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| ID | Type | Description | Link |
|---|---|---|---|
| V114-006 | Other Identifier | Merck Protocol Number |
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The purpose of this study is to assess the safety, tolerability, and immunogenicity of a single dose of different formulations of V114 (V114-A and V114-B) and Prevnar 13® (pneumococcal 13-valent conjugate vaccine) in adult participants
≥50 years of age in good health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V114 Formulation A | Experimental | Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1 |
|
| V114 Formulation B | Experimental | Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1 |
|
| Prevnar 13® | Active Comparator | Participants receive a single 0.5 mL intramuscular injection of Prevnar 13® on Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V114-A | Biological | Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Adverse Event (AE) | The percentage of participants experiencing ≥1 AE(s) in each arm was determined. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | Up to 14 days after vaccination |
| Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | The percentage of participants experiencing ≥1 solicited injection-site AE(s) in each arm was determined. | Up to 14 days after vaccination |
| Percentage of Participants With a Solicited Systemic Adverse Event (AE) | The percentage of participants experiencing ≥1 solicited systemic AE(s) in each arm was determined. | Up to 14 days after vaccination |
| Percentage of Participants With a Serious Adverse Event (SAE) | The percentage of participants experiencing ≥1 SAE(s) in each arm was determined. | Up to 30 days after vaccination |
| Percentage of Participants With Vaccine-Related Serious Adverse Event (SAE) | The percentage of participants experiencing ≥1 vaccine-related SAEs(s) in each arm was determined. | Up to 30 days after vaccination |
| Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination | The OPA GMTs of each common serotype (CS) and V114-specific serotype (VS) were determined in each arm. Titer levels were determined with the multiplexed opsonophagocytic assay (MOPA). |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination | The IgG GMCs of each common pneumococcal serotype (CS) and V114-specific pneumococcal serotype (VS) were determined for each arm. Concentrations were determined with pneumococcal electrochemiluminescence (PnECL). | Day 30 (one month after vaccination) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30648919 | Derived | Stacey HL, Rosen J, Peterson JT, Williams-Diaz A, Gakhar V, Sterling TM, Acosta CJ, Nolan KM, Li J, Pedley A, Benner P, Abeygunawardana C, Kosinski M, Smith WJ, Pujar H, Musey LK. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV-15) compared to PCV-13 in healthy older adults. Hum Vaccin Immunother. 2019;15(3):530-539. doi: 10.1080/21645515.2018.1532249. Epub 2019 Jan 16. |
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Healthy, pneumococcal vaccine-naïve adults ≥50 years of age were recruited at 23 sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | V114-A | Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1. Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress). |
| FG001 | V114-B | Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1. Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress). |
| FG002 | Prevnar 13® | Participants receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Baseline Analysis Population consists of all vaccinated participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | V114-A | Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1. Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 an Adverse Event (AE) | The percentage of participants experiencing ≥1 AE(s) in each arm was determined. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | All participants who received study vaccination are included. | Posted | Number | Percentage of Participants | Up to 14 days after vaccination |
|
Up to 30 days after vaccination
All participants who received study vaccination are included.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | V114-A | Participants receive a single 0.5 mL intramuscular injection of V114 Formulation A on Day 1. Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
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| V114-B | Biological | Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress). |
|
| Prevnar 13® | Biological | Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), and 6B (4.4 mcg) in each 0.5 mL dose. |
|
| Day 30 (one month after vaccination) |
| Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs) | The percentage of participants with ≥4-fold rise from baseline in OPA GMTs of each common serotype (CS) and V114-specific serotype (VS) were compared in the V114 and Prevnar® 13 arms. Estimated GMT, GMT ratio, 95% CI, and p-values were obtained from a constrained longitudinal data analysis (cLDA) model. | Baseline and Day 30 (one month after vaccination) |
| Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies | The percentage of participants with ≥4-fold rise from baseline in IgG GMCs of each common serotype (CS) and V114-specific serotype (VS) were compared in the V114 and Prevnar® 13 arms. Estimated GMT, GMT ratio, 95% CI, and p-values were obtained from a constrained longitudinal data analysis (cLDA) model. | Baseline and Day 30 (one month after vaccination) |
| Withdrawal by Subject |
|
| BG001 | V114-B | Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1. Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress). |
| BG002 | Prevnar 13® | Participants receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | V114-B | Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1. Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress). |
| OG002 | Prevnar 13® | Participants receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1. |
|
|
| Primary | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | The percentage of participants experiencing ≥1 solicited injection-site AE(s) in each arm was determined. | All participants who received study vaccination are included. | Posted | Number | Percentage of Participants | Up to 14 days after vaccination |
|
|
|
| Primary | Percentage of Participants With a Solicited Systemic Adverse Event (AE) | The percentage of participants experiencing ≥1 solicited systemic AE(s) in each arm was determined. | All participants who received study vaccination are included. | Posted | Number | Percentage of Participants | Up to 14 days after vaccination |
|
|
|
| Primary | Percentage of Participants With a Serious Adverse Event (SAE) | The percentage of participants experiencing ≥1 SAE(s) in each arm was determined. | All participants who received study vaccination are included. | Posted | Number | Percentage of Participants | Up to 30 days after vaccination |
|
|
|
| Primary | Percentage of Participants With Vaccine-Related Serious Adverse Event (SAE) | The percentage of participants experiencing ≥1 vaccine-related SAEs(s) in each arm was determined. | All participants who received study vaccination are included. | Posted | Number | Percentage of Participants | Up to 30 days after vaccination |
|
|
|
| Primary | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination | The OPA GMTs of each common serotype (CS) and V114-specific serotype (VS) were determined in each arm. Titer levels were determined with the multiplexed opsonophagocytic assay (MOPA). | All vaccinated participants with data available are included. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 30 (one month after vaccination) |
|
|
|
| Secondary | Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination | The IgG GMCs of each common pneumococcal serotype (CS) and V114-specific pneumococcal serotype (VS) were determined for each arm. Concentrations were determined with pneumococcal electrochemiluminescence (PnECL). | All vaccinated participants with data available are included. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Day 30 (one month after vaccination) |
|
|
|
| Secondary | Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs) | The percentage of participants with ≥4-fold rise from baseline in OPA GMTs of each common serotype (CS) and V114-specific serotype (VS) were compared in the V114 and Prevnar® 13 arms. Estimated GMT, GMT ratio, 95% CI, and p-values were obtained from a constrained longitudinal data analysis (cLDA) model. | All vaccinated participants with data available are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline and Day 30 (one month after vaccination) |
|
|
|
| Secondary | Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies | The percentage of participants with ≥4-fold rise from baseline in IgG GMCs of each common serotype (CS) and V114-specific serotype (VS) were compared in the V114 and Prevnar® 13 arms. Estimated GMT, GMT ratio, 95% CI, and p-values were obtained from a constrained longitudinal data analysis (cLDA) model. | All vaccinated participants with data available are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline and Day 30 (one month after vaccination) |
|
|
|
| 0 |
| 231 |
| 1 |
| 231 |
| 169 |
| 231 |
| EG001 | V114-B | Participants receive a single 0.5 mL intramuscular injection of V114 Formulation B on Day 1. Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress). | 0 | 231 | 2 | 231 | 163 | 231 |
| EG002 | Prevnar 13® | Participants receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1. | 0 | 227 | 0 | 227 | 148 | 227 |
| Osteomyelitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.
| D007239 | Infections |
| Title | Measurements |
|---|---|
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| Swelling |
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| Title | Measurements |
|---|---|
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| Headache |
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| Fatigue |
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| CS3 |
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| CS4 |
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| CS5 |
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| CS6A |
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| CS6B |
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| CS7F |
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| CS9V |
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| CS14 |
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| CS18C |
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| CS19A |
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| CS19F |
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| CS23F |
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| VS22F |
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| VS33F |
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| CS3 |
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| CS4 |
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| CS5 |
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| CS6A |
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| CS6B |
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| CS7F |
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| CS9V |
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| CS14 |
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| CS18C |
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| CS19A |
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| CS19F |
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| CS23F |
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| VS22F |
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| VS33F |
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| CS3 |
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| CS4 |
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| CS5 |
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| CS6A |
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| CS6B |
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| CS7F |
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| CS9V |
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| CS14 |
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| CS18C |
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| CS19A |
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| CS19F |
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| CS22F |
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| VS23F |
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| VS33F |
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| CS3 |
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| CS4 |
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| CS5 |
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| CS6A |
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| CS6B |
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| CS7F |
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| CS9V |
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| CS14 |
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| CS18C |
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| CS19A |
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| CS19F |
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| CS22F |
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| VS23F |
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| VS33F |
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