Pneumococcal DiseasePhase 3NCT05464420
A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)
A Phase 3 study testing V116 and PPSV23 in people with Pneumococcal Disease, run by Merck Sharp & Dohme LLC at 72 sites in 8 countries.
Trial summary
This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in pneumococcal vaccine-naïve adults 18 to 49 years of age. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy 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
- 2,162 participants
- Where
- 72 sitesin 8 countries
- Study dates
- 12 Aug 2022to 25 May 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 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has underlying chronic conditions but assessed to be stable as per investigator
- Has ability to complete electronic Vaccine Report Card (eVRC) data collection without assistance as per investigator
Who cannot join
- Has a history of invasive pneumococcal disease (IPD) or other culture-positive pneumococcal disease ≤3 years before Visit 1 (Day 1)
- Has a known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease
- Has a coagulation disorder contraindicating intramuscular vaccination
- Has a recent illness with fever
- Has a known malignancy that is progressing or has required active treatment <3 years before enrollment
- Is expected to receive any pneumococcal vaccine during the study outside of the protocol
Show all 11Show fewer
- Has received systemic corticosteroids for ≥14 consecutive days and has not completed treatment ≥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
- Has 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
- Has received any live vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live vaccine ≤30 days after receipt of study vaccine
- Has received a blood transfusion or blood products, including immunoglobulins ≤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
Trial locations and contacts
72 sites in 8 countries.
72 sites in 8 countries
United States30 sites
Lynn Institute of Denver ( Site 0003)
Aurora, Colorado, 80012
Kentucky Pediatric/ Adult Research ( Site 0036)
Bardstown, Kentucky, 40004
Charlottesville Medical Research ( Site 0013)
Charlottesville, Virginia, 22911
Velocity Clinical Research, Providence ( Site 0018)
East Greenwich, Rhode Island, 02818
Healthcare Research Network - Chicago ( Site 0006)
Flossmoor, Illinois, 60422
Methodist Physicians Clinic/CCT Research ( Site 0029)
Fremont, Nebraska, 68025
Velocity Clinical Research, Greenville ( Site 0021)
Greenville, South Carolina, 29615
Indago Research & Health Center, Inc ( Site 0011)
Hialeah, Florida, 33012
Alliance for Multispecialty Research, LLC ( Site 0031)
Kansas City, Missouri, 64114
Healor Primary Care / CCT Research ( Site 0028)
Las Vegas, Nevada, 89102
Baptist Health Center For Clinical Research ( Site 0015)
Little Rock, Arkansas, 72205
DCOL Center for Clinical Research ( Site 0025)
Longview, Texas, 75605
Desert Clinical Research/ CCT Research ( Site 0019)
Mesa, Arizona, 85213
L&C Professional Medical Research Institute ( Site 0012)
Miami, Florida, 33144
Clinical Research Associates Inc ( Site 0039)
Nashville, Tennessee, 37203
Health Research of Hampton Roads, Inc. ( Site 0002)
Newport News, Virginia, 23606
Valley Clinical Trials, Inc. ( Site 0023)
Northridge, California, 91325
Lynn Health Science Institute ( Site 0014)
Oklahoma City, Oklahoma, 73112
Headlands Research Orlando ( Site 0017)
Orlando, Florida, 32819
M3 Wake Research Associates ( Site 0035)
Raleigh, North Carolina, 27612
Clinical Research Prime Rexburg ( Site 0040)
Rexburg, Idaho, 83440
Rochester Clinical Research, Inc. ( Site 0033)
Rochester, New York, 14609
IMA Clinical Research San Antonio ( Site 0020)
San Antonio, Texas, 78229
Artemis Institute for Clinical Research ( Site 0027)
San Diego, California, 92103
Axces Research ( Site 0034)
Santa Fe, New Mexico, 87505
Millennium Clinical Trials ( Site 0004)
Simi Valley, California, 93065
Clinical Research Trials of Florida ( Site 0001)
Tampa, Florida, 33607
Fiel Family and Sports Medicine, PC/CCT Research ( Site 0008)
Tempe, Arizona, 85283
Dynamed Clinical Research, LP d/b/a DM Clinical Research ( Site 0016)
Tomball, Texas, 77375
Diablo Clinical Research, Inc. ( Site 0022)
Walnut Creek, California, 94598
Canada8 sites
Hamilton Medical Research Group ( Site 0208)
Hamilton, Ontario, L8M 1K7
Milestone Research Inc. ( Site 0201)
London, Ontario, N5W 6A2
Manna Research Mirabel ( Site 0207)
Mirabel, Quebec, J7J 2K8
Manna Research Montreal ( Site 0203)
Pointe-Claire, Quebec, H9R 4S3
Q&T Research Sherbrooke Inc. ( Site 0204)
Sherbrooke, Quebec, J1J 2G2
Manna Research Toronto ( Site 0209)
Toronto, Ontario, M9W 4L6
Diex Recherche Trois-Rivieres ( Site 0206)
Trois-Rivières, Quebec, G9A 4P3
Colchester Research Group ( Site 0202)
Truro, Nova Scotia, B2N 1L2
Finland7 sites
FVR, Espoon rokotetutkimusklinikka ( Site 0509)
Espoo, Uusimaa, 02230
FVR, Etelä-Helsingin rokotetutkimusklinikka ( Site 0503)
Helsinki, Uusimaa, 00100
Helsinki East Vaccine Research Clinic ( Site 0502)
Helsinki, Uusimaa, 00930
FVR, Oulun rokotetutkimusklinikka ( Site 0501)
Oulu, North Ostrobothnia, 90220
FVR, Porin rokotetutkimusklinikka ( Site 0508)
Pori, Satakunta, 28100
FVR, Seinäjoen rokotetutkimusklinikka ( Site 0504)
Seinäjoki, South Ostrobothnia, 60100
FVR, Turun rokotetutkimusklinikka ( Site 0500)
Turku, Southwest Finland, 20520
Israel6 sites
Rambam Health Care Campus ( Site 0603)
Haifa, 3109601
Maccabi Healthcare Services ( Site 0606)
Jerusalem, 71713
Hadassah Medical Center ( Site 0600)
Jerusalem, 9112001
Meir Medical Center ( Site 0601)
Kfar Saba, 4428164
Sheba Medical Center-Early Phase Clinical Trials Unit ( Site 0604)
Ramat Gan, 5265601
Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 0602)
Sakhnin, 3081000
Poland6 sites
IN VIVO ( Site 0711)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-048
Centrum Medyczne Pratia Bydgoszcz-Centrum Medyczne Pratia Bydgoszcz ( Site 0709)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796
Alergotest s.c Specjalistyczne Centrum Medyczne ( Site 0703)
Lublin, Lublin Voivodeship, 20-095
Centrum Medyczne Medyk ( Site 0704)
Rzeszów, Podkarpackie Voivodeship, 35-055
Clinmedica OMC ( Site 0701)
Skierniewice, Łódź Voivodeship, 96-100
MICS Centrum Medyczne Torun ( Site 0706)
Torun, Kuyavian-Pomeranian Voivodeship, 87-100
Spain6 sites
Centre d'Atenció Primària Vallcarca - Sant Gervasi ( Site 0801)
Barcelona, 08023
EAP Sardenya ( Site 0802)
Barcelona, 08025
EBA CENTELLES ( Site 0800)
Centelles, Catalonia, 08500
Hospital La Princesa-Clinical Pharmacology ( Site 0815)
Madrid, 28006
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Respiratory ( Site 0808)
Pozuelo de Alarcón, Madrid, 28223
Fundación Oftalmologica del Mediterraneo-Vaccine Research ( Site 0818)
Valencia, Valenciana, Comunitat, 46015
Denmark5 sites
Sanos Clinic - Nordjylland ( Site 0401)
Aalborg, North Denmark, 9362
Danske Lægers Vaccinations Service - Århus ( Site 0403)
Aarhus, Central Jutland, 8000
Sanos Clinic-Sanos Clinic ( Site 0402)
Herlev, Capital Region, 2730
Danske Lægers Vaccinations Service - Søborg ( Site 0404)
Søborg, Capital Region, 2860
Sanos Clinic - Syddanmark ( Site 0400)
Vejle, Region Syddanmark, 7100
Austria4 sites
Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 0304)
Graz, Styria, 8036
Medizinische Universitaet Innsbruck ( Site 0301)
Innsbruck, Tyrol, 6020
Tropeninstitut Wien 1060 ( Site 0300)
Vienna, State of Vienna, 1060
Medizinische Universität Wien ( Site 0302)
Vienna, 1090
About this study
Official title: A Phase 3 Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults 18 to 49 Years of Age
This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in pneumococcal vaccine-naïve adults 18 to 49 years of age.
The primary study hypothesis is that all 3 lots of V116 are equivalent as assessed by the serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) at 30 days postvaccination for all serotypes included in V116.
- 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
Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
PPSV23Biological
Also called PNEUMOVAX™23
Pneumococcal 23-valent conjugate vaccine with 25 μg of each of the following 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 in each 0.5 mL sterile solution
| Study group | Role | What they receive |
|---|---|---|
| V116 Lot 1 | Experimental | Participants will receive a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1. Receives: Biological: V116 |
| V116 Lot 2 | Experimental | Participants will receive a single 0.5 mL IM dose of V116 Lot 2 on Day 1. Receives: Biological: V116 |
| V116 Lot 3 | Experimental | Participants will receive a single 0.5 mL IM dose of V116 Lot 3 on Day 1. Receives: Biological: V116 |
| PPSV23 | Active comparator | Participants will receive a single 0.5 mL IM dose 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) Following Vaccination With Separate V116 Lots
An AE was 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 included pain/tenderness, redness/erythema, and swelling. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.
Measured: Up to 5 days
Percentage of Participants With Solicited Injection-site AEs Following Vaccination: Combined Lots of V116 or PPSV23
An AE was 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 included pain/tenderness, redness/erythema, and swelling. Per the statistical analysis plan, no within group method of dispersion (MOD) were planned or calculated.
Measured: Up to 5 days
Percentage of Participants With Solicited Systemic AEs Following Vaccination With Separate V116 Lots
An AE was 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 included headache, muscle aches/myalgia, tiredness/fatigue, and pyrexia. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.
Measured: Up to 5 days
Percentage of Participants With Solicited Systemic AEs Following Vaccination: Combined Lots of V116 or PPSV23
An AE was 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 included headache, muscle aches/myalgia, tiredness/fatigue, and pyrexia. Per the statistical analysis plan, no within group method of dispersion (MOD) were planned or calculated.
Measured: Up to 5 days
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) Following Vaccination With Separate V116 Lots
An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life threatening, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination were reported. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.
Measured: Up to 194 days
Percentage of Participants With Vaccine-related SAEs Following Vaccination: Combined Lots of V116 or PPSV23
An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life threatening, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination were reported. Per the statistical analysis plan, no within group MOD were planned or calculated.
Measured: Up to 194 days
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots
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) were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group CIs were not calculated and the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.
Measured: Day 30
Secondary outcomes (8)
GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23
Serotype-specific OPA titers for all serotypes in V116 following vaccination were determined using MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% CI were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group CIs were not calculated.
Measured: Day 30
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots
Serotype-specific IgG concentrations for all serotypes in V116 following vaccination were determined using pneumococcal electrochemiluminescence (PnECL). Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated and the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.
Measured: Day 30
GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23
Serotype-specific IgG concentrations for all serotypes in V116 following vaccination were determined using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.
Measured: Day 30
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots
Serotype-specific OPA GMFR for all serotypes in V116 following vaccination were determined using MOPA. The GMFR of each pneumococcal serotype was calculated as Day 30 GMT/Day 1 GMT. The 95% CIs were calculated based on based on the t-distribution. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.
Measured: Baseline (Day 1) and Day 30
Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots
Serotype-specific OPA titer were determined using MOPA. The percentage of participants with a ≥4-fold rise in serotype-specific OPA for all serotypes in V116 following vaccination were reported. The 95% CIs were calculated based on the exact binomial method proposed by Clopper and Pearson. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.
Measured: Baseline (Day 1) and Day 30
GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots
Serotype-specific IgG GMFR for all serotypes in V116 following vaccination were determined using PnECL. The GMFR for each pneumococcal IgG serotype was calculated as Day 30 GMC/Day 1 GMC. The 95% CIs were calculated based on the t-distribution. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.
Measured: Baseline (Day 1) and Day 30
Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots
Serotype-specific IgG concentrations were determined using PnECL. The percentage of participants with a ≥4-fold rise in serotype-specific IgG for all serotypes in V116 were reported. The 95% CIs were calculated based on the exact binomial method proposed by Clopper and Pearson. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.
Measured: Baseline (Day 1) and Day 30
GMTs of Serotype-specific OPA for Cross-reactive Serotypes Following Vaccination With Separate V116 Lots
Serotype-specific OPA titers for cross-reactive serotypes (6A, 6C, 15B, and 15C) were determined using MOPA. The 95% CIs for serotype-specific OPA GMTs were calculated based on based on the t-distribution. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start12 Aug 2022
- Primary completion25 May 2023
- Study completion25 May 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 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
- 2,162 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
- NCT05464420
- Sponsor's protocol ID
- V116-004
- Other IDs
- 2022-000265-41
- Status last verified
- Sep 2024
- First submitted
- 12 Jul 2022
- Last updated
- 24 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
Scott P, Ukkonen B, Caraco Y, Perez SN, Alpizar SA, Cardona JF, Greenberg D, Grijalva CG, Orenstein W, Wiedmann RT, Fernsler D, Cheon K, Li J, Platt HL. A phase 3, randomized trial to evaluate lot-to-lot consistency of V116, an adult-specific pneumococcal conjugate vaccine (STRIDE-4). Med. 2025 Oct 10;6(10):100748. doi: 10.1016/j.medj.2025.100748. Epub 2025 Jun 20.
PubMed 40543503
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults 18 to 49 Years of Age
- ClinicalTrials.gov ID
- NCT05464420
- Acronym / sponsor ID
- V116-004
- Conditions
- Pneumococcal Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,162 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 19 Jul 2022 (actual)
- Results
- Posted 24 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in pneumococcal vaccine-naïve adults 18 to 49 years of age.
The primary study hypothesis is that all 3 lots of V116 are equivalent as assessed by the serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) at 30 days postvaccination for all serotypes included in V116.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| V116 Lot 1 | Experimental | Biological: V116Participants will receive a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1. |
| V116 Lot 2 | Experimental | Biological: V116Participants will receive a single 0.5 mL IM dose of V116 Lot 2 on Day 1. |
| V116 Lot 3 | Experimental | Biological: V116Participants will receive a single 0.5 mL IM dose of V116 Lot 3 on Day 1. |
| PPSV23 | Active comparator | Biological: PPSV23Participants will receive a single 0.5 mL IM dose of PPSV23 on Day 1. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Has underlying chronic conditions but assessed to be stable as per investigator
- Has ability to complete electronic Vaccine Report Card (eVRC) data collection without assistance as per investigator
Key exclusion criteria (11 listed)
- Has a history of invasive pneumococcal disease (IPD) or other culture-positive pneumococcal disease ≤3 years before Visit 1 (Day 1)
- Has a known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease
- Has a coagulation disorder contraindicating intramuscular vaccination
- Has a recent illness with fever
- Has a known malignancy that is progressing or has required active treatment <3 years before enrollment
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 VaccinePneumococcal 21-valent conjugate vaccine with 4 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution | Biological | V116 Lot 1, V116 Lot 2, V116 Lot 3 |
| PPSV23Also: PNEUMOVAX™23Pneumococcal 23-valent conjugate vaccine with 25 μg of each of the following 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 in each 0.5 mL sterile solution | Biological | PPSV23 |
Primary outcome
Percentage of Participants With Solicited Injection-site Adverse Events (AEs) Following Vaccination With Separate V116 Lots
Time frame: Up to 5 days
An AE was 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 included pain/tenderness, redness/erythema, and swelling. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.
Percentage of Participants With Solicited Injection-site AEs Following Vaccination: Combined Lots of V116 or PPSV23
Time frame: Up to 5 days
An AE was 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 included pain/tenderness, redness/erythema, and swelling. Per the statistical analysis plan, no within group method of dispersion (MOD) were planned or calculated.
Percentage of Participants With Solicited Systemic AEs Following Vaccination With Separate V116 Lots
Time frame: Up to 5 days
An AE was 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 included headache, muscle aches/myalgia, tiredness/fatigue, and pyrexia. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.
Percentage of Participants With Solicited Systemic AEs Following Vaccination: Combined Lots of V116 or PPSV23
Time frame: Up to 5 days
An AE was 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 included headache, muscle aches/myalgia, tiredness/fatigue, and pyrexia. Per the statistical analysis plan, no within group method of dispersion (MOD) were planned or calculated.
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) Following Vaccination With Separate V116 Lots
Time frame: Up to 194 days
An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life threatening, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination were reported. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.
Percentage of Participants With Vaccine-related SAEs Following Vaccination: Combined Lots of V116 or PPSV23
Time frame: Up to 194 days
An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life threatening, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination were reported. Per the statistical analysis plan, no within group MOD were planned or calculated.
Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Activity (OPA) for All Serotypes in V116 Following Vaccination With Separate V116 Lots
Time frame: Day 30
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) were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group CIs were not calculated and the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116.
8 secondary outcomes
GMTs of Serotype-specific OPA for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23
Time frame: Day 30
Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) for All Serotypes in V116 Following Vaccination With Separate V116 Lots
Time frame: Day 30
GMCs of Serotype-specific IgG for All Serotypes in V116 Following Vaccination: Combined Lots of V116 or PPSV23
Time frame: Day 30
Geometric Mean Fold Rise (GMFR) in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots
Time frame: Baseline (Day 1) and Day 30
Percentage of Participants With ≥4-fold Rise in Serotype-specific OPA for All Serotypes in V116 Following Vaccination With Separate V116 Lots
Time frame: Baseline (Day 1) and Day 30
GMFR in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots
Time frame: Baseline (Day 1) and Day 30
Percentage of Participants With ≥4-fold Rise in Serotype-specific IgG for All Serotypes in V116 Following Vaccination With Separate V116 Lots
Time frame: Baseline (Day 1) and Day 30
GMTs of Serotype-specific OPA for Cross-reactive Serotypes Following Vaccination With Separate V116 Lots
Time frame: Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40543503Scott P, Ukkonen B, Caraco Y, Perez SN, Alpizar SA, Cardona JF, Greenberg D, Grijalva CG, Orenstein W, Wiedmann RT, Fernsler D, Cheon K, Li J, Platt HL. A phase 3, randomized trial to evaluate lot-to-lot consistency of V116, an adult-specific pneumococcal conjugate vaccine (STRIDE-4). Med. 2025 Oct 10;6(10):100748. doi: 10.1016/j.medj.2025.100748. Epub 2025 Jun 20.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/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
72 sites in 8 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 72 sites in 8 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 2 inclusion and 11 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 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United States, Canada, Finland, Israel, Poland and 3 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 24 May 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) Following Vaccination With Separate V116 Lots (time frame: Up to 5 days). The study lists 7 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 NCT05464420, 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 24 Sep 2024.