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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004542-18 | Other Identifier | EudraCT Number | |
| V114-002 | Other Identifier | Merck Protocol Number |
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The purpose of the study is to see if an investigational vaccine for Streptococcus pneumonia disease (V114) has comparable safety, tolerability, and antibody response to Pneumococcal Polysaccharide Vaccine (PNEUMOVAX® 23) and 13-valent Pneumococcal Conjugate Vaccine (PREVNAR 13®) when administered to healthy adults 50 years of age or older.
The primary hypothesis is the serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) as measured by the pneumococcal electrochemiluminescence (Pn ECL) assay at one month postvaccination in subjects who receive V114 will be noninferior to those measured in subjects who receive PNEUMOVAX® 23.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V114 | Experimental | Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1. |
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| PNEUMOVAX® 23 | Active Comparator | Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1. |
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| PREVNAR 13® | Active Comparator | Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumococcal Conjugate Vaccine (V114) | Biological | 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Adverse Event | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience. | All AEs: up to 14 days after vaccination; Serious Adverse Events (SAEs): up to 6 months after vaccination |
| Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | Injection-site AEs reported by >=2% of participants in one or more vaccination groups were assessed. | Up to Day 14 postvaccination |
| Percentage of Participants With a Systemic Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | Systemic AEs reported by >=2% of participants in one or more vaccination groups were assessed. | Up to Day 14 postvaccination |
| Percentage of Participants With a Serious Adverse Event | A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. | Up to 6 months postvaccination |
| Percentage of Participants With a Vaccine-related Serious Adverse Event | A SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs deemed by the investigator to be possibly, probably, or definitely related to study vaccine were reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay (MOPA-4) | One month postvaccination |
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Inclusion Criteria:
-Without fever for 72 hours prior to vaccination
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 |
|---|---|---|---|
| 29559167 | Derived | Ermlich SJ, Andrews CP, Folkerth S, Rupp R, Greenberg D, McFetridge RD, Hartzel J, Marchese RD, Stek JE, Abeygunawardana C, Musey LK. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults >/=50 years of age. Vaccine. 2018 Oct 29;36(45):6875-6882. doi: 10.1016/j.vaccine.2018.03.012. Epub 2018 Mar 17. |
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This trial was conducted at 25 trial centers: 10 in the United States; 2 in Canada; 2 in Denmark; 2 in Israel; 2 in Norway, 3 in Poland, 2 in Spain and 2 in Sweden.
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| ID | Title | Description |
|---|---|---|
| FG000 | V114 | Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1. |
| FG001 | PNEUMOVAX® 23 | Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| PNEUMOVAX® 23 | Biological | 23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose. |
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| PREVNAR 13® | Biological | 13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B (4.4 mcg each) and aluminum phosphate adjuvant (125 mcg) in each 0.5. mL dose. |
|
| Up to 6 months postvaccination |
| Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence (ECL) assay. | One month postvaccination |
| FG002 | PREVNAR 13® | Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1. |
| Vaccinated |
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| COMPLETED |
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| NOT COMPLETED |
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The baseline analysis population consisted of all randomized participants who received study vaccine.
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| ID | Title | Description |
|---|---|---|
| BG000 | V114 | Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1. |
| BG001 | PNEUMOVAX® 23 | Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1. |
| BG002 | PREVNAR 13® | Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1. |
| BG003 | 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, Customized | Count of Participants | Participants |
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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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With an Adverse Event | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience. | The analysis population consisted of those participants who received study vaccination and had safety follow-up. | Posted | Number | Percentage of Participants | All AEs: up to 14 days after vaccination; Serious Adverse Events (SAEs): up to 6 months after vaccination |
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| Primary | Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | Injection-site AEs reported by >=2% of participants in one or more vaccination groups were assessed. | The analysis population consisted of those participants who received study vaccination and had safety follow-up. | Posted | Number | Percentage of Participants | Up to Day 14 postvaccination |
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| Primary | Percentage of Participants With a Systemic Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups | Systemic AEs reported by >=2% of participants in one or more vaccination groups were assessed. | The analysis population consisted of those participants who received study vaccination and had safety follow-up. | Posted | Number | Percentage of Participants | Up to Day 14 postvaccination |
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| Primary | Percentage of Participants With a Serious Adverse Event | A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. | The analysis population consisted of those participants who received study vaccination and had safety follow-up. | Posted | Number | Percentage of Participants | Up to 6 months postvaccination |
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| Primary | Percentage of Participants With a Vaccine-related Serious Adverse Event | A SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs deemed by the investigator to be possibly, probably, or definitely related to study vaccine were reported. | The analysis population consisted of those participants who received study vaccination and had safety follow-up. | Posted | Number | Percentage of Participants | Up to 6 months postvaccination |
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| Primary | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies | Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence (ECL) assay. | The analysis population consisted of those participants who were not considered to have violated important protocol requirements that could have impacted the validity of the antibody response measured following vaccination. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | One month postvaccination |
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| Secondary | Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies | OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay (MOPA-4) | The analysis population consisted of those participants who were not considered to have violated important protocol requirements that could have impacted the validity of the antibody response measured following vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titer | One month postvaccination |
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Up to 6 months postvaccination
The at-risk population consisted of all participants who received study vaccination and had safety follow-up.
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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 | Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1. | 0 | 229 | 4 | 229 | 167 | 229 |
| EG001 | PNEUMOVAX® 23 | Healthy adult participants received a single 0.5 mL intramuscular injection of PNEUMOVAX® 23 on Day 1. | 1 | 230 | 7 | 230 | 149 | 230 |
| EG002 | PREVNAR 13® | Healthy adult participants received a single 0.5 mL intramuscular injection of PREVNAR 13® on Day 1. | 0 | 230 | 5 | 230 | 141 | 230 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Coronary artery occlusion | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 16.0 | Systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Death | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Anal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
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| Benign urinary tract neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
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| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
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| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
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The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
| 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 |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| C538862 | 13-valent pneumococcal vaccine |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| 65 to 74 years |
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| >= 75 years |
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| 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 |
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| Unknown or Not Reported |
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| Risk Difference (RD) |
| 9.5 |
| 2-Sided |
| 95 |
| 1.1 |
| 17.7 |
| Other |
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| Participants |
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