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| ID | Type | Description | Link |
|---|---|---|---|
| V116-008 | Other Identifier | MSD | |
| jRCT2061220106 | Registry Identifier | jRCT | |
| 2022-502791-22-01 | Registry Identifier | EU CT | |
| U1111-1282- 1460 | Registry Identifier | UTN |
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The primary objectives of this study are to evaluate the safety and tolerability of the pneumococcal 21 valent conjugate vaccine (V116), and to evaluate the serotype-specific opsonophagocytic activity (OPA) post-vaccination with V116 and PCV15 (a pneumococcal conjugate vaccine that includes 15 serotypes) + PPSV23 (comprised of the polysaccharides from 23 of the serotypes causing disease in adults) post-vaccination within each vaccination group separately.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V116 + Placebo | Experimental | Participants administered a single intramuscular (IM) dose of V116 on Day 1, and single IM dose of placebo on Week 8. |
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| PCV15 + PPSV23 | Active Comparator | Participants administered a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8. |
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| 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, 20, 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) From Day 1 Through Day 5 Post-vaccination | 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. The percentage of participants with solicited injection-site AEs was assessed following any vaccination. Solicited injection-site AEs consist of the following: pain/tenderness, redness/erythema, and swelling. | Up to 5 days following each vaccination |
| Participants With Solicited Systemic AEs From Day 1 Through Day 5 Post-vaccination | 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. The percentage of participants with solicited systemic AEs was assessed following any vaccination. Solicited systemic AEs consist of the following: fatigue (tiredness), headache, myalgia (muscle aches), and pyrexia (maximum temperature >= 100.4 °F/38.0 °C). | Up to 5 days following each vaccination |
| Participants With Vaccine-related Serious Adverse Events (SAEs) From Day 1 Through The Duration of Participation in The Study | A vaccine-related SAE is any untoward medical consequence that results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event, which is determined by the investigator to be related to the vaccine. The percentage of participants with SAEs was assessed following any vaccination. | Up to 194 days following Visit 2 (Day 1) |
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | The serotype specific OPA GMTs for the pneumococcal serotypes were determined using the multiplex opsonophagocytic assay (MOPA). The point estimate was calculated by exponentiating the estimates of the mean of the natural log values and within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. |
| Measure | Description | Time Frame |
|---|---|---|
| Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | The serotype specific IgG GMCs for the pneumococcal serotypes were determined using pneumococcal electrochemiluminescence assay (PnECL). The point estimate was calculated by exponentiating the estimates of the mean of the natural log values and within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aventiv Research ( Site 0022) | Mesa | Arizona | 85206 | United States | ||
| Indago Research & Health Center, Inc ( Site 0002) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41208546 | Result | Scott PT, Pathirana J, Kato A, Tytus R, Perez CM, Gilchrist NL, Kanou H, Ha Yoo K, Kania G, Nissen M, Russell AF, Fernsler D, Waleed M, Li J, Buchwald UK, Platt HL. A Phase 3, Randomized Trial Investigating the Safety, Tolerability, and Immunogenicity of V116, an Adult-Specific Pneumococcal Conjugate Vaccine, in Pneumococcal Vaccine-Naive Adults 18-64 Years of Age at Increased Risk of Pneumococcal Disease, STRIDE-8. Clin Infect Dis. 2026 Feb 25;82(2):e217-e226. doi: 10.1093/cid/ciaf604. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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Pneumococcal vaccine-naïve adults 18 to 64 years of age (inclusive) with increased risk of pneumococcal disease were enrolled in this study. Participants must have had documented results of ≥ 1 of the following risk conditions: diabetes mellitus, chronic heart disease, chronic kidney disease, chronic liver disease, and/or chronic lung disease. Participants with comorbidities were eligible if the conditions were assessed to be stable as per the investigator's judgment.
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| ID | Title | Description |
|---|---|---|
| FG000 | V116 + Placebo | Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single intramuscular (IM) dose of pneumococcal 21-valent conjugate vaccine (V116) at Visit 2 (Day 1) and a 0.5mL single IM dose of Placebo (sterile saline) at Visit 5 (Week 8). |
| FG001 | PCV15 + PPSV23 |
| 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 | Oct 24, 2022 |
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| Placebo | Biological | Saline in each 0.5 mL sterile solution |
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| PCV15 | Biological | Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the following PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; and 4 μg of PnPs antigen 6B in each 0.5 mL sterile suspension |
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| PPSV23 | Biological | Pneumococcal 23-valent polyvalent 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 |
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| 30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group. |
| 30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group. |
| Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | The geometric mean fold rise (GMFR) from baseline to post-vaccination in serotype specific OPA GMTs was determined using MOPA. The within-group 95% confidence intervals (Cis) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. | Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group) |
| Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | The GMFR from baseline to post-vaccination in serotype specific IgG GMCs was determined using Pn electrochemiluminescence (ECL) assay. The within-group 95% confidence intervals (Cis) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. | Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group) |
| Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | The percentage of participants with ≥4-fold rise from baseline to post-vaccination with V116 and PCV15+PPSV23 in serotype-specific OPA responses for pneumococcal serotypes contained in V116 was calculated using MOPA. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. | Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group) |
| Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | The percentage of participants with ≥4-fold rise from baseline to post-vaccination with V116 and PCV15+PPSV23 in serotype-specific OPA responses for pneumococcal serotypes contained in V116 was calculated using Pn ECL assay. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. | Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group) |
| Hialeah |
| Florida |
| 33012 |
| United States |
| Triple O Research Institute, P.A ( Site 0011) | West Palm Beach | Florida | 33407 | United States |
| SKY Integrative Medical Center/SKYCRNG ( Site 0012) | Ridgeland | Mississippi | 39157 | United States |
| Mid Hudson Medical Research ( Site 0008) | New Windsor | New York | 12553 | United States |
| Holston Medical Group ( Site 0010) | Kingsport | Tennessee | 37660 | United States |
| EmVenio Research ( Site 0018) | Fort Worth | Texas | 27713 | United States |
| Wenatchee Valley Hospital ( Site 0019) | Wenatchee | Washington | 98801 | United States |
| Holdsworth House Medical Practice ( Site 0402) | Darlinghurst | New South Wales | 2010 | Australia |
| Royal Brisbane and Women's Hospital ( Site 0400) | Brisbane | Queensland | 4029 | Australia |
| G A Research Associates ( Site 0100) | Moncton | New Brunswick | E1G 1A7 | Canada |
| Hamilton Medical Research Group ( Site 0107) | Hamilton | Ontario | L8M 1K7 | Canada |
| Milestone Research Inc. ( Site 0106) | London | Ontario | N5W 6A2 | Canada |
| Manna Research Mirabel ( Site 0105) | Mirabel | Quebec | J7J 2K8 | Canada |
| Clinique de médecine Urbaine du Quartier Latin ( Site 0111) | Montreal | Quebec | H2L 4E9 | Canada |
| Diex Recherche Trois-Rivieres ( Site 0110) | Trois-Rivières | Quebec | G9A 4P3 | Canada |
| Diex Recherche Victoriavile Inc. ( Site 0102) | Victoriaville | Quebec | G6P 6P6 | Canada |
| Hospital Dr. Hernán Henríquez Aravena ( Site 1001) | Temuco | Araucania | 4781151 | Chile |
| Centro de Investigación del Maule-Centro de Investigación 2 ( Site 1010) | Talca | Maule Region | 3460000 | Chile |
| Universidad San Sebastian - Providencia ( Site 1003) | Providencia | Region M. de Santiago | 7500000 | Chile |
| Centro de Investigaciones Medicas Respiratorias (CIMER) ( Site 1008) | Santiago | Region M. de Santiago | 7500692 | Chile |
| Centro de Investigacion Clinicadela Universidad Catolica ( Site 1004) | Santiago | Region M. de Santiago | 8330034 | Chile |
| Universidad de Chile - Hospital Clínico Universidad de Chile-Cardiology ( Site 1006) | Santiago | Region M. de Santiago | 8380420 | Chile |
| CESFAM Esmeralda ( Site 1009) | Santiago | Region M. de Santiago | 9340000 | Chile |
| Medical corporation Applied Bio-Pharmatech Kurume Clinical Pharmacology Clinic ( Site 0200) | Kurume | Fukuoka | 830-0011 | Japan |
| Shimonoseki Medical Center ( Site 0201) | Shimonoseki | Yamaguchi | 750-0061 | Japan |
| Pacific Clinical Research Network - Rotorua ( Site 0500) | Rotorua | Bay of Plenty | 3010 | New Zealand |
| P3 Research - Tauranga ( Site 0507) | Tauranga | Bay of Plenty | 3110 | New Zealand |
| CGM Research Trust ( Site 0505) | Christchurch | Canterbury | 8011 | New Zealand |
| Pacific Clinical Research Network - Forte ( Site 0501) | Christchurch | Canterbury | 8013 | New Zealand |
| P3 Research - Lower Hutt ( Site 0508) | Lower Hutt | Wellington Region | 5010 | New Zealand |
| P3 Research - Wellington ( Site 0503) | Wellington | 6021 | New Zealand |
| IN VIVO ( Site 0601) | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-048 | Poland |
| Centrum Medyczne Pratia Bydgoszcz-Centrum Medyczne Pratia Bydgoszcz ( Site 0607) | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-796 | Poland |
| MICS Centrum Medyczne Torun ( Site 0606) | Torun | Kuyavian-Pomeranian Voivodeship | 87-100 | Poland |
| Centrum Medyczne Medyk ( Site 0602) | Rzeszów | Podkarpackie Voivodeship | 35-055 | Poland |
| Centrum Medyczne Pratia Katowice ( Site 0604) | Katowice | Silesian Voivodeship | 40-081 | Poland |
| Clinical Medical Research ( Site 0605) | Katowice | Silesian Voivodeship | 40-156 | Poland |
| Clinmedica Research Sp. z. o. o. ( Site 0603) | Skierniewice | Łódź Voivodeship | 96-100 | Poland |
| Hallym University Sacred Heart Hospital ( Site 0303) | Anyang-si | Kyonggi-do | 14068 | South Korea |
| Korea University Anam Hospital ( Site 0305) | Seoul | 02841 | South Korea |
| Seoul National University Hospital ( Site 0300) | Seoul | 03080 | South Korea |
| Konkuk University Medical Center ( Site 0302) | Seoul | 05030 | South Korea |
| Hallym University Kangdong Sacred Heart Hospital ( Site 0301) | Seoul | 05355 | South Korea |
| Plain Language Summary | View source |
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single IM dose of a pneumococcal 15-valent conjugate vaccine (PCV15) at Visit 2 (Day 1) and a 0.5mL single IM dose of pneumococcal vaccine comprised of polysaccharides from 23 of the serotypes causing disease in adults (PPSV23) at Visit 5 (Week 8). |
| Vaccinated With V116 at Visit 2 |
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| Vaccinated With PCV15 at Visit 2 |
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| Vaccinated With Placebo at Visit 5 |
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| Vaccinated With PPSV23 at Visit 5 |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | V116 + Placebo | Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single intramuscular (IM) dose of pneumococcal 21-valent conjugate vaccine (V116) at Visit 2 (Day 1) and a 0.5mL single IM dose of Placebo (sterile saline) at Visit 5 (Week 8). |
| BG001 | PCV15 + PPSV23 | Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single IM dose of a pneumococcal 15-valent conjugate vaccine (PCV15) at Visit 2 (Day 1) and a 0.5mL single IM dose of pneumococcal vaccine comprised of polysaccharides from 23 of the serotypes causing disease in adults (PPSV23) at Visit 5 (Week 8). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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) From Day 1 Through Day 5 Post-vaccination | 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. The percentage of participants with solicited injection-site AEs was assessed following any vaccination. Solicited injection-site AEs consist of the following: pain/tenderness, redness/erythema, and swelling. | All participants who were randomized and received at least 1 dose of study intervention. Participants were included in the intervention group according to the study intervention actually received. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 5 days following each vaccination |
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| Primary | Participants With Solicited Systemic AEs From Day 1 Through Day 5 Post-vaccination | 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. The percentage of participants with solicited systemic AEs was assessed following any vaccination. Solicited systemic AEs consist of the following: fatigue (tiredness), headache, myalgia (muscle aches), and pyrexia (maximum temperature >= 100.4 °F/38.0 °C). | All participants who were randomized and received at least 1 dose of study intervention. Participants were included in the intervention group according to the study intervention actually received. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 5 days following each vaccination |
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| Primary | Participants With Vaccine-related Serious Adverse Events (SAEs) From Day 1 Through The Duration of Participation in The Study | A vaccine-related SAE is any untoward medical consequence that results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event, which is determined by the investigator to be related to the vaccine. The percentage of participants with SAEs was assessed following any vaccination. | All participants who were randomized and received at least 1 dose of study intervention. Participants were included in the intervention group according to the study intervention actually received. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 194 days following Visit 2 (Day 1) |
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| Primary | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Pneumococcal Serotypes Contained in V116 | The serotype specific OPA GMTs for the pneumococcal serotypes were determined using the multiplex opsonophagocytic assay (MOPA). The point estimate was calculated by exponentiating the estimates of the mean of the natural log values and within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. | The population analyzed was all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoints. Deviations include but are not limited to the following: failure to receive the study vaccine, receiving incorrect clinical material per the randomization schedule, or taking prohibited medications or vaccines prior to vaccination or blood sample collection outside the designated window. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group. |
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| Secondary | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Pneumococcal Serotypes Contained in V116 | The serotype specific IgG GMCs for the pneumococcal serotypes were determined using pneumococcal electrochemiluminescence assay (PnECL). The point estimate was calculated by exponentiating the estimates of the mean of the natural log values and within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. | The population analyzed was all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoints. Deviations include but are not limited to the following: failure to receive the study vaccine, receiving incorrect clinical material per the randomization schedule, or taking prohibited medications or vaccines prior to vaccination or blood sample collection outside the designated window. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | 30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group. |
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| Secondary | Serotype-specific Geometric Mean Fold Rises (GMFRs) for OPA Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | The geometric mean fold rise (GMFR) from baseline to post-vaccination in serotype specific OPA GMTs was determined using MOPA. The within-group 95% confidence intervals (Cis) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. | The population analyzed was all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoints. Deviations include but are not limited to the following: failure to receive the study vaccine, receiving incorrect clinical material per the randomization schedule, or taking prohibited medications or vaccines prior to vaccination or blood sample collection outside the designated window. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group) |
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| Secondary | Serotype-specific GMFRs for IgG Responses From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 | The GMFR from baseline to post-vaccination in serotype specific IgG GMCs was determined using Pn electrochemiluminescence (ECL) assay. The within-group 95% confidence intervals (Cis) were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. | The population analyzed was all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoints. Deviations include but are not limited to the following: failure to receive the study vaccine, receiving incorrect clinical material per the randomization schedule, or taking prohibited medications or vaccines prior to vaccination or blood sample collection outside the designated window. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group) |
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| Secondary | Percentage of Participants With ≥4-fold Change From Baseline to Post-vaccination With V116 and PCV15 + PPSV23 in Serotype Specific OPA Responses for Pneumococcal Serotypes Contained in V116 | The percentage of participants with ≥4-fold rise from baseline to post-vaccination with V116 and PCV15+PPSV23 in serotype-specific OPA responses for pneumococcal serotypes contained in V116 was calculated using MOPA. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. | The population analyzed was all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoints. Deviations include but are not limited to the following: failure to receive the study vaccine, receiving incorrect clinical material per the randomization schedule, or taking prohibited medications or vaccines prior to vaccination or blood sample collection outside the designated window. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group) |
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| Secondary | Percentage of Participants With ≥4-fold Change From Baseline to Post-Vaccination With V116 and PCV15 + PPSV23 in Serotype Specific IgG Responses for Pneumococcal Serotypes Contained in V116 | The percentage of participants with ≥4-fold rise from baseline to post-vaccination with V116 and PCV15+PPSV23 in serotype-specific OPA responses for pneumococcal serotypes contained in V116 was calculated using Pn ECL assay. The 13 common pneumococcal serotypes in both V116 and PCV15 + PPSV23 were as follows: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 17F, 19A, 20A, 22F, and 33F. The 8 unique pneumococcal serotypes in V116 were as follows: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B. | The population analyzed was all randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoints. Deviations include, but are not limited to the following: failure to receive the study vaccine, receiving incorrect clinical material per the randomization schedule, or taking prohibited medications or vaccines prior to vaccination or blood sample collection outside the designated window. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline (Day 1) and postvaccination (30 days following V116 [Day 30] for the V116 + Placebo group and 30 days following PPSV23 [Week 12] for the PCV15 + PPSV23 group) |
|
Up to ~ 194 Days following Visit 2 (Day 1)
The all-cause mortality population includes all randomized participants. The SAE and AE analysis population includes all participants who were randomized and received at least 1 dose of study intervention.
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 + Placebo | Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single intramuscular (IM) dose of pneumococcal 21-valent conjugate vaccine (V116) at Visit 2 (Day 1) and a 0.5mL single IM dose of Placebo (sterile saline) at Visit 5 (Week 8). | 0 | 387 | 10 | 386 | 240 | 386 |
| EG001 | PCV15 + PPSV23 | Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single IM dose of a pneumococcal 15-valent conjugate vaccine (PCV15) at Visit 2 (Day 1) and a 0.5mL single IM dose of pneumococcal vaccine comprised of polysaccharides from 23 of the serotypes causing disease in adults (PPSV23) at Visit 5 (Week 8). | 0 | 131 | 7 | 130 | 112 | 130 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery stenosis | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Aortic stenosis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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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 3, 2025 |
| Prot_SAP_000.pdf |
| 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 |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| Injection site swelling |
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| OG001 | PCV15 + PPSV23 | Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single IM dose of a pneumococcal 15-valent conjugate vaccine (PCV15) at Visit 2 (Day 1) and a 0.5mL single IM dose of pneumococcal vaccine comprised of polysaccharides from 23 of the serotypes causing disease in adults (PPSV23) at Visit 5 (Week 8). |
|
|
| OG001 | PCV15 + PPSV23 | Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single IM dose of a pneumococcal 15-valent conjugate vaccine (PCV15) at Visit 2 (Day 1) and a 0.5mL single IM dose of pneumococcal vaccine comprised of polysaccharides from 23 of the serotypes causing disease in adults (PPSV23) at Visit 5 (Week 8). |
|
|
| OG001 | PCV15 + PPSV23 | Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single IM dose of a pneumococcal 15-valent conjugate vaccine (PCV15) at Visit 2 (Day 1) and a 0.5mL single IM dose of pneumococcal vaccine comprised of polysaccharides from 23 of the serotypes causing disease in adults (PPSV23) at Visit 5 (Week 8). |
|
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| OG001 |
| PCV15 + PPSV23 |
Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single IM dose of a pneumococcal 15-valent conjugate vaccine (PCV15) at Visit 2 (Day 1) and a 0.5mL single IM dose of pneumococcal vaccine comprised of polysaccharides from 23 of the serotypes causing disease in adults (PPSV23) at Visit 5 (Week 8). |
|
|
| OG001 | PCV15 + PPSV23 | Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single IM dose of a pneumococcal 15-valent conjugate vaccine (PCV15) at Visit 2 (Day 1) and a 0.5mL single IM dose of pneumococcal vaccine comprised of polysaccharides from 23 of the serotypes causing disease in adults (PPSV23) at Visit 5 (Week 8). |
|
|
| OG001 | PCV15 + PPSV23 | Pneumococcal vaccine-naïve adult participants (18-64 years of age) received a 0.5mL single IM dose of a pneumococcal 15-valent conjugate vaccine (PCV15) at Visit 2 (Day 1) and a 0.5mL single IM dose of pneumococcal vaccine comprised of polysaccharides from 23 of the serotypes causing disease in adults (PPSV23) at Visit 5 (Week 8). |
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