Pneumococcal InfectionPhase 3NCT05158140
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 study testing V110, V114 and mRNA-1273 in people with Pneumococcal Infection, run by Merck Sharp & Dohme LLC at 46 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infection
- What is being tested?
- V110, V114 and mRNA-1273
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 850 participants
- Where
- 46 sitesin 2 countries
- Study dates
- 12 Jan 2022to 21 Feb 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
46 sites in 2 countries.
46 sites in 2 countries
United States42 sites
Atlanta Center For Medical Research ( Site 0053)
Atlanta, Georgia, 30331
Benchmark Research ( Site 0007)
Austin, Texas, 78705
Charlottesville Medical Research Center, LLC ( Site 0008)
Charlottesville, Virginia, 22911
Velocity Clinical Research- Cleveland ( Site 0023)
Cleveland, Ohio, 44122
Alliance for Multispecialty Research, LLC ( Site 0036)
Coral Gables, Florida, 33134
South Texas Clinical Research ( Site 0033)
Corpus Christi, Texas, 78413
Certified Research Associates ( Site 0042)
Cortland, New York, 13045
Velocity Clinical Research-Providence ( Site 0015)
East Greenwich, Rhode Island, 02818
Centennial Medical Group ( Site 0016)
Elkridge, Maryland, 21075
Benchmark Research ( Site 0039)
Fort Worth, Texas, 76135
University of Texas Medical Branch at Galveston ( Site 0037)
Galveston, Texas, 77555-1115
Indago Research and Health Center Inc ( Site 0006)
Hialeah, Florida, 33012
Corning Center for Clinical Research ( Site 0052)
Horseheads, New York, 14845
Texas Center For Drug Development ( Site 0013)
Houston, Texas, 77081
Alliance for Multispecialty Research, LLC ( Site 0011)
Kansas City, Missouri, 64114
Wake Research Clinical Research Center of Nevada, LLC ( Site 0021)
Las Vegas, Nevada, 89106
AMR Lexington ( Site 0055)
Lexington, Kentucky, 40509
Community Clinical Research Center ( Site 0032)
Marlborough, Massachusetts, 01752
Wellness Clinical Research Associates ( Site 0051)
McKinney, Texas, 75071
Optimal Research LLC ( Site 0019)
Melbourne, Florida, 32934
Advanced Medical Research, LLC ( Site 0030)
Miami, Florida, 33174
Lakes Research LLC ( Site 0012)
Miami Lakes, Florida, 33014
Health Research of Hampton Roads, Inc. ( Site 0014)
Newport News, Virginia, 23606
Alliance for Multispecialty Research, LLC ( Site 0018)
Newton, Kansas, 67114
Alliance for Multispecialty Research LLC (AMR - Norfolk) ( Site 0057)
Norfolk, Virginia, 23502
Coastal Carolina Research Center ( Site 0044)
North Charleston, South Carolina, 29405
Carbon Health ( Site 0045)
North Hollywood, California, 91606
Valley Clinical Trials Inc. ( Site 0002)
Northridge, California, 91325
Center for Clinical Trials, LLC ( Site 0022)
Paramount, California, 90723
Optimal Research ( Site 0054)
Peoria, Illinois, 61614
Clinical Research Partners, LLC. ( Site 0005)
Richmond, Virginia, 23226
Rochester Clinical Research, Inc. ( Site 0010)
Rochester, New York, 14609
Diagnostics Research Group ( Site 0001)
San Antonio, Texas, 78229
Artemis Institute for Clinical Research ( Site 0024)
San Diego, California, 92103
California Research Foundation ( Site 0004)
San Diego, California, 92123
AXCES Research Group ( Site 0017)
Santa Fe, New Mexico, 87505
Millennium Clinical Trials ( Site 0027)
Simi Valley, California, 93065
DM Clinical Research ( Site 0025)
Tomball, Texas, 77375
Crossroads Clinical Research LLC ( Site 0020)
Victoria, Texas, 77901
Diablo Clinical Research, Inc ( Site 0043)
Walnut Creek, California, 94598
Velocity Clinical Research, Salt Lake City ( Site 0035)
West Jordan, Utah, 84088
Accellacare - Winston-Salem ( Site 0049)
Winston-Salem, North Carolina, 27103
Puerto Rico4 sites
Cooperativa de Facultad Medica SANACOOP ( Site 0104)
Bayamón, 00961
CAIMED Center - Ponce School of Medicine ( Site 0103)
Ponce, 00716
Caparra Internal Medicine Research Center. PSC ( Site 0102)
Rio Grande, 00745
Clinical Research Puerto Rico ( Site 0105)
San Juan, 00909
About this study
Official title: 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.
- Conditions
- Pneumococcal Infection
- Being tested
- V110, V114, mRNA-1273, Placebo for V110, Placebo for V114
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V110Biological
Also called PNEUMOVAX™23, 23-Valent Pneumococcal Polysaccharide Vaccine
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
V114Biological
Also called VAXNEUVANCE™, 15-Valent Pneumococcal Conjugate, Vaccine
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-1273Biological
Single IM dose of 50 μg/0.25 mL mRNA-1273
Placebo for V110Biological
Single IM dose of 0.5 mL placebo for V110
Placebo for V114Biological
Single IM dose of 0.5 mL placebo for V114
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Biological: V114; Biological: mRNA-1273; Biological: Placebo for V114 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline and 30 days postvaccination with mRNA-1273 (Study Day 1 and Study Day 30, respectively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start12 Jan 2022
- Primary completion21 Feb 2023
- Study completion21 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumococcal InfectionStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 850 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158140
- Sponsor's protocol ID
- V110-911
- Status last verified
- Jul 2025
- First submitted
- 3 Dec 2021
- Last updated
- 18 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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.
PubMed 40006738
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05158140
- Acronym / sponsor ID
- V110-911
- Conditions
- Pneumococcal Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 850 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 21 Feb 2023 (actual)
- Study completion
- 21 Feb 2023 (actual)
- First posted
- 15 Dec 2021 (actual)
- Results
- Posted 13 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| V110 Concomitant with mRNA-1273 (V110 Concomitant) | Experimental | Biological: V110, Biological: mRNA-1273, Biological: Placebo for V110Participants 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 Nonconcomitant with mRNA-1273 (V110 Nonconcomitant) | Experimental | Biological: V110, Biological: mRNA-1273, Biological: Placebo for V110Participants 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. |
| V114 Concomitant with mRNA-1273 (V114 Concomitant) | Experimental | Biological: V114, Biological: mRNA-1273, Biological: Placebo for V114Participants 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 Nonconcomitant with mRNA-1273 (V114 Nonconcomitant) | Experimental | Biological: V114, Biological: mRNA-1273, Biological: Placebo for V114Participants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| V110Also: PNEUMOVAX™23, 23-Valent Pneumococcal Polysaccharide VaccineSingle 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 | Biological | V110 Concomitant with mRNA-1273 (V110 Concomitant), V110 Nonconcomitant with mRNA-1273 (V110 Nonconcomitant) |
| V114Also: VAXNEUVANCE™, 15-Valent Pneumococcal Conjugate, VaccineSingle 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 | Biological | V114 Concomitant with mRNA-1273 (V114 Concomitant), V114 Nonconcomitant with mRNA-1273 (V114 Nonconcomitant) |
| mRNA-1273Single IM dose of 50 μg/0.25 mL mRNA-1273 | Biological | 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 V110Single IM dose of 0.5 mL placebo for V110 | Biological | V110 Concomitant with mRNA-1273 (V110 Concomitant), V110 Nonconcomitant with mRNA-1273 (V110 Nonconcomitant) |
| Placebo for V114Single IM dose of 0.5 mL placebo for V114 | Biological | V114 Concomitant with mRNA-1273 (V114 Concomitant), V114 Nonconcomitant with mRNA-1273 (V114 Nonconcomitant) |
Primary outcome
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Among Participants Administered V110
Time frame: Up to Day 7 After Any Vaccination (Up to Study Day 37)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs include redness, swelling, pain/tenderness, and underarm gland swelling or tenderness/lymphadenopathy at the injection site. The percentage of participants with one or more solicited injection-site AEs following any vaccination was reported.
Percentage of Participants With Solicited Injection-Site Adverse Events Among Participants Administered V114
Time frame: Up to Day 7 After Any Vaccination (Up to Study Day 37)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs include redness, swelling, pain/tenderness, and underarm gland swelling or tenderness/lymphadenopathy at the injection site. The percentage of participants with one or more solicited injection-site AEs following any vaccination was reported.
Percentage of Participants With Solicited Systemic AEs Among Participants Administered V110
Time frame: Up to Day 7 After Any Vaccination (Up to Study Day 37)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Systemic adverse events (AEs) include headache, tiredness/fatigue, muscle aches all over body/myalgia, joint pain/arthralgia, nausea, vomiting, and chills. The percentage of participants with solicited systemic AEs following any vaccination was reported.
Percentage of Participants With Solicited Systemic AEs Among Participants Administered V114
Time frame: Up to Day 7 After Any Vaccination (Up to Study Day 37)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Systemic adverse events (AEs) include headache, tiredness/fatigue, muscle aches all over body/myalgia, joint pain/arthralgia, nausea, vomiting, and chills. The percentage of participants with solicited systemic AEs following any vaccination was reported.
Percentage of Participants With Vaccine-Related Serious AEs (SAEs) Among Participants Administered V110
Time frame: Up to Month 6
Serious adverse events (SAEs) are defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of a participant, or other important medical events. V110 vaccine-related SAEs as determined by investigator are summarized.
Percentage of Participants With Vaccine-Related SAEs Among Participants Administered V114
Time frame: Up to Month 6
SAEs are defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of a participant, or other important medical events. V114 vaccine-related SAEs as determined by investigator are summarized.
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) in Participants Administered V110
Time frame: Up to 30 days postvaccination with V110 (Study Day 30 for concomitant vaccination group, and Study Day 60 for nonconcomitant vaccination group, respectively)
Serotype-specific OPA GMTs for 14 of the serotypes contained in V110 were determined using a multiplexed opsonophagocytic assay (MOPA) at 30 days postvaccination with V110. The within-group 95% confidence intervals (CIs) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Serotype-specific OPA GMT in Participants Administered V114
Time frame: Up to 30 days postvaccination with V114 (Study Day 30 for concomitant vaccination group, and Study Day 60 for nonconcomitant vaccination group, respectively)
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.
SARS-CoV-2-specific Binding Antibody (bAb) GMT in Participants Administered Either V110 or V114
Time frame: Up to 30 days postvaccination with mRNA-1273 (Study Day 30)
Sera from participants were used to measure vaccine-induced bAb responses using a validated ligand-binding assay specific to the SARS-CoV-2 Spike protein at 30 days post vaccination. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. As prespecified by the protocol and statistical analysis plan, the V110 nonconcomitant group and V114 nonconcomitant group were combined for this analysis, as they shared the same administration for the first visit (mRNA-1273 and placebo).
6 secondary outcomes
Serotype-specific OPA Geometric Mean Fold Rise (GMFR) in Participants Administered V110
Time frame: Baseline and 30 days postvaccination with V110 (Study Day 1 and Study Day 30 for concomitant vaccination group, and Study Day 30 and Study Day 60 for nonconcomitant vaccination group, respectively)
Serotype-specific OPA GMFR in Participants Administered V114
Time frame: Baseline and 30 days postvaccination with V114 (Study Day 1 and Study Day 30 for concomitant vaccination group, and Study Day 30 and Study Day 60 for nonconcomitant vaccination group, respectively)
SARS-CoV-2-specific Binding Antibody (bAb) GMFR in Participants Administered Either V110 or V114
Time frame: 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
Time frame: Baseline and 30 days postvaccination with V110 (Study Day 1 and Study Day 30 for concomitant vaccination group, and Study Day 30 and Study Day 60 for nonconcomitant vaccination group, respectively)
Percentage of Participants Who Achieve a ≥4-fold Rise in Serotype-specific OPA Responses From Baseline to 30 Days Postvaccination With V114
Time frame: Baseline and 30 days postvaccination with V114 (Study Day 1 and Study Day 30 for concomitant vaccination group, and Study Day 30 and Study Day 60 for nonconcomitant vaccination group, respectively)
Percentage of Participants With ≥4 Fold Rise From Baseline in SARS-CoV-2-specific bAb Response
Time frame: Baseline and 30 days postvaccination with mRNA-1273 (Study Day 1 and Study Day 30, respectively)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40006738Omole 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.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
46 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing V110, V114 and mRNA-1273 in people with Pneumococcal Infection, run by Merck Sharp & Dohme LLC at 46 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Among Participants Administered V110 (time frame: Up to Day 7 After Any Vaccination (Up to Study Day 37)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05158140, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.