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| ID | Type | Description | Link |
|---|---|---|---|
| V212-013 | Other Identifier | Merck Protocol Number | |
| 2011-003153-25 | EudraCT Number |
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An open-label, multicenter study to evaluate the safety and immunogenicity of inactivated VZV vaccine (V212) in participants with hematologic malignancies (HM) who are currently receiving anti-CD20 monoclonal antibodies. The primary hypothesis is that vaccination with V212 vaccine will elicit significant VZV-specific immune responses at ~28 days after vaccination 4. The statistical criterion for significance requires that the lower bound of the 2-sided 90% confidence interval of the geometric mean fold rise in immune response in V212 recipients is >1.0.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V212 | Experimental | Participants receive V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V212 | Biological | V212 viral antigen for HZ |
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| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) of the VZV-specific Immune Responses Measured by VZV Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISPOT) | The VZV ELISPOT assay detects IFN-γ-secreting, VZV-specific cells from peripheral blood mononuclear cells (PBMCs). The unit of measure of the assay is ELISPOT cell count / 10^6 PBMCs, and is expressed as geometric mean count (GMC). The GMFR is GMC at ~28 days after Vaccination 4 / GMC on Day 1. | Prevaccination (Day 1) and ~28 days after Vaccination 4 (~Day 118) |
| 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 study vaccine, 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 product is also an adverse experience. The percentage of participants with any AE was summarized. | Up to ~28 days after Vaccination 4 (~Day 118) |
| Percentage of Participants With an Injection-site 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 study vaccine, 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 product is also an adverse experience. The percentage of participants with any injection-site AE was summarized. | Up to 5 days after any vaccination |
| Percentage of Participants With a Systemic 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 study vaccine, 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 product is also an adverse experience. The percentage of participants with any systemic AE was summarized. |
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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 |
|---|---|---|---|
| 28268074 | Result | Parrino J, McNeil SA, Lawrence SJ, Kimby E, Pagnoni MF, Stek JE, Zhao Y, Chan IS, Kaplan SS. Safety and immunogenicity of inactivated varicella-zoster virus vaccine in adults with hematologic malignancies receiving treatment with anti-CD20 monoclonal antibodies. Vaccine. 2017 Mar 27;35(14):1764-1769. doi: 10.1016/j.vaccine.2016.10.055. Epub 2017 Mar 3. |
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A total of 88 participants were screened and 80 were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | V212 | Participants received V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Up to ~28 days after Vaccination 4 (~Day 118) |
| Percentage of Participants With a Serious Adverse Event | A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs an inpatient hospitalization, is a congenital anomaly or birth defect, is an overdose, is a cancer, or is another important medical event. The percentage of participants with any SAE was summarized. | Up to ~28 days after Vaccination 4 (~Day 118) |
| Percentage of Participants With a Vaccine-related Serious Adverse Event | A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs an inpatient hospitalization, is a congenital anomaly or birth defect, is an overdose, is a cancer, or is another important medical event. The percentage of participants with any SAE that was deemed by the investigator to be possibly, probably, or definitely related to study vaccine was summarized. | Up to ~28 days after Vaccination 4 (~Day 118) |
| Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event | An 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 study vaccine, 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 product is also an adverse experience. The percentage of participants with study vaccine withdrawn due to an AE was summarized. | Up to Vaccination 4 (~Day 90) |
| Vaccination 1 (Day 1) |
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| Vaccination 2 (~Day 30) |
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| Vaccination 3 (~Day 60) |
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| Vaccination 4 (~Day 90) |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | V212 | Participants received V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose |
| 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 | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 Fold Rise (GMFR) of the VZV-specific Immune Responses Measured by VZV Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISPOT) | The VZV ELISPOT assay detects IFN-γ-secreting, VZV-specific cells from peripheral blood mononuclear cells (PBMCs). The unit of measure of the assay is ELISPOT cell count / 10^6 PBMCs, and is expressed as geometric mean count (GMC). The GMFR is GMC at ~28 days after Vaccination 4 / GMC on Day 1. | Vaccinated participants having valid results at Baseline (Day 1) and/or at ~28 days after Vaccination 4. | Posted | Geometric Mean | 90% Confidence Interval | Ratio | Prevaccination (Day 1) and ~28 days after Vaccination 4 (~Day 118) |
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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 study vaccine, 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 product is also an adverse experience. The percentage of participants with any AE was summarized. | All enrolled participants | Posted | Number | Percentage of participants | Up to ~28 days after Vaccination 4 (~Day 118) |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With an Injection-site 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 study vaccine, 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 product is also an adverse experience. The percentage of participants with any injection-site AE was summarized. | All enrolled participants | Posted | Number | Percentage of participants | Up to 5 days after any vaccination |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With a Systemic 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 study vaccine, 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 product is also an adverse experience. The percentage of participants with any systemic AE was summarized. | All enrolled participants | Posted | Number | Percentage of participants | Up to ~28 days after Vaccination 4 (~Day 118) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With a Serious Adverse Event | A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs an inpatient hospitalization, is a congenital anomaly or birth defect, is an overdose, is a cancer, or is another important medical event. The percentage of participants with any SAE was summarized. | All enrolled participants | Posted | Number | Percentage of participants | Up to ~28 days after Vaccination 4 (~Day 118) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With a Vaccine-related Serious Adverse Event | A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs an inpatient hospitalization, is a congenital anomaly or birth defect, is an overdose, is a cancer, or is another important medical event. The percentage of participants with any SAE that was deemed by the investigator to be possibly, probably, or definitely related to study vaccine was summarized. | All enrolled participants | Posted | Number | Percentage of participants | Up to ~28 days after Vaccination 4 (~Day 118) |
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| Primary | Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event | An 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 study vaccine, 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 product is also an adverse experience. The percentage of participants with study vaccine withdrawn due to an AE was summarized. | All enrolled participants | Posted | Number | Percentage of participants | Up to Vaccination 4 (~Day 90) |
|
|
Up to Day 140
All participants who received at least one dose of V212
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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 | V212 | Participants received V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose | 1 | 80 | 12 | 80 | 67 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Candidiasis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Salmonellosis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Oesophageal squamous cell carcinoma stage 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Gastric ulcer | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Glossodynia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Lip blister | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Injection site haematoma | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Injection site movement impairment | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Injection site paraesthesia | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Injection site rash | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Mucosal dryness | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Spinal pain | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Hepatic cyst | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
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| Acariasis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Anal abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Trichophytosis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Viral tracheitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Vulvovaginal candidiasis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Jaw disorder | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
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| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
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| Carotid artery stenosis | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Motor dysfunction | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Peripheral motor neuropathy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Hallucination, auditory | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Pulmonary granuloma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Papule | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Rash vesicular | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Peripheral coldness | Vascular disorders | MedDRA 15.1 | 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 |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
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