Safety, Tolerability, and Immunogenicity of V110 or V114 Co-administered With a Booster Dose of mRNA-1273 in Healthy Adults (V110-911)
NCT ID: NCT05158140
Last Updated: 2025-07-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
850 participants
INTERVENTIONAL
2022-01-12
2023-02-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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.
V110
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
mRNA-1273
Single IM dose of 50 μg/0.25 mL mRNA-1273
Placebo for V110
Single IM dose of 0.5 mL placebo for V110
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 injection of mRNA-1273, followed by a single 0.5 mL IM injection of V110 on Day 30.
V110
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
mRNA-1273
Single IM dose of 50 μg/0.25 mL mRNA-1273
Placebo for V110
Single IM dose of 0.5 mL placebo for V110
V114 Concomitant with mRNA-1273 (V114 Concomitant)
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.
V114
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
mRNA-1273
Single IM dose of 50 μg/0.25 mL mRNA-1273
Placebo for V114
Single IM dose of 0.5 mL placebo for V114
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 injection of mRNA-1273, followed by a single 0.5 mL IM injection of V114 on Day 30.
V114
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
mRNA-1273
Single IM dose of 50 μg/0.25 mL mRNA-1273
Placebo for V114
Single IM dose of 0.5 mL placebo for V114
Interventions
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V110
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
V114
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
mRNA-1273
Single IM dose of 50 μg/0.25 mL mRNA-1273
Placebo for V110
Single IM dose of 0.5 mL placebo for V110
Placebo for V114
Single IM dose of 0.5 mL placebo for V114
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
50 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Carbon Health ( Site 0045)
North Hollywood, California, United States
Valley Clinical Trials Inc. ( Site 0002)
Northridge, California, United States
Center for Clinical Trials, LLC ( Site 0022)
Paramount, California, United States
Artemis Institute for Clinical Research ( Site 0024)
San Diego, California, United States
California Research Foundation ( Site 0004)
San Diego, California, United States
Millennium Clinical Trials ( Site 0027)
Simi Valley, California, United States
Diablo Clinical Research, Inc ( Site 0043)
Walnut Creek, California, United States
Alliance for Multispecialty Research, LLC ( Site 0036)
Coral Gables, Florida, United States
Indago Research and Health Center Inc ( Site 0006)
Hialeah, Florida, United States
Optimal Research LLC ( Site 0019)
Melbourne, Florida, United States
Advanced Medical Research, LLC ( Site 0030)
Miami, Florida, United States
Lakes Research LLC ( Site 0012)
Miami Lakes, Florida, United States
Atlanta Center For Medical Research ( Site 0053)
Atlanta, Georgia, United States
Optimal Research ( Site 0054)
Peoria, Illinois, United States
Alliance for Multispecialty Research, LLC ( Site 0018)
Newton, Kansas, United States
AMR Lexington ( Site 0055)
Lexington, Kentucky, United States
Centennial Medical Group ( Site 0016)
Elkridge, Maryland, United States
Community Clinical Research Center ( Site 0032)
Marlborough, Massachusetts, United States
Alliance for Multispecialty Research, LLC ( Site 0011)
Kansas City, Missouri, United States
Wake Research Clinical Research Center of Nevada, LLC ( Site 0021)
Las Vegas, Nevada, United States
AXCES Research Group ( Site 0017)
Santa Fe, New Mexico, United States
Certified Research Associates ( Site 0042)
Cortland, New York, United States
Corning Center for Clinical Research ( Site 0052)
Horseheads, New York, United States
Rochester Clinical Research, Inc. ( Site 0010)
Rochester, New York, United States
Accellacare - Winston-Salem ( Site 0049)
Winston-Salem, North Carolina, United States
Velocity Clinical Research- Cleveland ( Site 0023)
Cleveland, Ohio, United States
Velocity Clinical Research-Providence ( Site 0015)
East Greenwich, Rhode Island, United States
Coastal Carolina Research Center ( Site 0044)
North Charleston, South Carolina, United States
Benchmark Research ( Site 0007)
Austin, Texas, United States
South Texas Clinical Research ( Site 0033)
Corpus Christi, Texas, United States
Benchmark Research ( Site 0039)
Fort Worth, Texas, United States
University of Texas Medical Branch at Galveston ( Site 0037)
Galveston, Texas, United States
Texas Center For Drug Development ( Site 0013)
Houston, Texas, United States
Wellness Clinical Research Associates ( Site 0051)
McKinney, Texas, United States
Diagnostics Research Group ( Site 0001)
San Antonio, Texas, United States
DM Clinical Research ( Site 0025)
Tomball, Texas, United States
Crossroads Clinical Research LLC ( Site 0020)
Victoria, Texas, United States
Velocity Clinical Research, Salt Lake City ( Site 0035)
West Jordan, Utah, United States
Charlottesville Medical Research Center, LLC ( Site 0008)
Charlottesville, Virginia, United States
Health Research of Hampton Roads, Inc. ( Site 0014)
Newport News, Virginia, United States
Alliance for Multispecialty Research LLC (AMR - Norfolk) ( Site 0057)
Norfolk, Virginia, United States
Clinical Research Partners, LLC. ( Site 0005)
Richmond, Virginia, United States
Cooperativa de Facultad Medica SANACOOP ( Site 0104)
Bayamón, , Puerto Rico
CAIMED Center - Ponce School of Medicine ( Site 0103)
Ponce, , Puerto Rico
Caparra Internal Medicine Research Center. PSC ( Site 0102)
Río Grande, , Puerto Rico
Clinical Research Puerto Rico ( Site 0105)
San Juan, , Puerto Rico
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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V110-911
Identifier Type: -
Identifier Source: org_study_id
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