Zika Virus
Conditions
Keywords
Flavivirus, mRNA-1893, Zika vaccine, Moderna
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.
Interventions
BIOLOGICALmRNA-1893
Solution for injection
BIOLOGICALPlacebo
0.9% sodium chloride solution for injection
Sponsors
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT80 | Day 57 | 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. |
| Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) | Up to 7 days post-vaccination | 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. |
| Number of Participants With Unsolicited Adverse Events (AEs) | Up to 28 days post-vaccination | 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. |
| Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs) | Day 1 through Day 196 for Main Study and Day 197 through Day 700 for Extension Period | 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. |
| Number of Participants With Medically Attended AEs (MAAEs) | Day 1 through Day 196 for Main Study and Day 197 through Day 700 for Extension Period | 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. |
| Geometric Mean Titer (GMT) of Zika Virus (ZIKV)-Specific Neutralizing Antibodies (nAbs) at Day 57, as Measured by 50% Plaque Reduction Neutralization Test (PRNT50) | Day 57 | 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. |
| GMT of ZIKV-specific nAbs at Day 57, as Measured by 80% Plaque Reduction Neutralization Test (PRNT80) | Day 57 | 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. |
| Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT50 | Day 57 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Days 8, 29, and 36 | 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. |
| 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 | Days 8, 29, 36, and 57 | ≥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 |
| Percentage of Initially Seropositive Participants With a 2-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Days 8, 29, 36, and 57 | ≥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. |
| Percentage of Initially Seropositive Participants With a 4-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Days 8, 29, 36, and 57 | ≥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. |
| 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 | Days 8, 29, 36, and 57 | ≥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 |
| Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, 36, and 57, as Measured by MN | Days 8, 29, 36, and 57 | 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. |
| GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Days 1, 8, 29, and 36 | 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. |
| GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Days 1, 8, 29, 36, and 57 | 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. |
| Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Days 8, 29, 36, and 57 | 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. |
| GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Days 8, 29, 36, and 57 | 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. |
| Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Days 8, 29, and 36 | 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. |
| Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Days 8, 29, 36, and 57 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Deaths Related to Study Drug | Day 1 through Day 196 for Main Study and Day 197 through Day 700 for Extension Period | 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. |
Countries
Puerto Rico, United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 201 |
| 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). | 201 |
| 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). | 202 |
| 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. | 198 |
| Total | 802 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Extension Period (Day 197 to Day 700) | Death | 0 | 1 | 0 | 0 |
| Extension Period (Day 197 to Day 700) | Lost to Follow-up | 8 | 3 | 5 | 11 |
| Extension Period (Day 197 to Day 700) | Other Than Specified | 1 | 0 | 1 | 1 |
| Extension Period (Day 197 to Day 700) | Pregnancy | 1 | 0 | 1 | 1 |
| Extension Period (Day 197 to Day 700) | Protocol Violation | 0 | 1 | 0 | 0 |
| Extension Period (Day 197 to Day 700) | Withdrawal by Subject | 6 | 8 | 8 | 10 |
| Main Study (196 Days) | Adverse Event | 0 | 1 | 0 | 0 |
| Main Study (196 Days) | Death | 0 | 0 | 0 | 1 |
| Main Study (196 Days) | Lost to Follow-up | 14 | 26 | 20 | 11 |
| Main Study (196 Days) | Other Than Specified | 1 | 0 | 1 | 2 |
| Main Study (196 Days) | Physician Decision | 0 | 0 | 0 | 1 |
| Main Study (196 Days) | Pregnancy | 1 | 1 | 0 | 0 |
| Main Study (196 Days) | Withdrawal by Subject | 14 | 7 | 6 | 8 |
Baseline characteristics
| Characteristic | mRNA-1893 High Dose (1-Dose Regimen) ( | Placebo | mRNA-1893 Low Dose (2-Dose Regimen) | mRNA-1893 High Dose (2-Dose Regimen) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 198 Participants | 201 Participants | 201 Participants | 202 Participants | 802 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 107 Participants | 106 Participants | 106 Participants | 110 Participants | 429 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 90 Participants | 94 Participants | 94 Participants | 91 Participants | 369 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 2 Participants | 0 Participants | 3 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized Race Asian | 2 Participants | 0 Participants | 2 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Race Black or African American | 21 Participants | 28 Participants | 25 Participants | 22 Participants | 96 Participants |
| Race/Ethnicity, Customized Race Multiracial | 1 Participants | 3 Participants | 1 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Not reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Other | 0 Participants | 1 Participants | 3 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Race White | 172 Participants | 167 Participants | 167 Participants | 174 Participants | 680 Participants |
| Seroresponse Flavivirus Seronegative Participants | 111 Participants | 96 Participants | 92 Participants | 105 Participants | 404 Participants |
| Seroresponse Flavivirus Seropositive Participants | 82 Participants | 102 Participants | 103 Participants | 94 Participants | 381 Participants |
| Seroresponse Missing | 5 Participants | 3 Participants | 6 Participants | 3 Participants | 17 Participants |
| Sex: Female, Male Female | 114 Participants | 111 Participants | 119 Participants | 119 Participants | 463 Participants |
| Sex: Female, Male Male | 84 Participants | 90 Participants | 82 Participants | 83 Participants | 339 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 203 | 0 / 202 | 0 / 203 | 1 / 201 | 0 / 113 | 1 / 109 | 0 / 104 | 0 / 116 |
| other Total, other adverse events | 18 / 201 | 20 / 202 | 24 / 202 | 16 / 198 | 8 / 113 | 5 / 109 | 8 / 104 | 10 / 116 |
| serious Total, serious adverse events | 5 / 201 | 2 / 202 | 4 / 202 | 7 / 198 | 5 / 113 | 4 / 109 | 5 / 104 | 7 / 116 |
Outcome results
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.
Time frame: Day 57
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | Geometric Mean Titer (GMT) of Zika Virus (ZIKV)-Specific Neutralizing Antibodies (nAbs) at Day 57, as Measured by 50% Plaque Reduction Neutralization Test (PRNT50) | All Participants | 61.06 titer |
| Placebo | Geometric Mean Titer (GMT) of Zika Virus (ZIKV)-Specific Neutralizing Antibodies (nAbs) at Day 57, as Measured by 50% Plaque Reduction Neutralization Test (PRNT50) | Flavivirus-seropositive Participants | 79.46 titer |
| Placebo | Geometric Mean Titer (GMT) of Zika Virus (ZIKV)-Specific Neutralizing Antibodies (nAbs) at Day 57, as Measured by 50% Plaque Reduction Neutralization Test (PRNT50) | Flavivirus-seronegative Participants | 45.50 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | Geometric Mean Titer (GMT) of Zika Virus (ZIKV)-Specific Neutralizing Antibodies (nAbs) at Day 57, as Measured by 50% Plaque Reduction Neutralization Test (PRNT50) | All Participants | 427.53 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | Geometric Mean Titer (GMT) of Zika Virus (ZIKV)-Specific Neutralizing Antibodies (nAbs) at Day 57, as Measured by 50% Plaque Reduction Neutralization Test (PRNT50) | Flavivirus-seropositive Participants | 539.17 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | Geometric Mean Titer (GMT) of Zika Virus (ZIKV)-Specific Neutralizing Antibodies (nAbs) at Day 57, as Measured by 50% Plaque Reduction Neutralization Test (PRNT50) | Flavivirus-seronegative Participants | 327.95 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | Geometric Mean Titer (GMT) of Zika Virus (ZIKV)-Specific Neutralizing Antibodies (nAbs) at Day 57, as Measured by 50% Plaque Reduction Neutralization Test (PRNT50) | Flavivirus-seronegative Participants | 363.03 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | Geometric Mean Titer (GMT) of Zika Virus (ZIKV)-Specific Neutralizing Antibodies (nAbs) at Day 57, as Measured by 50% Plaque Reduction Neutralization Test (PRNT50) | Flavivirus-seropositive Participants | 502.11 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | Geometric Mean Titer (GMT) of Zika Virus (ZIKV)-Specific Neutralizing Antibodies (nAbs) at Day 57, as Measured by 50% Plaque Reduction Neutralization Test (PRNT50) | All Participants | 434.92 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | Geometric Mean Titer (GMT) of Zika Virus (ZIKV)-Specific Neutralizing Antibodies (nAbs) at Day 57, as Measured by 50% Plaque Reduction Neutralization Test (PRNT50) | Flavivirus-seropositive Participants | 558.49 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | Geometric Mean Titer (GMT) of Zika Virus (ZIKV)-Specific Neutralizing Antibodies (nAbs) at Day 57, as Measured by 50% Plaque Reduction Neutralization Test (PRNT50) | Flavivirus-seronegative Participants | 68.96 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | Geometric Mean Titer (GMT) of Zika Virus (ZIKV)-Specific Neutralizing Antibodies (nAbs) at Day 57, as Measured by 50% Plaque Reduction Neutralization Test (PRNT50) | All Participants | 163.28 titer |
95% CI: [5.451, 8.992]
95% CI: [5.467, 9.279]
95% CI: [1.961, 3.646]
95% CI: [5.428, 9.571]
95% CI: [6.106, 10.425]
95% CI: [1.229, 1.869]
95% CI: [4.562, 10.092]
95% CI: [4.03, 9.909]
95% CI: [4.056, 12.18]
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.
Time frame: Day 57
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | GMT of ZIKV-specific nAbs at Day 57, as Measured by 80% Plaque Reduction Neutralization Test (PRNT80) | All Participants | 20.80 titer |
| Placebo | GMT of ZIKV-specific nAbs at Day 57, as Measured by 80% Plaque Reduction Neutralization Test (PRNT80) | Flavivirus-seronegative Participants | 16.50 titer |
| Placebo | GMT of ZIKV-specific nAbs at Day 57, as Measured by 80% Plaque Reduction Neutralization Test (PRNT80) | Flavivirus-seropositive Participants | 25.60 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-specific nAbs at Day 57, as Measured by 80% Plaque Reduction Neutralization Test (PRNT80) | All Participants | 110.52 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-specific nAbs at Day 57, as Measured by 80% Plaque Reduction Neutralization Test (PRNT80) | Flavivirus-seropositive Participants | 166.23 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-specific nAbs at Day 57, as Measured by 80% Plaque Reduction Neutralization Test (PRNT80) | Flavivirus-seronegative Participants | 69.64 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-specific nAbs at Day 57, as Measured by 80% Plaque Reduction Neutralization Test (PRNT80) | All Participants | 111.21 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-specific nAbs at Day 57, as Measured by 80% Plaque Reduction Neutralization Test (PRNT80) | Flavivirus-seronegative Participants | 87.45 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-specific nAbs at Day 57, as Measured by 80% Plaque Reduction Neutralization Test (PRNT80) | Flavivirus-seropositive Participants | 139.57 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-specific nAbs at Day 57, as Measured by 80% Plaque Reduction Neutralization Test (PRNT80) | Flavivirus-seronegative Participants | 19.89 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-specific nAbs at Day 57, as Measured by 80% Plaque Reduction Neutralization Test (PRNT80) | All Participants | 48.36 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-specific nAbs at Day 57, as Measured by 80% Plaque Reduction Neutralization Test (PRNT80) | Flavivirus-seropositive Participants | 174.18 titer |
95% CI: [4.149, 6.802]
95% CI: [4.128, 6.922]
95% CI: [1.721, 3.14]
95% CI: [3.322, 5.363]
95% CI: [4.243, 6.62]
95% CI: [1.033, 1.407]
95% CI: [4.358, 9.674]
95% CI: [3.43, 8.665]
95% CI: [3.928, 11.784]
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.
Time frame: Day 1 through Day 196 for Main Study and Day 197 through Day 700 for Extension Period
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Medically Attended AEs (MAAEs) | 62 Participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Number of Participants With Medically Attended AEs (MAAEs) | 50 Participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Number of Participants With Medically Attended AEs (MAAEs) | 62 Participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Number of Participants With Medically Attended AEs (MAAEs) | 63 Participants |
| Extension Period: Placebo | Number of Participants With Medically Attended AEs (MAAEs) | 29 Participants |
| Extension Period: mRNA-1893 Low Dose (2-Dose Regimen) | Number of Participants With Medically Attended AEs (MAAEs) | 24 Participants |
| Extension Period: mRNA-1893 High Dose (2-Dose Regimen) | Number of Participants With Medically Attended AEs (MAAEs) | 30 Participants |
| Extension Period: mRNA-1893 High Dose (1-Dose Regimen) | Number of Participants With Medically Attended AEs (MAAEs) | 31 Participants |
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.
Time frame: Day 1 through Day 196 for Main Study and Day 197 through Day 700 for Extension Period
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs) | AESIs | 0 Participants |
| Placebo | Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs) | SAEs | 5 Participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs) | AESIs | 0 Participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs) | SAEs | 2 Participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs) | AESIs | 0 Participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs) | SAEs | 4 Participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs) | SAEs | 7 Participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs) | AESIs | 0 Participants |
| Extension Period: Placebo | Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs) | SAEs | 5 Participants |
| Extension Period: Placebo | Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs) | AESIs | 0 Participants |
| Extension Period: mRNA-1893 Low Dose (2-Dose Regimen) | Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs) | SAEs | 4 Participants |
| Extension Period: mRNA-1893 Low Dose (2-Dose Regimen) | Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs) | AESIs | 0 Participants |
| Extension Period: mRNA-1893 High Dose (2-Dose Regimen) | Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs) | SAEs | 5 Participants |
| Extension Period: mRNA-1893 High Dose (2-Dose Regimen) | Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs) | AESIs | 0 Participants |
| Extension Period: mRNA-1893 High Dose (1-Dose Regimen) | Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs) | AESIs | 0 Participants |
| Extension Period: mRNA-1893 High Dose (1-Dose Regimen) | Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs) | SAEs | 7 Participants |
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.
Time frame: Up to 7 days post-vaccination
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) | 86 Participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) | 164 Participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) | 183 Participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) | 163 Participants |
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.
Time frame: Up to 28 days post-vaccination
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Unsolicited Adverse Events (AEs) | 39 Participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Number of Participants With Unsolicited Adverse Events (AEs) | 47 Participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Number of Participants With Unsolicited Adverse Events (AEs) | 52 Participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Number of Participants With Unsolicited Adverse Events (AEs) | 45 Participants |
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.
Time frame: Day 57
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT50 | Flavivirus-seropositive Participants | 8.1 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT50 | All Participants | 4.3 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT50 | Flavivirus-seronegative Participants | 0 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT50 | Flavivirus-seronegative Participants | 86.1 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT50 | Flavivirus-seropositive Participants | 75.9 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT50 | All Participants | 81.0 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT50 | Flavivirus-seronegative Participants | 87.7 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT50 | All Participants | 82.1 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT50 | Flavivirus-seropositive Participants | 75.9 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT50 | All Participants | 39.9 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT50 | Flavivirus-seronegative Participants | 20.4 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT50 | Flavivirus-seropositive Participants | 65.7 percentage of participants |
95% CI: [13.47, 29.75]
95% CI: [55.69, 77.07]
95% CI: [55.36, 77.44]
95% CI: [43.81, 69.08]
95% CI: [69.1, 82.68]
95% CI: [70.29, 83.67]
95% CI: [27.47, 43.74]
95% CI: [76.25, 92.29]
95% CI: [78.71, 93.17]
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.
Time frame: Day 57
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT80 | Flavivirus-seronegative Participants | 0 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT80 | Flavivirus-seropositive Participants | 2.3 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT80 | All Participants | 1.2 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT80 | Flavivirus-seronegative Participants | 77.8 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT80 | Flavivirus-seropositive Participants | 74.7 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT80 | All Participants | 76.7 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT80 | Flavivirus-seronegative Participants | 82.7 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT80 | All Participants | 76.5 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT80 | Flavivirus-seropositive Participants | 69.6 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT80 | Flavivirus-seronegative Participants | 9.7 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT80 | Flavivirus-seropositive Participants | 65.7 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Day 57, as Measured by PRNT80 | All Participants | 32.5 percentage of participants |
95% CI: [68.12, 81.49]
95% CI: [67.94, 81.38]
95% CI: [24.23, 38.96]
95% CI: [66.87, 85.85]
95% CI: [73.02, 89.43]
95% CI: [4.63, 17.41]
95% CI: [61.56, 80.83]
95% CI: [55.72, 76.78]
95% CI: [50.75, 74]
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.
Time frame: Days 8, 29, 36, and 57
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT80 | 1.03 ratio |
| Placebo | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 29: All Participants by PRNT80 | 1.00 ratio |
| Placebo | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-positive Participants by PRNT50 | 1.18 ratio |
| Placebo | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 57: All Participants by PRNT80 | 0.99 ratio |
| Placebo | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 8: All Participants by PRNT80 | 0.97 ratio |
| Placebo | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 57: Flavivirus-positive Participants by PRNT50 | 1.01 ratio |
| Placebo | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-positive Participants by PRNT50 | 0.93 ratio |
| Placebo | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 36: All Participants by PRNT50 | 0.96 ratio |
| Placebo | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-positive Participants by PRNT80 | 0.98 ratio |
| Placebo | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 36: All Participants by PRNT80 | 0.97 ratio |
| Placebo | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-positive Participants by PRNT50 | 1.04 ratio |
| Placebo | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT50 | 1.00 ratio |
| Placebo | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 29: All Participants by PRNT50 | 1.10 ratio |
| Placebo | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 57: Flavivirus-negative Participants by PRNT50 | 1.00 ratio |
| Placebo | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT50 | 1.02 ratio |
| Placebo | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-positive Participants by PRNT80 | 0.94 ratio |
| Placebo | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 57: All Participants by PRNT50 | 1.01 ratio |
| Placebo | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 57: Flavivirus-positive Participants by PRNT80 | 0.98 ratio |
| Placebo | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT50 | 1.00 ratio |
| Placebo | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 8: All Participants by PRNT50 | 1.02 ratio |
| Placebo | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-positive Participants by PRNT80 | 0.95 ratio |
| Placebo | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT80 | 1.00 ratio |
| Placebo | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 57: Flavivirus-negative Participants by PRNT80 | 1.00 ratio |
| Placebo | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT80 | 1.00 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-positive Participants by PRNT80 | 4.76 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 29: All Participants by PRNT50 | 2.47 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 36: All Participants by PRNT50 | 8.06 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT50 | 0.99 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT50 | 1.14 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 57: Flavivirus-negative Participants by PRNT50 | 6.46 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-positive Participants by PRNT50 | 4.84 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-positive Participants by PRNT50 | 7.00 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 57: Flavivirus-positive Participants by PRNT50 | 7.44 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 8: All Participants by PRNT80 | 1.93 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT80 | 1.04 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT80 | 5.31 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 57: Flavivirus-negative Participants by PRNT80 | 3.86 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-positive Participants by PRNT80 | 3.36 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-positive Participants by PRNT80 | 6.36 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 57: Flavivirus-positive Participants by PRNT80 | 6.77 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 8: All Participants by PRNT50 | 1.91 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 57: All Participants by PRNT50 | 6.98 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT50 | 9.43 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-positive Participants by PRNT50 | 3.39 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 29: All Participants by PRNT80 | 2.35 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 36: All Participants by PRNT80 | 5.85 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 57: All Participants by PRNT80 | 5.21 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT80 | 1.02 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT50 | 7.56 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 36: All Participants by PRNT50 | 7.55 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT80 | 5.43 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 57: Flavivirus-negative Participants by PRNT50 | 7.98 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 57: Flavivirus-negative Participants by PRNT80 | 5.30 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 36: All Participants by PRNT80 | 6.40 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-positive Participants by PRNT80 | 3.90 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-positive Participants by PRNT80 | 7.40 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 57: Flavivirus-positive Participants by PRNT80 | 6.38 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-positive Participants by PRNT80 | 4.57 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT50 | 1.48 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 57: All Participants by PRNT80 | 5.87 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 57: All Participants by PRNT50 | 7.97 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT50 | 1.06 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 29: All Participants by PRNT50 | 2.57 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-positive Participants by PRNT50 | 7.38 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 8: All Participants by PRNT50 | 1.94 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 57: Flavivirus-positive Participants by PRNT50 | 7.60 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-positive Participants by PRNT50 | 4.48 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 29: All Participants by PRNT80 | 2.29 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 8: All Participants by PRNT80 | 1.98 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT80 | 1.04 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-positive Participants by PRNT50 | 3.70 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT80 | 1.16 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-positive Participants by PRNT50 | 0.90 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 57: Flavivirus-positive Participants by PRNT50 | 7.03 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 29: All Participants by PRNT80 | 1.01 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT80 | 1.08 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 57: All Participants by PRNT80 | 2.47 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 8: All Participants by PRNT50 | 0.98 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT50 | 1.04 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 57: Flavivirus-negative Participants by PRNT80 | 1.13 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT50 | 1.16 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 57: All Participants by PRNT50 | 2.75 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT80 | 1.00 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-positive Participants by PRNT80 | 1.09 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 57: Flavivirus-negative Participants by PRNT50 | 1.42 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-positive Participants by PRNT80 | 1.01 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 36: All Participants by PRNT80 | 2.02 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT80 | 1.00 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-positive Participants by PRNT80 | 4.95 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT50 | 1.01 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 29: All Participants by PRNT50 | 1.00 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-positive Participants by PRNT50 | 4.27 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 57: Flavivirus-positive Participants by PRNT80 | 7.61 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-positive Participants by PRNT50 | 1.00 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 36: All Participants by PRNT50 | 1.98 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | Geometric Mean Fold Rise (GMFR) of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by PRNT50 and PRNT80 | Day 8: All Participants by PRNT80 | 1.03 ratio |
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.
Time frame: Days 8, 29, 36, and 57
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 29: Flavivirus-negative Participants | 1.00 ratio |
| Placebo | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 29: Flavivirus-positive Participants | 1.10 ratio |
| Placebo | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 57: Flavivirus-negative Participants | 1.00 ratio |
| Placebo | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 36: Flavivirus-negative Participants | 1.00 ratio |
| Placebo | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 29: All Participants | 1.05 ratio |
| Placebo | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 8: All Participants | 0.91 ratio |
| Placebo | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 57: All Participants | 1.03 ratio |
| Placebo | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 8: Flavivirus-positive Participants | 0.84 ratio |
| Placebo | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 8: Flavivirus-negative Participants | 1.00 ratio |
| Placebo | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 36: All Participants | 0.90 ratio |
| Placebo | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 57: Flavivirus-positive Participants | 1.07 ratio |
| Placebo | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 36: Flavivirus-positive Participants | 0.83 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 57: Flavivirus-positive Participants | 36.45 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 8: All Participants | 2.31 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 57: All Participants | 68.55 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 8: Flavivirus-negative Participants | 1.09 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 57: Flavivirus-negative Participants | 140.99 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 29: Flavivirus-positive Participants | 16.89 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 36: Flavivirus-positive Participants | 20.45 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 29: All Participants | 14.75 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 36: All Participants | 39.99 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 29: Flavivirus-negative Participants | 12.29 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 36: Flavivirus-negative Participants | 87.88 ratio |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 8: Flavivirus-positive Participants | 4.46 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 36: Flavivirus-positive Participants | 31.91 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 57: Flavivirus-positive Participants | 47.79 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 36: All Participants | 54.33 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 57: All Participants | 89.69 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 36: Flavivirus-negative Participants | 88.42 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 8: Flavivirus-positive Participants | 7.40 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 57: Flavivirus-negative Participants | 159.68 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 29: All Participants | 21.51 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 8: Flavivirus-negative Participants | 1.44 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 29: Flavivirus-negative Participants | 20.42 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 8: All Participants | 3.19 ratio |
| mRNA-1893 High Dose (2-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 29: Flavivirus-positive Participants | 22.64 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 8: All Participants | 0.88 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 8: Flavivirus-negative Participants | 0.98 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 36: Flavivirus-positive Participants | 7.90 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 36: All Participants | 2.91 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 57: Flavivirus-positive Participants | 32.02 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 29: All Participants | 1.02 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 29: Flavivirus-positive Participants | 0.98 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 57: Flavivirus-negative Participants | 17.57 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 36: Flavivirus-negative Participants | 1.45 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 29: Flavivirus-negative Participants | 1.06 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 57: All Participants | 23.01 ratio |
| mRNA-1893 High Dose (1-Dose Regimen) | GMFR of ZIKV-Specific nAbs at Days 8, 29, 36, and 57, as Measured by MN | Day 8: Flavivirus-positive Participants | 0.76 ratio |
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.
Time frame: Days 1, 8, 29, 36, and 57
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 57: Flavivirus-positive Participants | 65.50 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 29: All Participants | 32.05 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 1: All Participants | 30.54 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 8: All Participants | 27.99 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 36: Flavivirus-negative Participants | 14.00 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 29: Flavivirus-negative Participants | 14.00 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 8: Flavivirus-negative Participants | 14.00 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 1: Flavivirus-positive Participants | 61.39 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 57: Flavivirus-negative Participants | 14.00 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 8: Flavivirus-positive Participants | 51.65 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 1: Flavivirus-negative Participants | 14.00 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 57: All Participants | 31.60 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 29: Flavivirus-positive Participants | 67.27 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 36: All Participants | 27.74 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 36: Flavivirus-positive Participants | 51.54 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 1: Flavivirus-negative Participants | 16.25 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 57: Flavivirus-positive Participants | 2246.56 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 36: Flavivirus-negative Participants | 1428.20 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 1: Flavivirus-positive Participants | 61.63 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 29: All Participants | 489.20 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 36: Flavivirus-positive Participants | 1260.49 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 57: Flavivirus-negative Participants | 2291.24 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 1: All Participants | 32.98 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 8: All Participants | 76.17 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 57: All Participants | 2261.02 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 29: Flavivirus-positive Participants | 1040.81 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 8: Flavivirus-positive Participants | 275.14 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 29: Flavivirus-negative Participants | 200.15 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 8: Flavivirus-negative Participants | 17.73 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 36: All Participants | 1318.97 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 8: Flavivirus-negative Participants | 20.22 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 8: All Participants | 80.70 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 29: All Participants | 544.38 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 1: Flavivirus-negative Participants | 14.00 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 57: Flavivirus-negative Participants | 2235.55 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 1: Flavivirus-positive Participants | 47.15 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 8: Flavivirus-positive Participants | 348.73 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 29: Flavivirus-positive Participants | 1067.67 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 36: Flavivirus-positive Participants | 1504.49 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 57: Flavivirus-positive Participants | 2253.47 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 36: All Participants | 1380.12 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 57: All Participants | 2270.12 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 1: All Participants | 25.31 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 29: Flavivirus-negative Participants | 285.93 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 36: Flavivirus-negative Participants | 1237.86 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 1: Flavivirus-negative Participants | 15.99 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 36: All Participants | 81.79 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 8: Flavivirus-positive Participants | 47.58 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 1: Flavivirus-positive Participants | 62.55 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 29: All Participants | 28.61 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 57: Flavivirus-negative Participants | 280.91 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 29: Flavivirus-negative Participants | 16.92 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 36: Flavivirus-negative Participants | 23.16 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 57: All Participants | 643.02 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 8: Flavivirus-negative Participants | 15.66 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 1: All Participants | 27.94 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 8: All Participants | 24.68 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 57: Flavivirus-positive Participants | 2002.83 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 36: Flavivirus-positive Participants | 493.88 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, 36, and 57, as Measured by Microneutralization (MN) | Day 29: Flavivirus-positive Participants | 61.27 titer |
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.
Time frame: Days 1, 8, 29, and 36
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT80 | 16.95 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-positive Participants by PRNT80 | 24.84 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT80 | 16.50 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: All Participants by PRNT50 | 66.66 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: All Participants by PRNT50 | 62.15 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 1: All Participants by PRNT50 | 60.64 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 1: Flavivirus-negative Participants by PRNT80 | 16.50 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: All Participants by PRNT80 | 20.40 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-positive Participants by PRNT50 | 81.87 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: All Participants by PRNT80 | 20.50 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-positive Participants by PRNT80 | 25.61 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 1: All Participants by PRNT80 | 21.06 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 1: Flavivirus-positive Participants by PRNT80 | 26.21 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-positive Participants by PRNT50 | 73.48 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-positive Participants by PRNT50 | 92.15 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: All Participants by PRNT80 | 21.07 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-positive Participants by PRNT80 | 24.73 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 1: Flavivirus-positive Participants by PRNT50 | 78.42 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT50 | 45.50 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT50 | 46.45 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT50 | 45.50 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT80 | 16.50 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 1: Flavivirus-negative Participants by PRNT50 | 45.50 titer |
| Placebo | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: All Participants by PRNT50 | 58.51 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: All Participants by PRNT80 | 40.88 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT50 | 57.81 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-positive Participants by PRNT50 | 507.03 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 1: All Participants by PRNT50 | 61.21 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: All Participants by PRNT80 | 49.95 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-positive Participants by PRNT80 | 82.41 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: All Participants by PRNT50 | 116.92 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: All Participants by PRNT50 | 151.34 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: All Participants by PRNT50 | 493.59 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 1: Flavivirus-negative Participants by PRNT50 | 50.76 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT50 | 50.24 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT50 | 478.42 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 1: Flavivirus-positive Participants by PRNT50 | 72.45 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-positive Participants by PRNT50 | 245.67 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-positive Participants by PRNT50 | 350.77 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 1: All Participants by PRNT80 | 21.23 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: All Participants by PRNT80 | 124.30 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 1: Flavivirus-negative Participants by PRNT80 | 18.06 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT80 | 18.43 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT80 | 18.75 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT80 | 95.88 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 1: Flavivirus-positive Participants by PRNT80 | 24.56 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-positive Participants by PRNT80 | 116.95 titer |
| mRNA-1893 Low Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-positive Participants by PRNT80 | 156.24 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 1: Flavivirus-negative Participants by PRNT80 | 16.50 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT50 | 67.45 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: All Participants by PRNT80 | 43.46 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 1: Flavivirus-positive Participants by PRNT50 | 66.06 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 1: Flavivirus-positive Participants by PRNT80 | 21.89 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-positive Participants by PRNT50 | 295.81 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: All Participants by PRNT80 | 37.44 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-positive Participants by PRNT50 | 487.78 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 1: All Participants by PRNT80 | 18.94 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-positive Participants by PRNT50 | 245.31 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: All Participants by PRNT80 | 121.27 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-positive Participants by PRNT80 | 161.96 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-positive Participants by PRNT80 | 99.92 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT80 | 19.06 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: All Participants by PRNT50 | 412.24 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: All Participants by PRNT50 | 105.78 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-positive Participants by PRNT80 | 85.57 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT50 | 344.02 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: All Participants by PRNT50 | 140.50 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 1: All Participants by PRNT50 | 54.57 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT80 | 17.24 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT80 | 89.62 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 1: Flavivirus-negative Participants by PRNT50 | 45.50 titer |
| mRNA-1893 High Dose (2-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT50 | 48.05 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: All Participants by PRNT80 | 39.69 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT50 | 56.46 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT50 | 48.85 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: All Participants by PRNT80 | 19.72 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: All Participants by PRNT50 | 118.04 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 1: Flavivirus-negative Participants by PRNT80 | 17.63 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-positive Participants by PRNT80 | 113.38 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT80 | 19.02 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-positive Participants by PRNT80 | 23.21 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-positive Participants by PRNT50 | 71.60 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: All Participants by PRNT80 | 20.10 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 1: Flavivirus-positive Participants by PRNT80 | 22.89 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT50 | 50.30 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-positive Participants by PRNT50 | 79.46 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 1: All Participants by PRNT50 | 59.41 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-positive Participants by PRNT50 | 339.16 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT80 | 17.58 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-positive Participants by PRNT80 | 24.49 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT80 | 17.64 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 1: All Participants by PRNT80 | 19.60 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 1: Flavivirus-negative Participants by PRNT50 | 48.58 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 1: Flavivirus-positive Participants by PRNT50 | 79.50 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: All Participants by PRNT50 | 59.59 titer |
| mRNA-1893 High Dose (1-Dose Regimen) | GMT of ZIKV-Specific nAbs at Days 1, 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: All Participants by PRNT50 | 57.98 titer |
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.
Time frame: Days 8, 29, 36, and 57
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, 36, and 57, as Measured by MN | Day 8: Flavivirus-negative Participants | 0 percentage of participants |
| Placebo | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, 36, and 57, as Measured by MN | Day 57: Flavivirus-negative Participants | 0 percentage of participants |
| Placebo | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, 36, and 57, as Measured by MN | Day 29: Flavivirus-negative Participants | 0 percentage of participants |
| Placebo | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, 36, and 57, as Measured by MN | Day 36: Flavivirus-negative Participants | 0 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, 36, and 57, as Measured by MN | Day 36: Flavivirus-negative Participants | 98.6 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, 36, and 57, as Measured by MN | Day 57: Flavivirus-negative Participants | 98.6 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, 36, and 57, as Measured by MN | Day 8: Flavivirus-negative Participants | 5.8 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, 36, and 57, as Measured by MN | Day 29: Flavivirus-negative Participants | 97.1 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, 36, and 57, as Measured by MN | Day 29: Flavivirus-negative Participants | 95.1 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, 36, and 57, as Measured by MN | Day 8: Flavivirus-negative Participants | 16.0 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, 36, and 57, as Measured by MN | Day 57: Flavivirus-negative Participants | 100.0 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, 36, and 57, as Measured by MN | Day 36: Flavivirus-negative Participants | 97.5 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, 36, and 57, as Measured by MN | Day 57: Flavivirus-negative Participants | 94.4 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, 36, and 57, as Measured by MN | Day 8: Flavivirus-negative Participants | 0 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, 36, and 57, as Measured by MN | Day 29: Flavivirus-negative Participants | 1.1 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, 36, and 57, as Measured by MN | Day 36: Flavivirus-negative Participants | 15.7 percentage of participants |
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.
Time frame: Days 8, 29, and 36
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT50 | 0 percentage of participants |
| Placebo | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT80 | 0 percentage of participants |
| Placebo | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT50 | 1.3 percentage of participants |
| Placebo | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT80 | 1.3 percentage of participants |
| Placebo | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT80 | 0 percentage of participants |
| Placebo | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT50 | 0 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT50 | 0 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT50 | 88.6 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT80 | 0 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT50 | 8.7 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT80 | 2.9 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT80 | 77.1 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT50 | 25.9 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT80 | 1.2 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT50 | 2.5 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT80 | 71.3 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT50 | 78.8 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT80 | 7.4 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT80 | 0 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT50 | 1.1 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT80 | 0 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT80 | 0 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT50 | 2.2 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Initially Seronegative Participants With a Seroresponse at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT50 | 1.1 percentage of participants |
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.
Time frame: Days 8, 29, 36, and 57
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Initially Seropositive Participants With a 2-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 36: Flavivirus-positive Participants | 4.7 percentage of participants |
| Placebo | Percentage of Initially Seropositive Participants With a 2-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 57: Flavivirus-positive Participants | 2.3 percentage of participants |
| Placebo | Percentage of Initially Seropositive Participants With a 2-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 8: Flavivirus-positive Participants | 3.5 percentage of participants |
| Placebo | Percentage of Initially Seropositive Participants With a 2-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 29: Flavivirus-positive Participants | 2.3 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Initially Seropositive Participants With a 2-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 29: Flavivirus-positive Participants | 87.4 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Initially Seropositive Participants With a 2-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 8: Flavivirus-positive Participants | 58.6 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Initially Seropositive Participants With a 2-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 57: Flavivirus-positive Participants | 97.7 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Initially Seropositive Participants With a 2-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 36: Flavivirus-positive Participants | 92.0 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Initially Seropositive Participants With a 2-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 8: Flavivirus-positive Participants | 63.3 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Initially Seropositive Participants With a 2-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 29: Flavivirus-positive Participants | 96.2 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Initially Seropositive Participants With a 2-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 57: Flavivirus-positive Participants | 98.7 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Initially Seropositive Participants With a 2-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 36: Flavivirus-positive Participants | 97.5 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Initially Seropositive Participants With a 2-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 29: Flavivirus-positive Participants | 0 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Initially Seropositive Participants With a 2-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 36: Flavivirus-positive Participants | 71.6 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Initially Seropositive Participants With a 2-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 57: Flavivirus-positive Participants | 100.0 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Initially Seropositive Participants With a 2-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 8: Flavivirus-positive Participants | 4.5 percentage of participants |
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
Time frame: Days 8, 29, 36, and 57
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 | Day 36: Flavivirus-positive Participants by PRNT80 | 1.2 percentage of participants |
| Placebo | 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 | Day 8: Flavivirus-positive Participants by PRNT80 | 0 percentage of participants |
| Placebo | 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 | Day 29: Flavivirus-positive Participants by PRNT80 | 0 percentage of participants |
| Placebo | 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 | Day 57: Flavivirus-positive Participants by PRNT80 | 3.5 percentage of participants |
| Placebo | 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 | Day 29: Flavivirus-positive Participants by PRNT50 | 10.5 percentage of participants |
| Placebo | 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 | Day 36: Flavivirus-positive Participants by PRNT50 | 4.7 percentage of participants |
| Placebo | 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 | Day 57: Flavivirus-positive Participants by PRNT50 | 5.8 percentage of participants |
| Placebo | 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 | Day 8: Flavivirus-positive Participants by PRNT50 | 8.1 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | 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 | Day 29: Flavivirus-positive Participants by PRNT50 | 55.2 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | 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 | Day 57: Flavivirus-positive Participants by PRNT50 | 63.2 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | 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 | Day 8: Flavivirus-positive Participants by PRNT80 | 40.2 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | 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 | Day 8: Flavivirus-positive Participants by PRNT50 | 41.4 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | 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 | Day 29: Flavivirus-positive Participants by PRNT80 | 49.4 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | 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 | Day 36: Flavivirus-positive Participants by PRNT50 | 60.9 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | 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 | Day 57: Flavivirus-positive Participants by PRNT80 | 63.2 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | 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 | Day 36: Flavivirus-positive Participants by PRNT80 | 63.2 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | 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 | Day 57: Flavivirus-positive Participants by PRNT80 | 60.8 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | 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 | Day 29: Flavivirus-positive Participants by PRNT50 | 44.3 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | 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 | Day 8: Flavivirus-positive Participants by PRNT50 | 38.5 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | 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 | Day 36: Flavivirus-positive Participants by PRNT50 | 63.3 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | 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 | Day 57: Flavivirus-positive Participants by PRNT50 | 63.3 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | 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 | Day 8: Flavivirus-positive Participants by PRNT80 | 38.5 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | 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 | Day 29: Flavivirus-positive Participants by PRNT80 | 43.0 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | 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 | Day 36: Flavivirus-positive Participants by PRNT80 | 62.0 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | 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 | Day 29: Flavivirus-positive Participants by PRNT80 | 1.5 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | 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 | Day 57: Flavivirus-positive Participants by PRNT50 | 62.7 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | 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 | Day 36: Flavivirus-positive Participants by PRNT50 | 46.3 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | 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 | Day 29: Flavivirus-positive Participants by PRNT50 | 6.0 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | 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 | Day 36: Flavivirus-positive Participants by PRNT80 | 50.7 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | 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 | Day 8: Flavivirus-positive Participants by PRNT50 | 6.1 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | 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 | Day 8: Flavivirus-positive Participants by PRNT80 | 4.5 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | 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 | Day 57: Flavivirus-positive Participants by PRNT80 | 61.2 percentage of participants |
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.
Time frame: Days 8, 29, 36, and 57
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Initially Seropositive Participants With a 4-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 8: Flavivirus-positive Participants | 2.3 percentage of participants |
| Placebo | Percentage of Initially Seropositive Participants With a 4-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 29: Flavivirus-positive Participants | 2.3 percentage of participants |
| Placebo | Percentage of Initially Seropositive Participants With a 4-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 36: Flavivirus-positive Participants | 1.2 percentage of participants |
| Placebo | Percentage of Initially Seropositive Participants With a 4-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 57: Flavivirus-positive Participants | 2.3 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Initially Seropositive Participants With a 4-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 29: Flavivirus-positive Participants | 79.3 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Initially Seropositive Participants With a 4-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 36: Flavivirus-positive Participants | 81.6 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Initially Seropositive Participants With a 4-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 57: Flavivirus-positive Participants | 93.1 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Initially Seropositive Participants With a 4-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 8: Flavivirus-positive Participants | 43.7 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Initially Seropositive Participants With a 4-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 36: Flavivirus-positive Participants | 92.4 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Initially Seropositive Participants With a 4-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 29: Flavivirus-positive Participants | 87.3 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Initially Seropositive Participants With a 4-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 57: Flavivirus-positive Participants | 93.7 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Initially Seropositive Participants With a 4-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 8: Flavivirus-positive Participants | 50.6 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Initially Seropositive Participants With a 4-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 57: Flavivirus-positive Participants | 92.5 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Initially Seropositive Participants With a 4-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 29: Flavivirus-positive Participants | 0 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Initially Seropositive Participants With a 4-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 8: Flavivirus-positive Participants | 1.5 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Initially Seropositive Participants With a 4-Fold Increase in ZIKV-Specific nAb Titers as Compared With Baseline, as Measured by MN | Day 36: Flavivirus-positive Participants | 58.2 percentage of participants |
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
Time frame: Days 8, 29, 36, and 57
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 | Day 8: Flavivirus-positive Participants by PRNT50 | 2.3 percentage of participants |
| Placebo | 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 | Day 57: Flavivirus-positive Participants by PRNT50 | 2.3 percentage of participants |
| Placebo | 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 | Day 8: Flavivirus-positive Participants by PRNT80 | 0 percentage of participants |
| Placebo | 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 | Day 29: Flavivirus-positive Participants by PRNT50 | 7.0 percentage of participants |
| Placebo | 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 | Day 36: Flavivirus-positive Participants by PRNT50 | 1.2 percentage of participants |
| Placebo | 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 | Day 29: Flavivirus-positive Participants by PRNT80 | 0 percentage of participants |
| Placebo | 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 | Day 36: Flavivirus-positive Participants by PRNT80 | 0 percentage of participants |
| Placebo | 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 | Day 57: Flavivirus-positive Participants by PRNT80 | 1.2 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | 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 | Day 8: Flavivirus-positive Participants by PRNT80 | 35.6 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | 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 | Day 8: Flavivirus-positive Participants by PRNT50 | 35.6 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | 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 | Day 29: Flavivirus-positive Participants by PRNT50 | 42.5 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | 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 | Day 36: Flavivirus-positive Participants by PRNT50 | 50.6 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | 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 | Day 57: Flavivirus-positive Participants by PRNT80 | 50.6 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | 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 | Day 29: Flavivirus-positive Participants by PRNT80 | 40.2 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | 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 | Day 36: Flavivirus-positive Participants by PRNT80 | 50.6 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | 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 | Day 57: Flavivirus-positive Participants by PRNT50 | 52.9 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | 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 | Day 57: Flavivirus-positive Participants by PRNT80 | 43.0 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | 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 | Day 57: Flavivirus-positive Participants by PRNT50 | 48.1 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | 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 | Day 8: Flavivirus-positive Participants by PRNT50 | 35.9 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | 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 | Day 36: Flavivirus-positive Participants by PRNT50 | 50.6 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | 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 | Day 29: Flavivirus-positive Participants by PRNT80 | 38.0 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | 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 | Day 36: Flavivirus-positive Participants by PRNT80 | 50.6 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | 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 | Day 29: Flavivirus-positive Participants by PRNT50 | 40.5 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | 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 | Day 8: Flavivirus-positive Participants by PRNT80 | 33.3 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | 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 | Day 29: Flavivirus-positive Participants by PRNT50 | 4.5 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | 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 | Day 8: Flavivirus-positive Participants by PRNT80 | 1.5 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | 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 | Day 57: Flavivirus-positive Participants by PRNT50 | 47.8 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | 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 | Day 29: Flavivirus-positive Participants by PRNT80 | 0 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | 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 | Day 36: Flavivirus-positive Participants by PRNT50 | 38.8 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | 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 | Day 8: Flavivirus-positive Participants by PRNT50 | 4.5 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | 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 | Day 36: Flavivirus-positive Participants by PRNT80 | 43.3 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | 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 | Day 57: Flavivirus-positive Participants by PRNT80 | 49.3 percentage of participants |
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.
Time frame: Days 8, 29, 36, and 57
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 8: Flavivirus-positive Participants | 2.3 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 57: Flavivirus-positive Participants | 3.5 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 29: Flavivirus-negative Participants | 0 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 57: Flavivirus-negative Participants | 0 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 36: Flavivirus-negative Participants | 0 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 36: Flavivirus-positive Participants | 2.4 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 8: All Participants | 1.2 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 29: Flavivirus-positive Participants | 3.5 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 29: All Participants | 1.8 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 36: All Participants | 1.2 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 57: All Participants | 1.8 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 8: Flavivirus-negative Participants | 0 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 57: All Participants | 95.7 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 8: All Participants | 35.0 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 36: Flavivirus-negative Participants | 98.6 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 57: Flavivirus-positive Participants | 93.1 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 29: Flavivirus-negative Participants | 97.2 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 8: Flavivirus-positive Participants | 58.6 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 8: Flavivirus-negative Participants | 8.3 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 57: Flavivirus-negative Participants | 98.6 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 36: All Participants | 92.6 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 29: Flavivirus-positive Participants | 89.7 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 29: All Participants | 93.2 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 36: Flavivirus-positive Participants | 87.4 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 29: All Participants | 95.7 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 36: All Participants | 96.3 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 29: Flavivirus-positive Participants | 96.2 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 8: All Participants | 41.4 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 57: All Participants | 97.5 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 8: Flavivirus-negative Participants | 16.0 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 29: Flavivirus-negative Participants | 95.1 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 36: Flavivirus-negative Participants | 97.5 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 57: Flavivirus-negative Participants | 100.0 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 8: Flavivirus-positive Participants | 68.4 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 36: Flavivirus-positive Participants | 94.9 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 57: Flavivirus-positive Participants | 94.9 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 57: All Participants | 95.7 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 29: All Participants | 1.8 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 36: All Participants | 40.7 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 8: Flavivirus-positive Participants | 3.0 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 8: All Participants | 1.2 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 29: Flavivirus-positive Participants | 3.0 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 57: Flavivirus-positive Participants | 97.0 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 29: Flavivirus-negative Participants | 1.1 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 8: Flavivirus-negative Participants | 0 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 36: Flavivirus-positive Participants | 71.6 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 36: Flavivirus-negative Participants | 18.5 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, 36, and 57, as Measured by MN | Day 57: Flavivirus-negative Participants | 94.6 percentage of participants |
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.
Time frame: Days 8, 29, and 36
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: All Participants by PRNT50 | 3.1 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: All Participants by PRNT80 | 1.2 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: All Participants by PRNT80 | 1.2 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: All Participants by PRNT50 | 6.7 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: All Participants by PRNT80 | 0 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-positive Participants by PRNT50 | 3.5 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-positive Participants by PRNT50 | 5.8 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT50 | 0 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-positive Participants by PRNT80 | 1.2 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: All Participants by PRNT50 | 1.9 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-positive Participants by PRNT80 | 2.4 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT50 | 1.3 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-positive Participants by PRNT80 | 0 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT80 | 0 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT80 | 1.3 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT50 | 0 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT80 | 0 percentage of participants |
| Placebo | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-positive Participants by PRNT50 | 11.6 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-positive Participants by PRNT50 | 55.2 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: All Participants by PRNT50 | 20.9 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT50 | 0 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT50 | 8.5 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-positive Participants by PRNT50 | 66.7 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: All Participants by PRNT80 | 19.6 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: All Participants by PRNT80 | 31.5 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: All Participants by PRNT80 | 72.4 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT80 | 0 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT80 | 2.8 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT80 | 75.0 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-positive Participants by PRNT80 | 69.0 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: All Participants by PRNT50 | 33.3 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: All Participants by PRNT50 | 76.1 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT50 | 86.1 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-positive Participants by PRNT50 | 39.1 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-positive Participants by PRNT80 | 36.8 percentage of participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-positive Participants by PRNT80 | 56.3 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT50 | 78.8 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-positive Participants by PRNT80 | 50.6 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-positive Participants by PRNT80 | 72.2 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT80 | 7.4 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-positive Participants by PRNT50 | 41.0 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-positive Participants by PRNT80 | 38.5 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: All Participants by PRNT50 | 75.2 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: All Participants by PRNT80 | 19.3 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: All Participants by PRNT50 | 38.3 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT80 | 71.3 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-positive Participants by PRNT50 | 70.9 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: All Participants by PRNT80 | 29.0 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT50 | 2.5 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-positive Participants by PRNT50 | 50.6 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT80 | 1.2 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: All Participants by PRNT80 | 72.0 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT50 | 25.9 percentage of participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: All Participants by PRNT50 | 21.1 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-positive Participants by PRNT50 | 9.1 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT50 | 1.1 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT80 | 3.3 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-negative Participants by PRNT80 | 0 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: All Participants by PRNT50 | 4.3 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT50 | 1.1 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-positive Participants by PRNT80 | 50.7 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: All Participants by PRNT50 | 3.7 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-positive Participants by PRNT80 | 3.0 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-negative Participants by PRNT50 | 4.3 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: All Participants by PRNT50 | 21.0 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-positive Participants by PRNT80 | 0 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: Flavivirus-positive Participants by PRNT50 | 44.8 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: All Participants by PRNT80 | 1.2 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: Flavivirus-positive Participants by PRNT50 | 7.5 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 29: All Participants by PRNT80 | 0 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 36: All Participants by PRNT80 | 22.8 percentage of participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Percentage of Participants With Seroconversion at Days 8, 29, and 36, as Measured by PRNT50 and PRNT80 | Day 8: Flavivirus-negative Participants by PRNT80 | 0 percentage of participants |
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.
Time frame: Day 1 through Day 196 for Main Study and Day 197 through Day 700 for Extension Period
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Deaths Related to Study Drug | Deaths | 0 Participants |
| Placebo | Number of Deaths Related to Study Drug | Deaths Related to Study Drug | 0 Participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Number of Deaths Related to Study Drug | Deaths | 0 Participants |
| mRNA-1893 Low Dose (2-Dose Regimen) | Number of Deaths Related to Study Drug | Deaths Related to Study Drug | 0 Participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Number of Deaths Related to Study Drug | Deaths | 0 Participants |
| mRNA-1893 High Dose (2-Dose Regimen) | Number of Deaths Related to Study Drug | Deaths Related to Study Drug | 0 Participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Number of Deaths Related to Study Drug | Deaths | 1 Participants |
| mRNA-1893 High Dose (1-Dose Regimen) | Number of Deaths Related to Study Drug | Deaths Related to Study Drug | 0 Participants |
| Extension Period: Placebo | Number of Deaths Related to Study Drug | Deaths | 0 Participants |
| Extension Period: Placebo | Number of Deaths Related to Study Drug | Deaths Related to Study Drug | 0 Participants |
| Extension Period: mRNA-1893 Low Dose (2-Dose Regimen) | Number of Deaths Related to Study Drug | Deaths | 1 Participants |
| Extension Period: mRNA-1893 Low Dose (2-Dose Regimen) | Number of Deaths Related to Study Drug | Deaths Related to Study Drug | 0 Participants |
| Extension Period: mRNA-1893 High Dose (2-Dose Regimen) | Number of Deaths Related to Study Drug | Deaths Related to Study Drug | 0 Participants |
| Extension Period: mRNA-1893 High Dose (2-Dose Regimen) | Number of Deaths Related to Study Drug | Deaths | 0 Participants |
| Extension Period: mRNA-1893 High Dose (1-Dose Regimen) | Number of Deaths Related to Study Drug | Deaths | 0 Participants |
| Extension Period: mRNA-1893 High Dose (1-Dose Regimen) | Number of Deaths Related to Study Drug | Deaths Related to Study Drug | 0 Participants |