Zika Virus
Conditions
Keywords
mRNA-1893, zika vaccine, Moderna
Brief summary
This clinical study will evaluate the safety, tolerability and reactogenicity of mRNA-1893 Zika vaccines in flavivirus seronegative and flavivirus seropositive participants
Interventions
BIOLOGICALmRNA-1893
Zika vaccine
OTHERPlacebo
0.9% sodium chloride
Sponsors
Biomedical Advanced Research and Development Authority
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Observer blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Agrees to comply with the study procedures and provides written informed consent * 18 to 49 years of age * In the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., complete diary cards, return for follow-up visits, be available for safety telephone calls). * Is in good general health, as determined by medical history, clinical laboratory assessments, vital sign measurements, and physical examination at screening. * Negative urine pregnancy test at the Screening visit and at the day of each vaccination for females of childbearing potential. * Male participants must agree to practice adequate contraception from the time of the first vaccination and through 3 months following the last vaccination. * For flavivirus-seropositive group, has positive flavivirus test results (including dengue, West Nile, and Zika) as determined by enzyme-linked immunosorbent assay (ELISA) or other commercially available serological assay. * For flavivirus-seronegative group, has negative flavivirus test results (including dengue, West Nile, and Zika) as determined by ELISA or other commercially available serological assay.
Exclusion criteria
* Has any acute or chronic, Clinically Significant disease in the opinion of the investigator. * Has received a vaccine for dengue, Japanese encephalitis, tick-borne encephalitis, West Nile, Yellow Fever, or Zika. * Has a neurologic disorder * Has a body mass index that is ≤ 18 or ≥ 35 kg/m2. * Has elevated liver function tests * Has clinical laboratory test results (hematology, serum chemistry, or coagulation) with a toxicity score of Grade ≥ 1 at Screening. * Has a bleeding disorder that would contraindicate IM injections or phlebotomy. * Reports a diagnosis of congenital or acquired immunodeficiency (including HIV infection), or autoimmune disease. * Has a history of hypersensitivity or severe reactions to previous vaccinations or any component of the study vaccine. * Has a history of idiopathic urticaria. * Reports a previous diagnosis of hematologic malignancy or pre-malignancy or a diagnosis of any other malignancy within the previous 10 years (excluding nonmelanoma skin cancer). * Has a medical, psychiatric, or occupational condition that, in the opinion of the investigator, might pose an additional risk to the participant due to participation in the study or would interfere with the evaluation of the study vaccines or the interpretation of study results. * Is acutely ill or febrile on the day of screening (Day 0) or randomization (Day 1). * Has a history of inflammatory arthritis. * Has a history of febrile disease with arthritis or arthralgia within 2 weeks of administration of any study vaccine. * Has received an investigational or nonregistered product (drug or vaccine) within 30 days before the first dose of study vaccine or has plans for administration during the study period. * Has received or is scheduled to receive an inactivated vaccine within the period from 14 days before, or through 14 days after, administration of any study vaccination. * Has received or is scheduled to receive a live virus vaccine administered within the period from 28 days before, or through 28 days after, any dose of study vaccine. * Has received chronic administration (defined as \> 14 total days) of immunosuppressants or other immune-modifying drugs within 6 months before the first study vaccine dose. * Has received immunoglobulins and/or blood products within the 3 months before the first study vaccine dose or has plans for administration during the study period. * Has a positive test result at the Screening Visit for hepatitis B surface antigen, hepatitis C virus antibody, or HIV type 1 or 2 antibodies. * Has donated \> 450 mL of whole blood or blood products within 30 days of enrollment or plans to do so during the study period. * Is an immediate family member or household member of study personnel. * Previously participated in an investigational study involving LNPs. * Has a positive urine drug screen result at Screening for any of the following nonprescription drugs of abuse: amphetamines, benzodiazepines, cocaine, methadone, opiates, and phencyclidine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Up to Day 7 after first vaccination (up to 8 days) | Solicited ARs (local and systemic) were collected in the daily diary. Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the first study vaccination only. A summary of all serious adverse events (SAEs) and all nonserious AEs (Other), regardless of causality, is in Reported Adverse Events section. |
| Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Up to Day 7 after second vaccination (Day 29 to Day 36) | Solicited ARs (local and systemic) were collected in the daily diary. Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the second study vaccination only. A summary of all serious adverse events (SAEs) and all nonserious AEs (Other), regardless of causality, is in Reported Adverse Events section. |
| Number of Participants With Unsolicited Adverse Events (AEs) | Up to Day 392 (all AEs considered an SAE were collected till end of study [Day 392]; the Other AEs [non-SAE] were collected up to Day 57) | 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. A treatment-emergent adverse event (TEAE) was 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 Adverse Event of Special Interest (AESI) and Serious Adverse Events (SAEs) | Day 1 to the end of study visit (up to Day 392) | An SAE was defined as any AE that resulted in death, is 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. AESIs included potentially immune-mediated medical conditions (autoimmune or autoinflammatory diseases) that may have the theoretical potential for association with novel vaccines. A summary of all SAEs and all nonserious AEs (Other), regardless of causality, is located in the Reported Adverse Events section. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test | Day 29, Day 57, Month 7, and Month 13 | Seroconversion is defined as a change of PRNT from below the LLOQ to a PRNT equal to or above LLOQ for the assay, or a multiplication by at least 4 in participants with pre-existing PRNT titers. |
| Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 1, 29, 57, Month 7 and 13 | GMT 95% CI is calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation. |
| Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Day 29, Day 57, Month 7, and Month 13 | Seroconversion is defined as a change of Plaque Reduction Neutralization Test from below the lower limit of quantification (LLOQ) to a PRNT equal to or above LLOQ for the assay, or a multiplication by at least 4 in participants with pre-existing PRNT titers. |
| Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 1, 29, 57, Month 7 and 13 | GMT 95% CI is calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation. |
| Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 1, 29, 57, Month 7 and 13 | GMT 95% CI is calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation. |
| Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13 | Day 1 (baseline) to Day 29, from Day 1 to Day 57, from Day 1 to Month 7, and from Day 1 to Month 13. | Seroconversion is defined as a change of PRNT from below the lower limit of quantification (LLOQ) to a PRNT equal to or above LLOQ for the assay, or a multiplication by at least 4 in participants with pre-existing PRNT titers. |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo matched to mRNA-1893 by IM injection on Days 1 and 29. | 24 |
| mRNA-1893 10 mcg Participants received mRNA-1893 10 mcg by IM injection on Days 1 and 29. | 24 |
| mRNA-1893 30 mcg Participants received mRNA-1893 30 mcg by IM injection on Days 1 and 29. | 24 |
| mRNA-1893 100 mcg Participants received mRNA-1893 100 mcg by IM injection on Days 1 and 29. | 24 |
| mRNA-1893 250 mcg Participants received mRNA-1893 250 mcg by IM injection on Days 1 and 29. | 24 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 3 | 1 | 4 | 2 |
Baseline characteristics
| Characteristic | Placebo | mRNA-1893 10 mcg | mRNA-1893 30 mcg | mRNA-1893 100 mcg | mRNA-1893 250 mcg | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 24 Participants | 24 Participants | 24 Participants | 24 Participants | 120 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 5 Participants | 8 Participants | 5 Participants | 5 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 19 Participants | 16 Participants | 19 Participants | 19 Participants | 91 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Flavivirus Serostatus Seronegative | 20 Participants | 20 Participants | 20 Participants | 20 Participants | 20 Participants | 100 Participants |
| Flavivirus Serostatus Seropositive | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 20 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants | 2 Participants | 9 Participants | 1 Participants | 12 Participants | 28 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 20 Participants | 21 Participants | 14 Participants | 22 Participants | 12 Participants | 89 Participants |
| Sex: Female, Male Female | 16 Participants | 18 Participants | 11 Participants | 14 Participants | 11 Participants | 70 Participants |
| Sex: Female, Male Male | 8 Participants | 6 Participants | 13 Participants | 10 Participants | 13 Participants | 50 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 17 / 24 | 21 / 24 | 21 / 24 | 22 / 24 | 20 / 24 |
| serious Total, serious adverse events | 3 / 24 | 0 / 24 | 0 / 24 | 0 / 24 | 1 / 24 |
Outcome results
Primary
Number of Participants With Adverse Event of Special Interest (AESI) and Serious Adverse Events (SAEs)
An SAE was defined as any AE that resulted in death, is 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. AESIs included potentially immune-mediated medical conditions (autoimmune or autoinflammatory diseases) that may have the theoretical potential for association with novel vaccines. 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 to the end of study visit (up to Day 392)
Population: The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Adverse Event of Special Interest (AESI) and Serious Adverse Events (SAEs) | SAEs | 3 Participants |
| Placebo | Number of Participants With Adverse Event of Special Interest (AESI) and Serious Adverse Events (SAEs) | AESI | 0 Participants |
| mRNA-1893 10 mcg | Number of Participants With Adverse Event of Special Interest (AESI) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| mRNA-1893 10 mcg | Number of Participants With Adverse Event of Special Interest (AESI) and Serious Adverse Events (SAEs) | AESI | 0 Participants |
| mRNA-1893 30 mcg | Number of Participants With Adverse Event of Special Interest (AESI) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| mRNA-1893 30 mcg | Number of Participants With Adverse Event of Special Interest (AESI) and Serious Adverse Events (SAEs) | AESI | 0 Participants |
| mRNA-1893 100 mcg | Number of Participants With Adverse Event of Special Interest (AESI) and Serious Adverse Events (SAEs) | AESI | 0 Participants |
| mRNA-1893 100 mcg | Number of Participants With Adverse Event of Special Interest (AESI) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| mRNA-1893 250 mcg | Number of Participants With Adverse Event of Special Interest (AESI) and Serious Adverse Events (SAEs) | SAEs | 1 Participants |
| mRNA-1893 250 mcg | Number of Participants With Adverse Event of Special Interest (AESI) and Serious Adverse Events (SAEs) | AESI | 0 Participants |
Primary
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination
Solicited ARs (local and systemic) were collected in the daily diary. Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the first study vaccination only. A summary of all serious adverse events (SAEs) and all nonserious AEs (Other), regardless of causality, is in Reported Adverse Events section.
Time frame: Up to Day 7 after first vaccination (up to 8 days)
Population: The First Vaccination Solicited Safety Set consisted of all participants in the Safety Set who had received the first study vaccination and had contributed any solicited AR data (local or systemic reactogenicity events) from the time of first study vaccination through the following 7 days. Here, number analyzed signifies those participants who were evaluable at specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Nausea | 0 Participants |
| Placebo | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Headache | 4 Participants |
| Placebo | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Chills | 0 Participants |
| Placebo | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Myalgia | 2 Participants |
| Placebo | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Arthralgia | 1 Participants |
| Placebo | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Local ARs- Swelling (Hardness) | 0 Participants |
| Placebo | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Local ARs- Pain | 1 Participants |
| Placebo | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Fever | 0 Participants |
| Placebo | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Fatigue | 3 Participants |
| Placebo | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Local ARs- Erythema (Redness) | 0 Participants |
| Placebo | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Rash | 0 Participants |
| mRNA-1893 10 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Arthralgia | 2 Participants |
| mRNA-1893 10 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Fatigue | 8 Participants |
| mRNA-1893 10 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Fever | 1 Participants |
| mRNA-1893 10 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Headache | 7 Participants |
| mRNA-1893 10 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Myalgia | 5 Participants |
| mRNA-1893 10 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Nausea | 4 Participants |
| mRNA-1893 10 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Rash | 1 Participants |
| mRNA-1893 10 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Local ARs- Erythema (Redness) | 0 Participants |
| mRNA-1893 10 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Local ARs- Pain | 12 Participants |
| mRNA-1893 10 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Local ARs- Swelling (Hardness) | 0 Participants |
| mRNA-1893 10 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Chills | 1 Participants |
| mRNA-1893 30 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Local ARs- Swelling (Hardness) | 0 Participants |
| mRNA-1893 30 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Fatigue | 5 Participants |
| mRNA-1893 30 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Nausea | 3 Participants |
| mRNA-1893 30 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Headache | 5 Participants |
| mRNA-1893 30 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Myalgia | 3 Participants |
| mRNA-1893 30 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Fever | 0 Participants |
| mRNA-1893 30 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Local ARs- Erythema (Redness) | 0 Participants |
| mRNA-1893 30 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Arthralgia | 2 Participants |
| mRNA-1893 30 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Local ARs- Pain | 12 Participants |
| mRNA-1893 30 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Rash | 0 Participants |
| mRNA-1893 30 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Chills | 0 Participants |
| mRNA-1893 100 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Nausea | 3 Participants |
| mRNA-1893 100 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Local ARs- Swelling (Hardness) | 0 Participants |
| mRNA-1893 100 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Rash | 0 Participants |
| mRNA-1893 100 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Fatigue | 3 Participants |
| mRNA-1893 100 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Headache | 3 Participants |
| mRNA-1893 100 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Local ARs- Erythema (Redness) | 1 Participants |
| mRNA-1893 100 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Local ARs- Pain | 17 Participants |
| mRNA-1893 100 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Chills | 0 Participants |
| mRNA-1893 100 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Fever | 1 Participants |
| mRNA-1893 100 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Myalgia | 1 Participants |
| mRNA-1893 100 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Arthralgia | 0 Participants |
| mRNA-1893 250 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Myalgia | 6 Participants |
| mRNA-1893 250 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Nausea | 0 Participants |
| mRNA-1893 250 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Rash | 0 Participants |
| mRNA-1893 250 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Arthralgia | 1 Participants |
| mRNA-1893 250 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Local ARs- Erythema (Redness) | 2 Participants |
| mRNA-1893 250 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Fatigue | 4 Participants |
| mRNA-1893 250 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Chills | 2 Participants |
| mRNA-1893 250 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Local ARs- Pain | 14 Participants |
| mRNA-1893 250 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Local ARs- Swelling (Hardness) | 1 Participants |
| mRNA-1893 250 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Headache | 3 Participants |
| mRNA-1893 250 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination | Systemic ARs- Fever | 0 Participants |
Primary
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination
Solicited ARs (local and systemic) were collected in the daily diary. Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the second study vaccination only. A summary of all serious adverse events (SAEs) and all nonserious AEs (Other), regardless of causality, is in Reported Adverse Events section.
Time frame: Up to Day 7 after second vaccination (Day 29 to Day 36)
Population: The Second Vaccination Solicited Safety Set consisted of all participants in the Safety Set who had received the second study vaccination and had contributed any solicited AR data (local or systemic reactogenicity events) from the time of first study vaccination through the following 7 days. Here, number analyzed signifies those participants who were evaluable at specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Fatigue | 3 Participants |
| Placebo | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Fever | 1 Participants |
| Placebo | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Local ARs- Erythema (Redness) | 0 Participants |
| Placebo | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Myalgia | 1 Participants |
| Placebo | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Arthralgia | 2 Participants |
| Placebo | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Nausea | 2 Participants |
| Placebo | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Rash | 0 Participants |
| Placebo | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Local ARs- Swelling (Hardness) | 0 Participants |
| Placebo | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Headache | 4 Participants |
| Placebo | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Chills | 3 Participants |
| Placebo | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Local ARs- Pain | 2 Participants |
| mRNA-1893 10 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Chills | 1 Participants |
| mRNA-1893 10 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Fever | 1 Participants |
| mRNA-1893 10 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Fatigue | 6 Participants |
| mRNA-1893 10 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Local ARs- Pain | 8 Participants |
| mRNA-1893 10 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Local ARs- Erythema (Redness) | 0 Participants |
| mRNA-1893 10 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Nausea | 2 Participants |
| mRNA-1893 10 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Local ARs- Swelling (Hardness) | 0 Participants |
| mRNA-1893 10 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Rash | 0 Participants |
| mRNA-1893 10 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Myalgia | 7 Participants |
| mRNA-1893 10 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Arthralgia | 4 Participants |
| mRNA-1893 10 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Headache | 5 Participants |
| mRNA-1893 30 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Fatigue | 10 Participants |
| mRNA-1893 30 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Local ARs- Erythema (Redness) | 1 Participants |
| mRNA-1893 30 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Local ARs- Pain | 11 Participants |
| mRNA-1893 30 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Local ARs- Swelling (Hardness) | 2 Participants |
| mRNA-1893 30 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Arthralgia | 4 Participants |
| mRNA-1893 30 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Chills | 5 Participants |
| mRNA-1893 30 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Fever | 3 Participants |
| mRNA-1893 30 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Headache | 8 Participants |
| mRNA-1893 30 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Myalgia | 4 Participants |
| mRNA-1893 30 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Nausea | 1 Participants |
| mRNA-1893 30 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Rash | 0 Participants |
| mRNA-1893 100 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Arthralgia | 9 Participants |
| mRNA-1893 100 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Local ARs- Erythema (Redness) | 2 Participants |
| mRNA-1893 100 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Local ARs- Pain | 15 Participants |
| mRNA-1893 100 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Rash | 1 Participants |
| mRNA-1893 100 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Nausea | 4 Participants |
| mRNA-1893 100 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Local ARs- Swelling (Hardness) | 1 Participants |
| mRNA-1893 100 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Fatigue | 10 Participants |
| mRNA-1893 100 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Headache | 9 Participants |
| mRNA-1893 100 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Myalgia | 10 Participants |
| mRNA-1893 100 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Chills | 11 Participants |
| mRNA-1893 100 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Fever | 7 Participants |
| mRNA-1893 250 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Local ARs- Erythema (Redness) | 2 Participants |
| mRNA-1893 250 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Fever | 11 Participants |
| mRNA-1893 250 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Arthralgia | 7 Participants |
| mRNA-1893 250 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Headache | 13 Participants |
| mRNA-1893 250 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Local ARs- Swelling (Hardness) | 3 Participants |
| mRNA-1893 250 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Rash | 0 Participants |
| mRNA-1893 250 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Myalgia | 15 Participants |
| mRNA-1893 250 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Local ARs- Pain | 14 Participants |
| mRNA-1893 250 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Nausea | 5 Participants |
| mRNA-1893 250 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Fatigue | 13 Participants |
| mRNA-1893 250 mcg | Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination | Systemic ARs- Chills | 14 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. A treatment-emergent adverse event (TEAE) was 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 Day 392 (all AEs considered an SAE were collected till end of study [Day 392]; the Other AEs [non-SAE] were collected up to Day 57)
Population: The Safety Set consisted of all participants who received at least 1 dose of study vaccine (mRNA-1893 or placebo).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Unsolicited Adverse Events (AEs) | 14 Participants |
| mRNA-1893 10 mcg | Number of Participants With Unsolicited Adverse Events (AEs) | 12 Participants |
| mRNA-1893 30 mcg | Number of Participants With Unsolicited Adverse Events (AEs) | 13 Participants |
| mRNA-1893 100 mcg | Number of Participants With Unsolicited Adverse Events (AEs) | 15 Participants |
| mRNA-1893 250 mcg | Number of Participants With Unsolicited Adverse Events (AEs) | 10 Participants |
Secondary
Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)
GMT 95% CI is calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Time frame: Day 1, 29, 57, Month 7 and 13
Population: Per-Protocol Set consisted of all participants who did not had a major protocol deviation, received vaccine within the acceptable vaccination window and received full dose of assigned vaccine, had immunogenicity samples taken within acceptable visit windows, had a pre-vaccination and the corresponding 1 post-vaccination serum sample available for testing. Here, number analyzed signifies those participants were evaluable at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 7 | 8.9 Titer |
| Placebo | Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 1 | 9.1 Titer |
| Placebo | Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 13 | 9.0 Titer |
| Placebo | Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 29 | 9.1 Titer |
| Placebo | Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 57 | 9.3 Titer |
| mRNA-1893 10 mcg | Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 7 | 42.7 Titer |
| mRNA-1893 10 mcg | Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 57 | 200.5 Titer |
| mRNA-1893 10 mcg | Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 29 | 13.6 Titer |
| mRNA-1893 10 mcg | Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 13 | 41.0 Titer |
| mRNA-1893 10 mcg | Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 1 | 10.1 Titer |
| mRNA-1893 30 mcg | Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 57 | 267.2 Titer |
| mRNA-1893 30 mcg | Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 1 | 8.9 Titer |
| mRNA-1893 30 mcg | Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 29 | 19.8 Titer |
| mRNA-1893 30 mcg | Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 7 | 68.0 Titer |
| mRNA-1893 30 mcg | Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 13 | 47.8 Titer |
| mRNA-1893 100 mcg | Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 13 | 100.8 Titer |
| mRNA-1893 100 mcg | Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 1 | 9.1 Titer |
| mRNA-1893 100 mcg | Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 7 | 174.8 Titer |
| mRNA-1893 100 mcg | Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 57 | 393.0 Titer |
| mRNA-1893 100 mcg | Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 29 | 54.6 Titer |
| mRNA-1893 250 mcg | Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 57 | 230.0 Titer |
| mRNA-1893 250 mcg | Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 7 | 116.7 Titer |
| mRNA-1893 250 mcg | Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 1 | 8.0 Titer |
| mRNA-1893 250 mcg | Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 13 | 100.2 Titer |
| mRNA-1893 250 mcg | Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 29 | 29.2 Titer |
Secondary
Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)
GMT 95% CI is calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Time frame: Day 1, 29, 57, Month 7 and 13
Population: Per-Protocol Set: All participants who did not had a major protocol deviation, received vaccine within acceptable vaccination window and received full dose of assigned vaccine, had immunogenicity samples taken within acceptable visit windows, had a pre-vaccination and the corresponding 1 post-vaccination serum sample available for testing. Number of participants analyzed signifies who were evaluable for this endpoint and number analyzed signifies who were evaluable at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 1 | 8.0 Titer |
| Placebo | Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 13 | 8.0 Titer |
| Placebo | Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 7 | 8.0 Titer |
| Placebo | Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 29 | 8.0 Titer |
| Placebo | Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 57 | 8.0 Titer |
| mRNA-1893 10 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 29 | 8.5 Titer |
| mRNA-1893 10 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 57 | 195.6 Titer |
| mRNA-1893 10 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 1 | 8.0 Titer |
| mRNA-1893 10 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 7 | 38.2 Titer |
| mRNA-1893 10 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 13 | 35.0 Titer |
| mRNA-1893 30 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 57 | 303.4 Titer |
| mRNA-1893 30 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 1 | 8.0 Titer |
| mRNA-1893 30 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 29 | 14.4 Titer |
| mRNA-1893 30 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 7 | 66.7 Titer |
| mRNA-1893 30 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 13 | 48.3 Titer |
| mRNA-1893 100 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 13 | 112.3 Titer |
| mRNA-1893 100 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 29 | 45.9 Titer |
| mRNA-1893 100 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 7 | 170.1 Titer |
| mRNA-1893 100 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 57 | 454.2 Titer |
| mRNA-1893 100 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 1 | 8.0 Titer |
| mRNA-1893 250 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 57 | 273.6 Titer |
| mRNA-1893 250 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 7 | 137.7 Titer |
| mRNA-1893 250 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 29 | 27.6 Titer |
| mRNA-1893 250 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 13 | 113.2 Titer |
| mRNA-1893 250 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 1 | 8.0 Titer |
Secondary
Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)
GMT 95% CI is calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Time frame: Day 1, 29, 57, Month 7 and 13
Population: Per-Protocol Set: All participants who did not had a major protocol deviation, received vaccine within acceptable vaccination window and received full dose of assigned vaccine, had immunogenicity samples taken within acceptable visit windows, had a pre-vaccination and the corresponding 1 post-vaccination serum sample available for testing. Number of participants analyzed signifies who were evaluable for this endpoint and number analyzed signifies who were evaluable at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 7 | 15.2 Titer |
| Placebo | Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 1 | 17.0 Titer |
| Placebo | Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 13 | 15.9 Titer |
| Placebo | Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 29 | 17.8 Titer |
| Placebo | Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 57 | 18.6 Titer |
| mRNA-1893 10 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 7 | 68.8 Titer |
| mRNA-1893 10 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 57 | 224.1 Titer |
| mRNA-1893 10 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 29 | 147.9 Titer |
| mRNA-1893 10 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 13 | 77.6 Titer |
| mRNA-1893 10 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 1 | 32.2 Titer |
| mRNA-1893 30 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 57 | 150.9 Titer |
| mRNA-1893 30 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 1 | 15.2 Titer |
| mRNA-1893 30 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 29 | 88.1 Titer |
| mRNA-1893 30 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 7 | 74.2 Titer |
| mRNA-1893 30 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 13 | 45.6 Titer |
| mRNA-1893 100 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 13 | 60.9 Titer |
| mRNA-1893 100 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 1 | 17.4 Titer |
| mRNA-1893 100 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 7 | 196.3 Titer |
| mRNA-1893 100 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 57 | 190.5 Titer |
| mRNA-1893 100 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 29 | 130.6 Titer |
| mRNA-1893 250 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 57 | 100.9 Titer |
| mRNA-1893 250 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 7 | 53.2 Titer |
| mRNA-1893 250 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 1 | 8.0 Titer |
| mRNA-1893 250 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Month 13 | 59.6 Titer |
| mRNA-1893 250 mcg | Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50) | Day 29 | 38.2 Titer |
Secondary
Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test
Seroconversion is defined as a change of PRNT from below the LLOQ to a PRNT equal to or above LLOQ for the assay, or a multiplication by at least 4 in participants with pre-existing PRNT titers.
Time frame: Day 29, Day 57, Month 7, and Month 13
Population: Per-Protocol Set: All participants who did not had a major protocol deviation, received vaccine within the acceptable vaccination window and received full dose of assigned vaccine, had immunogenicity samples taken within acceptable visit windows, had a pre-vaccination and the corresponding 1 post-vaccination serum sample available for testing. Number of participants analyzed signifies who were evaluable for this endpoint and number analyzed signifies who were evaluable at specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test | Month 7 | 0 Participants |
| Placebo | Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test | Month 13 | 0 Participants |
| Placebo | Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test | Day 57 | 0 Participants |
| Placebo | Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test | Day 29 | 0 Participants |
| mRNA-1893 10 mcg | Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test | Day 57 | 17 Participants |
| mRNA-1893 10 mcg | Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test | Day 29 | 1 Participants |
| mRNA-1893 10 mcg | Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test | Month 13 | 10 Participants |
| mRNA-1893 10 mcg | Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test | Month 7 | 12 Participants |
| mRNA-1893 30 mcg | Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test | Day 57 | 18 Participants |
| mRNA-1893 30 mcg | Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test | Day 29 | 8 Participants |
| mRNA-1893 30 mcg | Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test | Month 7 | 15 Participants |
| mRNA-1893 30 mcg | Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test | Month 13 | 11 Participants |
| mRNA-1893 100 mcg | Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test | Day 57 | 20 Participants |
| mRNA-1893 100 mcg | Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test | Month 7 | 17 Participants |
| mRNA-1893 100 mcg | Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test | Day 29 | 14 Participants |
| mRNA-1893 100 mcg | Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test | Month 13 | 14 Participants |
| mRNA-1893 250 mcg | Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test | Day 57 | 19 Participants |
| mRNA-1893 250 mcg | Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test | Month 13 | 17 Participants |
| mRNA-1893 250 mcg | Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test | Month 7 | 19 Participants |
| mRNA-1893 250 mcg | Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test | Day 29 | 13 Participants |
Secondary
Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test
Seroconversion is defined as a change of Plaque Reduction Neutralization Test from below the lower limit of quantification (LLOQ) to a PRNT equal to or above LLOQ for the assay, or a multiplication by at least 4 in participants with pre-existing PRNT titers.
Time frame: Day 29, Day 57, Month 7, and Month 13
Population: Per-Protocol Set consisted of all participants who did not had a major protocol deviation, received vaccine within the acceptable vaccination window and received full dose of assigned vaccine, had immunogenicity samples taken within acceptable visit windows, had a pre-vaccination and the corresponding 1 post-vaccination serum sample available for testing. Here, Number of participants analyzed signifies those participants who were evaluable for this endpoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Day 29: >= 2-fold increase | 0 Participants |
| Placebo | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Day 29: >= 4-fold increase | 0 Participants |
| Placebo | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Day 57: >= 2-fold increase | 0 Participants |
| Placebo | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Day 57: >= 4-fold increase | 0 Participants |
| Placebo | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Month 7: >= 2-fold increase | 0 Participants |
| Placebo | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Month 7: >= 4-fold increase | 0 Participants |
| Placebo | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Month 13: >= 2-fold increase | 0 Participants |
| Placebo | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Month 13: >= 4-fold increase | 0 Participants |
| mRNA-1893 10 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Day 57: >= 2-fold increase | 4 Participants |
| mRNA-1893 10 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Month 7: >= 4-fold increase | 1 Participants |
| mRNA-1893 10 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Day 29: >= 2-fold increase | 3 Participants |
| mRNA-1893 10 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Day 57: >= 4-fold increase | 3 Participants |
| mRNA-1893 10 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Day 29: >= 4-fold increase | 2 Participants |
| mRNA-1893 10 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Month 13: >= 4-fold increase | 1 Participants |
| mRNA-1893 10 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Month 7: >= 2-fold increase | 2 Participants |
| mRNA-1893 10 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Month 13: >= 2-fold increase | 2 Participants |
| mRNA-1893 30 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Month 13: >= 2-fold increase | 2 Participants |
| mRNA-1893 30 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Month 13: >= 4-fold increase | 2 Participants |
| mRNA-1893 30 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Day 57: >= 4-fold increase | 3 Participants |
| mRNA-1893 30 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Month 7: >= 4-fold increase | 2 Participants |
| mRNA-1893 30 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Day 57: >= 2-fold increase | 3 Participants |
| mRNA-1893 30 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Day 29: >= 4-fold increase | 2 Participants |
| mRNA-1893 30 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Day 29: >= 2-fold increase | 3 Participants |
| mRNA-1893 30 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Month 7: >= 2-fold increase | 3 Participants |
| mRNA-1893 100 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Day 29: >= 4-fold increase | 3 Participants |
| mRNA-1893 100 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Day 57: >= 2-fold increase | 3 Participants |
| mRNA-1893 100 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Day 57: >= 4-fold increase | 3 Participants |
| mRNA-1893 100 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Month 7: >= 2-fold increase | 3 Participants |
| mRNA-1893 100 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Month 7: >= 4-fold increase | 3 Participants |
| mRNA-1893 100 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Month 13: >= 4-fold increase | 2 Participants |
| mRNA-1893 100 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Day 29: >= 2-fold increase | 3 Participants |
| mRNA-1893 100 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Month 13: >= 2-fold increase | 2 Participants |
| mRNA-1893 250 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Day 57: >= 4-fold increase | 3 Participants |
| mRNA-1893 250 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Month 13: >= 4-fold increase | 2 Participants |
| mRNA-1893 250 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Day 57: >= 2-fold increase | 3 Participants |
| mRNA-1893 250 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Month 13: >= 2-fold increase | 2 Participants |
| mRNA-1893 250 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Day 29: >= 2-fold increase | 2 Participants |
| mRNA-1893 250 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Month 7: >= 4-fold increase | 2 Participants |
| mRNA-1893 250 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Day 29: >= 4-fold increase | 2 Participants |
| mRNA-1893 250 mcg | Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test | Month 7: >= 2-fold increase | 2 Participants |
Secondary
Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13
Seroconversion is defined as a change of PRNT from below the lower limit of quantification (LLOQ) to a PRNT equal to or above LLOQ for the assay, or a multiplication by at least 4 in participants with pre-existing PRNT titers.
Time frame: Day 1 (baseline) to Day 29, from Day 1 to Day 57, from Day 1 to Month 7, and from Day 1 to Month 13.
Population: Per-Protocol Set consisted of all participants who did not had a major protocol deviation, received vaccine within the acceptable vaccination window and received full dose of assigned vaccine, had immunogenicity samples taken within acceptable visit windows, had a pre-vaccination and the corresponding 1 post-vaccination serum sample available for testing.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13 | Day 1 (baseline) to Day 29 | 0 percentage of participants |
| Placebo | Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13 | Day 1 to Day 57 | 0 percentage of participants |
| Placebo | Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13 | Day 1 to Month 7 | 0 percentage of participants |
| Placebo | Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13 | Day 1 to Month 13 | 0 percentage of participants |
| mRNA-1893 10 mcg | Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13 | Day 1 (baseline) to Day 29 | 12.5 percentage of participants |
| mRNA-1893 10 mcg | Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13 | Day 1 to Month 13 | 60.0 percentage of participants |
| mRNA-1893 10 mcg | Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13 | Day 1 to Day 57 | 90.9 percentage of participants |
| mRNA-1893 10 mcg | Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13 | Day 1 to Month 7 | 66.7 percentage of participants |
| mRNA-1893 30 mcg | Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13 | Day 1 to Month 13 | 61.9 percentage of participants |
| mRNA-1893 30 mcg | Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13 | Day 1 to Day 57 | 95.5 percentage of participants |
| mRNA-1893 30 mcg | Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13 | Day 1 to Month 7 | 81.8 percentage of participants |
| mRNA-1893 30 mcg | Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13 | Day 1 (baseline) to Day 29 | 47.8 percentage of participants |
| mRNA-1893 100 mcg | Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13 | Day 1 (baseline) to Day 29 | 75.0 percentage of participants |
| mRNA-1893 100 mcg | Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13 | Day 1 to Day 57 | 100.0 percentage of participants |
| mRNA-1893 100 mcg | Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13 | Day 1 to Month 13 | 94.1 percentage of participants |
| mRNA-1893 100 mcg | Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13 | Day 1 to Month 7 | 100.0 percentage of participants |
| mRNA-1893 250 mcg | Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13 | Day 1 to Month 13 | 95.2 percentage of participants |
| mRNA-1893 250 mcg | Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13 | Day 1 to Month 7 | 95.7 percentage of participants |
| mRNA-1893 250 mcg | Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13 | Day 1 to Day 57 | 95.7 percentage of participants |
| mRNA-1893 250 mcg | Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13 | Day 1 (baseline) to Day 29 | 66.7 percentage of participants |