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

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Concomitant Administration of Either 23-Valent Pneumococcal Polysaccharide Vaccine or 15-Valent Pneumococcal Conjugate Vaccine With a Booster Dose of SARS-CoV-2 mRNA Vaccine in Healthy Adults 50 Years of Age or Older.

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.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Infection
• Intervention / Treatment: Biological: Placebo for V110; Biological: V114; Biological: Placebo for V114; Biological: mRNA-1273; Biological: V110

• Study Type: Interventional
• Enrollment (Actual): 850
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • Bayamon, Puerto Rico, 00961
    • Cooperativa de Facultad Medica SANACOOP ( Site 0104)
  • Ponce, Puerto Rico, 00716
    • CAIMED Center - Ponce School of Medicine ( Site 0103)
  • Rio Grande, Puerto Rico, 00745
    • Caparra Internal Medicine Research Center. PSC ( Site 0102)
  • San Juan, Puerto Rico, 00909
    • Clinical Research Puerto Rico ( Site 0105)
• United States
  • California
    • North Hollywood, California, United States, 91606
      • Carbon Health ( Site 0045)
    • Northridge, California, United States, 91325
      • Valley Clinical Trials Inc. ( Site 0002)
    • Paramount, California, United States, 90723
      • Center for Clinical Trials, LLC ( Site 0022)
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research ( Site 0024)
    • San Diego, California, United States, 92123
      • California Research Foundation ( Site 0004)
    • Simi Valley, California, United States, 93065
      • Millennium Clinical Trials ( Site 0027)
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc ( Site 0043)
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Alliance for Multispecialty Research, LLC ( Site 0036)
    • Hialeah, Florida, United States, 33012
      • Indago Research and Health Center Inc ( Site 0006)
    • Melbourne, Florida, United States, 32934
      • Optimal Research LLC ( Site 0019)
    • Miami, Florida, United States, 33174
      • Advanced Medical Research, LLC ( Site 0030)
    • Miami Lakes, Florida, United States, 33014
      • Lakes Research LLC ( Site 0012)
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Atlanta Center For Medical Research ( Site 0053)
  • Illinois
    • Peoria, Illinois, United States, 61614
      • Optimal Research ( Site 0054)
  • Kansas
    • Newton, Kansas, United States, 67114
      • Alliance for Multispecialty Research, LLC ( Site 0018)
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • AMR Lexington ( Site 0055)
  • Maryland
    • Elkridge, Maryland, United States, 21075
      • Centennial Medical Group ( Site 0016)
  • Massachusetts
    • Marlborough, Massachusetts, United States, 01752
      • Community Clinical Research Center ( Site 0032)
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Alliance for Multispecialty Research, LLC ( Site 0011)
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Wake Research Clinical Research Center of Nevada, LLC ( Site 0021)
  • New Mexico
    • Santa Fe, New Mexico, United States, 87505
      • AXCES Research Group ( Site 0017)
  • New York
    • Cortland, New York, United States, 13045
      • Certified Research Associates ( Site 0042)
    • Horseheads, New York, United States, 14845
      • Corning Center for Clinical Research ( Site 0052)
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, Inc. ( Site 0010)
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Accellacare - Winston-Salem ( Site 0049)
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Velocity Clinical Research- Cleveland ( Site 0023)
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Velocity Clinical Research-Providence ( Site 0015)
  • South Carolina
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Research Center ( Site 0044)
  • Texas
    • Austin, Texas, United States, 78705
      • Benchmark Research ( Site 0007)
    • Corpus Christi, Texas, United States, 78413
      • South Texas Clinical Research ( Site 0033)
    • Fort Worth, Texas, United States, 76135
      • Benchmark Research ( Site 0039)
    • Galveston, Texas, United States, 77555-1115
      • University of Texas Medical Branch at Galveston ( Site 0037)
    • Houston, Texas, United States, 77081
      • Texas Center For Drug Development ( Site 0013)
    • McKinney, Texas, United States, 75071
      • Wellness Clinical Research Associates ( Site 0051)
    • San Antonio, Texas, United States, 78229
      • Diagnostics Research Group ( Site 0001)
    • Tomball, Texas, United States, 77375
      • DM Clinical Research ( Site 0025)
    • Victoria, Texas, United States, 77901
      • Crossroads Clinical Research LLC ( Site 0020)
  • Utah
    • West Jordan, Utah, United States, 84088
      • Velocity Clinical Research, Salt Lake City ( Site 0035)
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research Center, LLC ( Site 0008)
    • Newport News, Virginia, United States, 23606
      • Health Research of Hampton Roads, Inc. ( Site 0014)
    • Norfolk, Virginia, United States, 23502
      • Alliance for Multispecialty Research LLC (AMR - Norfolk) ( Site 0057)
    • Richmond, Virginia, United States, 23226
      • Clinical Research Partners, LLC. ( Site 0005)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: Placebo for V110; Single IM dose of 0.5 mL placebo for V110; Biological: mRNA-1273; Single IM dose of 50 μg/0.25 mL mRNA-1273; Biological: 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; Other Names: PNEUMOVAX™23; 23-Valent Pneumococcal Polysaccharide Vaccine
Experimental: 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.	Biological: Placebo for V110; Single IM dose of 0.5 mL placebo for V110; Biological: mRNA-1273; Single IM dose of 50 μg/0.25 mL mRNA-1273; Biological: 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; Other Names: PNEUMOVAX™23; 23-Valent Pneumococcal Polysaccharide Vaccine
Experimental: 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.	Biological: 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; Other Names: VAXNEUVANCE™; Vaccine; 15-Valent Pneumococcal Conjugate; Biological: Placebo for V114; Single IM dose of 0.5 mL placebo for V114; Biological: mRNA-1273; Single IM dose of 50 μg/0.25 mL mRNA-1273
Experimental: 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.	Biological: 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; Other Names: VAXNEUVANCE™; Vaccine; 15-Valent Pneumococcal Conjugate; Biological: Placebo for V114; Single IM dose of 0.5 mL placebo for V114; Biological: mRNA-1273; Single IM dose of 50 μg/0.25 mL mRNA-1273

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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 Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• 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.

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2022
• Primary Completion (Actual): February 21, 2023
• Study Completion (Actual): February 21, 2023

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: December 3, 2021
• First Posted (Actual): December 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 8, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Pneumococcal Infections; Immunologic Factors; Physiological Effects of Drugs; Heptavalent Pneumococcal Conjugate Vaccine; Vaccines
• Other Study ID Numbers: V110-911 (Merck); 2021-003414-39 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No