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| ID | Type | Description | Link |
|---|---|---|---|
| 152859 | Registry Identifier | JAPIC-CTI |
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The purpose of this study is to determine if revaccination with pneumococcal vaccine (PNEUMOVAX™ 23, V110) is well tolerated and produces an immune response in older Japanese adults. The primary hypothesis being tested is that the geometric mean concentration of antibodies to pneumococcal polysaccharide serotypes 3, 6B, and 23F at 4 weeks after revaccination will be superior to that before revaccination in Japanese adults who received a primary vaccination at least 5 years before revaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Revaccination Group | Experimental | 0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior |
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| Primary Vaccination Group | Experimental | 0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PNEUMOVAX™ 23 | Biological | PNEUMOVAX™ 23 (23-Valent Pneumococcal Polysaccharide Vaccination, V110, PPV23) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Revaccination | Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline. | Baseline and 4 weeks after revaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Primary Vaccination | Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline. |
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Inclusion 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 |
|---|---|---|---|
| 27265450 | Result | Kawakami K, Kishino H, Kanazu S, Toshimizu N, Takahashi K, Sterling T, Wang M, Musey L. Revaccination with 23-valent pneumococcal polysaccharide vaccine in the Japanese elderly is well tolerated and elicits immune responses. Vaccine. 2016 Jul 19;34(33):3875-81. doi: 10.1016/j.vaccine.2016.05.052. Epub 2016 Jun 10. |
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Depending on prior history of Pneumovax™ 23 vaccination, 161 participants with a history of prior Pneumovax™ 23 vaccination were enrolled into the Revaccination group and 82 participants without a history of prior Pneumovax™ vaccination were enrolled into the Primary vaccination group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Revaccination Group | 0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior. |
| FG001 | Primary Vaccination Group | 0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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One participant in the Primary Vaccination Group was withdrawn from the study before vaccination because of a protocol violation. Baseline Characteristics are based on the Full Analysis Set: participants who received at least one vaccination.
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| ID | Title | Description |
|---|---|---|
| BG000 | Revaccination Group | 0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior. |
| BG001 | Primary Vaccination Group |
| 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 |
| 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 | Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Revaccination | Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline. | Per Protocol Set: all participants in the Revaccination Group except those with a protocol deviation, including those with blood collection outside the protocol-specified window. | Posted | Geometric Mean | 95% Confidence Interval | Geometric Mean Fold Rise | Baseline and 4 weeks after revaccination |
|
All adverse events: up to 14 days after vaccination; deaths and vaccine-related serious adverse events: up to 36 days after vaccination
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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 | Revaccination Group | 0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection-site erythema | General disorders | MedDRA 17.1 | 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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| Baseline and 4 weeks after primary vaccination |
| Percentage of Participants With an Adverse Event of Injection-site Erythema | An adverse event is 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. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site erythema recorded on the Vaccine Report Card (VRC) during the first 5 days after vaccination was recorded. | Up to 5 days after vaccination |
| Percentage of Participants With an Adverse Event of Injection-site Swelling | An adverse event is 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. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site swelling recorded on the VRC during the first 5 days after vaccination was recorded. | Up to 5 days after vaccination |
| Percentage of Participants With an Adverse Event of Injection-site Pain | An adverse event is 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. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site pain recorded on the VRC during the first 5 days after vaccination was recorded. | Up to 5 days after vaccination |
| Percentage of Participants With an Adverse Event of Pyrexia | Percentage of participants with an adverse event of pyrexia (>=37.5°C, oral) recorded on the VRC during the first 5 days after vaccination was recorded. | Up to 5 days after vaccination |
| Percentage of Participants With an Adverse Event of Myalgia | An adverse event is 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. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of myalgia recorded on the VRC during the first 14 days after vaccination was recorded. | Up to 14 days after vaccination |
| Percentage of Participants With an Adverse Event of Arthralgia | An adverse event is 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. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of arthralgia recorded on the VRC during the first 14 days after vaccination was recorded. | Up to 14 days after vaccination |
| Percentage of Participants With an Adverse Event of Headache | An adverse event is 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. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of headache recorded on the VRC during the first 14 days after vaccination was recorded. | Up to 14 days after vaccination |
| Percentage of Participants With an Adverse Event of Fatigue | An adverse event is 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. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of fatigue recorded on the VRC during the first 14 days after vaccination was recorded. | Up to 14 days after vaccination |
0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Primary Vaccination | Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline. | Per Protocol Set: all participants in the Primary Vaccination Group except those with a protocol deviation, including those with blood collection outside the protocol-specified window | Posted | Geometric Mean | 95% Confidence Interval | Geometric Mean Fold Rise | Baseline and 4 weeks after primary vaccination |
|
|
|
| Secondary | Percentage of Participants With an Adverse Event of Injection-site Erythema | An adverse event is 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. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site erythema recorded on the Vaccine Report Card (VRC) during the first 5 days after vaccination was recorded. | All Subjects as Treated set: all participants who received study vaccine. | Posted | Number | Percentage of participants | Up to 5 days after vaccination |
|
|
|
| Secondary | Percentage of Participants With an Adverse Event of Injection-site Swelling | An adverse event is 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. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site swelling recorded on the VRC during the first 5 days after vaccination was recorded. | All Subjects as Treated set: all participants who received study vaccine. | Posted | Number | Percentage of participants | Up to 5 days after vaccination |
|
|
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| Secondary | Percentage of Participants With an Adverse Event of Injection-site Pain | An adverse event is 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. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site pain recorded on the VRC during the first 5 days after vaccination was recorded. | All Subjects as Treated set: all participants who received study vaccine. | Posted | Number | Percentage of participants | Up to 5 days after vaccination |
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| Secondary | Percentage of Participants With an Adverse Event of Pyrexia | Percentage of participants with an adverse event of pyrexia (>=37.5°C, oral) recorded on the VRC during the first 5 days after vaccination was recorded. | All Subjects as Treated set: all participants who received study vaccine. | Posted | Number | Percentage of participants | Up to 5 days after vaccination |
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|
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| Secondary | Percentage of Participants With an Adverse Event of Myalgia | An adverse event is 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. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of myalgia recorded on the VRC during the first 14 days after vaccination was recorded. | All Subjects as Treated set: all participants who received study vaccine. | Posted | Number | Percentage of participants | Up to 14 days after vaccination |
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| Secondary | Percentage of Participants With an Adverse Event of Arthralgia | An adverse event is 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. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of arthralgia recorded on the VRC during the first 14 days after vaccination was recorded. | All Subjects as Treated set: all participants who received study vaccine. | Posted | Number | Percentage of participants | Up to 14 days after vaccination |
|
|
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| Secondary | Percentage of Participants With an Adverse Event of Headache | An adverse event is 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. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of headache recorded on the VRC during the first 14 days after vaccination was recorded. | All Subjects as Treated set: all participants who received study vaccine. | Posted | Number | Percentage of participants | Up to 14 days after vaccination |
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| Secondary | Percentage of Participants With an Adverse Event of Fatigue | An adverse event is 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. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of fatigue recorded on the VRC during the first 14 days after vaccination was recorded. | All Subjects as Treated set: all participants who received study vaccine. | Posted | Number | Percentage of participants | Up to 14 days after vaccination |
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| 4 |
| 161 |
| 113 |
| 161 |
| EG001 | Primary Vaccination Group | 0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination. | 0 | 81 | 41 | 81 |
| Herpes virus infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Injection-site pain | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Injection-site pruritus | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Injection-site swelling | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
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The investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial.
| D007239 | Infections |
| Title | Measurements |
|---|---|
|