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The purpose of this study is to determine if Pneumovax™ 23 (V110) is safe and immunogenic in participants from the Russian population who are 50 years of age and older or 2 to 49 years of age and at increased risk for pneumococcal disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pneumovax™ 23: Participants Between 2 and 49 Years | Experimental | Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1 |
|
| Pneumovax™ 23: Participants >=50 Years | Experimental | Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumovax™ 23 | Biological | Vaccine contains 25 µg of each of the 23 pneumococcal polysaccharides serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays | Prevaccination and Day 28 after vaccination |
| Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. A >=2-fold increase in serum antibody is a marker for serologic response to pneumococcal vaccination in adults. | Day 28 postvaccination |
| Number of Participants With Elevated Body Temperature (>=37.6 °C Axillary / >=38.0 °C Oral or Equivalent) | Up to 5 days postvaccination | |
| Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by >=4 Participants | 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 of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE. Injection-site or systemic AEs that occurred in >=4 participants were reported for this endpoint. | Up to Day 14 postvaccination |
| Number of Participants Reporting Serious Adverse Experiences | A serious AE (SAE) is an AE that 1) results in death, 2) is life threatening, 3) results in a persistent or significant disability or incapacity, 4) results in or prolongs an existing inpatient hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) is another important medical event which, based on appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention |
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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 |
|---|---|---|---|
| 27149114 | Result | Ciprero K, Zykov KA, Briko NI, Shekar T, Sterling TM, Bitieva E, Stek JE, Musey L. Safety and immunogenicity of a single dose 23-valent pneumococcal polysaccharide vaccine in Russian subjects. Hum Vaccin Immunother. 2016 Aug 2;12(8):2142-2147. doi: 10.1080/21645515.2016.1165373. Epub 2016 May 5. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pneumovax™ 23: Participants Between 2 and 49 Years | Participants received a single 0.5 mL intramuscular injection on Day 1 |
| FG001 | Pneumovax™ 23: Participants >=50 Years | Participants received a single 0.5 mL intramuscular injection on Day 1 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pneumovax™ 23: Participants Between 2 and 49 Years | Participants received a single 0.5 mL intramuscular injection on Day 1 |
| BG001 | Pneumovax™ 23: Participants >=50 Years | Participants received a single 0.5 mL intramuscular injection on Day 1 |
| 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 | Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays | The per protocol immunogenicity population included all enrolled participants except 2 who were excluded because blood samples were collected outside the allowable day range | Posted | Mean | 95% Confidence Interval | ug/mL | Prevaccination and Day 28 after vaccination |
|
All adverse experiences were collected through Day 14 postvaccination; serious adverse experiences were collected through Day 28 postvaccination
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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 | Pneumovax™ 23 | Participants received a single 0.5 mL intramuscular injection on Day 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA 16.1 |
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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 |
|---|---|
| C006045 | 2,4,5,4'-tetrachlorodiphenylsulfoxide |
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|
| Up to Day 28 postvaccination |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants received a single 0.5 mL intramuscular injection on Day 1
|
|
| Primary | Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine | Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. A >=2-fold increase in serum antibody is a marker for serologic response to pneumococcal vaccination in adults. | The per protocol immunogenicity population included all enrolled participants except 2 who were excluded because blood samples were collected outside the allowable day range | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 28 postvaccination |
|
|
|
| Primary | Number of Participants With Elevated Body Temperature (>=37.6 °C Axillary / >=38.0 °C Oral or Equivalent) | The All Subjects as Treated population included all enrolled participants | Posted | Number | Number of participants | Up to 5 days postvaccination |
|
|
|
| Primary | Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by >=4 Participants | 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 of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE. Injection-site or systemic AEs that occurred in >=4 participants were reported for this endpoint. | The All Subjects as Treated population included all enrolled participants | Posted | Number | Number of participants | Up to Day 14 postvaccination |
|
|
|
| Primary | Number of Participants Reporting Serious Adverse Experiences | A serious AE (SAE) is an AE that 1) results in death, 2) is life threatening, 3) results in a persistent or significant disability or incapacity, 4) results in or prolongs an existing inpatient hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) is another important medical event which, based on appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention | The All Subjects as Treated population included all enrolled participants | Posted | Number | Number of participants | Up to Day 28 postvaccination |
|
|
|
| 0 |
| 102 |
| 14 |
| 102 |
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.
| D007239 | Infections |
| Serotype 14 |
|
| Serotype 19F |
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| Serotype 23F |
|