI: All FAS for AMI participants who a) complied with vaccination schedule, b) complied with timings of blood sampling to have post-vaccination results available for at least 1 assay component, c) had no major protocol deviations that impacted immune response. Number Analyzed=participants evaluable at specified timepoints. Data collected based on participant serostatus and the treatment group to which the participant was randomized regardless of the part of the study.
Posted
Geometric Mean
95% Confidence Interval
Ratio
Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
ID
Title
Description
OG000
Seronegative mRNA-1647 - Total
CMV-seronegative participants received mRNA-1647 (50, 100, and 150 ug) by IM injection on Day 1, Day 56, and Day 168.
OG001
Seropositive mRNA-1647 - Total
Secondary
Percentage of Participants With ≥2-Fold, 3-Fold, and 4-Fold Increases Over Baseline of Serum nAb Against Epithelial Cell Infection and Against Fibroblast Infection in the CMV-Seropositive and CMV-Seronegative Groups
Blood samples for antibody-mediated immunogenicity analysis were collected during protocol-specified study visits. Serological assessment of serum anti-CMV nAb titers against epithelial cell infection and fibroblast infection were measured by a neutralization assay. A ≥z-fold increase from baseline at participant level was defined as a ≥z * the LLOQ for participants with baseline antibody level below the LLOQ, or a z-times or higher-level ratio in participants with baseline antibody level equal to or above the LLOQ. LLOQ=16. Results are reported as percentage of participants with ≥2-fold, 3-fold, and 4-fold increases in serum anti-CMV nAb titers from baseline. 95% CI for percentage is calculated using the Clopper-Pearson method.
Per-Protocol Set for AMI: All FAS for AMI participants who a) complied with vaccination schedule, b) complied with timings of blood sampling to have post-vaccination results available for at least 1 assay component, c) had no major protocol deviations that impacted immune response. Number Analyzed=participants evaluable at specified timepoints. Data collected based on participant serostatus and the treatment group to which the participant was randomized regardless of the part of the study.
Posted
Number
95% Confidence Interval
percentage of participants
Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
ID
Title
Description
OG000
Seronegative mRNA-1647 - Total
CMV-seronegative participants received mRNA-1647 (50, 100, and 150 ug) by IM injection on Day 1, Day 56, and Day 168.
Secondary
GMT of Antigen-Specific IgG (ELISA) at Each Timepoint in the CMV-Seropositive and CMV-Seronegative Groups
Blood samples for antibody-mediated immunogenicity were collected during protocol-specified study visits. Serological assessment for anti-gB-specific IgG and anti-Pentamer-specific IgG binding was measured with ELISA. Results are reported as fold dilution (titer). GMT 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Per-Protocol Set for AMI: All FAS for AMI participants who a) complied with vaccination schedule, b) complied with timings of blood sampling to have post-vaccination results available for at least 1 assay component, c) had no major protocol deviations that impacted immune response. Number Analyzed=participants evaluable at specified timepoints. Data collected based on participant serostatus and the treatment group to which the participant was randomized regardless of the part of the study.
Posted
Geometric Mean
95% Confidence Interval
titer
Baseline (Day 1), Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
ID
Title
Description
OG000
Seronegative mRNA-1647 - Total
CMV-seronegative participants received mRNA-1647 (50, 100, and 150 ug) by IM injection on Day 1, Day 56, and Day 168.
OG001
Seropositive mRNA-1647 - Total
CMV-seropositive participants received mRNA-1647 (50, 100, and 150 ug) by IM injection on Day 1, Day 56, and Day 168.
Secondary
GMR of Antigen-Specific IgG (ELISA) at Each Timepoint in the CMV-Seropositive and CMV-Seronegative Groups
Blood samples for antibody-mediated immunogenicity were collected during protocol-specified study visits. Serological assessment for anti-gB-specific IgG and anti-Pentamer-specific IgG binding was measured with ELISA. The GMR measures the changes in immunogenicity titers within participants. Results are reported as a ratio (post-baseline/baseline titers). GMR 95% CI was calculated based on the t-distribution of the log-transformed values then back transformed to the original scale for presentation.
Per-Protocol Set for AMI: All FAS for AMI participants who a) complied with vaccination schedule, b) complied with timings of blood sampling to have post-vaccination results available for at least 1 assay component, c) had no major protocol deviations that impacted immune response. Number Analyzed=participants evaluable at specified timepoints. Data collected based on participant serostatus and the treatment group to which the participant was randomized regardless of the part of the study.
Posted
Geometric Mean
95% Confidence Interval
Ratio
Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504
ID
Title
Description
OG000
Seronegative mRNA-1647 - Total
CMV-seronegative participants received mRNA-1647 (50, 100, and 150 ug) by IM injection on Day 1, Day 56, and Day 168.
OG001
Seropositive mRNA-1647 - Total
CMV-seropositive participants received mRNA-1647 (50, 100, and 150 ug) by IM injection on Day 1, Day 56, and Day 168.
Time Frame
18 months
Description
Adverse events and all-cause mortality based upon the Safety Set: all randomized participants who received any study vaccination. Safety data were collected based on the treatment a participant received, regardless of the part of the study.
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
Seronegative mRNA-1647 (50 ug)
CMV-seronegative participants received mRNA-1647 (50 ug) by IM injection on Day 1, Day 56, and Day 168.
0
45
0
45
40
45
EG001
Seronegative mRNA-1647 (100 ug)
CMV-seronegative participants received mRNA-1647 (100 ug) by IM injection on Day 1, Day 56, and Day 168.
0
72
1
72
67
72
EG002
Seronegative mRNA-1647 (150 ug)
CMV-seronegative participants received mRNA-1647 (150 ug) by IM injection on Day 1, Day 56, and Day 168.
0
45
0
45
44
45
EG003
Seronegative Placebo
CMV-seronegative participants received a placebo-matching IM injection on Day 1, Day 56, and Day 168.
0
53
0
53
38
53
EG004
Seropositive mRNA-1647 (50 ug)
CMV-seropositive participants received mRNA-1647 (50 ug) by IM injection on Day 1, Day 56, and Day 168.
0
18
0
18
18
18
EG005
Seropositive mRNA-1647 (100 ug)
CMV-seropositive participants received mRNA-1647 (100 ug) by IM injection on Day 1, Day 56, and Day 168.
0
37
1
37
36
37
EG006
Seropositive mRNA-1647 (150 ug)
CMV-seropositive participants received mRNA-1647 (150 ug) by IM injection on Day 1, Day 56, and Day 168.
0
18
0
18
18
18
EG007
Seropositive Placebo
CMV-seropositive participants received a placebo-matching IM injection on Day 1, Day 56, and Day 168.
0
27
0
27
20
27
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anxiety
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
At the time of assessment, the investigator determined this Anxiety was not related to the investigational product and the event resolved.
EG0000 affected45 at risk
EG0011 affected72 at risk
EG0020 affected45 at risk
EG0030 affected53 at risk
EG004
Depression
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
At the time of assessment, the investigator determined this Depression was not related to the investigational product and the event resolved.
EG0000 affected45 at risk
EG0011 affected72 at risk
EG0020 affected45 at risk
EG003
Follicular thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
At the time of assessment, the investigator determined this Follicular thyroid cancer was not related to the investigational product and the event resolved.