Pneumonia, PneumococcalPhase 3NCT05420961
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)
A Phase 3 study testing V116, PCV15 and PPSV23 in people with Pneumonia, Pneumococcal, run by Merck Sharp & Dohme LLC at 51 sites in 9 countries.
Trial summary
This a study of V116 in adults ≥50 years of age who previously received a pneumococcal vaccination ≥1 year before enrollment. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Pneumococcal
- What is being tested?
- V116, PCV15 and PPSV23
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 717 participants
- Where
- 51 sitesin 9 countries
- Study dates
- 12 Jul 2022to 16 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has received pneumococcal vaccine >= 1 year before enrollment (PCV13, PCV15, PCV20, PPSV23, PCV13+PPSV23, PPSV23+PCV13, or PCV15+PPSV23).
Who cannot join
- Has a history of invasive pneumococcal disease (IPD).
- Has a known hypersensitivity to any component of V116, PCV15, PCV20, 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 intramuscular vaccination.
- Has a known malignancy that is progressing or has required active treatment.
- Has received PPSV23 followed by either PCV15 or PCV20.
Show all 11Show fewer
- Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day).
- 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 any study vaccine.
- Has 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.
- Has 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 post-vaccination blood draw is complete.
Trial locations and contacts
51 sites in 9 countries.
51 sites in 9 countries
United States15 sites
Central Research Associates ( Site 0024)
Birmingham, Alabama, 35205
Alliance for Multispecialty Research, LLC ( Site 0020)
Coral Gables, Florida, 33134
Centennial Medical Group ( Site 0002)
Elkridge, Maryland, 21075
Southland Clinical Research Center ( Site 0026)
Fountain Valley, California, 92708
University of Texas Medical Branch-Sealy Institute for Vaccine Sciences Clinical Trials Program ( Si
Galveston, Texas, 77555
Lenzmeier Family Medicine/CCT Research ( Site 0008)
Glendale, Arizona, 85308
Indago Research & Health Center, Inc ( Site 0005)
Hialeah, Florida, 33012
Advanced Medical Research ( Site 0001)
Maumee, Ohio, 43537
Solaris Clinical Research ( Site 0025)
Meridian, Idaho, 83646
Advanced Medical Research Institute ( Site 0018)
Miami, Florida, 33174
Health Research of Hampton Roads, Inc. ( Site 0003)
Newport News, Virginia, 23606
Meridian Clinical Research, LLC ( Site 0009)
Norfolk, Nebraska, 68701
Fiel Family and Sports Medicine, PC/CCT Research ( Site 0006)
Tempe, Arizona, 85283
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0016)
Troy, Michigan, 48098
Diablo Clinical Research, Inc. ( Site 0019)
Walnut Creek, California, 94598
Israel7 sites
Rambam Health Care Campus ( Site 0303)
Haifa, 3109601
Maccabi Health Services - Holon ( Site 0305)
Holon
Maccabi Healthcare Services ( Site 0306)
Jerusalem, 71713
Hadassah Medical Center-Clinical Reaserch Unit ( Site 0300)
Jerusalem, 9112001
Meir Medical Center ( Site 0301)
Kfar Saba, 4428164
Sheba Medical Center-Early Phase Clinical Trials Unit ( Site 0304)
Ramat Gan, 5265601
Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 0302)
Sakhnin, 3081000
South Korea6 sites
Korea University Ansan Hospital ( Site 0751)
Ansan-si, Kyonggi-do, 15355
Gachon University Gil Medical Center ( Site 0755)
Namdong-gu, Incheon, 21565
The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 0752)
Seoul, 03312
The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 0753)
Seoul, 06591
Hallym University Kangnam Sacred Heart Hospital-Internal Medicine ( Site 0754)
Seoul, 07441
Korea University Guro Hospital ( Site 0750)
Seoul
Spain6 sites
HOSPITAL CLÍNIC DE BARCELONA-Medicina Preventiva i Epidemiologia ( Site 0503)
Barcelona, Catalonia, 08036
Hospital Internacional Xanit ( Site 0520)
Benalmádena, Malaga, 29630
EBA CENTELLES ( Site 0500)
Centelles, Catalonia, 08500
Hospital Universitari de Bellvitge ( Site 0505)
L'Hospitalet de Llobregat, Catalonia, 08907
Hospital La Princesa ( Site 0515)
Madrid, 28006
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Respiratory ( Site 0508)
Pozuelo de Alarcón, Madrid, 28223
Canada5 sites
Hamilton Medical Research Group ( Site 0114)
Hamilton, Ontario, L8M 1K7
Milestone Research Inc. ( Site 0104)
London, Ontario, N5W 6A2
Manna Research Mirabel ( Site 0109)
Mirabel, Quebec, J7J 2K8
CHU de Québec-Université Laval-Équipe de recherche en vaccination ( Site 0120)
Québec, Quebec, G1E 7G9
Diex Recherche Sherbrooke Inc. ( Site 0101)
Sherbrooke, Quebec, J1L 0H8
France4 sites
CHRU de Brest ( Site 0200)
Brest, Finistere, 29609
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0203)
Paris, 75679
CHU Bordeaux Haut-Leveque ( Site 0202)
Pessac, Aquitaine, 33600
centre hospitalier lyon sud ( Site 0204)
Pierre-Bénite, Rhone, 69310
Italy4 sites
Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia ( Site 0405)
Foggia, 71100
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0400)
Milan, Lombardy, 20122
Ospedale San Raffaele ( Site 0403)
Milan, Lombardy, 20132
A.O.U. Policlinico Paolo Giaccone ( Site 0402)
Palermo, Sicily, 90127
Japan2 sites
PS Clinic ( Site 0700)
Fukuoka, 812-0025
Nishikumamoto Hospital ( Site 0701)
Kumamoto, 861-4157
Taiwan2 sites
National Cheng Kung University Hospital ( Site 0801)
Tainan, 704
National Taiwan University Hospital ( Site 0800)
Taipei, 100
About this study
Official title: A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older
This a study of V116 in adults ≥50 years of age who previously received a pneumococcal vaccination ≥1 year before enrollment. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116.
Read the detailed description
Participants will be randomized to 1 of 3 cohorts depending upon prior vaccinations. Prior vaccinations by cohort include: PPSV23 (pneumococcal vaccine, polyvalent [23-valent], PNEUMOVAX™23) for Cohort 1; PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) for Cohort 2; PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™), PCV20 (pneumococcal 20-valent conjugate vaccine; PREVNAR 20™), PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 for Cohort 3.
- Conditions
- Pneumonia, Pneumococcal
- Being tested
- V116, PCV15, PPSV23
- Medical subject headings
- Pneumonia, Pneumococcal
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 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
PCV15Biological
Also called VAXNEUVANCE™
Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F, and 4 μg of 6B in each 0.5 mL sterile suspension
PPSV23Biological
Also called PNEUMOVAX™23
Pneumococcal 23-valent vaccine with 25 μg of each of the 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 |
|---|---|---|
| Cohort 1: V116 | Experimental | Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 prior to the enrollment. Receives: Biological: V116 |
| Cohort 1: PCV15 | Active comparator | Participants will receive a single 0.5 mL IM injection of PCV15 on Day 1. Participants in this arm received PPSV23 prior to the enrollment. Receives: Biological: PCV15 |
| Cohort 2: V116 | Experimental | Participants will receive a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 prior to the enrollment. Receives: Biological: V116 |
| Cohort 2: PPSV23 | Active comparator | Participants will receive a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment. Receives: Biological: PPSV23 |
| Cohort 3: V116 | Experimental | Participants will receive a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV20, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment. Receives: Biological: V116 |
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 adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any injection with either V116, PCV15, or PPSV23 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were erythema, pain, and swelling.
Measured: Up to 5 days post-vaccination
Percentage of Participants With Solicited Systemic AEs
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any of the injections with either V116, PCV15, or PPSV23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia.
Measured: Up to 5 days post-vaccination
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, 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 another important medical event. The percentage of participants with one or more SAE that were assessed by the investigator to be at least possibly related to the study vaccination are presented.
Measured: Up to ~180 days
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
OPA for the serotypes contained in V116 were determined using a multiplex opsonophagocytic assay (MOPA). GMT is defined as geometric mean titer (1/dil). Serotype-specific OPA GMTs with 95% confidence intervals are presented.
Measured: 30 Days post-vaccination
Secondary outcomes (5)
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in V116 was determined using a pneumococcal electrochemiluminescence (PnECL) assay. Serotype-specific pneumococcal IgG GMCs with 95% confidence intervals are presented.
Measured: 30 Days post-vaccination
Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
Activity for the serotypes contained in V116 was determined using a multiplex opsonophagocytic assay (MOPA). Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. The GMFRs in OPA responses from baseline to 30 days post-vaccination with 95% confidence intervals are presented.
Measured: Day 1 (Baseline) and 30 days post-vaccination
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
Activity for the serotypes contained in V116 was determined using a MOPA. The percentage of participants with a ≥4-fold rise from baseline to at 30 days post-vaccination for OPA responses with 95% confidence intervals are presented.
Measured: Day 1 (Baseline) and 30 days post-vaccination
Geometric Mean Fold Rise of Serotype-specific IgG
Activity for the serotypes contained in V116 was determined using a PnECL assay. Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. The GMFRs IgG responses from baseline to 30 days post-vaccination with 95% confidence intervals are presented.
Measured: Day 1 (Baseline) and 30 days post-vaccination
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
Activity for the serotypes contained in V116 was determined using a PnECL assay. The percentage of participants with a ≥4-fold rise from baseline to at 30 days post-vaccination for IgG responses with 95% confidence intervals are presented.
Measured: Day 1 (Baseline) and 30 days post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start12 Jul 2022
- Primary completion16 May 2023
- Study completion16 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 Pneumonia, PneumococcalStudies 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
- 717 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
- NCT05420961
- Sponsor's protocol ID
- V116-006
- Other IDs
- jRCT2071220025, 2021-006679-41
- Status last verified
- Oct 2024
- First submitted
- 13 Jun 2022
- Last updated
- 26 Oct 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, Haranaka M, Choi JH, Stacey H, Dionne M, Greenberg D, Grijalva CG, Orenstein WA, Fernsler D, Gallagher N, Zeng T, Li J, Platt HL; STRIDE-6 Study Group. A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older (STRIDE-6). Clin Infect Dis. 2024 Dec 17;79(6):1366-1374. doi: 10.1093/cid/ciae383.
PubMed 39082735
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older
- ClinicalTrials.gov ID
- NCT05420961
- Acronym / sponsor ID
- V116-006
- Conditions
- Pneumonia, Pneumococcal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 717 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 16 May 2023 (actual)
- First posted
- 16 Jun 2022 (actual)
- Results
- Posted 1 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 a study of V116 in adults ≥50 years of age who previously received a pneumococcal vaccination ≥1 year before enrollment. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116.
Detailed description
Participants will be randomized to 1 of 3 cohorts depending upon prior vaccinations. Prior vaccinations by cohort include: PPSV23 (pneumococcal vaccine, polyvalent [23-valent], PNEUMOVAX™23) for Cohort 1; PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) for Cohort 2; PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™), PCV20 (pneumococcal 20-valent conjugate vaccine; PREVNAR 20™), PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 for Cohort 3.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: V116 | Experimental | Biological: V116Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 prior to the enrollment. |
| Cohort 1: PCV15 | Active comparator | Biological: PCV15Participants will receive a single 0.5 mL IM injection of PCV15 on Day 1. Participants in this arm received PPSV23 prior to the enrollment. |
| Cohort 2: V116 | Experimental | Biological: V116Participants will receive a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 prior to the enrollment. |
| Cohort 2: PPSV23 | Active comparator | Biological: PPSV23Participants will receive a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment. |
| Cohort 3: V116 | Experimental | Biological: V116Participants will receive a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV20, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Has received pneumococcal vaccine >= 1 year before enrollment (PCV13, PCV15, PCV20, PPSV23, PCV13+PPSV23, PPSV23+PCV13, or PCV15+PPSV23).
Key exclusion criteria (11 listed)
- Has a history of invasive pneumococcal disease (IPD).
- Has a known hypersensitivity to any component of V116, PCV15, PCV20, 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 intramuscular vaccination.
- Has a known malignancy that is progressing or has required active treatment.
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 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 | Cohort 1: V116, Cohort 2: V116, Cohort 3: V116 |
| PCV15Also: VAXNEUVANCE™Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F, and 4 μg of 6B in each 0.5 mL sterile suspension | Biological | Cohort 1: PCV15 |
| PPSV23Also: PNEUMOVAX™23Pneumococcal 23-valent vaccine with 25 μg of each of the 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 | Cohort 2: PPSV23 |
Primary outcome
Percentage of Participants With Solicited Injection-site Adverse Events (AEs)
Time frame: Up to 5 days post-vaccination
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any injection with either V116, PCV15, or PPSV23 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were erythema, pain, and swelling.
Percentage of Participants With Solicited Systemic AEs
Time frame: Up to 5 days post-vaccination
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any of the injections with either V116, PCV15, or PPSV23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia.
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)
Time frame: Up to ~180 days
A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, 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 another important medical event. The percentage of participants with one or more SAE that were assessed by the investigator to be at least possibly related to the study vaccination are presented.
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)
Time frame: 30 Days post-vaccination
OPA for the serotypes contained in V116 were determined using a multiplex opsonophagocytic assay (MOPA). GMT is defined as geometric mean titer (1/dil). Serotype-specific OPA GMTs with 95% confidence intervals are presented.
5 secondary outcomes
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Time frame: 30 Days post-vaccination
Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
Time frame: Day 1 (Baseline) and 30 days post-vaccination
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
Time frame: Day 1 (Baseline) and 30 days post-vaccination
Geometric Mean Fold Rise of Serotype-specific IgG
Time frame: Day 1 (Baseline) and 30 days post-vaccination
Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
Time frame: Day 1 (Baseline) and 30 days post-vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39082735Scott P, Haranaka M, Choi JH, Stacey H, Dionne M, Greenberg D, Grijalva CG, Orenstein WA, Fernsler D, Gallagher N, Zeng T, Li J, Platt HL; STRIDE-6 Study Group. A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older (STRIDE-6). Clin Infect Dis. 2024 Dec 17;79(6):1366-1374. doi: 10.1093/cid/ciae383.
- 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
51 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing V116, PCV15 and PPSV23 in people with Pneumonia, Pneumococcal, run by Merck Sharp & Dohme LLC at 51 sites in 9 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 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 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Israel, South Korea, Spain, Canada and 4 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 1 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) (time frame: Up to 5 days post-vaccination). The study lists 4 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 NCT05420961, 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 26 Oct 2024.