| Primary | Number of Participants With Solicited Local and Systemic ARs | Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section. | The Solicited Safety Set included all participants who received the study intervention and contributed any solicited AR data. | Posted | | Count of Participants | | Participants | | Up to Day 64 (Within 7 days after study vaccination) | | | | ID | Title | Description |
|---|
| OG000 | BEXSERO | Participants received 2 IM injections of BEXSERO, each dose administered at 0 and 2 months (Day 1 and Day 57). | | OG001 | mRNA-1608 Dose Level 1 | Participants received 2 IM injections of mRNA-1608 at Dose Level 1, each dose administered at 0 and 2 months (Day 1 and Day 57). | | OG002 | mRNA-1608 Dose Level 2 | Participants received 2 IM injections of mRNA-1608 at Dose Level 2, each dose administered at 0 and 2 months (Day 1 and Day 57). | | OG003 | mRNA-1608 Dose Level 3 | Participants received 2 IM injections of mRNA-1608 at Dose Level 3, each dose administered at 0 and 2 months (Day 1 and Day 57). |
| | Units | Counts |
|---|
| Participants | - OG00076
- OG00175
- OG00276
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00074
- OG00175
- OG00275
- OG003
|
|
| |
| Primary | Number of Participants With Unsolicited Adverse Events (AEs) | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section. | The safety set included all participants who received the study intervention. | Posted | | Count of Participants | | Participants | | Up to Day 85 (Up to 28 days after study vaccination) | | | | ID | Title | Description |
|---|
| OG000 | BEXSERO | Participants received 2 IM injections of BEXSERO, each dose administered at 0 and 2 months (Day 1 and Day 57). | | OG001 | mRNA-1608 Dose Level 1 | Participants received 2 IM injections of mRNA-1608 at Dose Level 1, each dose administered at 0 and 2 months (Day 1 and Day 57). | | OG002 | mRNA-1608 Dose Level 2 | |
|
| Primary | Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Study Discontinuation | An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, 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 SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section. | The safety set included all participants who received the study intervention. | Posted | | Count of Participants | | Participants | | Day 1 through Day 393 | | | | ID | Title | Description |
|---|
| OG000 | BEXSERO | Participants received 2 IM injections of BEXSERO, each dose administered at 0 and 2 months (Day 1 and Day 57). | | OG001 | mRNA-1608 Dose Level 1 | Participants received 2 IM injections of mRNA-1608 at Dose Level 1, each dose administered at 0 and 2 months (Day 1 and Day 57). | | OG002 | mRNA-1608 Dose Level 2 | |
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| Primary | Number of Participants With Medically Attended AEs (MAAEs) | A MAAE is an AE that led to an unscheduled visit to a healthcare practitioner. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section. | The safety set included all participants who received the study intervention. | Posted | | Count of Participants | | Participants | | Day 1 through Day 393 | | | | ID | Title | Description |
|---|
| OG000 | BEXSERO | Participants received 2 IM injections of BEXSERO, each dose administered at 0 and 2 months (Day 1 and Day 57). | | OG001 | mRNA-1608 Dose Level 1 | Participants received 2 IM injections of mRNA-1608 at Dose Level 1, each dose administered at 0 and 2 months (Day 1 and Day 57). | | OG002 | mRNA-1608 Dose Level 2 | Participants received 2 IM injections of mRNA-1608 at Dose Level 2, each dose administered at 0 and 2 months (Day 1 and Day 57). | | OG003 | mRNA-1608 Dose Level 3 | Participants received 2 IM injections of mRNA-1608 at Dose Level 3, each dose administered at 0 and 2 months (Day 1 and Day 57). |
|
| Secondary | Number of Genital Herpes Recurrence Episode Per Participant, Counted Starting 14 Days After the Second Study Injection to 6 Months After Second Study Injection | An episode of recurrence was defined as one or more consecutive "yes" to the "Do you have genital herpes lesion?" question either from Genital Herpes Signs and Symptoms (GHSS) or daily recurrence eDiary within a 14-day period from the first "yes" response regardless of "no" or missing entries in between. The start date of an episode was the first date of "yes" response, and the end date of an episode was the last date of "yes" within the episode. The recurrence analysis period up to 6 months included the time from 14 days after the second injection until the last GHSS or daily recurrence eDiary collected up to the 1) the Day 225 visit date or 2) if Day 225 visit date is not available, the earliest of study Day 225 or study discontinuation date. | The mFAS included all randomly assigned participants who received 2 doses of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | recurrence episodes per participant | | Day 71 up to Day 225 | | | | ID | Title | Description |
|---|
| OG000 | BEXSERO | Participants received 2 IM injections of BEXSERO, each dose administered at 0 and 2 months (Day 1 and Day 57). | | OG001 | mRNA-1608 Dose Level 1 | Participants received 2 IM injections of mRNA-1608 at Dose Level 1, each dose administered at 0 and 2 months (Day 1 and Day 57). |
|
| Secondary | Number of Genital Herpes Recurrence Episode Per Participant, Counted Starting 14 Days After the Second Study Injection to 12 Months After Second Study Injection | An episode of recurrence was defined as one or more consecutive "yes" to the "Do you have genital herpes lesion?" question either from GHSS or daily recurrence eDiary within a 14-day period from the first "yes" response regardless of "no" or missing entries in between. The start date of an episode was the first date of "yes" response, and the end date of an episode was the last date of "yes" within the episode. The recurrence analysis period up to 12 months included the time from 14 days after the second injection until the last GHSS or daily recurrence eDiary collected up to the 1) the Day 393 visit date or 2) if Day 393 visit date is not available, the earliest of study Day 393 or study discontinuation date. | The mFAS included all randomly assigned participants who received 2 doses of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | recurrence episodes per participant | | Day 71 up to Day 393 | | | | ID | Title | Description |
|---|
| OG000 | BEXSERO | Participants received 2 IM injections of BEXSERO, each dose administered at 0 and 2 months (Day 1 and Day 57). | | OG001 | mRNA-1608 Dose Level 1 | Participants received 2 IM injections of mRNA-1608 at Dose Level 1, each dose administered at 0 and 2 months (Day 1 and Day 57). |
|
| Secondary | Change From Baseline (28 Days Prior to the First Study Injection) to 2 Months After the Second Study Injection in Genital Herpes Lesion Rate (Percentage of Days With Lesions Present) | Genital herpes lesion rate was defined for each 28-day swabbing period as the number of days with lesion present according to the eDiary divided by the number of days during the 28-day swabbing period. | The mFAS included all randomly assigned participants who received 2 doses of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | percentage of days with lesion present | | Baseline (Day -27 to Day 1), Day 113 | | | | ID | Title | Description |
|---|
| OG000 | BEXSERO | Participants received 2 IM injections of BEXSERO, each dose administered at 0 and 2 months (Day 1 and Day 57). | | OG001 | mRNA-1608 Dose Level 1 | Participants received 2 IM injections of mRNA-1608 at Dose Level 1, each dose administered at 0 and 2 months (Day 1 and Day 57). | | OG002 | mRNA-1608 Dose Level 2 | Participants received 2 IM injections of mRNA-1608 at Dose Level 2, each dose administered at 0 and 2 months (Day 1 and Day 57). |
|
| Secondary | Change From Baseline (28 Days Prior to the First Study Injection) to 6 Months After the Second Study Injection in Genital Herpes Lesion Rate (Percentage of Days With Lesions Present) | Genital herpes lesion rate was defined for each 28-day swabbing period as the number of days with lesion present according to the eDiary divided by the number of days during the 28-day swabbing period. | The mFAS included all randomly assigned participants who received 2 doses of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | percentage of days with lesion present | | Baseline (Day -27 to Day 1), Day 225 | | | | ID | Title | Description |
|---|
| OG000 | BEXSERO | Participants received 2 IM injections of BEXSERO, each dose administered at 0 and 2 months (Day 1 and Day 57). | | OG001 | mRNA-1608 Dose Level 1 | Participants received 2 IM injections of mRNA-1608 at Dose Level 1, each dose administered at 0 and 2 months (Day 1 and Day 57). | | OG002 | mRNA-1608 Dose Level 2 | Participants received 2 IM injections of mRNA-1608 at Dose Level 2, each dose administered at 0 and 2 months (Day 1 and Day 57). |
|
| Secondary | Change From Baseline (28 Days Prior to the First Study Injection) to 2 Months After the Second Study Injection in HSV-2 Genital Shedding Rate (Percentage of HSV-2 Deoxyribonucleic Acid [DNA] Positive Anogenital Swabs) | Genital shedding rate was defined for each 28-day swabbing period as the number of anogenital swabs with HSV-2 DNA positive results (that is, positive results per polymerase chain reaction [PCR]) divided by the number of swabs during the swabbing period. | The mFAS included all randomly assigned participants who received 2 doses of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | percentage of anogenital swabs | | Baseline (Day -27 to Day 1), Day 113 | | | | ID | Title | Description |
|---|
| OG000 | BEXSERO | Participants received 2 IM injections of BEXSERO, each dose administered at 0 and 2 months (Day 1 and Day 57). | | OG001 | mRNA-1608 Dose Level 1 | Participants received 2 IM injections of mRNA-1608 at Dose Level 1, each dose administered at 0 and 2 months (Day 1 and Day 57). | | OG002 | mRNA-1608 Dose Level 2 | Participants received 2 IM injections of mRNA-1608 at Dose Level 2, each dose administered at 0 and 2 months (Day 1 and Day 57). |
|
| Secondary | Change From Baseline (28 Days Prior to the First Study Injection) to 6 Months After the Second Study Injection in HSV-2 Genital Shedding Rate (Percentage of HSV-2 DNA Positive Anogenital Swabs) | Genital shedding rate was defined for each 28-day swabbing period as the number of anogenital swabs with HSV-2 DNA positive results (that is, positive results per PCR) divided by the number of swabs during the swabbing period. | The mFAS included all randomly assigned participants who received 2 doses of the study intervention. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | percentage of anogenital swabs | | Baseline (Day -27 to Day 1), Day 225 | | | | ID | Title | Description |
|---|
| OG000 | BEXSERO | Participants received 2 IM injections of BEXSERO, each dose administered at 0 and 2 months (Day 1 and Day 57). | | OG001 | mRNA-1608 Dose Level 1 | Participants received 2 IM injections of mRNA-1608 at Dose Level 1, each dose administered at 0 and 2 months (Day 1 and Day 57). | | OG002 | mRNA-1608 Dose Level 2 | Participants received 2 IM injections of mRNA-1608 at Dose Level 2, each dose administered at 0 and 2 months (Day 1 and Day 57). |
|
| Secondary | Geometric Mean (GM) Value of mRNA-1608 Antigen-Specific Binding Antibodies (bAbs) | Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5 * LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ if actual values were not available. LLOQ was 1220 units (U)/milliliter (mL) and ULOQ was 6890000 U/mL for HSV2 gB. LLOQ was 1230 U/mL and ULOQ was 21300000 U/mL for HSV2 gC. LLOQ was 2220 U/mL and ULOQ was 23900000 U/mL for HSV2 gD. 95% confidence interval (CI) was calculated based on the t-distribution of the log-transformed values for GM, then back transformed to the original scale for presentation. | PP set included all randomly assigned participants who received the study intervention, complied with the vaccination schedule, complied with the timings of immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, and had no important protocol deviations that impacted the immune response. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category. | Posted | | Geometric Mean | 95% Confidence Interval | U/mL | | Days 85 and 197 | | | | ID | Title | Description |
|---|
| OG000 | BEXSERO | Participants received 2 IM injections of BEXSERO, each dose administered at 0 and 2 months (Day 1 and Day 57). | | OG001 | mRNA-1608 Dose Level 1 | Participants received 2 IM injections of mRNA-1608 at Dose Level 1, each dose administered at 0 and 2 months (Day 1 and Day 57). |
|
| Secondary | Geometric Mean Fold Rise (GMFR) of mRNA-1608 Antigen-Specific bAbs | Antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 1220 U/mL and ULOQ was 6890000 U/mL for HSV2 gB. LLOQ was 1230 U/mL and ULOQ was 21300000 U/mL for HSV2 gC. LLOQ was 2220 U/mL and ULOQ was 23900000 U/mL for HSV2 gD. 95% CI was calculated based on the t-distribution of the difference in the log-transformed values for GMFR, then back transformed to the original scale for presentation. | PP set included all randomly assigned participants who received the study intervention, complied with the vaccination schedule, complied with the timings of immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, and had no important protocol deviations that impacted the immune response. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category. | Posted | | Geometric Mean | 95% Confidence Interval | ratio | | Days 85 and 197 | | | | ID | Title | Description |
|---|
| OG000 | BEXSERO | Participants received 2 IM injections of BEXSERO, each dose administered at 0 and 2 months (Day 1 and Day 57). | | OG001 | mRNA-1608 Dose Level 1 | Participants received 2 IM injections of mRNA-1608 at Dose Level 1, each dose administered at 0 and 2 months (Day 1 and Day 57). |
|
| Secondary | Percentage of Participants With Vaccine Seroresponse | Seroresponse was defined as a change from baseline below the LLOQ to equal or above 4 * LLOQ, or at least a 4-fold rise if baseline was equal to or above the LLOQ. LLOQ was 1220 U/mL and ULOQ was 6890000 U/mL for HSV2 gB. LLOQ was 1230 U/mL and ULOQ was 21300000 U/mL for HSV2 gC. LLOQ was 2220 U/mL and ULOQ was 23900000 U/mL for HSV2 gD. 95% CI was calculated using the Clopper-Pearson method. | PP set included all randomly assigned participants who received the study intervention, complied with the vaccination schedule, complied with the timings of immunogenicity blood sampling to have a baseline and at least 1 post-injection assessment, and had no important protocol deviations that impacted the immune response. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 85 | | | | ID | Title | Description |
|---|
| OG000 | BEXSERO | Participants received 2 IM injections of BEXSERO, each dose administered at 0 and 2 months (Day 1 and Day 57). | | OG001 | mRNA-1608 Dose Level 1 | Participants received 2 IM injections of mRNA-1608 at Dose Level 1, each dose administered at 0 and 2 months (Day 1 and Day 57). | | OG002 | mRNA-1608 Dose Level 2 |
|