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| ID | Type | Description | Link |
|---|---|---|---|
| V116-013 | Other Identifier | MSD | |
| jRCT2031230559 | Registry Identifier | jRCT | |
| 2023-506236-32 | Registry Identifier | EU CT | |
| U1111-1293-4944 | Registry Identifier | UTN |
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The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children and teenagers 2 through 17 years of age, who had completed routine pneumococcal vaccine as infants/toddlers. Researchers want to learn if V116 is as good as, or is better than the PPSV23 vaccine in terms of the antibody immune response. V116 and PPSV23 will be studied in children and teenagers who have a higher risk of getting pneumococcal disease (PD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V116 | Experimental | Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 on Day 1 |
|
| PPSV23 | Active Comparator | Participants will receive a single 0.5 mL IM dose of PPSV23 on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V116 | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | 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. | Up to 5 days postvaccination |
| Percentage of Participants With Solicited Systemic AEs | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs included muscle aches all over the body (myalgia), headache, tiredness (fatigue), hives or welts (urticaria), irritability, joint pain (arthralgia), drowsiness (somnolence), feeling sick (malaise), and fever (pyrexia). | Up to 5 days post vaccination |
| Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) | A vaccine-related 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. | Up to approximately 6 months |
| Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses | Opsonophagocytic activity (OPA) for the serotypes in V116 will be determined using a multiplexed 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. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 9 unique pneumococcal serotypes in V116 were as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination | The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (PnECL). Serotype-specific IgGs and GMC ratios with 95% CIs were calculated using a cLDA model. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 9 unique pneumococcal serotypes in V116 were as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Research Associates ( Site 0145) | Birmingham | Alabama | 35205 | United States | ||
| Velocity Clinical Research, Phoenix ( Site 0122) |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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Children and adolescents between 2 and 18 years of age with an increased risk of pneumococcal disease were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | V116 | Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. |
| FG001 | PPSV23 | Participants received a single 0.5 mL IM dose of PPSV23 on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 | Feb 20, 2024 |
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| PPSV23 | Biological | 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 |
|
|
| 30 days postvaccination |
| 30 days postvaccination |
| Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs | The GMFR from baseline in serotype-specific OPA GMTs was determined using MOPA at baseline and 30 days postvaccination and derived from a cLDA model. The GMFR (Day 30 GMT/Day 1 GMT) from baseline (Day 1) to Day 30 of each pneumococcal OPA serotype was calculated. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 9 unique pneumococcal serotypes in V116 were as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. | Baseline (Day 1) and 30 days postvaccination |
| Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs | The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMTs of each pneumococcal serotype was calculated. Titer levels were determined by the MOPA and derived from a cLDA model. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 9 unique pneumococcal serotypes in V116 were as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. | Baseline (Day 1) and Day 30 postvaccination |
| GMFR From Baseline in Serotype-specific IgG GMCs | The GMFR from baseline in serotype-specific IgG GMCs was determined using PnECL at baseline and 30 days postvaccination and derived from a cLDA model. The GMFR (Day 30 GMT/Day 1 GMT) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype was calculated. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. | Baseline (Day 1) and Day 30 postvaccination |
| Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs | The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMCs of each pneumococcal serotype was calculated. Titer levels were determined by PnECL and derived from a cLDA model. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 9 unique pneumococcal serotypes in V116 were as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. | Baseline (Day 1) and Day 30 postvaccination |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| Madera Family Medical Group ( Site 0120) | Madera | California | 93637 | United States |
| Optumcare Colorado Springs, LLC ( Site 0113) | Colorado Springs | Colorado | 80922 | United States |
| Accel Research Sites Network- Nona Pediatric Center ( Site 0109) | Orlando | Florida | 32829 | United States |
| University of South Florida-Department of Pediatrics ( Site 0110) | Tampa | Florida | 33606 | United States |
| Velocity Clinical Research at Primary Pediatrics, Macon ( Site 0128) | Macon | Georgia | 31210 | United States |
| Bingham Memorial Hospital ( Site 0149) | Blackfoot | Idaho | 83221 | United States |
| Clinical Research Prime ( Site 0105) | Idaho Falls | Idaho | 83404 | United States |
| Clinical Research Prime Rexburg ( Site 0104) | Rexburg | Idaho | 83440 | United States |
| University of Louisville, Norton Children's Research Institute ( Site 0148) | Louisville | Kentucky | 40202 | United States |
| Velocity Clinical Research, Lafayette ( Site 0103) | Lafayette | Louisiana | 70508 | United States |
| Velocity Clinical Research, Gulfport ( Site 0115) | Gulfport | Mississippi | 39503 | United States |
| Velocity Clinical Research, Hastings ( Site 0114) | Hastings | Nebraska | 68901 | United States |
| Midwest Children's Health Research Institute ( Site 0117) | Lincoln | Nebraska | 68504 | United States |
| Midwest Children's Health Research Institute ( Site 0106) | Lincoln | Nebraska | 68505 | United States |
| Midwest Children's Health Research Institute-Research ( Site 0119) | Lincoln | Nebraska | 68516 | United States |
| Midwest Children's Health Research Institute-Research ( Site 0102) | Lincoln | Nebraska | 68522 | United States |
| Velocity Clinical Research, Albuquerque ( Site 0112) | Albuquerque | New Mexico | 87107 | United States |
| Velocity Clinical Research, Vestal ( Site 0121) | Vestal | New York | 13850 | United States |
| Epic Medical Research - Oklahoma ( Site 0134) | Chickasha | Oklahoma | 73018 | United States |
| Tribe Clinical Research, LLC-Pediatrics ( Site 0118) | Greenville | South Carolina | 29607 | United States |
| Tribe Clinical Research - Spartanburg ( Site 0108) | Spartanburg | South Carolina | 29301 | United States |
| Velocity Clinical Research, Austin ( Site 0129) | Austin | Texas | 78759 | United States |
| PanAmerican Clinical Research ( Site 0132) | Brownsville | Texas | 78521 | United States |
| Epic Medical Research ( Site 0133) | DeSoto | Texas | 75115 | United States |
| Epic Medical Research - Mesquite ( Site 0144) | Mesquite | Texas | 75150 | United States |
| Alliance for Multispecialty Research, LLC ( Site 0140) | Layton | Utah | 84041 | United States |
| Velocity Clinical Research, Salt Lake City ( Site 0124) | West Jordan | Utah | 84088 | United States |
| Canadian Center for Vaccinology ( Site 0004) | Halifax | Nova Scotia | B3K6R8 | Canada |
| Premier Clinical Trial Network ( Site 0008) | Hamilton | Ontario | L8L 5G4 | Canada |
| Children's Hospital of Eastern Ontario ( Site 0001) | Ottawa | Ontario | K1H 8L1 | Canada |
| CHU Sainte-Justine ( Site 0007) | Montreal | Quebec | H3T 1C5 | Canada |
| McGill University Health Centre - Vaccine Study Centre ( Site 0005) | Pierrefonds | Quebec | H9H 4Y6 | Canada |
| CHU de Québec-Université Laval ( Site 0006) | Québec | Quebec | G1E 7G9 | Canada |
| Hospital Dr. Hernán Henríquez Aravena ( Site 0208) | Temuco | Araucania | 4781151 | Chile |
| Centro de Estudios Clínicos (ICIM, Facultad de Medicina Clínica Alemana Universidad del Desarrollo) | Santiago | Region M. de Santiago | 7590943 | Chile |
| Pontificia Universidad Catolica de Chile-Pediatric Infectious Diseases and Immunology ( Site 0209) | Santiago | Region M. de Santiago | 8330077 | Chile |
| Hospital Roberto del Río-Infectología Pediátrica ( Site 0200) | Santiago | Region M. de Santiago | 8380418 | Chile |
| Hospital Padre Hurtado-NEONATOLOGY/PEDIATRICS ( Site 0204) | Santiago | Region M. de Santiago | 8880465 | Chile |
| Clinica Somer ( Site 0405) | Rionegro | Antioquia | 054040 | Colombia |
| Oncomedica S.A.S ( Site 0402) | Montería | Departamento de Córdoba | 230001 | Colombia |
| Fundación Valle del Lili ( Site 0404) | Cali | Valle del Cauca Department | 760032 | Colombia |
| CEIP - Centro de Estudios en Infectología Pediátrica ( Site 0401) | Cali | Valle del Cauca Department | 760042 | Colombia |
| FVR, Kokkolan rokotetutkimusklinikka ( Site 0602) | Kokkola | Keski-Pohjanmaa | 67100 | Finland |
| FVR, Oulun rokotetutkimusklinikka ( Site 0600) | Oulu | North Ostrobothnia | 90220 | Finland |
| FVR, Tampereen rokotetutkimusklinikka ( Site 0603) | Tampere | Pirkanmaa | 33100 | Finland |
| FVR, Seinäjoen rokotetutkimusklinikka ( Site 0604) | Seinäjoki | South Ostrobothnia | 60100 | Finland |
| FVR, Turun rokotetutkimusklinikka ( Site 0606) | Turku | Southwest Finland | 20520 | Finland |
| FVR, Espoon rokotetutkimusklinikka ( Site 0608) | Espoo | Uusimaa | 02230 | Finland |
| MeVac - Meilahti Vaccine Research Center ( Site 0609) | Helsinki | Uusimaa | 00290 | Finland |
| Centre Hospitalier Universitaire de Caen - Hôpital Côte de N-Centre de Recherche Clinique Pédiatriq | Caen | Calvados | 14033 | France |
| Hôpital Jeanne de Flandre ( Site 0702) | Lille | Nord | 59037 | France |
| Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita | Paris | 75019 | France |
| Rambam Health Care Campus ( Site 0900) | Haifa | 3109601 | Israel |
| Hadassah Mount Scopus Medical Centre ( Site 0902) | Jerusalem | 9124001 | Israel |
| Schneider Children's Medical Center ( Site 0903) | Petah Tikva | 4920235 | Israel |
| Saiseikai Yokohamashi Tobu Hospital ( Site 1714) | Yokohama | Kanagawa | 230-0012 | Japan |
| Okinawa Prefectural Nanbu Medical Center and Children's Medical Center ( Site 1701) | Kanegusuku | Okinawa | 901-1193 | Japan |
| Juntendo University Hospital ( Site 1700) | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| Aquakids Clinic ( Site 1709) | Edogawa-ku | Tokyo | 133-0056 | Japan |
| Miyazaki Prefectural Miyazaki Hospital ( Site 1711) | Miyazaki | 880-8510 | Japan |
| University of Miyazaki Hospital ( Site 1705) | Miyazaki | 889-1692 | Japan |
| National Hospital Organization Okayama Medical Center ( Site 1713) | Okayama | 701-1192 | Japan |
| Saitama Prefectural Children's Medical Center ( Site 1702) | Saitama | 330-8777 | Japan |
| IN VIVO ( Site 1006) | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-048 | Poland |
| Centrum Medyczne Pratia Bydgoszcz ( Site 1004) | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-796 | Poland |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Pediatrii i Chorob Infekcyjnyc | Wroclaw | Lower Silesian Voivodeship | 50-368 | Poland |
| SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 1007) | Łomianki | Masovian Voivodeship | 05-092 | Poland |
| Gravita Diagnostyka i Leczenie Niepłodności ( Site 1005) | Lodz | Łódź Voivodeship | 91-347 | Poland |
| Hospital Germans Trias i Pujol ( Site 1104) | Badalona | Barcelona | 08916 | Spain |
| Hospital Sant Joan de Déu ( Site 1113) | Esplugues de Llobregat | Barcelona | 08950 | Spain |
| Hospital Universitari Vall d'Hebron ( Site 1115) | Barcelona | Catalonia | 08035 | Spain |
| CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 1111) | Santiago de Compostela | La Coruna | 15706 | Spain |
| Hospital Universitario Severo Ochoa ( Site 1114) | Leganés | Madrid | 28911 | Spain |
| Hospital Universitario La Paz-Pediatria y Enfermedades Infecciosas ( Site 1105) | Madrid | Madrid, Comunidad de | 28046 | Spain |
| Hospital Universitario 12 de Octubre-Unidad Pediátrica de Investigación y Ensayos Clínicos ( Site 11 | Madrid | 28041 | Spain |
| HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1112) | Seville | 41013 | Spain |
| CTC Karolinska ( Site 1201) | Solna | Stockholm County | 171 64 | Sweden |
| Norrlands universitetssjukhus ( Site 1200) | Umeå | Västerbotten County | 901 85 | Sweden |
| CTC GoCo ( Site 1202) | Mölndal | Västra Götaland County | 431 53 | Sweden |
| Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 1601) | Bangkoknoi | Bangkok | 10700 | Thailand |
| Chulalongkorn University-Pediatrics ( Site 1602) | Pathumwan | Bangkok | 10330 | Thailand |
| Faculty of Tropical Medicine, Mahidol University - Vaccine Trial Centre ( Site 1604) | Ratchathewi | Bangkok | 10400 | Thailand |
| Songklanagarind hospital-Department of Pediatrics ( Site 1603) | Hat Yai | Changwat Songkhla | 90110 | Thailand |
| Çukurova Üniversitesi Tıp Fakültesi Adana Hastanesi-Pediatric Infection ( Site 1302) | Sarçam | Adana | 01250 | Turkey (Türkiye) |
| Hacettepe Universite Hastaneleri ( Site 1300) | Ankara | 06230 | Turkey (Türkiye) |
| Ankara Universitesi Tip Fakultesi Hastanesi ( Site 1304) | Ankara | 06590 | Turkey (Türkiye) |
| Ankara Bilkent Şehir Hastanesi-Infectious Disease and Clinical Microbiology ( Site 1301) | Ankara | 06800 | Turkey (Türkiye) |
| Sisli Etfal Training and Research Hospital ( Site 1305) | Istanbul | 34360 | Turkey (Türkiye) |
| Ege Universitesi Hastanesi ( Site 1306) | Izmir | 35100 | Turkey (Türkiye) |
| Erciyes Universitesi Tıp Fakultesi Hastaneleri-pediatric infection ( Site 1303) | Kayseri | 38039 | Turkey (Türkiye) |
| Vaccinated |
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| Safety Analysis Population |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | V116 | Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. |
| BG001 | PPSV23 | Participants received a single 0.5 mL IM dose of PPSV23 on Day 1. |
| BG002 | 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 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. | The analysis population consisted of all participants who received study vaccination and had documented initial consent. | Posted | Number | Percentage of Participants | Up to 5 days postvaccination |
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| Primary | Percentage of Participants With Solicited Systemic AEs | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs included muscle aches all over the body (myalgia), headache, tiredness (fatigue), hives or welts (urticaria), irritability, joint pain (arthralgia), drowsiness (somnolence), feeling sick (malaise), and fever (pyrexia). | The analysis population consisted of all participants who received study vaccination and had documented initial consent. | Posted | Number | Percentage of Participants | Up to 5 days post vaccination |
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| Primary | Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) | A vaccine-related 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 analysis population consisted of all participants who received study vaccination and had documented initial consent. | Posted | Number | Percentage of Participants | Up to approximately 6 months |
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| Primary | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses | Opsonophagocytic activity (OPA) for the serotypes in V116 will be determined using a multiplexed 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. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 9 unique pneumococcal serotypes in V116 were as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. | All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation and with non-missing OPA serology data for the respective serotype. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 30 days postvaccination |
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| Secondary | Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) After Vaccination | The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (PnECL). Serotype-specific IgGs and GMC ratios with 95% CIs were calculated using a cLDA model. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 9 unique pneumococcal serotypes in V116 were as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. | All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation and with baseline and post-vaccination IgG serology data for the respective serotype. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | 30 days postvaccination |
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| Secondary | Geometric Mean Fold Rise (GMFR) From Baseline in Serotype-specific OPA GMTs | The GMFR from baseline in serotype-specific OPA GMTs was determined using MOPA at baseline and 30 days postvaccination and derived from a cLDA model. The GMFR (Day 30 GMT/Day 1 GMT) from baseline (Day 1) to Day 30 of each pneumococcal OPA serotype was calculated. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 9 unique pneumococcal serotypes in V116 were as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. | All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation and with baseline and post-vaccination OPA serology data for the respective serotype. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Baseline (Day 1) and 30 days postvaccination |
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| Secondary | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific OPAs GMTs | The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMTs of each pneumococcal serotype was calculated. Titer levels were determined by the MOPA and derived from a cLDA model. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 9 unique pneumococcal serotypes in V116 were as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. | All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation and with baseline and post-vaccination OPA serology data for the respective serotype. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline (Day 1) and Day 30 postvaccination |
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| Secondary | GMFR From Baseline in Serotype-specific IgG GMCs | The GMFR from baseline in serotype-specific IgG GMCs was determined using PnECL at baseline and 30 days postvaccination and derived from a cLDA model. The GMFR (Day 30 GMT/Day 1 GMT) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype was calculated. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. | All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation and with baseline and post-vaccination OPA serology data for the respective serotype. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Baseline (Day 1) and Day 30 postvaccination |
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| Secondary | Percentage of Participants With ≥4-fold Rise From Baseline in Serotype-specific IgG GMCs | The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMCs of each pneumococcal serotype was calculated. Titer levels were determined by PnECL and derived from a cLDA model. The 12 common pneumococcal serotypes in both V116 and PPSV23 were as follows: 3, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 9 unique pneumococcal serotypes in V116 were as follows: 6A, 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. | All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. Overall participants analyzed were the number of participants randomized and vaccinated with available serotype data; number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation and with baseline and post-vaccination OPA serology data for the respective serotype. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline (Day 1) and Day 30 postvaccination |
|
Up to approximately 6 months
The All-Cause Mortality population consisted of all randomized participants. The Serious Adverse Events and Other Adverse Events consisted of all participants who were randomized, received a study vaccination, and had documented informed consent. One participant in the V116 arm and one participant in the PPSV23 arm were vaccinated without initial consent and were excluded from analysis, per protocol.
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 | V116 | Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. | 0 | 531 | 29 | 527 | 408 | 527 |
| EG001 | PPSV23 | Participants received a single 0.5 mL IM dose of PPSV23 on Day 1. | 2 | 351 | 25 | 347 | 237 | 347 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cyclic vomiting syndrome | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Inflammatory bowel disease | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Achromobacter infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Cystitis viral | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Gastroenteritis rotavirus | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Medical device site infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Metapneumovirus infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pertussis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Respiratory tract infection bacterial | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diabetic metabolic decompensation | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Air embolism | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
|
The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, 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 |
| Feb 9, 2026 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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 swelling |
|
| Difference in Percentage |
| 13.3 |
| 2-Sided |
| 95 |
| 6.7 |
| 19.8 |
| Other |
| Injection Site Swelling: Estimated difference in percent (V116 minus PPSV23) and 95% CI were based on the Miettinen & Nurminen method. | Difference in Percentage | 0.6 | 2-Sided | 95 | -4.8 | 5.8 | Other |
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