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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V110 Concomitant with mRNA-1273 (V110 Concomitant) | Experimental | 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. |
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| V110 Nonconcomitant with mRNA-1273 (V110 Nonconcomitant) | Experimental | Participants received a single 0.5 mL IM injection of placebo for V110 on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273, followed by a single 0.5 mL IM injection of V110 on Day 30. |
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| V114 Concomitant with mRNA-1273 (V114 Concomitant) | Experimental | Participants received a single 0.5 mL IM injection of V114 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 V114 on Day 30. |
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| V114 Nonconcomitant with mRNA-1273 (V114 Nonconcomitant) | Experimental | Participants received single 0.5 mL IM injection of placebo for V114 on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273, followed by a single 0.5 mL IM injection of V114 on Day 30. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V110 | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Day 7 After Any Vaccination (Up to Study Day 37) |
| 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. | Up to Day 7 After Any Vaccination (Up to Study Day 37) |
| 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. | Up to Day 7 After Any Vaccination (Up to Study Day 37) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carbon Health ( Site 0045) | North Hollywood | California | 91606 | United States | ||
| Valley Clinical Trials Inc. ( Site 0002) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40006738 | Result | Omole T, Pelayo E, Weinberg AS, Chalkias S, Endale Z, Tamms G, Sterling TM, Good L, Shekar T, Johnson M, Banniettis N, Buchwald UK, Esteves-Jaramillo A. Safety, Tolerability, and Immunogenicity of the Pneumococcal Vaccines PPSV23 or PCV15 Co-Administered with a Booster Dose of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Adults >/=50 Years of Age. Vaccines (Basel). 2025 Feb 15;13(2):192. doi: 10.3390/vaccines13020192. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | V110 Nonconcomitant With mRNA-1273 (V110 Nonconcomitant) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 12, 2022 |
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| V114 | Biological | 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 |
|
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| mRNA-1273 | Biological | Single IM dose of 50 μg/0.25 mL mRNA-1273 |
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| Placebo for V110 | Biological | Single IM dose of 0.5 mL placebo for V110 |
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| Placebo for V114 | Biological | Single IM dose of 0.5 mL placebo for V114 |
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| Up to Day 7 After Any Vaccination (Up to Study Day 37) |
| 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. | Up to Month 6 |
| 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. | Up to Month 6 |
| 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. | 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 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. | Up to 30 days postvaccination with V114 (Study Day 30 for concomitant vaccination group, and Study Day 60 for nonconcomitant vaccination group, respectively) |
| 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). | Up to 30 days postvaccination with mRNA-1273 (Study Day 30) |
| 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 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. | 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) |
| 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). | Baseline and 30 days postvaccination with mRNA-1273 (Study Day 1 and Study Day 30, respectively) |
| 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. | 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) |
| 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. | 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) |
| 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). | Baseline and 30 days postvaccination with mRNA-1273 (Study Day 1 and Study Day 30, respectively) |
| Northridge |
| California |
| 91325 |
| United States |
| Center for Clinical Trials, LLC ( Site 0022) | Paramount | California | 90723 | United States |
| Artemis Institute for Clinical Research ( Site 0024) | San Diego | California | 92103 | United States |
| California Research Foundation ( Site 0004) | San Diego | California | 92123 | United States |
| Millennium Clinical Trials ( Site 0027) | Simi Valley | California | 93065 | United States |
| Diablo Clinical Research, Inc ( Site 0043) | Walnut Creek | California | 94598 | United States |
| Alliance for Multispecialty Research, LLC ( Site 0036) | Coral Gables | Florida | 33134 | United States |
| Indago Research and Health Center Inc ( Site 0006) | Hialeah | Florida | 33012 | United States |
| Optimal Research LLC ( Site 0019) | Melbourne | Florida | 32934 | United States |
| Advanced Medical Research, LLC ( Site 0030) | Miami | Florida | 33174 | United States |
| Lakes Research LLC ( Site 0012) | Miami Lakes | Florida | 33014 | United States |
| Atlanta Center For Medical Research ( Site 0053) | Atlanta | Georgia | 30331 | United States |
| Optimal Research ( Site 0054) | Peoria | Illinois | 61614 | United States |
| Alliance for Multispecialty Research, LLC ( Site 0018) | Newton | Kansas | 67114 | United States |
| AMR Lexington ( Site 0055) | Lexington | Kentucky | 40509 | United States |
| Centennial Medical Group ( Site 0016) | Elkridge | Maryland | 21075 | United States |
| Community Clinical Research Center ( Site 0032) | Marlborough | Massachusetts | 01752 | United States |
| Alliance for Multispecialty Research, LLC ( Site 0011) | Kansas City | Missouri | 64114 | United States |
| Wake Research Clinical Research Center of Nevada, LLC ( Site 0021) | Las Vegas | Nevada | 89106 | United States |
| AXCES Research Group ( Site 0017) | Santa Fe | New Mexico | 87505 | United States |
| Certified Research Associates ( Site 0042) | Cortland | New York | 13045 | United States |
| Corning Center for Clinical Research ( Site 0052) | Horseheads | New York | 14845 | United States |
| Rochester Clinical Research, Inc. ( Site 0010) | Rochester | New York | 14609 | United States |
| Accellacare - Winston-Salem ( Site 0049) | Winston-Salem | North Carolina | 27103 | United States |
| Velocity Clinical Research- Cleveland ( Site 0023) | Cleveland | Ohio | 44122 | United States |
| Velocity Clinical Research-Providence ( Site 0015) | East Greenwich | Rhode Island | 02818 | United States |
| Coastal Carolina Research Center ( Site 0044) | North Charleston | South Carolina | 29405 | United States |
| Benchmark Research ( Site 0007) | Austin | Texas | 78705 | United States |
| South Texas Clinical Research ( Site 0033) | Corpus Christi | Texas | 78413 | United States |
| Benchmark Research ( Site 0039) | Fort Worth | Texas | 76135 | United States |
| University of Texas Medical Branch at Galveston ( Site 0037) | Galveston | Texas | 77555-1115 | United States |
| Texas Center For Drug Development ( Site 0013) | Houston | Texas | 77081 | United States |
| Wellness Clinical Research Associates ( Site 0051) | McKinney | Texas | 75071 | United States |
| Diagnostics Research Group ( Site 0001) | San Antonio | Texas | 78229 | United States |
| DM Clinical Research ( Site 0025) | Tomball | Texas | 77375 | United States |
| Crossroads Clinical Research LLC ( Site 0020) | Victoria | Texas | 77901 | United States |
| Velocity Clinical Research, Salt Lake City ( Site 0035) | West Jordan | Utah | 84088 | United States |
| Charlottesville Medical Research Center, LLC ( Site 0008) | Charlottesville | Virginia | 22911 | United States |
| Health Research of Hampton Roads, Inc. ( Site 0014) | Newport News | Virginia | 23606 | United States |
| Alliance for Multispecialty Research LLC (AMR - Norfolk) ( Site 0057) | Norfolk | Virginia | 23502 | United States |
| Clinical Research Partners, LLC. ( Site 0005) | Richmond | Virginia | 23226 | United States |
| Cooperativa de Facultad Medica SANACOOP ( Site 0104) | Bayamón | 00961 | Puerto Rico |
| CAIMED Center - Ponce School of Medicine ( Site 0103) | Ponce | 00716 | Puerto Rico |
| Caparra Internal Medicine Research Center. PSC ( Site 0102) | Rio Grande | 00745 | Puerto Rico |
| Clinical Research Puerto Rico ( Site 0105) | San Juan | 00909 | Puerto Rico |
| Plain Language Summary | View source |
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. |
| FG002 | 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. |
| FG003 | 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. |
| Received Any Vaccination |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
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| 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. | All randomized participants who received 1 dose of V110 concomitantly or nonconcomitantly with mRNA-1273. | Posted | Number | Percentage of Participants | Up to Day 7 After Any Vaccination (Up to Study Day 37) |
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| 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. | All randomized participants who received 1 dose of V114 concomitantly or nonconcomitantly with mRNA-1273. | Posted | Number | Percentage of Participants | Up to Day 7 After Any Vaccination (Up to Study Day 37) |
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| 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. | All randomized participants who received 1 dose of V110 concomitantly or nonconcomitantly with mRNA-1273. | Posted | Number | Percentage of Participants | Up to Day 7 After Any Vaccination (Up to Study Day 37) |
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| 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. | 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. | Posted | Number | Percentage of Participants | Up to Day 7 After Any Vaccination (Up to Study Day 37) |
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| 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. | All randomized participants who received 1 dose of V110 concomitantly or nonconcomitantly with mRNA-1273. | Posted | Number | Percentage of Participants | Up to Month 6 |
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| 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. | 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. | Posted | Number | Percentage of Participants | Up to Month 6 |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Up to 30 days postvaccination with V110 (Study Day 30 for concomitant vaccination group, and Study Day 60 for nonconcomitant vaccination group, respectively) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Up to 30 days postvaccination with V114 (Study Day 30 for concomitant vaccination group, and Study Day 60 for nonconcomitant vaccination group, respectively) |
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| 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). | 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). | Posted | Geometric Mean | 95% Confidence Interval | Titers | Up to 30 days postvaccination with mRNA-1273 (Study Day 30) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | 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) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | 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) |
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| 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). | 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). | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Baseline and 30 days postvaccination with mRNA-1273 (Study Day 1 and Study Day 30, respectively) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 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) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 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) |
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| 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). | 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). | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline and 30 days postvaccination with mRNA-1273 (Study Day 1 and Study Day 30, respectively) |
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Non-serious adverse events were collected up to 28 days following any vaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 6 months.
All-Cause Mortality reported for all randomized participants. All randomized participants who received at least 1 dose of any study vaccination and had follow-up data are analyzed in Serious Adverse Events and Other Adverse Events. One participant in the V114 Concomitant Group received two doses of mRNA-1273 in error at Visit 1 and was excluded from the safety population per statistical analysis plan.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 214 | 2 | 214 | 171 | 214 |
| EG001 | 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. | 0 | 212 | 2 | 211 | 170 | 211 |
| EG002 | 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. | 0 | 214 | 6 | 209 | 163 | 209 |
| EG003 | 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. | 1 | 210 | 4 | 208 | 172 | 208 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute left ventricular failure | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Brain cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Breast cancer female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Invasive breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bladder perforation | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Essential hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. A coordinating investigator will be designated by mutual agreement. If publication activity is not directed by Sponsor, investigator agrees to submit all manuscripts or abstracts to Sponsor before submission, allowing Sponsor to protect proprietary information and provide comments. Authorship will be determined by mutual agreement in line with ICMJE authorship requirements.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Jan 18, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C006045 | 2,4,5,4'-tetrachlorodiphenylsulfoxide |
| C414006 | 23-valent pneumococcal capsular polysaccharide vaccine |
| D014612 | Vaccines |
| D000090983 | 2019-nCoV Vaccine mRNA-1273 |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Injection site swelling |
|
| Lymphadenopathy |
|
| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
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| Participants |
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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.
|
|
|
|
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. |
| OG002 | Combined V110/V114 Nonconcomitant | Per protocol, participants received a single 0.5 mL IM injection of placebo on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273. |
|
|
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. |
|
|
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.
|
|
| OG001 | 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. |
| OG002 | Combined V110/V114 Nonconcomitant | Participants received single 0.5 mL IM injection of placebo on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273. |
|
|
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. |
|
|
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. |
|
|
| OG001 | 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. |
| OG002 | Combined V110/V114 Nonconcomitant | Participants received single 0.5 mL IM injection of placebo on Day 1 concomitantly with a single 0.25 mL IM injection of mRNA-1273. |
|
|