A Study of Zika Vaccine mRNA-1893 in Adult Participants L... | NCT04917861 | Trialant
NCT04917861
Sponsor
ModernaTX, Inc.
Status
Completed
Last Update Posted
Sep 25, 2025Actual
Enrollment
808Actual
Phase
Phase 2
Conditions
Zika Virus
Interventions
mRNA-1893
Placebo
Countries
United States
Puerto Rico
Protocol Section
Identification Module
NCT ID
NCT04917861
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
mRNA-1893-P201
Secondary IDs
ID
Type
Description
Link
HHSO100201600029C
Other Grant/Funding Number
BARDA
Brief Title
A Study of Zika Vaccine mRNA-1893 in Adult Participants Living in Endemic and Non-Endemic Flavivirus Areas
Official Title
A Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose Confirmation Study to Evaluate the Safety, Tolerability, and Immunogenicity of Zika Vaccine mRNA-1893 in Adults Aged 18 Through 65 Years and Living in Endemic and Non-Endemic Flavivirus Areas
Acronym
Not provided
Organization
ModernaTX, Inc.INDUSTRY
Status Module
Record Verification Date
Aug 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
Jun 7, 2021Actual
Primary Completion Date
Jul 26, 2024Actual
Completion Date
Jul 26, 2024Actual
First Submitted Date
Jun 2, 2021
First Submission Date that Met QC Criteria
Jun 2, 2021
First Posted Date
Jun 8, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Jul 25, 2025
Results First Submitted that Met QC Criteria
Sep 5, 2025
Results First Posted Date
Sep 25, 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
Sep 5, 2025
Last Update Posted Date
Sep 25, 2025Actual
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 evaluate the safety, tolerability, and reactogenicity of 2 dose levels of messenger RNA (mRNA)-1893 Zika vaccine in comparison to a placebo control in healthy participants who are flavivirus-seronegative and in participants who are flavivirus-seropositive.
Detailed Description
Not provided
Conditions Module
Conditions
Zika Virus
Keywords
Flavivirus
mRNA-1893
Zika vaccine
Moderna
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
808Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
mRNA-1893 Low Dose (2-Dose Regimen)
Experimental
Participants will receive mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day (-3/+7 days) interval between vaccinations (administered on Day 1 and Day 29).
Biological: mRNA-1893
mRNA-1893 High Dose (2-Dose Regimen)
Experimental
Participants will receive mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day (-3/+7 days) interval between vaccinations (administered on Day 1 and Day 29).
Biological: mRNA-1893
mRNA-1893 High Dose (1-Dose Regimen)
Experimental
Participants will receive placebo matching to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There will be 28-day (-3/+7 days) interval between vaccinations.
Biological: mRNA-1893
Biological: Placebo
Placebo
Placebo Comparator
Participants will receive placebo matching to mRNA-1893 administered as a 2-dose regimen with 28-day (-3/+7 days) interval between vaccinations (administered on Day 1 and Day 29).
Biological: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
mRNA-1893
Biological
Solution for injection
mRNA-1893 High Dose (1-Dose Regimen)
mRNA-1893 High Dose (2-Dose Regimen)
mRNA-1893 Low Dose (2-Dose Regimen)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Solicited ARs (local and systemic) were collected in the electronic diary. Local ARs included: pain, erythema (redness), swelling/induration (hardness). Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, body temperature (potentially fever), and chills. A summary of all serious adverse events (SAEs) and all nonserious adverse events (AEs) ("Other"), regardless of causality, is in Reported "Adverse Events" section.
Up to 7 days post-vaccination
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. Unsolicited AEs were AEs that were not included in the protocol-defined solicited ARs. A treatment-emergent adverse event (TEAE) was defined as any AE not present before exposure to vaccine or any AE already present that worsened in intensity or frequency after exposure. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Up to 28 days post-vaccination
Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs)
An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, was a congenital anomaly/birth defect, or was an important medical event. An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor were required. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Day 1 through Day 196 for Main Study and Day 197 through Day 700 for Extension Period
Secondary Outcomes
Measure
Description
Time Frame
GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80
Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values that were greater than the ULOQ were converted to the ULOQ. LLOQ=91; ULOQ=24814. 95% CI was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Days 1, 8, 29, and 36
Other Outcomes
Measure
Description
Time Frame
Number of Deaths Related to Study Drug
A death that occurred during the study or that came to the attention of the investigator during the study was reported to the Sponsor, irrespective of its perceived relationship to the study drug. The Investigator assessed the causality by determining whether there was a reasonable possibility that the death was related to the study drug, using the following classifications: Not related: There was not a reasonable possibility of a relationship to the study drug. The temporal sequence of the death relative to administration of the study drug was not reasonable AND/OR the death was more likely explained by a cause other than the study drug. Related: There was a reasonable possibility of a relationship to the study drug. There was evidence of exposure to the study drug. The temporal sequence of the death relative to the administration of the study drug was reasonable.
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Understands and agrees to comply with the study procedures and provides written informed consent.
According to investigator assessment, is in good general health and can comply with study procedures.
Female participants of childbearing potential may be enrolled in the study if the participant: has a negative pregnancy test at the Eligibility Visit and on the day of the first investigational product (IP) injection; has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first IP injection; has agreed to continue adequate contraception through 3 months following the last IP injection; and is not currently breastfeeding.
Key Exclusion Criteria:
Participant is acutely ill or febrile (temperature ≥38.0°Celsius/100.4°Farenheight) on the day of the first or second vaccination.
Participant had prior administration of a ZIKV vaccine candidate during a clinical study investigation.
Participant had prior administration of a marketed dengue vaccine or dengue vaccine candidate under clinical study investigation.
Participant has a body mass index (BMI) from ≤18 or ≥35 kilograms (kg)/square meter (m^2).
Participant has a history of myocarditis, pericarditis, or myopericarditis.
Participant has a history of a diagnosis or condition that, in the judgement of the investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures. "Clinically unstable" is defined as a diagnosis or condition requiring significant changes in management or medication within the 2 months prior to screening and includes ongoing work-up of an undiagnosed illness that could lead to a new diagnosis or condition.
Participant has any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that in the opinion of the investigator, might pose a risk due to participation in the study or could interfere with the interpretation of study results.
Participant has as a history of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine, including an mRNA vaccine or any components of an mRNA vaccine.
Participant has received or plans to receive a nonstudy vaccine (including authorized or approved vaccines for the prevention of COVID-19) ≤28 days prior to the first IP injection or within 28 days prior to or after any IP injection. Licensed influenza vaccine received within 14 days prior to the first IP injection or plans to receive a licensed influenza vaccine 14 days prior to through 14 days following each IP injection are not exclusionary.
Participant has received systemic immunoglobulins or blood products within 3 months prior to the day of enrollment.
Participant has donated ≥450 milliliters (mL) of blood products within 28 days of the Day 1 Visit.
Participant has participated in an interventional clinical study within 28 days prior to the day of enrollment or plans to do so while enrolled in this study.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
65 Years
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
Meridian Clinical Research (Sioux City, IA)
Sioux City
Iowa
51106
United States
Johnson County Clin-Trials
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 808 participants were enrolled. One participant was randomized at two sites and received two injections. This participant was not presented under Per-Protocol Set but kept in Full Analysis Set, Safety Set, and Solicited Safety Set. This participant was discontinued from the study at one site upon the discovery of the duplicate participation and the incident was documented.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Participants received placebo matched to mRNA-1893 administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
Number of Participants With Medically Attended AEs (MAAEs)
An MAAE was an AE that led to an unscheduled visit to a healthcare practitioner. Note that the generation of the tables for the MAAE data for the Main Study occurred after the start of the Extension Period. Therefore, some of the MAAE data for this outcome measure may appear both in the Main Study and the Extension Period. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Day 1 through Day 196 for Main Study and Day 197 through Day 700 for Extension Period
Geometric Mean Titer (GMT) of Zika Virus (ZIKV)-Specific Neutralizing Antibodies (nAbs) at Day 57, as Measured by 50% Plaque Reduction Neutralization Test (PRNT50)
Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5 * LLOQ. Values that were greater than the upper limit of quantification (ULOQ) were converted to the ULOQ. LLOQ=91; ULOQ=24814. 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.
Day 57
GMT of ZIKV-specific nAbs at Day 57, as Measured by 80% Plaque Reduction Neutralization Test (PRNT80)
Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values that were greater than the ULOQ were converted to the ULOQ. LLOQ=91; ULOQ=24814. 95% CI was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Day 57
Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT50
Seroconversion was defined as an increase in ZIKV-specific nAb titer from below the LLOQ to a titer equal to or above LLOQ, or an increase of at least 4-fold in ZIKV-specific nAb titer in participants with pre-existing nAb titers. LLOQ=91; ULOQ=24814.
Day 57
Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT80
Seroconversion was defined as an increase in ZIKV-specific nAb titer from below the LLOQ to a titer equal to or above LLOQ, or an increase of at least 4-fold in ZIKV-specific nAb titer in participants with pre-existing nAb titers. LLOQ=91; ULOQ=24814.
Day 57
GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN)
Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values that were greater than the ULOQ were converted to the ULOQ. LLOQ=28; ULOQ=11589. 95% CI was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Days 1, 8, 29, 36, and 57
Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80
Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values that were greater than the ULOQ were converted to the ULOQ. LLOQ=91; ULOQ=248. 95% CI was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation.
Days 8, 29, 36, and 57
GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN
Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values that were greater than the ULOQ were converted to the ULOQ. LLOQ=28; ULOQ=11589. 95% CI was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation.
Days 8, 29, 36, and 57
Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80
Seroconversion was defined as an increase in ZIKV-specific nAb titer from below the LLOQ to a titer equal to or above LLOQ, or an increase of at least 4-fold in ZIKV-specific nAb titer in participants with pre-existing nAb titers. LLOQ=91; ULOQ=24814.
Days 8, 29, and 36
Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN
Seroconversion was defined as an increase in ZIKV-specific nAb titer from below the LLOQ to a titer equal to or above LLOQ, or an increase of at least 4-fold in ZIKV-specific nAb titer in participants with pre-existing nAb titers. LLOQ=28; ULOQ=11589.
Days 8, 29, 36, and 57
Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80
Seroresponse was defined as an increase in ZIKV-specific nAb titer from below the LLOQ to greater than or equal to the LLOQ. LLOQ=91; ULOQ=24814.
Days 8, 29, and 36
Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, 36, and 57, as Measured by MN
Seroresponse was defined as an increase in ZIKV-specific nAb titer from below the LLOQ to greater than or equal to the LLOQ. LLOQ=28; ULOQ=11589.
Days 8, 29, 36, and 57
Percentage of Initially Seropositive Participants With a 2-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by PRNT50 and PRNT80
≥2-fold increase from baseline was defined as a ≥2 * LLOQ for participants with baseline undetectable antibody titer, or a 2-times or higher ratio in participants with pre-existing nAb titers. LLOQ=91
Days 8, 29, 36, and 57
Percentage of Initially Seropositive Participants With a 4-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by PRNT50 and PRNT80
≥4-fold increase from baseline was defined as a ≥4 * LLOQ for participants with baseline undetectable antibody titer, or a 4-times or higher ratio in participants with pre-existing nAb titers. LLOQ=91
Days 8, 29, 36, and 57
Percentage of Initially Seropositive Participants With a 2-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN
≥2-fold increase from baseline was defined as a ≥2 * LLOQ for participants with baseline undetectable antibody titer, or a 2-times or higher ratio in participants with pre-existing nAb titers. LLOQ=28.
Days 8, 29, 36, and 57
Percentage of Initially Seropositive Participants With a 4-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN
≥4-fold increase from baseline was defined as a ≥4 * LLOQ for participants with baseline undetectable antibody titer, or a 4-times or higher ratio in participants with pre-existing nAb titers. LLOQ=28.
Days 8, 29, 36, and 57
Day 1 through Day 196 for Main Study and Day 197 through Day 700 for Extension Period
Lenexa
Kansas
66219
United States
Benchmark Research - Fort Worth
Fort Worth
Texas
76135
United States
Clinical Research Puerto Rico, Inc.
Guayama
PR
00784
Puerto Rico
Ponce Medical School Foundation, Inc.
Ponce
PR
00713
Puerto Rico
Ponce Medical School Foundation, Inc.
Ponce
PR
00716
Puerto Rico
Clinical Research Puerto Rico, Inc.
San Juan
PR
00909
Puerto Rico
Latin Clinical Trial Center, Inc.
San Juan
PR
00909
Puerto Rico
GCM Medical Group, PSC
San Juan
PR
00917
Puerto Rico
Carribean Medical Research
San Juan
PR
00918
Puerto Rico
University of Puerto Rico
San Juan
PR
00935
Puerto Rico
Participants received mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
FG002
mRNA-1893 High Dose (2-Dose Regimen)
Participants received mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
FG003
mRNA-1893 High Dose (1-Dose Regimen)
Participants received placebo matched to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There was 28-day interval between vaccinations.
FG000203 subjects
FG001201 subjects
FG002203 subjects
FG003201 subjects
Received First Injection
FG000201 subjects
FG001201 subjects
FG002202 subjects
FG003198 subjects
Received Second Injection
FG000187 subjects
FG001188 subjects
FG002187 subjects
FG003191 subjects
Randomized at Second Site
Randomized to mRNA-1893 High Dose (2-Dose Regimen) and then mRNA-1893 Low Dose (2-Dose Regimen)
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
COMPLETED
FG000173 subjects
FG001166 subjects
FG002176 subjects
FG003178 subjects
NOT COMPLETED
FG00030 subjects
FG00135 subjects
FG00227 subjects
FG00323 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Lost to Follow-up
FG00014 subjects
FG00126 subjects
FG00220 subjects
FG00311 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Pregnancy
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Withdrawal by Subject
FG00014 subjects
FG0017 subjects
FG0026 subjects
FG0038 subjects
Other Than Specified
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
Extension Period (Day 197 to Day 700)
Type
Comment
Milestone Data
STARTED
FG000113 subjects
FG001109 subjects
FG002104 subjects
FG003116 subjects
COMPLETED
FG00097 subjects
FG00196 subjects
FG00289 subjects
FG00393 subjects
NOT COMPLETED
FG00016 subjects
FG00113 subjects
FG00215 subjects
FG00323 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0008 subjects
FG0013 subjects
FG0025 subjects
FG003
The Safety Set included all participants who were randomized and received any study injection. One participant who was randomized at two sites and received two injections, has been included only once here for reporting the 'Baseline Characteristics' data. This participant was kept in both arms (Randomized to mRNA-1893 High Dose [2-Dose Regimen] and mRNA-1893 Low Dose [2-Dose Regimen]) in Full Analysis Set, Safety Set, and Solicited Safety Set for collection and reporting data.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received placebo matched to mRNA-1893 administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
BG001
mRNA-1893 Low Dose (2-Dose Regimen)
Participants received mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
BG002
mRNA-1893 High Dose (2-Dose Regimen)
Participants received mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
BG003
mRNA-1893 High Dose (1-Dose Regimen) (
Participants received placebo matched to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There was 28-day interval between vaccinations.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000201
BG001201
BG002202
BG003198
BG004802
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000111
BG001119
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG000106
BG001106
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Race
Title
Measurements
White
BG000167
BG001167
BG002
Seroresponse
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Flavivirus Seronegative Participants
BG00096
BG00192
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 Reactogenicity Adverse Reactions (ARs)
Solicited ARs (local and systemic) were collected in the electronic diary. Local ARs included: pain, erythema (redness), swelling/induration (hardness). Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, body temperature (potentially fever), and chills. A summary of all serious adverse events (SAEs) and all nonserious adverse events (AEs) ("Other"), regardless of causality, is in Reported "Adverse Events" section.
The Solicited Safety Set included all participants who were randomized, received any study injection, and contributed with any solicited AR data. One participant who was randomized at two sites and received two injections was kept in both arms (Randomized to mRNA-1893 High Dose [2-Dose Regimen] and mRNA-1893 Low Dose [2-Dose Regimen]) in Solicited Safety Set for collection and reporting data.
Posted
Count of Participants
Participants
Up to 7 days post-vaccination
ID
Title
Description
OG000
Placebo
Participants received placebo matched to mRNA-1893 administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG001
mRNA-1893 Low Dose (2-Dose Regimen)
Participants received mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG002
mRNA-1893 High Dose (2-Dose Regimen)
Participants received mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG003
mRNA-1893 High Dose (1-Dose Regimen)
Participants received placebo matched to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There was 28-day interval between vaccinations.
Units
Counts
Participants
OG000200
OG001201
OG002201
OG003
Title
Denominators
Categories
Title
Measurements
OG00086
OG001164
OG002183
OG003
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. Unsolicited AEs were AEs that were not included in the protocol-defined solicited ARs. A treatment-emergent adverse event (TEAE) was defined as any AE not present before exposure to vaccine or any AE already present that worsened in intensity or frequency after exposure. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
The Safety Set included all participants who were randomized and received any study injection. One participant who was randomized at two sites and received two injections was kept in both arms (Randomized to mRNA-1893 High Dose [2-Dose Regimen] and mRNA-1893 Low Dose [2-Dose Regimen]) in Safety Set for collection and reporting data.
Posted
Count of Participants
Participants
Up to 28 days post-vaccination
ID
Title
Description
OG000
Placebo
Participants received placebo matched to mRNA-1893 administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG001
mRNA-1893 Low Dose (2-Dose Regimen)
Participants received mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
Primary
Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs)
An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, was a congenital anomaly/birth defect, or was an important medical event. An AESI was an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor were required. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
The Safety Set included all participants who were randomized and received any study injection. One participant who was randomized at two sites and received two injections was kept in both arms (Randomized to mRNA-1893 High Dose [2-Dose Regimen] and mRNA-1893 Low Dose [2-Dose Regimen]) in Safety Set for collection and reporting data.
Posted
Count of Participants
Participants
Day 1 through Day 196 for Main Study and Day 197 through Day 700 for Extension Period
ID
Title
Description
OG000
Main Study: Placebo
Participants received placebo matched to mRNA-1893 administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG001
Main Study: mRNA-1893 Low Dose (2-Dose Regimen)
Primary
Number of Participants With Medically Attended AEs (MAAEs)
An MAAE was an AE that led to an unscheduled visit to a healthcare practitioner. Note that the generation of the tables for the MAAE data for the Main Study occurred after the start of the Extension Period. Therefore, some of the MAAE data for this outcome measure may appear both in the Main Study and the Extension Period. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
The Safety Set included all participants who were randomized and received any study injection. One participant who was randomized at two sites and received two injections was kept in both arms (Randomized to mRNA-1893 High Dose [2-Dose Regimen] and mRNA-1893 Low Dose [2-Dose Regimen]) in Safety Set for collection and reporting data.
Posted
Count of Participants
Participants
Day 1 through Day 196 for Main Study and Day 197 through Day 700 for Extension Period
ID
Title
Description
OG000
Main Study: Placebo
Participants received placebo matched to mRNA-1893 administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG001
Main Study: mRNA-1893 Low Dose (2-Dose Regimen)
Participants received mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
Primary
Geometric Mean Titer (GMT) of Zika Virus (ZIKV)-Specific Neutralizing Antibodies (nAbs) at Day 57, as Measured by 50% Plaque Reduction Neutralization Test (PRNT50)
Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5 * LLOQ. Values that were greater than the upper limit of quantification (ULOQ) were converted to the ULOQ. LLOQ=91; ULOQ=24814. 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.
The Per-Protocol Set for Antibody-Mediated Immunogenicity (PPAMI) included all participants who received any study injection, who did not have major protocol deviations that impacted AMI response, and who complied with the injection schedule and the timing of immunogenicity blood sampling to have post-injection results available for at least 1 assay component of AMI at the corresponding visit. Here, 'Number analyzed' = participants evaluable for specified categories.
Posted
Geometric Mean
95% Confidence Interval
titer
Day 57
ID
Title
Description
OG000
Placebo
Participants received placebo matched to mRNA-1893 administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG001
mRNA-1893 Low Dose (2-Dose Regimen)
Participants received mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
Primary
GMT of ZIKV-specific nAbs at Day 57, as Measured by 80% Plaque Reduction Neutralization Test (PRNT80)
Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values that were greater than the ULOQ were converted to the ULOQ. LLOQ=91; ULOQ=24814. 95% CI was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
The PPAMI included all participants who received any study injection, who did not have major protocol deviations that impacted AMI response, and who complied with the injection schedule and the timing of immunogenicity blood sampling to have post-injection results available for at least 1 assay component of AMI at the corresponding visit. Here, 'Number analyzed' = participants evaluable for specified categories.
Posted
Geometric Mean
95% Confidence Interval
titer
Day 57
ID
Title
Description
OG000
Placebo
Participants received placebo matched to mRNA-1893 administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG001
mRNA-1893 Low Dose (2-Dose Regimen)
Participants received mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG002
mRNA-1893 High Dose (2-Dose Regimen)
Primary
Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT50
Seroconversion was defined as an increase in ZIKV-specific nAb titer from below the LLOQ to a titer equal to or above LLOQ, or an increase of at least 4-fold in ZIKV-specific nAb titer in participants with pre-existing nAb titers. LLOQ=91; ULOQ=24814.
The PPAMI included all participants who received any study injection, who did not have major protocol deviations that impacted AMI response, and who complied with the injection schedule and the timing of immunogenicity blood sampling to have post-injection results available for at least 1 assay component of AMI at the corresponding visit. Here, 'Number analyzed' = participants evaluable for specified categories.
Posted
Number
95% Confidence Interval
percentage of participants
Day 57
ID
Title
Description
OG000
Placebo
Participants received placebo matched to mRNA-1893 administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG001
mRNA-1893 Low Dose (2-Dose Regimen)
Participants received mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG002
mRNA-1893 High Dose (2-Dose Regimen)
Primary
Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT80
Seroconversion was defined as an increase in ZIKV-specific nAb titer from below the LLOQ to a titer equal to or above LLOQ, or an increase of at least 4-fold in ZIKV-specific nAb titer in participants with pre-existing nAb titers. LLOQ=91; ULOQ=24814.
The PPAMI included all participants who received any study injection, who did not have major protocol deviations that impacted AMI response, and who complied with the injection schedule and the timing of immunogenicity blood sampling to have post-injection results available for at least 1 assay component of AMI at the corresponding visit. Here, 'Number analyzed' = participants evaluable for specified categories.
Posted
Number
95% Confidence Interval
percentage of participants
Day 57
ID
Title
Description
OG000
Placebo
Participants received placebo matched to mRNA-1893 administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG001
mRNA-1893 Low Dose (2-Dose Regimen)
Participants received mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG002
mRNA-1893 High Dose (2-Dose Regimen)
Secondary
GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80
Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values that were greater than the ULOQ were converted to the ULOQ. LLOQ=91; ULOQ=24814. 95% CI was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
The PPAMI included all participants who received any study injection, who did not have major protocol deviations that impacted AMI response, and who complied with the injection schedule and the timing of immunogenicity blood sampling to have post-injection results available for at least 1 assay component of AMI at the corresponding visit. Here, 'Number analyzed' = participants evaluable for specified categories.
Posted
Geometric Mean
95% Confidence Interval
titer
Days 1, 8, 29, and 36
ID
Title
Description
OG000
Placebo
Participants received placebo matched to mRNA-1893 administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG001
mRNA-1893 Low Dose (2-Dose Regimen)
Participants received mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG002
mRNA-1893 High Dose (2-Dose Regimen)
Secondary
GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN)
Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values that were greater than the ULOQ were converted to the ULOQ. LLOQ=28; ULOQ=11589. 95% CI was calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
The PPAMI included all participants who received any study injection, who did not have major protocol deviations that impacted AMI response, and who complied with the injection schedule and the timing of immunogenicity blood sampling to have post-injection results available for at least 1 assay component of AMI at the corresponding visit. Here, 'Number analyzed' = participants evaluable for specified categories.
Posted
Geometric Mean
95% Confidence Interval
titer
Days 1, 8, 29, 36, and 57
ID
Title
Description
OG000
Placebo
Participants received placebo matched to mRNA-1893 administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG001
mRNA-1893 Low Dose (2-Dose Regimen)
Participants received mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG002
Secondary
Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80
Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values that were greater than the ULOQ were converted to the ULOQ. LLOQ=91; ULOQ=248. 95% CI was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation.
The PPAMI included all participants who received any study injection, who did not have major protocol deviations that impacted AMI response, and who complied with the injection schedule and the timing of immunogenicity blood sampling to have post-injection results available for at least 1 assay component of AMI at the corresponding visit. Here, 'Number analyzed' = participants evaluable for specified categories.
Posted
Geometric Mean
95% Confidence Interval
ratio
Days 8, 29, 36, and 57
ID
Title
Description
OG000
Placebo
Participants received placebo matched to mRNA-1893 administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG001
mRNA-1893 Low Dose (2-Dose Regimen)
Participants received mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG002
Secondary
GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN
Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values that were greater than the ULOQ were converted to the ULOQ. LLOQ=28; ULOQ=11589. 95% CI was calculated based on the t-distribution of the difference in the log-transformed values, then back transformed to the original scale for presentation.
The PPAMI included all participants who received any study injection, who did not have major protocol deviations that impacted AMI response, and who complied with the injection schedule and the timing of immunogenicity blood sampling to have post-injection results available for at least 1 assay component of AMI at the corresponding visit. Here, 'Number analyzed' = participants evaluable for specified categories.
Posted
Geometric Mean
95% Confidence Interval
ratio
Days 8, 29, 36, and 57
ID
Title
Description
OG000
Placebo
Participants received placebo matched to mRNA-1893 administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG001
mRNA-1893 Low Dose (2-Dose Regimen)
Participants received mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG002
mRNA-1893 High Dose (2-Dose Regimen)
Secondary
Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80
Seroconversion was defined as an increase in ZIKV-specific nAb titer from below the LLOQ to a titer equal to or above LLOQ, or an increase of at least 4-fold in ZIKV-specific nAb titer in participants with pre-existing nAb titers. LLOQ=91; ULOQ=24814.
The PPAMI included all participants who received any study injection, who did not have major protocol deviations that impacted AMI response, and who complied with the injection schedule and the timing of immunogenicity blood sampling to have post-injection results available for at least 1 assay component of AMI at the corresponding visit. Here, 'Number analyzed' = participants evaluable for specified categories.
Posted
Number
95% Confidence Interval
percentage of participants
Days 8, 29, and 36
ID
Title
Description
OG000
Placebo
Participants received placebo matched to mRNA-1893 administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG001
mRNA-1893 Low Dose (2-Dose Regimen)
Participants received mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG002
mRNA-1893 High Dose (2-Dose Regimen)
Secondary
Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN
Seroconversion was defined as an increase in ZIKV-specific nAb titer from below the LLOQ to a titer equal to or above LLOQ, or an increase of at least 4-fold in ZIKV-specific nAb titer in participants with pre-existing nAb titers. LLOQ=28; ULOQ=11589.
The PPAMI included all participants who received any study injection, who did not have major protocol deviations that impacted AMI response, and who complied with the injection schedule and the timing of immunogenicity blood sampling to have post-injection results available for at least 1 assay component of AMI at the corresponding visit. Here, 'Number analyzed' = participants evaluable for specified categories.
Posted
Number
95% Confidence Interval
percentage of participants
Days 8, 29, 36, and 57
ID
Title
Description
OG000
Placebo
Participants received placebo matched to mRNA-1893 administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG001
mRNA-1893 Low Dose (2-Dose Regimen)
Participants received mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG002
mRNA-1893 High Dose (2-Dose Regimen)
Secondary
Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80
Seroresponse was defined as an increase in ZIKV-specific nAb titer from below the LLOQ to greater than or equal to the LLOQ. LLOQ=91; ULOQ=24814.
The PPAMI included all participants who received any study injection, who did not have major protocol deviations that impacted AMI response, and who complied with the injection schedule and timing of immunogenicity blood sampling to have post-injection results available for at least 1 assay component of AMI at the corresponding visit. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified categories.
Posted
Number
95% Confidence Interval
percentage of participants
Days 8, 29, and 36
ID
Title
Description
OG000
Placebo
Participants received placebo matched to mRNA-1893 administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG001
mRNA-1893 Low Dose (2-Dose Regimen)
Participants received mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG002
mRNA-1893 High Dose (2-Dose Regimen)
Secondary
Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, 36, and 57, as Measured by MN
Seroresponse was defined as an increase in ZIKV-specific nAb titer from below the LLOQ to greater than or equal to the LLOQ. LLOQ=28; ULOQ=11589.
The PPAMI included all participants who received any study injection, who did not have major protocol deviations that impacted AMI response, and who complied with the injection schedule and timing of immunogenicity blood sampling to have post-injection results available for at least 1 assay component of AMI at the corresponding visit. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified categories.
Posted
Number
95% Confidence Interval
percentage of participants
Days 8, 29, 36, and 57
ID
Title
Description
OG000
Placebo
Participants received placebo matched to mRNA-1893 administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG001
mRNA-1893 Low Dose (2-Dose Regimen)
Participants received mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG002
mRNA-1893 High Dose (2-Dose Regimen)
Secondary
Percentage of Initially Seropositive Participants With a 2-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by PRNT50 and PRNT80
≥2-fold increase from baseline was defined as a ≥2 * LLOQ for participants with baseline undetectable antibody titer, or a 2-times or higher ratio in participants with pre-existing nAb titers. LLOQ=91
The PPAMI included all participants who received any study injection, who did not have major protocol deviations that impacted AMI response, and who complied with the injection schedule and timing of immunogenicity blood sampling to have post-injection results available for at least 1 assay component of AMI at the corresponding visit. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified categories.
Posted
Number
95% Confidence Interval
percentage of participants
Days 8, 29, 36, and 57
ID
Title
Description
OG000
Placebo
Participants received placebo matched to mRNA-1893 administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG001
mRNA-1893 Low Dose (2-Dose Regimen)
Participants received mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
Secondary
Percentage of Initially Seropositive Participants With a 4-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by PRNT50 and PRNT80
≥4-fold increase from baseline was defined as a ≥4 * LLOQ for participants with baseline undetectable antibody titer, or a 4-times or higher ratio in participants with pre-existing nAb titers. LLOQ=91
The PPAMI included all participants who received any study injection, who did not have major protocol deviations that impacted AMI response, and who complied with the injection schedule and timing of immunogenicity blood sampling to have post-injection results available for at least 1 assay component of AMI at the corresponding visit. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified categories.
Posted
Number
95% Confidence Interval
percentage of participants
Days 8, 29, 36, and 57
ID
Title
Description
OG000
Placebo
Participants received placebo matched to mRNA-1893 administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG001
mRNA-1893 Low Dose (2-Dose Regimen)
Participants received mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
Secondary
Percentage of Initially Seropositive Participants With a 2-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN
≥2-fold increase from baseline was defined as a ≥2 * LLOQ for participants with baseline undetectable antibody titer, or a 2-times or higher ratio in participants with pre-existing nAb titers. LLOQ=28.
The PPAMI included all participants who received any study injection, who did not have major protocol deviations that impacted AMI response, and who complied with the injection schedule and timing of immunogenicity blood sampling to have post-injection results available for at least 1 assay component of AMI at the corresponding visit. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified categories.
Posted
Number
95% Confidence Interval
percentage of participants
Days 8, 29, 36, and 57
ID
Title
Description
OG000
Placebo
Participants received placebo matched to mRNA-1893 administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG001
mRNA-1893 Low Dose (2-Dose Regimen)
Participants received mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG002
Secondary
Percentage of Initially Seropositive Participants With a 4-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN
≥4-fold increase from baseline was defined as a ≥4 * LLOQ for participants with baseline undetectable antibody titer, or a 4-times or higher ratio in participants with pre-existing nAb titers. LLOQ=28.
The PPAMI included all participants who received any study injection, who did not have major protocol deviations that impacted AMI response, and who complied with the injection schedule and timing of immunogenicity blood sampling to have post-injection results available for at least 1 assay component of AMI at the corresponding visit. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified categories.
Posted
Number
95% Confidence Interval
percentage of participants
Days 8, 29, 36, and 57
ID
Title
Description
OG000
Placebo
Participants received placebo matched to mRNA-1893 administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG001
mRNA-1893 Low Dose (2-Dose Regimen)
Participants received mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG002
Other Pre-specified
Number of Deaths Related to Study Drug
A death that occurred during the study or that came to the attention of the investigator during the study was reported to the Sponsor, irrespective of its perceived relationship to the study drug. The Investigator assessed the causality by determining whether there was a reasonable possibility that the death was related to the study drug, using the following classifications: Not related: There was not a reasonable possibility of a relationship to the study drug. The temporal sequence of the death relative to administration of the study drug was not reasonable AND/OR the death was more likely explained by a cause other than the study drug. Related: There was a reasonable possibility of a relationship to the study drug. There was evidence of exposure to the study drug. The temporal sequence of the death relative to the administration of the study drug was reasonable.
The Randomized Set included all participants who were randomized in the study, regardless of the participant's treatment status in the study. One participant who was randomized at two sites and received two injections was kept in both arms (Randomized to mRNA-1893 High Dose [2-Dose Regimen] and mRNA-1893 Low Dose [2-Dose Regimen]) in Randomized Set for collection and reporting data.
Posted
Count of Participants
Participants
Day 1 through Day 196 for Main Study and Day 197 through Day 700 for Extension Period
ID
Title
Description
OG000
Main Study: Placebo
Participants received placebo matched to mRNA-1893 administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
Time Frame
All-cause mortality and serious adverse events were collected from Day 1 through Day 196 for Main Study and Day 197 through Day 700 for Extension Period. Other (not including serious) unsolicited adverse events were collected up to 28 days after study injection (that is, Day 1 up to Day 57) unless they met the criteria for AESIs, MAAEs or AEs led to discontinuation.
Description
The all-cause mortality was based on the randomized set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all randomized participants who received any study injection. One participant who was randomized at two sites and received two injections was kept in both arms (Randomized to mRNA-1893 High Dose [2-Dose Regimen] and mRNA-1893 Low Dose [2-Dose Regimen]) in Randomized Set and Safety Set for collection and reporting data.
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
Main Study: Placebo
Participants received placebo matched to mRNA-1893 administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
0
203
5
201
18
201
EG001
Main Study: mRNA-1893 Low Dose (2-Dose Regimen)
Participants received mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
0
202
2
202
20
202
EG002
Main Study: mRNA-1893 High Dose (2-Dose Regimen)
Participants received mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
0
203
4
202
24
202
EG003
Main Study: mRNA-1893 High Dose (1-Dose Regimen)
Participants received placebo matched to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There was 28-day interval between vaccinations.
1
201
7
198
16
198
EG004
Extension Period: Placebo
Participants were followed up for up to Day 700 in the extension period.
Participants received mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG003
mRNA-1893 High Dose (1-Dose Regimen)
Participants received placebo matched to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There was 28-day interval between vaccinations.
Units
Counts
Participants
OG000201
OG001202
OG002202
OG003198
Title
Denominators
Categories
Title
Measurements
OG00039
OG00147
OG00252
OG00345
Participants received mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG002
Main Study: mRNA-1893 High Dose (2-Dose Regimen)
Participants received mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG003
Main Study: mRNA-1893 High Dose (1-Dose Regimen)
Participants received placebo matched to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There was 28-day interval between vaccinations.
OG004
Extension Period: Placebo
Participants were followed up for up to Day 700 in the extension period.
Participants were followed up for up to Day 700 in the extension period.
OG006
Extension Period: mRNA-1893 High Dose (2-Dose Regimen)
Participants were followed up for up to Day 700 in the extension period.
OG007
Extension Period: mRNA-1893 High Dose (1-Dose Regimen)
Participants were followed up for up to Day 700 in the extension period.
Units
Counts
Participants
OG000201
OG001202
OG002202
OG003198
OG004113
OG005109
OG006104
OG007116
Title
Denominators
Categories
SAEs
Title
Measurements
OG0005
OG0012
OG0024
OG0037
OG0045
OG0054
OG0065
OG0077
AESIs
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
Main Study: mRNA-1893 High Dose (2-Dose Regimen)
Participants received mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG003
Main Study: mRNA-1893 High Dose (1-Dose Regimen)
Participants received placebo matched to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There was 28-day interval between vaccinations.
OG004
Extension Period: Placebo
Participants were followed up for up to Day 700 in the extension period.
Participants were followed up for up to Day 700 in the extension period.
OG006
Extension Period: mRNA-1893 High Dose (2-Dose Regimen)
Participants were followed up for up to Day 700 in the extension period.
OG007
Extension Period: mRNA-1893 High Dose (1-Dose Regimen)
Participants were followed up for up to Day 700 in the extension period.
Units
Counts
Participants
OG000201
OG001202
OG002202
OG003198
OG004113
OG005109
OG006104
OG007116
Title
Denominators
Categories
Title
Measurements
OG00062
OG00150
OG00262
OG00363
OG00429
OG00524
OG00630
OG00731
OG002
mRNA-1893 High Dose (2-Dose Regimen)
Participants received mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG003
mRNA-1893 High Dose (1-Dose Regimen)
Participants received placebo matched to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There was 28-day interval between vaccinations.
Units
Counts
Participants
OG000163
OG001163
OG002162
OG003163
Title
Denominators
Categories
All Participants
ParticipantsOG000163
ParticipantsOG001163
ParticipantsOG002162
ParticipantsOG003163
Title
Measurements
OG00061.06(54.07 to 68.96)
OG001427.53(343.28 to 532.45)
OG002434.92(343.63 to 550.46)
OG003
Flavivirus-seronegative Participants
ParticipantsOG00076
ParticipantsOG00172
ParticipantsOG00281
ParticipantsOG00393
Flavivirus-seropositive Participants
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG00367
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Geometric Mean Ratio (GMR)
7.002
2-Sided
95
5.451
8.992
GMR (mRNA-1893 Low Dose [2-Dose Regimen] vs. Placebo) for all participants
Other
OG000
OG002
GMR
7.123
2-Sided
95
5.467
9.279
GMR (mRNA-1893 High Dose [2-Dose Regimen] vs. Placebo) for all participants
Other
OG000
OG003
GMR
2.674
2-Sided
95
1.961
3.646
GMR (mRNA-1893 High Dose [1-Dose Regimen] vs. Placebo) for all participants
Other
OG000
OG001
GMR
7.208
2-Sided
95
5.428
9.571
GMR (mRNA-1893 Low Dose [2-Dose Regimen] vs. Placebo) for flavivirus-seronegative participants
Other
OG000
OG002
GMR
7.979
2-Sided
95
6.106
10.425
GMR (mRNA-1893 High Dose [2-Dose Regimen] vs. Placebo) for flavivirus-seronegative participants
Other
OG000
OG003
GMR
1.516
2-Sided
95
1.229
1.869
GMR (mRNA-1893 High Dose [1-Dose Regimen] vs. Placebo) for flavivirus-seronegative participants
Other
OG000
OG001
GMR
6.785
2-Sided
95
4.562
10.092
GMR (mRNA-1893 Low Dose [2-Dose Regimen] vs. Placebo) for flavivirus-seropositive participants
Other
OG000
OG002
GMR
6.319
2-Sided
95
4.030
9.909
GMR (mRNA-1893 High Dose [2-Dose Regimen] vs. Placebo) for flavivirus-seropositive participants
Other
OG000
OG003
GMR
7.028
2-Sided
95
4.056
12.180
GMR (mRNA-1893 High Dose [1-Dose Regimen] vs. Placebo) for flavivirus-seropositive participants
Other
Participants received mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG003
mRNA-1893 High Dose (1-Dose Regimen)
Participants received placebo matched to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There was 28-day interval between vaccinations.
Units
Counts
Participants
OG000163
OG001163
OG002162
OG003163
Title
Denominators
Categories
All Participants
ParticipantsOG000163
ParticipantsOG001163
ParticipantsOG002162
ParticipantsOG003163
Title
Measurements
OG00020.80(18.60 to 23.26)
OG001110.52(88.59 to 137.88)
OG002111.21(88.04 to 140.48)
OG003
Flavivirus-seronegative Participants
ParticipantsOG00076
ParticipantsOG00172
ParticipantsOG00281
ParticipantsOG00393
Flavivirus-seropositive Participants
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG00367
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
GMR
5.312
2-Sided
95
4.149
6.802
GMR (mRNA-1893 Low Dose [2-Dose Regimen] vs. Placebo) for all participants
Other
OG000
OG002
GMR
5.346
2-Sided
95
4.128
6.922
GMR (mRNA-1893 High Dose [2-Dose Regimen] vs. Placebo) for all participants
Other
OG000
OG003
GMR
2.325
2-Sided
95
1.721
3.140
GMR (mRNA-1893 High Dose [1-Dose Regimen] vs. Placebo) for all participants
Other
OG000
OG001
GMR
4.221
2-Sided
95
3.322
5.363
GMR (mRNA-1893 Low Dose [2-Dose Regimen] vs. Placebo) for flavivirus-negative participants
Other
OG000
OG002
GMR
5.300
2-Sided
95
4.243
6.620
GMR (mRNA-1893 High Dose [2-Dose Regimen] vs. Placebo) for flavivirus-negative participants
Other
OG000
OG003
GMR
1.206
2-Sided
95
1.033
1.407
GMR (mRNA-1893 High Dose [1-Dose Regimen] vs. Placebo) for flavivirus-negative participants
Other
OG000
OG001
GMR
6.493
2-Sided
95
4.358
9.674
GMR (mRNA-1893 Low Dose [2-Dose Regimen] vs. Placebo) for flavivirus-positive participants
Other
OG000
OG002
GMR
5.452
2-Sided
95
3.430
8.665
GMR (mRNA-1893 High Dose [2-Dose Regimen] vs. Placebo) for flavivirus-positive participants
Other
OG000
OG003
GMR
6.804
2-Sided
95
3.928
11.784
GMR (mRNA-1893 High Dose [1-Dose Regimen] vs. Placebo) for flavivirus-positive participants
Other
Participants received mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG003
mRNA-1893 High Dose (1-Dose Regimen)
Participants received placebo matched to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There was 28-day interval between vaccinations.
Units
Counts
Participants
OG000163
OG001163
OG002162
OG003163
Title
Denominators
Categories
All Participants
ParticipantsOG000163
ParticipantsOG001163
ParticipantsOG002162
ParticipantsOG003163
Title
Measurements
OG0004.3(1.74 to 8.65)
OG00181.0(74.10 to 86.70)
OG00282.1(75.31 to 87.67)
OG003
Flavivirus-seronegative Participants
ParticipantsOG00076
ParticipantsOG00172
ParticipantsOG00281
ParticipantsOG00393
Flavivirus-seropositive Participants
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG00367
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
percentage difference
76.69
2-Sided
95
69.10
82.68
Percentage Difference (mRNA-1893 Low Dose [2-Dose Regimen] vs. Placebo) for all participants
Other
OG000
OG002
percentage difference
77.80
2-Sided
95
70.29
83.67
Percentage Difference (mRNA-1893 High Dose [2-Dose Regimen] vs. Placebo) for all participants
Other
OG000
OG003
percentage difference
35.58
2-Sided
95
27.47
43.74
Percentage Difference (mRNA-1893 High Dose [1-Dose Regimen] vs. Placebo) for all participants
Other
OG000
OG001
percentage difference
86.11
2-Sided
95
76.25
92.29
Percentage Difference (mRNA-1893 Low Dose [2-Dose Regimen] vs. Placebo) for flavivirus-negative participants
Other
OG000
OG002
percentage difference
87.65
2-Sided
95
78.71
93.17
Percentage Difference (mRNA-1893 High Dose [2-Dose Regimen] vs. Placebo) for flavivirus-negative participants
Other
OG000
OG003
percentage difference
20.43
2-Sided
95
13.47
29.75
Percentage Difference (mRNA-1893 High Dose [1-Dose Regimen] vs. Placebo) for flavivirus-negative participants
Other
OG000
OG001
percentage difference
67.72
2-Sided
95
55.69
77.07
Percentage Difference (mRNA-1893 Low Dose [2-Dose Regimen] vs. Placebo) for flavivirus-positive participants
Other
OG000
OG002
percentage difference
67.81
2-Sided
95
55.36
77.44
Percentage Difference (mRNA-1893 High Dose [2-Dose Regimen] vs. Placebo) for flavivirus-positive participants
Other
OG000
OG003
percentage difference
57.53
2-Sided
95
43.81
69.08
Percentage Difference (mRNA-1893 High Dose [1-Dose Regimen] vs. Placebo) for flavivirus-positive participants
Other
Participants received mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG003
mRNA-1893 High Dose (1-Dose Regimen)
Participants received placebo matched to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There was 28-day interval between vaccinations.
Units
Counts
Participants
OG000163
OG001163
OG002162
OG003163
Title
Denominators
Categories
All Participants
ParticipantsOG000163
ParticipantsOG001163
ParticipantsOG002162
ParticipantsOG003163
Title
Measurements
OG0001.2(0.15 to 4.36)
OG00176.7(69.43 to 82.94)
OG00276.5(69.25 to 82.83)
OG003
Flavivirus-seronegative Participants
ParticipantsOG00076
ParticipantsOG00172
ParticipantsOG00281
ParticipantsOG00393
Flavivirus-seropositive Participants
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG00367
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
percentage difference
75.46
2-Sided
95
68.12
81.49
Percentage Difference (mRNA-1893 Low Dose [2-Dose Regimen] vs. Placebo) for all participants
Other
OG000
OG002
percentage difference
75.32
2-Sided
95
67.94
81.38
Percentage Difference (mRNA-1893 High Dose [2-Dose Regimen] vs. Placebo) for all participants
Other
OG000
OG003
percentage difference
31.29
2-Sided
95
24.23
38.96
Percentage Difference (mRNA-1893 High Dose [1-Dose Regimen] vs. Placebo) for all participants
Other
OG000
OG001
percentage difference
77.78
2-Sided
95
66.87
85.85
Percentage Difference (mRNA-1893 Low Dose [2-Dose Regimen] vs. Placebo) for flavivirus-negative participants
Other
OG000
OG002
percentage difference
82.72
2-Sided
95
73.02
89.43
Percentage Difference (mRNA-1893 High Dose [2-Dose Regimen] vs. Placebo) for flavivirus-negative participants
Other
OG000
OG003
percentage difference
9.68
2-Sided
95
4.63
17.41
Percentage Difference (mRNA-1893 High Dose [1-Dose Regimen] vs. Placebo) for flavivirus-negative participants
Other
OG000
OG001
percentage difference
72.39
2-Sided
95
61.56
80.83
Percentage Difference (mRNA-1893 Low Dose [2-Dose Regimen] vs. Placebo) for flavivirus-positive participants
Other
OG000
OG002
percentage difference
67.29
2-Sided
95
55.72
76.78
Percentage Difference (mRNA-1893 High Dose [2-Dose Regimen] vs. Placebo) for flavivirus-positive participants
Other
OG000
OG003
percentage difference
63.35
2-Sided
95
50.75
74.00
Percentage Difference (mRNA-1893 High Dose [1-Dose Regimen] vs. Placebo) for flavivirus-positive participants
Other
Participants received mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG003
mRNA-1893 High Dose (1-Dose Regimen)
Participants received placebo matched to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There was 28-day interval between vaccinations.
Units
Counts
Participants
OG000163
OG001163
OG002162
OG003163
Title
Denominators
Categories
Day 1: All Participants by PRNT50
ParticipantsOG000163
ParticipantsOG001163
ParticipantsOG002162
ParticipantsOG003163
Title
Measurements
OG00060.64(53.33 to 68.95)
OG00161.21(53.93 to 69.46)
OG00254.57(49.53 to 60.13)
OG003
Day 8: All Participants by PRNT50
ParticipantsOG000162
ParticipantsOG001163
ParticipantsOG002161
ParticipantsOG003162
Day 29: All Participants by PRNT50
ParticipantsOG000163
ParticipantsOG001162
ParticipantsOG002162
ParticipantsOG003163
Day 36: All Participants by PRNT50
ParticipantsOG000162
ParticipantsOG001163
ParticipantsOG002161
ParticipantsOG003162
Day 1: Flavivirus-negative Participants by PRNT50
ParticipantsOG00076
ParticipantsOG00172
ParticipantsOG00281
ParticipantsOG003
Day 8: Flavivirus-negative Participants by PRNT50
ParticipantsOG00075
ParticipantsOG00172
ParticipantsOG00281
ParticipantsOG003
Day 29: Flavivirus-negative Participants by PRNT50
ParticipantsOG00076
ParticipantsOG00171
ParticipantsOG00281
ParticipantsOG003
Day 36: Flavivirus-negative Participants by PRNT50
ParticipantsOG00076
ParticipantsOG00172
ParticipantsOG00280
ParticipantsOG003
Day 1: Flavivirus-positive Participants by PRNT50
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
Day 8: Flavivirus-positive Participants by PRNT50
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00278
ParticipantsOG003
Day 29: Flavivirus-positive Participants by PRNT50
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
Day 36: Flavivirus-positive Participants by PRNT50
ParticipantsOG00085
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
Day 1: All Participants by PRNT80
ParticipantsOG000163
ParticipantsOG001163
ParticipantsOG002162
ParticipantsOG003163
Day 8: All Participants by PRNT80
ParticipantsOG000162
ParticipantsOG001163
ParticipantsOG002161
ParticipantsOG003162
Day 29: All Participants by PRNT80
ParticipantsOG000163
ParticipantsOG001162
ParticipantsOG002162
ParticipantsOG003163
Day 36: All Participants by PRNT80
ParticipantsOG000162
ParticipantsOG001163
ParticipantsOG002161
ParticipantsOG003162
Day 1: Flavivirus-negative Participants by PRNT80
ParticipantsOG00076
ParticipantsOG00172
ParticipantsOG00281
ParticipantsOG003
Day 8: Flavivirus-negative Participants by PRNT80
ParticipantsOG00075
ParticipantsOG00172
ParticipantsOG00281
ParticipantsOG003
Day 29: Flavivirus-negative Participants by PRNT80
ParticipantsOG00076
ParticipantsOG00171
ParticipantsOG00281
ParticipantsOG003
Day 36: Flavivirus-negative Participants by PRNT80
ParticipantsOG00076
ParticipantsOG00172
ParticipantsOG00280
ParticipantsOG003
Day 1: Flavivirus-positive Participants by PRNT80
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
Day 8: Flavivirus-positive Participants by PRNT80
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00278
ParticipantsOG003
Day 29: Flavivirus-positive Participants by PRNT80
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
Day 36: Flavivirus-positive Participants by PRNT80
ParticipantsOG00085
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
mRNA-1893 High Dose (2-Dose Regimen)
Participants received mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG003
mRNA-1893 High Dose (1-Dose Regimen)
Participants received placebo matched to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There was 28-day interval between vaccinations.
Units
Counts
Participants
OG000163
OG001163
OG002162
OG003163
Title
Denominators
Categories
Day 1: All Participants
ParticipantsOG000163
ParticipantsOG001163
ParticipantsOG002162
ParticipantsOG003163
Title
Measurements
OG00030.54(24.08 to 38.73)
OG00132.98(26.18 to 41.55)
OG00225.31(20.43 to 31.36)
OG003
Day 8: All Participants
ParticipantsOG000162
ParticipantsOG001163
ParticipantsOG002162
ParticipantsOG003163
Day 29: All Participants
ParticipantsOG000163
ParticipantsOG001162
ParticipantsOG002162
ParticipantsOG003163
Day 36: All Participants
ParticipantsOG000162
ParticipantsOG001163
ParticipantsOG002161
ParticipantsOG003162
Day 57: All Participants
ParticipantsOG000163
ParticipantsOG001163
ParticipantsOG002162
ParticipantsOG003163
Day 1: Flavivirus-negative Participants
ParticipantsOG00076
ParticipantsOG00172
ParticipantsOG00281
ParticipantsOG00393
Day 8: Flavivirus-negative Participants
ParticipantsOG00075
ParticipantsOG00172
ParticipantsOG00281
ParticipantsOG00393
Day 29: Flavivirus-negative Participants
ParticipantsOG00076
ParticipantsOG00171
ParticipantsOG00281
ParticipantsOG00393
Day 36: Flavivirus-negative Participants
ParticipantsOG00076
ParticipantsOG00172
ParticipantsOG00280
ParticipantsOG00392
Day 57: Flavivirus-negative Participants
ParticipantsOG00076
ParticipantsOG00172
ParticipantsOG00281
ParticipantsOG00393
Day 1: Flavivirus-positive Participants
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG00367
Day 8: Flavivirus-positive Participants
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG00367
Day 29: Flavivirus-positive Participants
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG00367
Day 36: Flavivirus-positive Participants
ParticipantsOG00085
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG00367
Day 57: Flavivirus-positive Participants
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG00367
mRNA-1893 High Dose (2-Dose Regimen)
Participants received mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG003
mRNA-1893 High Dose (1-Dose Regimen)
Participants received placebo matched to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There was 28-day interval between vaccinations.
Units
Counts
Participants
OG000163
OG001163
OG002162
OG003163
Title
Denominators
Categories
Day 8: All Participants by PRNT50
ParticipantsOG000162
ParticipantsOG001163
ParticipantsOG002161
ParticipantsOG003162
Title
Measurements
OG0001.02(0.94 to 1.11)
OG0011.91(1.55 to 2.36)
OG0021.94(1.54 to 2.43)
OG003
Day 29: All Participants by PRNT50
ParticipantsOG000163
ParticipantsOG001162
ParticipantsOG002162
ParticipantsOG003163
Day 36: All Participants by PRNT50
ParticipantsOG000162
ParticipantsOG001163
ParticipantsOG002161
ParticipantsOG003162
Day 57: All Participants by PRNT50
ParticipantsOG000163
ParticipantsOG001163
ParticipantsOG002162
ParticipantsOG003163
Day 8: Flavivirus-negative Participants by PRNT50
ParticipantsOG00075
ParticipantsOG00172
ParticipantsOG00281
ParticipantsOG003
Day 29: Flavivirus-negative Participants by PRNT50
ParticipantsOG00076
ParticipantsOG00171
ParticipantsOG00281
ParticipantsOG003
Day 36: Flavivirus-negative Participants by PRNT50
ParticipantsOG00076
ParticipantsOG00172
ParticipantsOG00280
ParticipantsOG003
Day 57: Flavivirus-negative Participants by PRNT50
ParticipantsOG00076
ParticipantsOG00172
ParticipantsOG00281
ParticipantsOG003
Day 8: Flavivirus-positive Participants by PRNT50
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00278
ParticipantsOG003
Day 29: Flavivirus-positive Participants by PRNT50
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
Day 36: Flavivirus-positive Participants by PRNT50
ParticipantsOG00085
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
Day 57: Flavivirus-positive Participants by PRNT50
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
Day 8: All Participants by PRNT80
ParticipantsOG000162
ParticipantsOG001163
ParticipantsOG002161
ParticipantsOG003162
Day 29: All Participants by PRNT80
ParticipantsOG000163
ParticipantsOG001162
ParticipantsOG002162
ParticipantsOG003163
Day 36: All Participants by PRNT80
ParticipantsOG000162
ParticipantsOG001163
ParticipantsOG002161
ParticipantsOG003162
Day 57: All Participants by PRNT80
ParticipantsOG000163
ParticipantsOG001163
ParticipantsOG002162
ParticipantsOG003163
Day 8: Flavivirus-negative Participants by PRNT80
ParticipantsOG00075
ParticipantsOG00172
ParticipantsOG00281
ParticipantsOG003
Day 29: Flavivirus-negative Participants by PRNT80
ParticipantsOG00076
ParticipantsOG00171
ParticipantsOG00281
ParticipantsOG003
Day 36: Flavivirus-negative Participants by PRNT80
ParticipantsOG00076
ParticipantsOG00172
ParticipantsOG00280
ParticipantsOG003
Day 57: Flavivirus-negative Participants by PRNT80
ParticipantsOG00076
ParticipantsOG00172
ParticipantsOG00281
ParticipantsOG003
Day 8: Flavivirus-positive Participants by PRNT80
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00278
ParticipantsOG003
Day 29: Flavivirus-positive Participants by PRNT80
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
Day 36: Flavivirus-positive Participants by PRNT80
ParticipantsOG00085
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
Day 57: Flavivirus-positive Participants by PRNT80
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
Participants received mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG003
mRNA-1893 High Dose (1-Dose Regimen)
Participants received placebo matched to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There was 28-day interval between vaccinations.
Units
Counts
Participants
OG000163
OG001163
OG002162
OG003163
Title
Denominators
Categories
Day 8: All Participants
ParticipantsOG000162
ParticipantsOG001163
ParticipantsOG002162
ParticipantsOG003163
Title
Measurements
OG0000.91(0.85 to 0.97)
OG0012.31(1.87 to 2.85)
OG0023.19(2.50 to 4.06)
OG003
Day 29: All Participants
ParticipantsOG000163
ParticipantsOG001162
ParticipantsOG002162
ParticipantsOG003163
Day 36: All Participants
ParticipantsOG000162
ParticipantsOG001163
ParticipantsOG002161
ParticipantsOG003162
Day 57: All Participants
ParticipantsOG000163
ParticipantsOG001163
ParticipantsOG002162
ParticipantsOG003163
Day 8: Flavivirus-negative Participants
ParticipantsOG00075
ParticipantsOG00172
ParticipantsOG00281
ParticipantsOG00393
Day 29: Flavivirus-negative Participants
ParticipantsOG00076
ParticipantsOG00171
ParticipantsOG00281
ParticipantsOG00393
Day 36: Flavivirus-negative Participants
ParticipantsOG00076
ParticipantsOG00172
ParticipantsOG00280
ParticipantsOG00392
Day 57: Flavivirus-negative Participants
ParticipantsOG00076
ParticipantsOG00172
ParticipantsOG00281
ParticipantsOG00393
Day 8: Flavivirus-positive Participants
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG00367
Day 29: Flavivirus-positive Participants
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG00367
Day 36: Flavivirus-positive Participants
ParticipantsOG00085
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG00367
Day 57: Flavivirus-positive Participants
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG00367
Participants received mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG003
mRNA-1893 High Dose (1-Dose Regimen)
Participants received placebo matched to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There was 28-day interval between vaccinations.
Units
Counts
Participants
OG000163
OG001163
OG002162
OG003163
Title
Denominators
Categories
Day 8: All Participants by PRNT50
ParticipantsOG000162
ParticipantsOG001163
ParticipantsOG002161
ParticipantsOG003162
Title
Measurements
OG0003.1(1.01 to 7.06)
OG00120.9(14.90 to 27.91)
OG00221.1(15.09 to 28.24)
OG003
Day 29: All Participants by PRNT50
ParticipantsOG000163
ParticipantsOG001162
ParticipantsOG002162
ParticipantsOG003163
Day 36: All Participants by PRNT50
ParticipantsOG000162
ParticipantsOG001163
ParticipantsOG002161
ParticipantsOG003162
Day 8: Flavivirus-negative Participants by PRNT50
ParticipantsOG00075
ParticipantsOG00172
ParticipantsOG00281
ParticipantsOG003
Day 29: Flavivirus-negative Participants by PRNT50
ParticipantsOG00076
ParticipantsOG00171
ParticipantsOG00281
ParticipantsOG003
Day 36: Flavivirus-negative Participants by PRNT50
ParticipantsOG00076
ParticipantsOG00172
ParticipantsOG00280
ParticipantsOG003
Day 8: Flavivirus-positive Participants by PRNT50
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00278
ParticipantsOG003
Day 29: Flavivirus-positive Participants by PRNT50
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
Day 36: Flavivirus-positive Participants by PRNT50
ParticipantsOG00085
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
Day 8: All Participants by PRNT80
ParticipantsOG000162
ParticipantsOG001163
ParticipantsOG002161
ParticipantsOG003162
Day 29: All Participants by PRNT80
ParticipantsOG000163
ParticipantsOG001162
ParticipantsOG002162
ParticipantsOG003163
Day 36: All Participants by PRNT80
ParticipantsOG000162
ParticipantsOG001163
ParticipantsOG002161
ParticipantsOG003162
Day 8: Flavivirus-negative Participants by PRNT80
ParticipantsOG00075
ParticipantsOG00172
ParticipantsOG00281
ParticipantsOG003
Day 29: Flavivirus-negative Participants by PRNT80
ParticipantsOG00076
ParticipantsOG00171
ParticipantsOG00281
ParticipantsOG003
Day 36: Flavivirus-negative Participants by PRNT80
ParticipantsOG00076
ParticipantsOG00172
ParticipantsOG00280
ParticipantsOG003
Day 8: Flavivirus-positive Participants by PRNT80
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00278
ParticipantsOG003
Day 29: Flavivirus-positive Participants by PRNT80
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
Day 36: Flavivirus-positive Participants by PRNT80
ParticipantsOG00085
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
Participants received mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG003
mRNA-1893 High Dose (1-Dose Regimen)
Participants received placebo matched to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There was 28-day interval between vaccinations.
Units
Counts
Participants
OG000163
OG001163
OG002162
OG003163
Title
Denominators
Categories
Day 8: All Participants
ParticipantsOG000162
ParticipantsOG001163
ParticipantsOG002162
ParticipantsOG003163
Title
Measurements
OG0001.2(0.15 to 4.39)
OG00135.0(27.68 to 42.82)
OG00241.4(33.69 to 49.35)
OG003
Day 29: All Participants
ParticipantsOG000163
ParticipantsOG001162
ParticipantsOG002162
ParticipantsOG003163
Day 36: All Participants
ParticipantsOG000162
ParticipantsOG001163
ParticipantsOG002161
ParticipantsOG003162
Day 57: All Participants
ParticipantsOG000163
ParticipantsOG001163
ParticipantsOG002162
ParticipantsOG003163
Day 8: Flavivirus-negative Participants
ParticipantsOG00075
ParticipantsOG00172
ParticipantsOG00281
ParticipantsOG00393
Day 29: Flavivirus-negative Participants
ParticipantsOG00076
ParticipantsOG00171
ParticipantsOG00281
ParticipantsOG00393
Day 36: Flavivirus-negative Participants
ParticipantsOG00076
ParticipantsOG00172
ParticipantsOG00280
ParticipantsOG00392
Day 57: Flavivirus-negative Participants
ParticipantsOG00076
ParticipantsOG00172
ParticipantsOG00281
ParticipantsOG00393
Day 8: Flavivirus-positive Participants
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG00367
Day 29: Flavivirus-positive Participants
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG00367
Day 36: Flavivirus-positive Participants
ParticipantsOG00085
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG00367
Day 57: Flavivirus-positive Participants
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG00367
Participants received mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG003
mRNA-1893 High Dose (1-Dose Regimen)
Participants received placebo matched to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There was 28-day interval between vaccinations.
Units
Counts
Participants
OG00076
OG00170
OG00281
OG00393
Title
Denominators
Categories
Day 8: Flavivirus-negative Participants by PRNT50
ParticipantsOG00075
ParticipantsOG00170
ParticipantsOG00281
ParticipantsOG00393
Title
Measurements
OG0000(0.00 to 4.80)
OG0010(0.00 to 5.13)
OG0022.5(0.30 to 8.64)
OG003
Day 29: Flavivirus-negative Participants by PRNT50
ParticipantsOG00076
ParticipantsOG00169
ParticipantsOG00281
ParticipantsOG003
Day 36: Flavivirus-negative Participants by PRNT50
ParticipantsOG00076
ParticipantsOG00170
ParticipantsOG00280
ParticipantsOG003
Day 8: Flavivirus-negative Participants by PRNT80
ParticipantsOG00075
ParticipantsOG00170
ParticipantsOG00281
ParticipantsOG003
Day 29: Flavivirus-negative Participants by PRNT80
ParticipantsOG00076
ParticipantsOG00169
ParticipantsOG00281
ParticipantsOG003
Day 36: Flavivirus-negative Participants by PRNT80
ParticipantsOG00076
ParticipantsOG00170
ParticipantsOG00280
ParticipantsOG003
Participants received mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG003
mRNA-1893 High Dose (1-Dose Regimen)
Participants received placebo matched to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There was 28-day interval between vaccinations.
Units
Counts
Participants
OG00076
OG00169
OG00281
OG00390
Title
Denominators
Categories
Day 8: Flavivirus-negative Participants
ParticipantsOG00075
ParticipantsOG00169
ParticipantsOG00281
ParticipantsOG00390
Title
Measurements
OG0000(0.00 to 4.80)
OG0015.8(1.60 to 14.18)
OG00216.0(8.83 to 25.88)
OG003
Day 29: Flavivirus-negative Participants
ParticipantsOG00076
ParticipantsOG00168
ParticipantsOG00281
ParticipantsOG00390
Day 36: Flavivirus-negative Participants
ParticipantsOG00076
ParticipantsOG00169
ParticipantsOG00280
ParticipantsOG00389
Day 57: Flavivirus-negative Participants
ParticipantsOG00076
ParticipantsOG00169
ParticipantsOG00281
ParticipantsOG00390
OG002
mRNA-1893 High Dose (2-Dose Regimen)
Participants received mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG003
mRNA-1893 High Dose (1-Dose Regimen)
Participants received placebo matched to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There was 28-day interval between vaccinations.
Units
Counts
Participants
OG00086
OG00187
OG00279
OG00367
Title
Denominators
Categories
Day 8: Flavivirus-positive Participants by PRNT50
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00278
ParticipantsOG00366
Title
Measurements
OG0008.1(3.34 to 16.05)
OG00141.4(30.92 to 52.45)
OG00238.5(27.66 to 50.17)
OG003
Day 29: Flavivirus-positive Participants by PRNT50
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
Day 36: Flavivirus-positive Participants by PRNT50
ParticipantsOG00085
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
Day 57: Flavivirus-positive Participants by PRNT50
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
Day 8: Flavivirus-positive Participants by PRNT80
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00278
ParticipantsOG003
Day 29: Flavivirus-positive Participants by PRNT80
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
Day 36: Flavivirus-positive Participants by PRNT80
ParticipantsOG00085
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
Day 57: Flavivirus-positive Participants by PRNT80
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
OG002
mRNA-1893 High Dose (2-Dose Regimen)
Participants received mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG003
mRNA-1893 High Dose (1-Dose Regimen)
Participants received placebo matched to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There was 28-day interval between vaccinations.
Units
Counts
Participants
OG00086
OG00187
OG00279
OG00367
Title
Denominators
Categories
Day 8: Flavivirus-positive Participants by PRNT50
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00278
ParticipantsOG00366
Title
Measurements
OG0002.3(0.28 to 8.15)
OG00135.6(25.65 to 46.62)
OG00235.9(25.34 to 47.56)
OG003
Day 29: Flavivirus-positive Participants by PRNT50
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
Day 36: Flavivirus-positive Participants by PRNT50
ParticipantsOG00085
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
Day 57: Flavivirus-positive Participants by PRNT50
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
Day 8: Flavivirus-positive Participants by PRNT80
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00278
ParticipantsOG003
Day 29: Flavivirus-positive Participants by PRNT80
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
Day 36: Flavivirus-positive Participants by PRNT80
ParticipantsOG00085
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
Day 57: Flavivirus-positive Participants by PRNT80
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG003
mRNA-1893 High Dose (2-Dose Regimen)
Participants received mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG003
mRNA-1893 High Dose (1-Dose Regimen)
Participants received placebo matched to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There was 28-day interval between vaccinations.
Units
Counts
Participants
OG00086
OG00187
OG00279
OG00367
Title
Denominators
Categories
Day 8: Flavivirus-positive Participants
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG00367
Title
Measurements
OG0003.5(0.73 to 9.86)
OG00158.6(47.55 to 69.08)
OG00263.3(51.69 to 73.86)
OG003
Day 29: Flavivirus-positive Participants
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG00367
Day 36: Flavivirus-positive Participants
ParticipantsOG00085
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG00367
Day 57: Flavivirus-positive Participants
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG00367
mRNA-1893 High Dose (2-Dose Regimen)
Participants received mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG003
mRNA-1893 High Dose (1-Dose Regimen)
Participants received placebo matched to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There was 28-day interval between vaccinations.
Units
Counts
Participants
OG00086
OG00187
OG00279
OG00367
Title
Denominators
Categories
Day 8: Flavivirus-positive Participants
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG00367
Title
Measurements
OG0002.3(0.28 to 8.15)
OG00143.7(33.06 to 54.74)
OG00250.6(39.14 to 62.08)
OG003
Day 29: Flavivirus-positive Participants
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG00367
Day 36: Flavivirus-positive Participants
ParticipantsOG00085
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG00367
Day 57: Flavivirus-positive Participants
ParticipantsOG00086
ParticipantsOG00187
ParticipantsOG00279
ParticipantsOG00367
OG001
Main Study: mRNA-1893 Low Dose (2-Dose Regimen)
Participants received mRNA-1893 at a low dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG002
Main Study: mRNA-1893 High Dose (2-Dose Regimen)
Participants received mRNA-1893 at a high dose level administered as a 2-dose regimen with 28-day interval between vaccinations (administered on Day 1 and Day 29).
OG003
Main Study: mRNA-1893 High Dose (1-Dose Regimen)
Participants received placebo matched to mRNA-1893 on Day 1 and mRNA-1893 at a high dose level administered as a 1-dose regimen (administered on Day 29). There was 28-day interval between vaccinations.
OG004
Extension Period: Placebo
Participants were followed up for up to Day 700 in the extension period.