Pneumococcal DiseasePhase 3NCT05569954
Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10)
A Phase 3 study testing V116 and PPSV23 in people with Pneumococcal Disease, run by Merck Sharp & Dohme LLC at 55 sites in 11 countries.
Trial summary
This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine-naïve adults 50 years of age and older. The polyvalent (23-valent) pneumococcal vaccine, PPSV23, is the active comparator. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Disease
- What is being tested?
- V116 and PPSV23
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,484 participants
- Where
- 55 sitesin 11 countries
- Study dates
- 7 Nov 2022to 7 Feb 2025
- 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
- For females, is not pregnant or breastfeeding and is either not a woman of childbearing potential (WOCBP) or is a WOCBP and uses acceptable contraception/abstinence; and has medical, menstrual, and recent sexual activity history reviewed by the investigator to decrease the chance of inclusion of an early undetected pregnancy
Who cannot join
- Has a history of invasive pneumococcal disease (IPD) [positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site] or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1)
- Has a known hypersensitivity to any component of V116 or PPSV23, including diphtheria toxoid
- 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 IM vaccination
- Had a recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for any 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 enrollment
Show all 12Show fewer
- Received prior pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol
- Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention ≥14 days before receipt of study vaccine
- Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
- Received any nonlive vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any nonlive vaccine ≤30 days after receipt of study vaccine (inactivated influenza and SARS-CoV2 vaccines may be acceptable)
- 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 immunoglobulin ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product until the Day 30 postvaccination blood draw is complete
Trial locations and contacts
55 sites in 11 countries.
55 sites in 11 countries
South Korea15 sites
Korea University Ansan Hospital ( Site 1801)
Ansan-si, Kyonggi-do, 15355
Soon Chun Hyang University Bucheon Hospital ( Site 1812)
Bucheon-si, Kyonggi-do, 14584
Dong-A University Hospital ( Site 1810)
Busan, Pusan-Kwangyokshi, 49201
Kyungpook National University Chilgok Hospital-Division of Infectious Diseases ( Site 1804)
Deagu, Taegu-Kwangyokshi, 41404
Chonnam National University Hospital-Infectious Diseases ( Site 1811)
Gwangju, Kwangju-Kwangyokshi, 61469
Hallym University Dongtan Sacred Heart Hospital ( Site 1813)
Hwaseong-si, Kyonggi-do, 18450
Chungnam national university hospital ( Site 1814)
Junggu, Taejon-Kwangyokshi, 35015
The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 1802)
Seoul, 03312
Asan Medical Center ( Site 1809)
Seoul, 05505
The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 1806)
Seoul, 06591
Hallym University Kangnam Sacred Heart Hospital ( Site 1807)
Seoul, 07441
Ewha Womans University Mokdong Hospital-Infectious Diseases ( Site 1805)
Seoul, 07985
Korea University Guro Hospital ( Site 1800)
Seoul, 08308
The Catholic University Of Korea St. Vincent's Hospital-Internal Medicine ( Site 1803)
Suwon, Kyonggi-do, 16247
Wonju Severance Christian Hospital ( Site 1808)
Wŏnju, Kang-won-do, 26426
Spain6 sites
Centre d'Atenció Primària Vallcarca - Sant Gervasi ( Site 1101)
Barcelona, 08023
EAP Sardenya ( Site 1102)
Barcelona, 08025
EBA CENTELLES ( Site 1100)
Centelles, Catalonia, 08500
Hospital Universitario Getafe ( Site 1111)
Getafe, Madrid, Comunidad de, 28905
Hospital La Princesa-Clinical Pharmacology ( Site 1115)
Madrid, 28006
Fundación Oftalmologica del Mediterraneo-Vaccine Research ( Site 1118)
Valencia, Valenciana, Comunitat, 46015
United Kingdom6 sites
Layton Medical Centre ( Site 1400)
Blackpool, Lancashire, FY3 7EN
Accellacare - Northamptonshire ( Site 1403)
Corby, Northamptonshire, NN18 9EZ
Accellacare - Warwickshire ( Site 1404)
Coventry, Warwickshire, CV3 4FJ
Barts Health NHS Trust-William Harvey Clinical Research Centre ( Site 1407)
London, England, EC1M 6BQ
Royal Free Hospital-Ian Charleson Day Centre RESEARCH ( Site 1402)
London, England, NW32QG
Accellacare - Yorkshire-MeDiNova Yorkshire ( Site 1405)
Shipley, Bradford, BD18 3SA
Germany5 sites
Universitaetsklinikum Koeln ( Site 0900)
Cologne, North Rhine-Westphalia, 50937
Medizentrum Essen Borbeck ( Site 0902)
Essen, North Rhine-Westphalia, 45355
InfektioResearch ( Site 0903)
Frankfurt am Main, Hesse, 60596
Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 0901)
Hamburg, 20246
klinikum rechts der isar der technischen universität münchen ( Site 0904)
München, Bavaria, 81675
Israel5 sites
Rambam Health Care Campus ( Site 1002)
Haifa, 3109601
Hadassah Medical Center-Clinical Reaserch Unit ( Site 1004)
Jerusalem, 9112001
Meir Medical Center-Infectious unit ( Site 1003)
Kfar Saba, 4428164
Sheba Medical Center ( Site 1000)
Ramat Gan, 5265601
Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 1001)
Sakhnin, 3081000
Turkey (Türkiye)5 sites
ANKARA UNIVERSITY IBNI SINA HOSPITAL ( Site 1304)
Ankara, 06230
Hacettepe Universite Hastaneleri-İnfection ( Site 1300)
Ankara, 06230
Gazi University Health Research and Application Center Gazi Hospital-Enfeksiyon Hastalıkları ( Site
Ankara, 06560
Acibadem Universitesi Atakent Hastanesi-Infectious Disease ( Site 1301)
Istanbul, 34303
Sancaktepe Şehit Prof.Dr. İlhan Varank Eğitim ve Arastirma Hastanesi ( Site 1305)
Sancaktepe, Istanbul, 34785
Taiwan4 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital-Infectious diseases Division, Department of
Kaohsiung City, 807
National Cheng Kung University Hospital ( Site 1901)
Tainan, 704
National Taiwan University Hospital ( Site 1900)
Taipei, 100
Chang Gung Medical Foundation-Linkou Branch ( Site 1902)
Taoyuan, 333
Australia3 sites
Paratus Clinical Research Brisbane ( Site 1501)
Albion, Queensland, 4010
Paratus Clinical Research Western Sydney ( Site 1500)
Blacktown, New South Wales, 2148
Northern Beaches Clinical Research ( Site 1502)
Brookvale, New South Wales, 2100
New Zealand3 sites
Optimal Clinical Trials ( Site 1600)
Auckland, 1010
P3 Research - Lower Hutt ( Site 1601)
Lower Hutt, Wellington Region, 5010
P3 Research - Palmerston North ( Site 1602)
Palmerston North, Manawatu-Wanganui, 4414
Colombia2 sites
IPS Centro Científico Asistencial S.A.S ( Site 0407)
Barranquilla, Atlántico, 80020
Fundacion Valle del Lili- CIC ( Site 0415)
Cali, Valle del Cauca Department, 760032
Argentina1 site
Fundacion Estudios Clinicos ( Site 0200)
Rosario, Santa Fe Province, S2000DEJ
About this study
Official title: A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older
This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine-naïve adults 50 years of age and older. The polyvalent (23-valent) pneumococcal vaccine, PPSV23, is the active comparator. In addition to studying safety/tolerability, it is hypothesized that, at 30 days postvaccination, the immunogenicity of V116 is noninferior to PPSV23 for the 12 common serotypes in V116 and PPSV23, and that V116 is superior to PPSV23 for the 9 serotypes unique to V116. It is also hypothesized that V116 is superior to PPSV23 in the percentage of participants with ≥4-fold rise from baseline in unique V116 serotypes, as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs).
Read the detailed description
Selected participants may be eligible for optional immunogenicity or PBMC substudies extension that will investigate the exploratory objectives.
- Conditions
- Pneumococcal Disease
- Being tested
- V116, PPSV23
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V116Biological
Also called Pneumococcal 21-valent Conjugate Vaccine
Sterile 0.5 mL solution in prefilled syringe containing 4 μg of each pneumococcal polysaccharide (PnPs) antigen 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B.
PPSV23Biological
Also called PNEUMOVAX™23
Sterile 0.5 mL solution in prefilled syringe containing 25 μg of each PnPs antigen 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F.
| Study group | Role | What they receive |
|---|---|---|
| V116 | Experimental | Participants will receive a single intramuscular (IM) vaccination of 0.5 mL of V116 on Day 1. Receives: Biological: V116 |
| PPSV23 | Active comparator | Participants will receive a single IM vaccination of 0.5 mL of PPSV23 on Day 1. Receives: Biological: PPSV23 |
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)
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 consisted of pain/tenderness, redness/erythema, and swelling. 95% confidence intervals (CIs) for between-group differences are provided using the Miettinen \& Nurminen method.
Measured: Up to 5 days postvaccination
Percentage of Participants With Solicited Systemic AEs
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 systemic AEs consist of the following: fatigue (tiredness), headache, myalgia (muscle aches), and pyrexia (maximum temperature ≥ 100.4 °F/38.0 °C). 95% confidence intervals (CIs) for between-group differences are provided using the Miettinen \& Nurminen method.
Measured: Up to 5 days postvaccination
Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an other important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination are summarized. 95% confidence intervals (CIs) for between-group differences are provided using the Miettinen \& Nurminen method.
Measured: Up to 6 months postvaccination
Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116
Serotype-specific OPA titers for all serotypes in V116 following vaccination were determined using multiplex opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals (CIs), and they hypothesis test (1-sided p-value), were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group CIs, or any other method of dispersion were not planned or calculated.
Measured: Day 30 postvaccination
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116
The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs for the unique pneumococcal serotypes contained in V116 was determined. The 9 unique pneumococcal serotypes in V116 are as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. Per protocol, within-group CIs, or any other method of dispersion were not planned or calculated.
Measured: Baseline (Day 1) and Day 30 postvaccination
Secondary outcomes (6)
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific Cross-Reactive OPAs
OPA induced by serotypes 6A and 15C in V116 but cross-reactive to serotypes 6C and 15B, respectively, were measured. The percentage of participants with ≥4-fold rise from baseline in serotype-specific cross-reactive OPAs was determined. Point estimate, 95% CI, and p-value are based on the Clopper-Pearson method. Per protocol, this outcome measure was not planned or analyzed in the PPSV23 study arm.
Measured: Baseline (Day 1) and Day 30 postvaccination
Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116
The GMFR from baseline in serotype-specific OPA GMTs for all serotypes in V116 was determined using MOPA. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Measured: Baseline (Day 1) and Day 30 postvaccination
Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116
The GMCs for serotype-specific IgG antibodies for all serotypes in V116 were determined using pneumococcal electrochemiluminescence (PnECL). The GMC ratio estimation and 95% CI were calculated using a cLDA method. Per protocol, within-group CIs, or any other method of dispersion were not planned or calculated.
Measured: Day 30 postvaccination
Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116
The GMFR from baseline in GMCs for serotype-specific IgG antibodies for all serotypes in V116 was determined using PnECL. The within-group 95% CIs are obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Measured: Baseline (Day 1) and Day 30 postvaccination
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116
The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPA GMTs for all serotypes in V116 was determined with MOPA. The within-group CIs were calculated based on the Clopper-Pearson method.
Measured: Baseline (Day 1) and Day 30 postvaccination
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116
The percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs for all serotypes in V116 was determined using PnECL. The within-group CIs were calculated based on the Clopper-Pearson method.
Measured: Baseline (Day 1) and Day 30 postvaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start7 Nov 2022
- Primary completion30 Oct 2023
- Study completion7 Feb 2025
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 DiseaseStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,484 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
- NCT05569954
- Sponsor's protocol ID
- V116-010
- Other IDs
- 2022-503144-40-00, U1111-1286-5378, 2022-001785-35
- Status last verified
- Feb 2026
- First submitted
- 4 Oct 2022
- Last updated
- 2 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
Jotterand V, Jagannath V, Diaz AA, Velez JD, Letica A, Perez SN, Clark R, Caraco Y, Degen O, Park KH, Unal S, Wittke F, Hurtado K, Churchill C, Zhang Y, Fernsler D, Li J, Buchwald UK, Platt H. A Phase 3 Randomized Trial Investigating the Safety, Tolerability, and Immunogenicity of V116, an Adult-Specific Pneumococcal Vaccine, Compared with PPSV23, in Adults >/=50 Years of Age (STRIDE-10). Vaccines (Basel). 2025 Mar 22;13(4):341. doi: 10.3390/vaccines13040341.
PubMed 40333240
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older
- ClinicalTrials.gov ID
- NCT05569954
- Acronym / sponsor ID
- V116-010
- Conditions
- Pneumococcal Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,484 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 7 Feb 2025 (actual)
- First posted
- 6 Oct 2022 (actual)
- Results
- Posted 31 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine-naïve adults 50 years of age and older. The polyvalent (23-valent) pneumococcal vaccine, PPSV23, is the active comparator. In addition to studying safety/tolerability, it is hypothesized that, at 30 days postvaccination, the immunogenicity of V116 is noninferior to PPSV23 for the 12 common serotypes in V116 and PPSV23, and that V116 is superior to PPSV23 for the 9 serotypes unique to V116. It is also hypothesized that V116 is superior to PPSV23 in the percentage of participants with ≥4-fold rise from baseline in unique V116 serotypes, as measured by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs).
Detailed description
Selected participants may be eligible for optional immunogenicity or PBMC substudies extension that will investigate the exploratory objectives.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V116 | Experimental | Biological: V116Participants will receive a single intramuscular (IM) vaccination of 0.5 mL of V116 on Day 1. |
| PPSV23 | Active comparator | Biological: PPSV23Participants will receive a single IM vaccination of 0.5 mL of PPSV23 on Day 1. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- For females, is not pregnant or breastfeeding and is either not a woman of childbearing potential (WOCBP) or is a WOCBP and uses acceptable contraception/abstinence; and has medical, menstrual, and recent sexual activity history reviewed by the investigator to decrease the chance of inclusion of an early undetected pregnancy
Key exclusion criteria (12 listed)
- Has a history of invasive pneumococcal disease (IPD) [positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site] or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1)
- Has a known hypersensitivity to any component of V116 or PPSV23, including diphtheria toxoid
- 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 IM vaccination
- Had a recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for any 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 |
|---|---|---|
| V116Also: Pneumococcal 21-valent Conjugate VaccineSterile 0.5 mL solution in prefilled syringe containing 4 μg of each pneumococcal polysaccharide (PnPs) antigen 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B. | Biological | V116 |
| PPSV23Also: PNEUMOVAX™23Sterile 0.5 mL solution in prefilled syringe containing 25 μg of each PnPs antigen 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 | PPSV23 |
Primary outcome
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)
Time frame: Up to 5 days postvaccination
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 consisted of pain/tenderness, redness/erythema, and swelling. 95% confidence intervals (CIs) for between-group differences are provided using the Miettinen \& Nurminen method.
Percentage of Participants With Solicited Systemic AEs
Time frame: Up to 5 days postvaccination
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 systemic AEs consist of the following: fatigue (tiredness), headache, myalgia (muscle aches), and pyrexia (maximum temperature ≥ 100.4 °F/38.0 °C). 95% confidence intervals (CIs) for between-group differences are provided using the Miettinen \& Nurminen method.
Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs)
Time frame: Up to 6 months postvaccination
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an other important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination are summarized. 95% confidence intervals (CIs) for between-group differences are provided using the Miettinen \& Nurminen method.
Serotype-Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) for All Serotypes in V116
Time frame: Day 30 postvaccination
Serotype-specific OPA titers for all serotypes in V116 following vaccination were determined using multiplex opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals (CIs), and they hypothesis test (1-sided p-value), were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group CIs, or any other method of dispersion were not planned or calculated.
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific OPAs for Serotypes Unique to V116
Time frame: Baseline (Day 1) and Day 30 postvaccination
The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs for the unique pneumococcal serotypes contained in V116 was determined. The 9 unique pneumococcal serotypes in V116 are as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. Per protocol, within-group CIs, or any other method of dispersion were not planned or calculated.
6 secondary outcomes
Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-Specific Cross-Reactive OPAs
Time frame: Baseline (Day 1) and Day 30 postvaccination
Serotype-Specific Geometric Mean Fold Rise (GMFR) of OPA GMTs for All Serotypes in V116
Time frame: Baseline (Day 1) and Day 30 postvaccination
Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for All Serotypes in V116
Time frame: Day 30 postvaccination
Serotype-Specific GMFR of IgG GMCs for All Serotypes in V116
Time frame: Baseline (Day 1) and Day 30 postvaccination
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific OPA GMTs for All Serotypes in V116
Time frame: Baseline (Day 1) and Day 30 postvaccination
Percentage of Participants With ≥4-Fold Rise From Baseline in Serotype-Specific IgG GMCs for All Serotypes in V116
Time frame: Baseline (Day 1) and Day 30 postvaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40333240Jotterand V, Jagannath V, Diaz AA, Velez JD, Letica A, Perez SN, Clark R, Caraco Y, Degen O, Park KH, Unal S, Wittke F, Hurtado K, Churchill C, Zhang Y, Fernsler D, Li J, Buchwald UK, Platt H. A Phase 3 Randomized Trial Investigating the Safety, Tolerability, and Immunogenicity of V116, an Adult-Specific Pneumococcal Vaccine, Compared with PPSV23, in Adults >/=50 Years of Age (STRIDE-10). Vaccines (Basel). 2025 Mar 22;13(4):341. doi: 10.3390/vaccines13040341.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Pneumococcal Disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
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
55 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing V116 and PPSV23 in people with Pneumococcal Disease, run by Merck Sharp & Dohme LLC at 55 sites in 11 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 1 inclusion and 12 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 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in South Korea, Spain, United Kingdom, Germany, Israel and 6 more countries. 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 31 Oct 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) (time frame: Up to 5 days postvaccination). The study lists 5 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 NCT05569954, 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 2 Mar 2026.