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| ID | Type | Description | Link |
|---|---|---|---|
| V114-007 | Other Identifier | Merck Protocol Number |
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This study is designed to assess the safety, tolerability, and immunogenicity of V114 compared with Prevnar 13™ in healthy adults 65 years of age or older previously vaccinated with 23-valent pneumococcal polysaccharide vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V114 | Experimental | Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine will receive a single 0.5 mL intramuscular injection of V114 on Day 1. |
|
| Prevnar 13™ | Active Comparator | Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine will receive a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V114 | Biological | V114 contains 2 µg of serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F, and 4 μg of serotype 6B; and 30 µg of CRM₁₉₇ and 125 µg of Aluminum Phosphate Adjuvant (APA) per 0.5 mL dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Adverse Event (AE) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | Up to Day 44 after vaccination |
| Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Solicited injection-site AEs consisted of erythema/redness, swelling, and pain/tenderness. | Up to Day 5 after vaccination |
| Percentage of Participants With a Solicited Systemic Adverse Event (AE) | Solicited systemic AEs consisted of fatigue, arthralgia, myalgia, and headache. | Up to Day 14 after vaccination |
| Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) | The IgG GMCs of each pneumococcal serotype were calculated on Day 1 (baseline) and Day 30 after vaccination. Concentrations were determined using pneumococcal electrochemiluminescence. | Baseline (Day 1) and Day 30 after vaccination |
| Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) | The GMFR (Day 30 geometric mean concentration [GMC] / Day 1 GMC) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype was calculated. Concentrations of each pneumococcal serotype were determined using pneumococcal electrochemiluminescence. | Baseline (Day 1) and Day 30 after vaccination |
| Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) | The OPA GMTs of each pneumococcal serotype were calculated on Day 1 (baseline) and Day 30 after vaccination. Titer levels were determined with multiplexed OPA (MOPA-4). | Baseline (Day 1) and Day 30 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 |
|---|---|---|---|
| 30427749 | Derived | Peterson JT, Stacey HL, MacNair JE, Li J, Hartzel JS, Sterling TM, Benner P, Tamms GM, Musey LK. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine compared to 13-valent pneumococcal conjugate vaccine in adults >/=65 years of age previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Hum Vaccin Immunother. 2019;15(3):540-548. doi: 10.1080/21645515.2018.1532250. Epub 2018 Nov 14. |
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Participants were recruited at 17 study centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | V114 | Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of V114 on Day 1. |
| FG001 | Prevnar 13™ | Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | V114 | Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of V114 on Day 1. |
| BG001 | Prevnar 13™ |
| 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) | An AE is any untoward medical occurrence in a participant 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 Day 44 after vaccination |
|
Nonserious AEs were monitored for up to 14 days after vaccination. Deaths and serious AEs (SAEs) were monitored up to 30 days after vaccination.
All participants who received study vaccination are included in the safety analysis.
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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 | Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of V114 on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 19.0 | 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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| Prevnar 13™ | Biological | Prevnar 13™ contains 2.2 μg of serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F, and 4.4 μg of serotype 6B; and 34 μg of CRM₁₉₇ and 125 μg of aluminum per 0.5mL dose. |
|
The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMCs of each pneumococcal serotype was calculated. Concentrations of each pneumococcal serotype were determined using pneumococcal electrochemiluminescence. |
| Baseline (Day 1) and Day 30 after vaccination |
| Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) |
The GMFR (Day 30 GMT / Day 1 GMT) from baseline (Day 1) to Day 30 of each OPA serotype was calculated. Titer levels were determined with multiplexed OPA (MOPA-4). |
| Baseline (Day 1) and Day 30 after vaccination |
| Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) | 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 with multiplexed OPA (MOPA-4). | Baseline (Day 1) and Day 30 after vaccination |
Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| Primary | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Solicited injection-site AEs consisted of erythema/redness, swelling, and pain/tenderness. | All participants who received study vaccination are included. | Posted | Number | Percentage of Participants | Up to Day 5 after vaccination |
|
|
|
| Primary | Percentage of Participants With a Solicited Systemic Adverse Event (AE) | Solicited systemic AEs consisted of fatigue, arthralgia, myalgia, and headache. | All participants who received study vaccination are included. | Posted | Number | Percentage of Participants | Up to Day 14 after vaccination |
|
|
|
|
| Primary | Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) | The IgG GMCs of each pneumococcal serotype were calculated on Day 1 (baseline) and Day 30 after vaccination. Concentrations were determined using pneumococcal electrochemiluminescence. | Randomized and vaccinated participants with no protocol violations are included. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Baseline (Day 1) and Day 30 after vaccination |
|
|
|
| Primary | Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) | The GMFR (Day 30 geometric mean concentration [GMC] / Day 1 GMC) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype was calculated. Concentrations of each pneumococcal serotype were determined using pneumococcal electrochemiluminescence. | Randomized and vaccinated participants with no protocol violations, and with data for both Day 1 and Day 30, are included. | Posted | Geometric Mean | 95% Confidence Interval | GMFR | Baseline (Day 1) and Day 30 after vaccination |
|
|
|
| Primary | Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) | The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMCs of each pneumococcal serotype was calculated. Concentrations of each pneumococcal serotype were determined using pneumococcal electrochemiluminescence. | Randomized and vaccinated participants with no protocol violations, and with data for both Day 1 and Day 30, are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline (Day 1) and Day 30 after vaccination |
|
|
|
| Secondary | Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) | The OPA GMTs of each pneumococcal serotype were calculated on Day 1 (baseline) and Day 30 after vaccination. Titer levels were determined with multiplexed OPA (MOPA-4). | Randomized and vaccinated participants with no protocol violations are included. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Baseline (Day 1) and Day 30 after vaccination |
|
|
|
| Secondary | Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) | The GMFR (Day 30 GMT / Day 1 GMT) from baseline (Day 1) to Day 30 of each OPA serotype was calculated. Titer levels were determined with multiplexed OPA (MOPA-4). | Randomized and vaccinated participants with no protocol violations, and with data for both Day 1 and Day 30, are included. | Posted | Geometric Mean | 95% Confidence Interval | GMFR | Baseline (Day 1) and Day 30 after vaccination |
|
|
|
| Secondary | Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) | 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 with multiplexed OPA (MOPA-4). | Randomized and vaccinated participants with no protocol violations, and with data for both Day 1 and Day 30, are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline (Day 1) and Day 30 after vaccination |
|
|
|
| 0 |
| 127 |
| 0 |
| 127 |
| 86 |
| 127 |
| EG001 | Prevnar 13® | Participants (≥65 years of age) who were vaccinated previously (≥1 year ago) with 23-valent pneumococcal polysaccharide vaccine received a single 0.5 mL intramuscular injection of Prevnar 13™ on Day 1. | 0 | 126 | 2 | 126 | 74 | 126 |
| Periprosthetic fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.0 | 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 |
| Tenderness/Pain |
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| Myalgia |
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| Headache |
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| Arthralgia difference |
| -3.2 |
| 2-Sided |
| 95 |
| -10.2 |
| 3.4 |
Difference and 95% CI calculated based on the Miettinen & Nurminen method. |
| Other |
Difference in % with arthralgia |
| Myalgia difference | 4.6 | 2-Sided | 95 | -3.9 | 13.3 | Difference and 95% CI calculated based on the Miettinen & Nurminen method. | Other | Difference in % with myalgia |
| Headache difference | -2.5 | 2-Sided | 95 | -11.4 | 6.4 | Difference and 95% CI calculated based on the Miettinen & Nurminen method. | Other | Difference in % with headache |
| Serotype 1 Day 30 |
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| Serotype 3 Day 1 |
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| Serotype 4 Day 1 |
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| Serotype 4 Day 30 |
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| Serotype 5 Day 1 |
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| Serotype 5 Day 30 |
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| Serotype 6A Day 1 |
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| Serotype 6A Day 30 |
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| Serotype 6B Day 1 |
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| Serotype 6B Day 30 |
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| Serotype 7F Day 1 |
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| Serotype 7F Day 30 |
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| Serotype 9V Day 1 |
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| Serotype 9V Day 30 |
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| Serotype 14 Day 1 |
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| Serotype 14 Day 30 |
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| Serotype 18C Day 1 |
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| Serotype 18C Day 30 |
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| Serotype 19A Day 1 |
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| Serotype 19A Day 30 |
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| Serotype 19F Day 1 |
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| Serotype 19F Day 30 |
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| Serotype 22F Day 1 |
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| Serotype 22F Day 30 |
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| Serotype 23F Day 1 |
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| Serotype 23F Day 30 |
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| Serotype 33F Day 1 |
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| Serotype 33F Day 30 |
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| Serotype 3 |
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| Serotype 4 |
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| Serotype 5 |
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| Serotype 6A |
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| Serotype 6B |
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| Serotype 7F |
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| Serotype 9V |
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| Serotype 14 |
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| Serotype 18C |
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| Serotype 19A |
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| Serotype 19F |
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| Serotype 22F |
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| Serotype 23F |
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| Serotype 33F |
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| Serotype 3 |
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| Serotype 4 |
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| Serotype 5 |
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| Serotype 6A |
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| Serotype 6B |
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| Serotype 7F |
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| Serotype 9V |
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| Serotype 14 |
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| Serotype 18C |
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| Serotype 19A |
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| Serotype 19F |
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| Serotype 22F |
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| Serotype 23F |
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| Serotype 33F |
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| Serotype 1 Day 30 |
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| Serotype 3 Day 1 |
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| Serotype 3 Day 30 |
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| Serotype 4 Day 1 |
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| Serotype 4 Day 30 |
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| Serotype 5 Day 1 |
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| Serotype 5 Day 30 |
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| Serotype 6A Day 1 |
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| Serotype 6A Day 30 |
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| Serotype 6B Day 1 |
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| Serotype 6B Day 30 |
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| Serotype 7F Day 1 |
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| Serotype 7F Day 30 |
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| Serotype 9V Day 1 |
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| Serotype 9V Day 30 |
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| Serotype 14 Day 1 |
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| Serotype 14 Day 30 |
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| Serotype 18C Day 1 |
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| Serotype 18C Day 30 |
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| Serotype 19A Day 1 |
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| Serotype 19A Day 30 |
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| Serotype 19F Day 1 |
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| Serotype 19F Day 30 |
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| Serotype 22F Day 1 |
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| Serotype 22F Day 30 |
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| Serotype 23F Day 1 |
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| Serotype 23F Day 30 |
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| Serotype 33F Day 1 |
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| Serotype 33F Day 30 |
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| Serotype 3 |
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| Serotype 4 |
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| Serotype 5 |
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| Serotype 6A |
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| Serotype 6B |
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| Serotype 7F |
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| Serotype 9V |
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| Serotype 14 |
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| Serotype 18C |
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| Serotype 19A |
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| Serotype 19F |
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| Serotype 22F |
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| Serotype 23F |
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| Serotype 33F |
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| Serotype 3 |
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| Serotype 4 |
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| Serotype 5 |
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| Serotype 6A |
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| Serotype 6B |
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| Serotype 7F |
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| Serotype 9V |
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| Serotype 14 |
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| Serotype 18C |
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| Serotype 19A |
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| Serotype 19F |
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| Serotype 22F |
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| Serotype 23F |
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| Serotype 33F |
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