Pneumococcal Infection
Conditions
Brief summary
The purpose of this study is to evaluate the concomitant and non-concomitant use of messenger ribonucleic acid (mRNA) mRNA-1273, the nucleoside-modified mRNA vaccine for active immunization to prevent coronavirus disease (COVID-19) caused by severe acute respiratory syndrome coronavirus (SARS-CoV-2), with a 23-valent pneumococcal polysaccharide vaccine (V110) for the prevention of pneumococcal disease, or a 15-valent pneumococcal conjugate vaccine (V114) indicated for the prevention of invasive pneumococcal disease.
Interventions
BIOLOGICALV110
Single intramuscular (IM) dose of 0.5 mL V110, a pneumococcal polysaccharide vaccine (PCV), containing the 23 serotypes: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F
BIOLOGICALV114
Single IM dose of 0.5 mL V114 a 15-valent PCV containing the 15 serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F
BIOLOGICALmRNA-1273
Single IM dose of 50 μg/0.25 mL mRNA-1273
BIOLOGICALPlacebo for V110
Single IM dose of 0.5 mL placebo for V110
BIOLOGICALPlacebo for V114
Single IM dose of 0.5 mL placebo for V114
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Is in good health * Any underlying chronic illness must be documented to be in stable condition * Has received a 2-dose primary series of the Moderna mRNA SARS-CoV-2 vaccine ≥5 months before receipt of study vaccine at Visit 1 * May have received either: a) A first booster dose of the Moderna mRNA SARS-CoV-2 vaccine ≥4 months before receipt of study vaccine at Visit 1, or b) No booster dose of the Moderna mRNA SARS-CoV-2 vaccine * A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR is a WOCBP and using an acceptable contraceptive method, or is abstinent from heterosexual intercourse
Exclusion criteria
* Has a current SARS-CoV-2 infection or a known history of SARS-CoV-2 infection \<3 months before receipt of study vaccine at Visit 1 * Has a history of myocarditis and/or pericarditis * Has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease * Has a coagulation disorder contraindicating intramuscular vaccinations * Had a recent illness with fever (defined as oral or tympanic temperature ≥100.4°F \[≥38.0°C\]; axillary or temporal temperature ≥99.4°F \[≥37.4°C\]) or received antibiotic therapy for an acute illness occurring \<72 hours before receipt of study vaccine * Has a known malignancy that is progressing or has required active treatment \<3 years before receipt of study vaccine at Visit 1 * Received prior administration of a pneumococcal polysaccharide vaccine \<5 years before study enrollment or is expected to receive a pneumococcal polysaccharide vaccine during the study outside the protocol * Received prior administration of a PCV \<1 year before receipt of study vaccine at Visit 1 or is expected to receive a PCV during the study outside the protocol * Received prior administration of any SARS-CoV-2 vaccine other than the 2-dose primary series of the Moderna mRNA vaccine with or without a first booster dose, or is expected to receive any SARS-CoV-2 vaccine during the study outside the protocol * Received prior monoclonal antibody treatment for SARS-CoV-2 infection * Received antiviral treatment for SARS-CoV-2 infection \<3 months before receipt of study vaccine at Visit 1 * Received systemic corticosteroids for ≥14 consecutive days and has not completed intervention ≥30 days before receipt of study vaccine at Visit 1 * Received systemic corticosteroids exceeding physiologic replacement doses ≤14 days before receipt of study vaccine * Is currently receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease * Received any non-live vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of study vaccine. Exception: Inactivated influenza vaccine allowed if given ≥7 days before or ≥15 days after receipt of study vaccine * Received any live virus vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of study vaccine * Received a blood transfusion or blood products (including globulin) ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product ≤30 days after receipt of study vaccine * Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SARS-CoV-2-specific Binding Antibody (bAb) GMT in Participants Administered Either V110 or V114 | Up to 30 days postvaccination with mRNA-1273 (Study Day 30) | Sera from participants were used to measure vaccine-induced bAb responses using a validated ligand-binding assay specific to the SARS-CoV-2 Spike protein at 30 days post vaccination. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. As prespecified by the protocol and statistical analysis plan, the V110 nonconcomitant group and V114 nonconcomitant group were combined for this analysis, as they shared the same administration for the first visit (mRNA-1273 and placebo). |
| Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110 | Up to Day 7 After Any Vaccination (Up to Study Day 37) | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Systemic adverse events (AEs) include headache, tiredness/fatigue, muscle aches all over body/myalgia, joint pain/arthralgia, nausea, vomiting, and chills. The percentage of participants with solicited systemic AEs following any vaccination was reported. |
| Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114 | Up to Day 7 After Any Vaccination (Up to Study Day 37) | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Systemic adverse events (AEs) include headache, tiredness/fatigue, muscle aches all over body/myalgia, joint pain/arthralgia, nausea, vomiting, and chills. The percentage of participants with solicited systemic AEs following any vaccination was reported. |
| Percentage of Participants With Vaccine-Related Serious AEs (SAEs) Among Participants Administered V110 | Up to Month 6 | Serious adverse events (SAEs) are defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of a participant, or other important medical events. V110 vaccine-related SAEs as determined by investigator are summarized. |
| Percentage of Participants With Vaccine-Related SAEs Among Participants Administered V114 | Up to Month 6 | SAEs are defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of a participant, or other important medical events. V114 vaccine-related SAEs as determined by investigator are summarized. |
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Up to 30 days postvaccination with V110 (Study Day 30 for concomitant vaccination group, and Study Day 60 for nonconcomitant vaccination group, respectively) | Serotype-specific OPA GMTs for 14 of the serotypes contained in V110 were determined using a multiplexed opsonophagocytic assay (MOPA) at 30 days postvaccination with V110. The within-group 95% confidence intervals (CIs) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. |
| Serotype-specific OPA GMT in Participants Administered V114 | Up to 30 days postvaccination with V114 (Study Day 30 for concomitant vaccination group, and Study Day 60 for nonconcomitant vaccination group, respectively) | Serotype-specific OPA GMTs for 15 of the serotypes contained in V114 were determined using a MOPA at 30 days postvaccination with V114. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. |
| Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Among Participants Administered V110 | Up to Day 7 After Any Vaccination (Up to Study Day 37) | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs include redness, swelling, pain/tenderness, and underarm gland swelling or tenderness/lymphadenopathy at the injection site. The percentage of participants with one or more solicited injection-site AEs following any vaccination was reported. |
| Percentage of Participants With Solicited Injection-Site Adverse Events Among Participants Administered V114 | Up to Day 7 After Any Vaccination (Up to Study Day 37) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs include redness, swelling, pain/tenderness, and underarm gland swelling or tenderness/lymphadenopathy at the injection site. The percentage of participants with one or more solicited injection-site AEs following any vaccination was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serotype-specific OPA GMFR in Participants Administered V114 | Baseline and 30 days postvaccination with V114 (Study Day 1 and Study Day 30 for concomitant vaccination group, and Study Day 30 and Study Day 60 for nonconcomitant vaccination group, respectively) | Serotype-specific OPA for all 15 of the serotypes contained in V114 were determined using a MOPA. GMFR is the geometric mean fold rise from baseline to 30 days postvaccination. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. |
| SARS-CoV-2-specific Binding Antibody (bAb) GMFR in Participants Administered Either V110 or V114 | Baseline and 30 days postvaccination with mRNA-1273 (Study Day 1 and Study Day 30, respectively) | Sera from participants was used to measure vaccine-induced bAb responses using a validated ligand-binding assay specific to the SARS-CoV-2 Spike protein. GMFR is the geometric mean fold rise from baseline to 30 days postvaccination. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. As prespecified by the protocol and statistical analysis plan, the V110 nonconcomitant group and V114 nonconcomitant group were combined for this analysis, as they shared the same administration for the first visit (mRNA-1273 and placebo). |
| Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Baseline and 30 days postvaccination with V110 (Study Day 1 and Study Day 30 for concomitant vaccination group, and Study Day 30 and Study Day 60 for nonconcomitant vaccination group, respectively) | Serotype-specific OPA for 14 of the serotypes contained in V110 was determined using a MOPA. The percentage of participants who achieved a ≥4-fold rise in OPA titer from baseline to 30 days postvaccination were calculated. The within-group 95% CIs are based on the exact binomial method proposed by Clopper and Pearson. |
| Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Baseline and 30 days postvaccination with V114 (Study Day 1 and Study Day 30 for concomitant vaccination group, and Study Day 30 and Study Day 60 for nonconcomitant vaccination group, respectively) | Serotype-specific OPA for all 15 of the serotypes in V114 were determined using a MOPA. The percentage of participants who achieved a ≥4-fold rise in OPA titer from baseline to 30 days postvaccination were calculated. The within-group 95% CIs are based on the exact binomial method proposed by Clopper and Pearson. |
| Percentage of Participants With ≥4 Fold Rise From Baseline in SARS-CoV-2-specific bAb Response | Baseline and 30 days postvaccination with mRNA-1273 (Study Day 1 and Study Day 30, respectively) | Sera from participants was used to measure vaccine-induced bAb responses using a validated ligand-binding assay specific to the SARS-CoV-2 Spike protein. The percentage of participants who achieved a ≥4-fold rise in bAb titer from baseline to 30 days postvaccination were calculated. The within-group 95% CIs are based on the exact binomial method proposed by Clopper and Pearson. As prespecified by the protocol and statistical analysis plan, the V110 nonconcomitant group and V114 nonconcomitant group were combined for this analysis, as they shared the same administration for the first visit (mRNA-1273 and placebo). |
| Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Baseline and 30 days postvaccination with V110 (Study Day 1 and Study Day 30 for concomitant vaccination group, and Study Day 30 and Study Day 60 for nonconcomitant vaccination group, respectively) | Serotype-specific OPA for 14 of the serotypes contained in V110 was determined using a MOPA. GMFR is the geometric mean fold rise from baseline to 30 days postvaccination. The within-group 95% confidence intervals (CIs) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| V110 Concomitant With mRNA-1273 (V110 Concomitant) Participants received a single 0.5 mL intramuscular (IM) injection of V110 concomitantly with a single 0.25 mL IM injection of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V110 on Day 30. | 214 |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) Participants received a single 0.5 mL IM injection of placebo for V110 on Day 1 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273, followed by a single 0.5 mL IM vaccination of V110 on Day 30. | 212 |
| V114 Concomitant With mRNA-1273 (V114 Concomitant) Participants received a single 0.5 mL IM vaccination of V114 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273 on Day 1, followed by a single 0.5 mL IM injection of placebo for V114 on Day 30. | 214 |
| V114 Nonconcomitant With mRNA-1273 (V114 Nonconcomitant) Participants received single 0.5 mL IM injection of placebo for V114 on Day 1 concomitantly with a single 0.25 mL IM vaccination of mRNA-1273, followed by a single 0.5 mL IM vaccination of V114 on Day 30. | 210 |
| Total | 850 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 6 | 4 | 3 |
| Overall Study | Randomized By Mistake Without Study Treatment | 0 | 0 | 4 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 7 | 3 | 7 |
Baseline characteristics
| Characteristic | V114 Nonconcomitant With mRNA-1273 (V114 Nonconcomitant) | V110 Concomitant With mRNA-1273 (V110 Concomitant) | V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | V114 Concomitant With mRNA-1273 (V114 Concomitant) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 60.3 Years STANDARD_DEVIATION 8.1 | 60.5 Years STANDARD_DEVIATION 8.1 | 60.4 Years STANDARD_DEVIATION 8.4 | 60.4 Years STANDARD_DEVIATION 7.8 | 60.4 Years STANDARD_DEVIATION 8.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 93 Participants | 87 Participants | 98 Participants | 90 Participants | 368 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 116 Participants | 127 Participants | 112 Participants | 124 Participants | 479 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 4 Participants | 3 Participants | 7 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 40 Participants | 41 Participants | 33 Participants | 36 Participants | 150 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 5 Participants | 3 Participants | 3 Participants | 16 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 159 Participants | 164 Participants | 173 Participants | 167 Participants | 663 Participants |
| Sex: Female, Male Female | 130 Participants | 107 Participants | 131 Participants | 113 Participants | 481 Participants |
| Sex: Female, Male Male | 80 Participants | 107 Participants | 81 Participants | 101 Participants | 369 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 214 | 0 / 212 | 0 / 214 | 1 / 210 |
| other Total, other adverse events | 171 / 214 | 170 / 211 | 163 / 209 | 172 / 208 |
| serious Total, serious adverse events | 2 / 214 | 2 / 211 | 6 / 209 | 4 / 208 |
Outcome results
Primary
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Among Participants Administered V110
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs include redness, swelling, pain/tenderness, and underarm gland swelling or tenderness/lymphadenopathy at the injection site. The percentage of participants with one or more solicited injection-site AEs following any vaccination was reported.
Time frame: Up to Day 7 After Any Vaccination (Up to Study Day 37)
Population: All randomized participants who received 1 dose of V110 concomitantly or nonconcomitantly with mRNA-1273.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Among Participants Administered V110 | Injection site erythema | 18.7 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Among Participants Administered V110 | Injection site pain | 74.8 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Among Participants Administered V110 | Injection site swelling | 23.4 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Among Participants Administered V110 | Lymphadenopathy | 17.3 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Among Participants Administered V110 | Lymphadenopathy | 25.1 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Among Participants Administered V110 | Injection site erythema | 14.7 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Among Participants Administered V110 | Injection site swelling | 26.5 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Among Participants Administered V110 | Injection site pain | 74.4 Percentage of Participants |
Primary
Percentage of Participants With Solicited Injection-Site Adverse Events Among Participants Administered V114
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs include redness, swelling, pain/tenderness, and underarm gland swelling or tenderness/lymphadenopathy at the injection site. The percentage of participants with one or more solicited injection-site AEs following any vaccination was reported.
Time frame: Up to Day 7 After Any Vaccination (Up to Study Day 37)
Population: All randomized participants who received 1 dose of V114 concomitantly or nonconcomitantly with mRNA-1273.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants With Solicited Injection-Site Adverse Events Among Participants Administered V114 | Injection site erythema | 15.3 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants With Solicited Injection-Site Adverse Events Among Participants Administered V114 | Injection site pain | 70.8 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants With Solicited Injection-Site Adverse Events Among Participants Administered V114 | Injection site swelling | 20.6 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants With Solicited Injection-Site Adverse Events Among Participants Administered V114 | Lymphadenopathy | 17.7 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants With Solicited Injection-Site Adverse Events Among Participants Administered V114 | Lymphadenopathy | 25.5 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants With Solicited Injection-Site Adverse Events Among Participants Administered V114 | Injection site erythema | 16.3 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants With Solicited Injection-Site Adverse Events Among Participants Administered V114 | Injection site swelling | 29.3 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants With Solicited Injection-Site Adverse Events Among Participants Administered V114 | Injection site pain | 76.9 Percentage of Participants |
Primary
Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Systemic adverse events (AEs) include headache, tiredness/fatigue, muscle aches all over body/myalgia, joint pain/arthralgia, nausea, vomiting, and chills. The percentage of participants with solicited systemic AEs following any vaccination was reported.
Time frame: Up to Day 7 After Any Vaccination (Up to Study Day 37)
Population: All randomized participants who received 1 dose of V110 concomitantly or nonconcomitantly with mRNA-1273.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110 | Fatigue | 40.7 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110 | Myalgia | 18.7 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110 | Chills | 18.7 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110 | Nausea | 10.7 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110 | Headache | 29.0 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110 | Vomiting | 3.7 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110 | Arthralgia | 15.4 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110 | Vomiting | 2.4 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110 | Arthralgia | 17.5 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110 | Chills | 17.5 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110 | Fatigue | 36.5 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110 | Headache | 34.1 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110 | Myalgia | 24.6 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110 | Nausea | 13.3 Percentage of Participants |
Primary
Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Systemic adverse events (AEs) include headache, tiredness/fatigue, muscle aches all over body/myalgia, joint pain/arthralgia, nausea, vomiting, and chills. The percentage of participants with solicited systemic AEs following any vaccination was reported.
Time frame: Up to Day 7 After Any Vaccination (Up to Study Day 37)
Population: All randomized participants who received 1 dose of V114 concomitantly or nonconcomitantly with mRNA-1273. One participant in the V114 Concomitant Group received 2 doses of mRNA-1273 in error and was excluded from the safety population per statistical analysis plan.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114 | Myalgia | 21.5 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114 | Nausea | 10.0 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114 | Vomiting | 1.4 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114 | Arthralgia | 16.7 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114 | Chills | 18.7 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114 | Fatigue | 41.1 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114 | Headache | 29.2 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114 | Myalgia | 26.9 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114 | Chills | 18.8 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114 | Nausea | 15.4 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114 | Headache | 38.0 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114 | Vomiting | 2.4 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114 | Fatigue | 46.6 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114 | Arthralgia | 18.8 Percentage of Participants |
Primary
Percentage of Participants With Vaccine-Related SAEs Among Participants Administered V114
SAEs are defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of a participant, or other important medical events. V114 vaccine-related SAEs as determined by investigator are summarized.
Time frame: Up to Month 6
Population: All randomized participants who received 1 dose of V114 concomitantly or nonconcomitantly with mRNA-1273. One participant in the V114 Concomitant Group received 2 doses of mRNA-1273 in error and was excluded from the safety population per statistical analysis plan.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants With Vaccine-Related SAEs Among Participants Administered V114 | 0.0 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants With Vaccine-Related SAEs Among Participants Administered V114 | 0.0 Percentage of Participants |
Primary
Percentage of Participants With Vaccine-Related Serious AEs (SAEs) Among Participants Administered V110
Serious adverse events (SAEs) are defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of a participant, or other important medical events. V110 vaccine-related SAEs as determined by investigator are summarized.
Time frame: Up to Month 6
Population: All randomized participants who received 1 dose of V110 concomitantly or nonconcomitantly with mRNA-1273.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants With Vaccine-Related Serious AEs (SAEs) Among Participants Administered V110 | 0.0 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants With Vaccine-Related Serious AEs (SAEs) Among Participants Administered V110 | 0.0 Percentage of Participants |
Primary
SARS-CoV-2-specific Binding Antibody (bAb) GMT in Participants Administered Either V110 or V114
Sera from participants were used to measure vaccine-induced bAb responses using a validated ligand-binding assay specific to the SARS-CoV-2 Spike protein at 30 days post vaccination. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. As prespecified by the protocol and statistical analysis plan, the V110 nonconcomitant group and V114 nonconcomitant group were combined for this analysis, as they shared the same administration for the first visit (mRNA-1273 and placebo).
Time frame: Up to 30 days postvaccination with mRNA-1273 (Study Day 30)
Population: All randomized participants who received 1 dose of either V110 or V114 concomitantly or nonconcomitantly with mRNA-1273, without protocol deviations substantially affecting immunogenicity endpoint results and with available bAb data. As prespecified by the protocol and statistical analysis plan, the V110 nonconcomitant group and V114 nonconcomitant group were combined for this analysis, as they shared the vaccinations at the first visit (mRNA-1273 and placebo).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | SARS-CoV-2-specific Binding Antibody (bAb) GMT in Participants Administered Either V110 or V114 | 824118.4 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | SARS-CoV-2-specific Binding Antibody (bAb) GMT in Participants Administered Either V110 or V114 | 861746.4 Titers |
| Combined V110/V114 Nonconcomitant | SARS-CoV-2-specific Binding Antibody (bAb) GMT in Participants Administered Either V110 or V114 | 1102295.7 Titers |
Primary
Serotype-specific OPA GMT in Participants Administered V114
Serotype-specific OPA GMTs for 15 of the serotypes contained in V114 were determined using a MOPA at 30 days postvaccination with V114. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Time frame: Up to 30 days postvaccination with V114 (Study Day 30 for concomitant vaccination group, and Study Day 60 for nonconcomitant vaccination group, respectively)
Population: All randomized participants who received 1 dose of V114 concomitantly or nonconcomitantly with mRNA-1273, without protocol deviations substantially affecting immunogenicity endpoint results. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation and with non-missing OPA serology data for the respective serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 6A | 4345.3 Titers |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 14 | 2487.2 Titers |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 3 | 237.5 Titers |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 18C | 3144.5 Titers |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 6B | 3655.5 Titers |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 19A | 3214.3 Titers |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 5 | 447.0 Titers |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 19F | 1742.0 Titers |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 7F | 3465.7 Titers |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 22F | 2282.7 Titers |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 4 | 1586.0 Titers |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 23F | 2326.3 Titers |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 9V | 1730.3 Titers |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 33F | 6788.5 Titers |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 1 | 208.3 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 33F | 9339.7 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 1 | 265.6 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 3 | 338.4 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 4 | 1758.6 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 5 | 505.5 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 6A | 5787.1 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 6B | 4992.9 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 7F | 3283.0 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 9V | 2026.6 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 14 | 2460.8 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 18C | 3183.5 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 19A | 4037.4 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 19F | 1950.1 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 22F | 2670.6 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMT in Participants Administered V114 | Serotype 23F | 2212.0 Titers |
Primary
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110
Serotype-specific OPA GMTs for 14 of the serotypes contained in V110 were determined using a multiplexed opsonophagocytic assay (MOPA) at 30 days postvaccination with V110. The within-group 95% confidence intervals (CIs) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Time frame: Up to 30 days postvaccination with V110 (Study Day 30 for concomitant vaccination group, and Study Day 60 for nonconcomitant vaccination group, respectively)
Population: All randomized participants who received 1 dose of V110 concomitantly or nonconcomitantly with mRNA-1273, without protocol deviations substantially affecting immunogenicity endpoint results. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation and with non-missing OPA serology data for the respective serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 14 | 3048.3 Titers |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 7F | 2614.4 Titers |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 18C | 1592.9 Titers |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 5 | 423.4 Titers |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 19A | 2135.7 Titers |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 3 | 174.3 Titers |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 19F | 1379.9 Titers |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 6B | 1336.7 Titers |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 22F | 2023.0 Titers |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 1 | 236.0 Titers |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 23F | 739.0 Titers |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 9V | 1651.1 Titers |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 33F | 10089.0 Titers |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 4 | 1384.5 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 33F | 10909.2 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 1 | 235.5 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 3 | 284.0 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 4 | 1704.4 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 5 | 376.3 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 7F | 2420.2 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 9V | 1809.2 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 14 | 2618.4 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 18C | 2033.7 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 19A | 2626.1 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 19F | 1532.6 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 22F | 2178.4 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 23F | 839.9 Titers |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110 | Serotype 6B | 1326.8 Titers |
Secondary
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110
Serotype-specific OPA for 14 of the serotypes contained in V110 was determined using a MOPA. The percentage of participants who achieved a ≥4-fold rise in OPA titer from baseline to 30 days postvaccination were calculated. The within-group 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
Time frame: Baseline and 30 days postvaccination with V110 (Study Day 1 and Study Day 30 for concomitant vaccination group, and Study Day 30 and Study Day 60 for nonconcomitant vaccination group, respectively)
Population: All randomized participants receiving 1 dose of V110 concomitantly or nonconcomitantly with mRNA-1273, without protocol deviations substantially affecting immunogenicity endpoint results. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation and with baseline and post-vaccination OPA serology data for the respective serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 9V | 47.1 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 23F | 44.3 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 14 | 49.4 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 5 | 75.0 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 18C | 66.7 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 3 | 66.9 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 19A | 61.5 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 6B | 55.8 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 19F | 62.3 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 1 | 76.0 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 22F | 68.5 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 7F | 71.2 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 33F | 67.3 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 4 | 66.3 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 33F | 67.9 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 1 | 75.1 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 3 | 72.5 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 4 | 68.2 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 5 | 69.9 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 6B | 56.7 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 7F | 66.7 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 9V | 51.9 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 14 | 52.4 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 18C | 69.9 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 19A | 62.1 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 19F | 60.3 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 23F | 53.9 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V110 | Serotype 22F | 66.0 Percentage of Participants |
Secondary
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114
Serotype-specific OPA for all 15 of the serotypes in V114 were determined using a MOPA. The percentage of participants who achieved a ≥4-fold rise in OPA titer from baseline to 30 days postvaccination were calculated. The within-group 95% CIs are based on the exact binomial method proposed by Clopper and Pearson.
Time frame: Baseline and 30 days postvaccination with V114 (Study Day 1 and Study Day 30 for concomitant vaccination group, and Study Day 30 and Study Day 60 for nonconcomitant vaccination group, respectively)
Population: All randomized participants receiving 1 dose of V114 concomitantly or nonconcomitantly with mRNA-1273, without protocol deviations substantially affecting immunogenicity endpoint results. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation and with baseline and post-vaccination OPA serology data for the respective serotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 19A | 63.6 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 1 | 72.7 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 3 | 65.2 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 4 | 68.9 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 5 | 70.5 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 6A | 75.9 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 6B | 75.6 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 7F | 67.8 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 9V | 48.6 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 14 | 45.5 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 18C | 72.9 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 19F | 66.1 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 22F | 69.1 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 23F | 65.0 Percentage of Participants |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 33F | 56.2 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 19F | 67.7 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 9V | 53.2 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 1 | 73.4 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 23F | 70.1 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 3 | 79.3 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 14 | 51.8 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 4 | 73.2 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 22F | 72.5 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 5 | 73.2 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 18C | 75.4 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 6A | 82.6 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 19A | 68.6 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 6B | 76.5 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 33F | 63.6 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114 | Serotype 7F | 65.2 Percentage of Participants |
Secondary
Percentage of Participants With ≥4 Fold Rise From Baseline in SARS-CoV-2-specific bAb Response
Sera from participants was used to measure vaccine-induced bAb responses using a validated ligand-binding assay specific to the SARS-CoV-2 Spike protein. The percentage of participants who achieved a ≥4-fold rise in bAb titer from baseline to 30 days postvaccination were calculated. The within-group 95% CIs are based on the exact binomial method proposed by Clopper and Pearson. As prespecified by the protocol and statistical analysis plan, the V110 nonconcomitant group and V114 nonconcomitant group were combined for this analysis, as they shared the same administration for the first visit (mRNA-1273 and placebo).
Time frame: Baseline and 30 days postvaccination with mRNA-1273 (Study Day 1 and Study Day 30, respectively)
Population: All randomized participants who received 1 dose of either V110 or V114 concomitantly or nonconcomitantly with mRNA-1273, without protocol deviations substantially affecting immunogenicity endpoint results and with available baseline and post-vaccination bAb data. As prespecified by the protocol and statistical analysis plan, the V110 nonconcomitant group and V114 nonconcomitant group were combined for this analysis, as they shared the same vaccinations at the first visit (mRNA-1273 and placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Percentage of Participants With ≥4 Fold Rise From Baseline in SARS-CoV-2-specific bAb Response | 55.1 Percentage of Participants |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Percentage of Participants With ≥4 Fold Rise From Baseline in SARS-CoV-2-specific bAb Response | 52.3 Percentage of Participants |
| Combined V110/V114 Nonconcomitant | Percentage of Participants With ≥4 Fold Rise From Baseline in SARS-CoV-2-specific bAb Response | 55.9 Percentage of Participants |
Secondary
SARS-CoV-2-specific Binding Antibody (bAb) GMFR in Participants Administered Either V110 or V114
Sera from participants was used to measure vaccine-induced bAb responses using a validated ligand-binding assay specific to the SARS-CoV-2 Spike protein. GMFR is the geometric mean fold rise from baseline to 30 days postvaccination. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. As prespecified by the protocol and statistical analysis plan, the V110 nonconcomitant group and V114 nonconcomitant group were combined for this analysis, as they shared the same administration for the first visit (mRNA-1273 and placebo).
Time frame: Baseline and 30 days postvaccination with mRNA-1273 (Study Day 1 and Study Day 30, respectively)
Population: All randomized participants who received 1 dose of either V110 or V114 concomitantly or nonconcomitantly with mRNA-1273, without protocol deviations substantially affecting immunogenicity endpoint results and with available baseline and post-vaccination bAb data. As prespecified by the protocol and statistical analysis plan, the V110 nonconcomitant group and V114 nonconcomitant group were combined for this analysis, as they shared the same vaccinations at the first visit (mRNA-1273 and placebo).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | SARS-CoV-2-specific Binding Antibody (bAb) GMFR in Participants Administered Either V110 or V114 | 8.6 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | SARS-CoV-2-specific Binding Antibody (bAb) GMFR in Participants Administered Either V110 or V114 | 8.1 Ratio |
| Combined V110/V114 Nonconcomitant | SARS-CoV-2-specific Binding Antibody (bAb) GMFR in Participants Administered Either V110 or V114 | 9.1 Ratio |
Secondary
Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110
Serotype-specific OPA for 14 of the serotypes contained in V110 was determined using a MOPA. GMFR is the geometric mean fold rise from baseline to 30 days postvaccination. The within-group 95% confidence intervals (CIs) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Time frame: Baseline and 30 days postvaccination with V110 (Study Day 1 and Study Day 30 for concomitant vaccination group, and Study Day 30 and Study Day 60 for nonconcomitant vaccination group, respectively)
Population: All randomized participants receiving 1 dose of V110 concomitantly or nonconcomitantly with mRNA-1273, without protocol deviations substantially affecting immunogenicity endpoint results. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation and with baseline and post-vaccination OPA serology data for the respective serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 1 | 24.8 Ratio |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 3 | 7.1 Ratio |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 4 | 12.8 Ratio |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 5 | 15.1 Ratio |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 6B | 8.2 Ratio |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 7F | 14.5 Ratio |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 9V | 4.3 Ratio |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 14 | 6.0 Ratio |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 18C | 10.2 Ratio |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 19A | 7.8 Ratio |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 19F | 6.9 Ratio |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 22F | 25.6 Ratio |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 23F | 4.7 Ratio |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 33F | 12.2 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 19F | 6.7 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 1 | 24.2 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 14 | 7.0 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 3 | 11.6 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 23F | 6.2 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 4 | 15.7 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 18C | 10.9 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 5 | 13.8 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 22F | 30.8 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 6B | 8.6 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 19A | 8.7 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 7F | 14.8 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 33F | 16.9 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110 | Serotype 9V | 5.3 Ratio |
Secondary
Serotype-specific OPA GMFR in Participants Administered V114
Serotype-specific OPA for all 15 of the serotypes contained in V114 were determined using a MOPA. GMFR is the geometric mean fold rise from baseline to 30 days postvaccination. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Time frame: Baseline and 30 days postvaccination with V114 (Study Day 1 and Study Day 30 for concomitant vaccination group, and Study Day 30 and Study Day 60 for nonconcomitant vaccination group, respectively)
Population: All randomized participants receiving 1 dose of V114 concomitantly or nonconcomitantly with mRNA-1273, without protocol deviations substantially affecting immunogenicity endpoint results. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation and with baseline and post-vaccination OPA serology data for the respective serotype.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 19A | 9.5 Ratio |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 6A | 12.7 Ratio |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 1 | 17.3 Ratio |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 3 | 9.0 Ratio |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 4 | 13.3 Ratio |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 5 | 14.7 Ratio |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 6B | 19.6 Ratio |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 7F | 17.6 Ratio |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 9V | 4.7 Ratio |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 14 | 4.8 Ratio |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 18C | 16.6 Ratio |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 19F | 8.6 Ratio |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 22F | 40.7 Ratio |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 23F | 13.9 Ratio |
| V110 Concomitant With mRNA-1273 (V110 Concomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 33F | 7.9 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 19F | 9.8 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 9V | 5.2 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 6A | 23.0 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 23F | 17.0 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 1 | 24.5 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 14 | 6.3 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 3 | 14.5 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 22F | 43.9 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 4 | 20.6 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 18C | 17.6 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 5 | 18.7 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 19A | 15.2 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 6B | 28.4 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 33F | 12.4 Ratio |
| V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) | Serotype-specific OPA GMFR in Participants Administered V114 | Serotype 7F | 14.9 Ratio |