Safety, Tolerability, and Immunogenicity of V110 or V114 Co-administered With a Booster Dose of mRNA-1273 in Healthy Adults (V110-911)

NCT05158140 | Completed Phase 3 Results FDA Drug

• 1 other identifier: V110-911
• Study Type: interventional
• Target: 850
• Locations: 2 countries
• Sites: 46

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.

Conditions

Pneumococcal Infection

Outcome Measures

Primary Outcomes (9)

• 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.

  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)

Secondary Outcomes (6)

• 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 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)

• 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)

• 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)

• 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)

Study Arms (4)

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.

Biological: V110; Biological: mRNA-1273; Biological: Placebo for V110

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.

Biological: V110; Biological: mRNA-1273; Biological: Placebo for V110

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.

Biological: V114; Biological: mRNA-1273; Biological: Placebo for V114

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.

Biological: V114; Biological: mRNA-1273; Biological: Placebo for V114

Interventions

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

Also known as: PNEUMOVAX™23, 23-Valent Pneumococcal Polysaccharide Vaccine

V110 Concomitant with mRNA-1273 (V110 Concomitant); V110 Nonconcomitant with mRNA-1273 (V110 Nonconcomitant)

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

Also known as: VAXNEUVANCE™, 15-Valent Pneumococcal Conjugate, Vaccine

V114 Concomitant with mRNA-1273 (V114 Concomitant); V114 Nonconcomitant with mRNA-1273 (V114 Nonconcomitant)

mRNA-1273 BIOLOGICAL

Single IM dose of 50 μg/0.25 mL mRNA-1273

V110 Concomitant with mRNA-1273 (V110 Concomitant); V110 Nonconcomitant with mRNA-1273 (V110 Nonconcomitant); V114 Concomitant with mRNA-1273 (V114 Concomitant); V114 Nonconcomitant with mRNA-1273 (V114 Nonconcomitant)

Placebo for V110 BIOLOGICAL

Single IM dose of 0.5 mL placebo for V110

V110 Concomitant with mRNA-1273 (V110 Concomitant); V110 Nonconcomitant with mRNA-1273 (V110 Nonconcomitant)

Placebo for V114 BIOLOGICAL

Single IM dose of 0.5 mL placebo for V114

V114 Concomitant with mRNA-1273 (V114 Concomitant); V114 Nonconcomitant with mRNA-1273 (V114 Nonconcomitant)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (46)

Carbon Health ( Site 0045)

North Hollywood, California, 91606, United States

Location

Valley Clinical Trials Inc. ( Site 0002)

Northridge, California, 91325, United States

Location

Center for Clinical Trials, LLC ( Site 0022)

Paramount, California, 90723, United States

Location

Artemis Institute for Clinical Research ( Site 0024)

San Diego, California, 92103, United States

Location

California Research Foundation ( Site 0004)

San Diego, California, 92123, United States

Location

Millennium Clinical Trials ( Site 0027)

Simi Valley, California, 93065, United States

Location

Diablo Clinical Research, Inc ( Site 0043)

Walnut Creek, California, 94598, United States

Location

Alliance for Multispecialty Research, LLC ( Site 0036)

Coral Gables, Florida, 33134, United States

Location

Indago Research and Health Center Inc ( Site 0006)

Hialeah, Florida, 33012, United States

Location

Optimal Research LLC ( Site 0019)

Melbourne, Florida, 32934, United States

Location

Advanced Medical Research, LLC ( Site 0030)

Miami, Florida, 33174, United States

Location

Lakes Research LLC ( Site 0012)

Miami Lakes, Florida, 33014, United States

Location

Atlanta Center For Medical Research ( Site 0053)

Atlanta, Georgia, 30331, United States

Location

Optimal Research ( Site 0054)

Peoria, Illinois, 61614, United States

Location

Alliance for Multispecialty Research, LLC ( Site 0018)

Newton, Kansas, 67114, United States

Location

AMR Lexington ( Site 0055)

Lexington, Kentucky, 40509, United States

Location

Centennial Medical Group ( Site 0016)

Elkridge, Maryland, 21075, United States

Location

Community Clinical Research Center ( Site 0032)

Marlborough, Massachusetts, 01752, United States

Location

Alliance for Multispecialty Research, LLC ( Site 0011)

Kansas City, Missouri, 64114, United States

Location

Wake Research Clinical Research Center of Nevada, LLC ( Site 0021)

Las Vegas, Nevada, 89106, United States

Location

AXCES Research Group ( Site 0017)

Santa Fe, New Mexico, 87505, United States

Location

Certified Research Associates ( Site 0042)

Cortland, New York, 13045, United States

Location

Corning Center for Clinical Research ( Site 0052)

Horseheads, New York, 14845, United States

Location

Rochester Clinical Research, Inc. ( Site 0010)

Rochester, New York, 14609, United States

Location

Accellacare - Winston-Salem ( Site 0049)

Winston-Salem, North Carolina, 27103, United States

Location

Velocity Clinical Research- Cleveland ( Site 0023)

Cleveland, Ohio, 44122, United States

Location

Velocity Clinical Research-Providence ( Site 0015)

East Greenwich, Rhode Island, 02818, United States

Location

Coastal Carolina Research Center ( Site 0044)

North Charleston, South Carolina, 29405, United States

Location

Benchmark Research ( Site 0007)

Austin, Texas, 78705, United States

Location

South Texas Clinical Research ( Site 0033)

Corpus Christi, Texas, 78413, United States

Location

Benchmark Research ( Site 0039)

Fort Worth, Texas, 76135, United States

Location

University of Texas Medical Branch at Galveston ( Site 0037)

Galveston, Texas, 77555-1115, United States

Location

Texas Center For Drug Development ( Site 0013)

Houston, Texas, 77081, United States

Location

Wellness Clinical Research Associates ( Site 0051)

McKinney, Texas, 75071, United States

Location

Diagnostics Research Group ( Site 0001)

San Antonio, Texas, 78229, United States

Location

DM Clinical Research ( Site 0025)

Tomball, Texas, 77375, United States

Location

Crossroads Clinical Research LLC ( Site 0020)

Victoria, Texas, 77901, United States

Location

Velocity Clinical Research, Salt Lake City ( Site 0035)

West Jordan, Utah, 84088, United States

Location

Charlottesville Medical Research Center, LLC ( Site 0008)

Charlottesville, Virginia, 22911, United States

Location

Health Research of Hampton Roads, Inc. ( Site 0014)

Newport News, Virginia, 23606, United States

Location

Alliance for Multispecialty Research LLC (AMR - Norfolk) ( Site 0057)

Norfolk, Virginia, 23502, United States

Location

Clinical Research Partners, LLC. ( Site 0005)

Richmond, Virginia, 23226, United States

Location

Cooperativa de Facultad Medica SANACOOP ( Site 0104)

Bayamón, 00961, Puerto Rico

Location

CAIMED Center - Ponce School of Medicine ( Site 0103)

Ponce, 00716, Puerto Rico

Location

Caparra Internal Medicine Research Center. PSC ( Site 0102)

Río Grande, 00745, Puerto Rico

Location

Clinical Research Puerto Rico ( Site 0105)

San Juan, 00909, Puerto Rico

Location

Related Publications (1)

• 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.

  PMID: 40006738 RESULT

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

2,4,5,4'-tetrachlorodiphenylsulfoxide; 23-valent pneumococcal capsular polysaccharide vaccine; Vaccines; 2019-nCoV Vaccine mRNA-1273

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures; mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 15, 2021
• Study Start: January 12, 2022
• Primary Completion: February 21, 2023
• Study Completion: February 21, 2023
• Last Updated: July 18, 2025
• Results First Posted: February 13, 2024

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

PR (4); US (42)