Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2071220025 | Registry Identifier | jRCT | |
| 2021-006679-41 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V116 | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 Days post-vaccination |
Not provided
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Research Associates ( Site 0024) | Birmingham | Alabama | 35205 | United States | ||
| Lenzmeier Family Medicine/CCT Research ( Site 0008) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39082735 | Result | 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. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
Not provided
Not provided
Not provided
Not provided
717 adults were randomized to 1 of 3 cohorts. One participant randomized to receive PCV15 in Cohort 1 incorrectly received V116. Per protocol the participant was included in the Cohort 1 V116 group. One participant randomized to receive PCV15 in Cohort 1 incorrectly received PPSV23 (intervention for Cohort 2). Per protocol this participant was excluded from the all participants as treated population because the actual intervention received was not 1 of the 2 designated interventions in Cohort 1.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: V116 | Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent [23-valent], PNEUMOVAX™23) prior to the enrollment. |
| FG001 | Cohort 1: PCV15 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 6, 2022 |
Not provided
Not provided
Not provided
Not provided
Cohorts 1 and 2: participants, investigator, sponsor Cohort 3: no blinding
|
| PCV15 | Biological | 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 |
|
|
| PPSV23 | Biological | 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 |
|
|
| 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. | 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. | 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. | 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. | Day 1 (Baseline) and 30 days post-vaccination |
| Glendale |
| Arizona |
| 85308 |
| United States |
| Fiel Family and Sports Medicine, PC/CCT Research ( Site 0006) | Tempe | Arizona | 85283 | United States |
| Southland Clinical Research Center ( Site 0026) | Fountain Valley | California | 92708 | United States |
| Diablo Clinical Research, Inc. ( Site 0019) | Walnut Creek | California | 94598 | United States |
| Alliance for Multispecialty Research, LLC ( Site 0020) | Coral Gables | Florida | 33134 | United States |
| Indago Research & Health Center, Inc ( Site 0005) | Hialeah | Florida | 33012 | United States |
| Advanced Medical Research Institute ( Site 0018) | Miami | Florida | 33174 | United States |
| Solaris Clinical Research ( Site 0025) | Meridian | Idaho | 83646 | United States |
| Centennial Medical Group ( Site 0002) | Elkridge | Maryland | 21075 | United States |
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0016) | Troy | Michigan | 48098 | United States |
| Meridian Clinical Research, LLC ( Site 0009) | Norfolk | Nebraska | 68701 | United States |
| Advanced Medical Research ( Site 0001) | Maumee | Ohio | 43537 | United States |
| University of Texas Medical Branch-Sealy Institute for Vaccine Sciences Clinical Trials Program ( Si | Galveston | Texas | 77555 | United States |
| Health Research of Hampton Roads, Inc. ( Site 0003) | Newport News | Virginia | 23606 | United States |
| Hamilton Medical Research Group ( Site 0114) | Hamilton | Ontario | L8M 1K7 | Canada |
| Milestone Research Inc. ( Site 0104) | London | Ontario | N5W 6A2 | Canada |
| Manna Research Mirabel ( Site 0109) | Mirabel | Quebec | J7J 2K8 | Canada |
| CHU de Québec-Université Laval-Équipe de recherche en vaccination ( Site 0120) | Québec | Quebec | G1E 7G9 | Canada |
| Diex Recherche Sherbrooke Inc. ( Site 0101) | Sherbrooke | Quebec | J1L 0H8 | Canada |
| CHU Bordeaux Haut-Leveque ( Site 0202) | Pessac | Aquitaine | 33600 | France |
| CHRU de Brest ( Site 0200) | Brest | Finistere | 29609 | France |
| centre hospitalier lyon sud ( Site 0204) | Pierre-Bénite | Rhone | 69310 | France |
| Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0203) | Paris | 75679 | France |
| Rambam Health Care Campus ( Site 0303) | Haifa | 3109601 | Israel |
| Maccabi Health Services - Holon ( Site 0305) | Holon | Israel |
| Maccabi Healthcare Services ( Site 0306) | Jerusalem | 71713 | Israel |
| Hadassah Medical Center-Clinical Reaserch Unit ( Site 0300) | Jerusalem | 9112001 | Israel |
| Meir Medical Center ( Site 0301) | Kfar Saba | 4428164 | Israel |
| Sheba Medical Center-Early Phase Clinical Trials Unit ( Site 0304) | Ramat Gan | 5265601 | Israel |
| Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 0302) | Sakhnin | 3081000 | Israel |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0400) | Milan | Lombardy | 20122 | Italy |
| Ospedale San Raffaele ( Site 0403) | Milan | Lombardy | 20132 | Italy |
| A.O.U. Policlinico Paolo Giaccone ( Site 0402) | Palermo | Sicily | 90127 | Italy |
| Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia ( Site 0405) | Foggia | 71100 | Italy |
| PS Clinic ( Site 0700) | Fukuoka | 812-0025 | Japan |
| Nishikumamoto Hospital ( Site 0701) | Kumamoto | 861-4157 | Japan |
| Gachon University Gil Medical Center ( Site 0755) | Namdong-gu | Incheon | 21565 | South Korea |
| Korea University Ansan Hospital ( Site 0751) | Ansan-si | Kyonggi-do | 15355 | South Korea |
| The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 0752) | Seoul | 03312 | South Korea |
| The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 0753) | Seoul | 06591 | South Korea |
| Hallym University Kangnam Sacred Heart Hospital-Internal Medicine ( Site 0754) | Seoul | 07441 | South Korea |
| Korea University Guro Hospital ( Site 0750) | Seoul | South Korea |
| HOSPITAL CLÍNIC DE BARCELONA-Medicina Preventiva i Epidemiologia ( Site 0503) | Barcelona | Catalonia | 08036 | Spain |
| EBA CENTELLES ( Site 0500) | Centelles | Catalonia | 08500 | Spain |
| Hospital Universitari de Bellvitge ( Site 0505) | L'Hospitalet de Llobregat | Catalonia | 08907 | Spain |
| HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Respiratory ( Site 0508) | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Hospital Internacional Xanit ( Site 0520) | Benalmádena | Malaga | 29630 | Spain |
| Hospital La Princesa ( Site 0515) | Madrid | 28006 | Spain |
| National Cheng Kung University Hospital ( Site 0801) | Tainan | 704 | Taiwan |
| National Taiwan University Hospital ( Site 0800) | Taipei | 100 | Taiwan |
| Plain Language Summary | View source |
Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment. |
| FG002 | Cohort 2: V116 | Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment. |
| FG003 | Cohort 2: PPSV23 | Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment. |
| FG004 | Cohort 3: V116 | Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment. |
| Day 1 - Vaccinated With V116 |
|
| Day 1 - Vaccinated With PCV15 |
|
| Day 1 - Vaccinated With PPSV23 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: V116 | Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent [23-valent], PNEUMOVAX™23) prior to the enrollment. |
| BG001 | Cohort 1: PCV15 | Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment. |
| BG002 | Cohort 2: V116 | Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment. |
| BG003 | Cohort 2: PPSV23 | Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment. |
| BG004 | Cohort 3: V116 | Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All randomized participants who received at least 1 dose of study vaccination were analyzed. | Posted | Number | Percentage of Participants | Up to 5 days post-vaccination |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | 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. | All randomized participants who received at least 1 dose of study vaccination were analyzed. | Posted | Number | Percentage of Participants | Up to 5 days post-vaccination |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | All randomized participants who received at least 1 dose of study vaccination were analyzed. | Posted | Number | Percentage of Participants | Up to ~180 days |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 30 Days post-vaccination |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | 30 Days post-vaccination |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Day 1 (Baseline) and 30 days post-vaccination |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 1 (Baseline) and 30 days post-vaccination |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Day 1 (Baseline) and 30 days post-vaccination |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 1 (Baseline) and 30 days post-vaccination |
|
Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
The analysis population for All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who received the study vaccination.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: V116 | Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent [23-valent], PNEUMOVAX™23) prior to the enrollment. | 0 | 231 | 2 | 230 | 107 | 230 |
| EG001 | Cohort 1: PCV15 | Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment. | 0 | 119 | 4 | 117 | 66 | 117 |
| EG002 | Cohort 2: V116 | Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment. | 0 | 176 | 2 | 174 | 85 | 174 |
| EG003 | Cohort 2: PPSV23 | Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment. | 0 | 85 | 3 | 85 | 52 | 85 |
| EG004 | Cohort 3: V116 | Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment. | 0 | 106 | 2 | 105 | 51 | 105 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Aortoenteric fistula | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Mallory-Weiss syndrome | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site cellulitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
The investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Apr 4, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011018 | Pneumonia, Pneumococcal |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018410 | Pneumonia, Bacterial |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C414006 | 23-valent pneumococcal capsular polysaccharide vaccine |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Injection site pain |
|
| Injection site swelling |
|
| OG003 | Cohort 2: PPSV23 | Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment. |
| OG004 | Cohort 3: V116 | Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment. |
|
|
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.
| OG003 | Cohort 2: PPSV23 | Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment. |
| OG004 | Cohort 3: V116 | Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment. |
|
|
| OG003 | Cohort 2: PPSV23 | Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment. |
| OG004 | Cohort 3: V116 | Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment. |
|
|
| OG003 | Cohort 2: PPSV23 | Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment. |
| OG004 | Cohort 3: V116 | Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment. |
|
|
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment. |
| OG003 | Cohort 2: PPSV23 | Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment. |
| OG004 | Cohort 3: V116 | Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment. |
|
|
| OG003 | Cohort 2: PPSV23 | Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment. |
| OG004 | Cohort 3: V116 | Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment. |
|
|
Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.
| OG003 | Cohort 2: PPSV23 | Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment. |
| OG004 | Cohort 3: V116 | Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment. |
|
|
| OG003 | Cohort 2: PPSV23 | Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment. |
| OG004 | Cohort 3: V116 | Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|