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| ID | Type | Description | Link |
|---|---|---|---|
| 2006_557 |
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The purpose of the study was to assess the safety, tolerability, and immunogenicity of ZOSTAVAX™ in patients receiving chronic/maintenance corticosteroids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZOSTAVAX™ | Experimental | Participants administered ZOSTAVAX™ on Day 1. |
|
| Placebo | Placebo Comparator | Participants administered Placebo on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoster Vaccine, Live | Biological | A single dose of 0.65 ml Zoster Vaccine, Live, injected subcutaneously on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAE) | A serious adverse event is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement. | Up to 182 days postvaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibodies at 42 Days Postvaccination | The Geometric Mean Titer (GMT) of VZV antibodies in participants' serum samples was assessed by a glycoprotein enzyme-linked immunosorbent assay (gpELISA). | 42 days postvaccination |
| Geometric Mean Fold Rise (GMFR) of the VZV Antibody Response From Day 1 to Day 42 Postvaccination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25964168 | Result | Russell AF, Parrino J, Fisher CL Jr, Spieler W, Stek JE, Coll KE, Su SC, Xu J, Li X, Schlienger K, Silber JL. Safety, tolerability, and immunogenicity of zoster vaccine in subjects on chronic/maintenance corticosteroids. Vaccine. 2015 Jun 17;33(27):3129-34. doi: 10.1016/j.vaccine.2015.04.090. Epub 2015 May 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ZOSTAVAX™ | Participants administered ZOSTAVAX™ on Day 1. |
| FG001 | Placebo | Participants administered Placebo on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ZOSTAVAX™ | Participants administered ZOSTAVAX™ on Day 1. |
| BG001 | Placebo | Participants administered Placebo 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 | Number of Participants With Serious Adverse Events (SAE) | A serious adverse event is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement. | All participants who were vaccinated and had any safety follow-up were included in the safety analysis. | Posted | Number | Participants | Up to 182 days postvaccination |
|
Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
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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 | ZOSTAVAX™ | Participants administered ZOSTAVAX™ on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA 13.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 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 |
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| ID | Term |
|---|---|
| D053061 | Herpes Zoster Vaccine |
| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
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| Comparator: Placebo | Biological | A single dose of 0.65 ml Placebo to ZOSTAVAX™ injected subcutaneously on Day 1. |
|
The geometric mean fold rise (GMFR) of the VZV antibodies from Day 1 to Week 6 postvaccination. |
| 42 days postvaccination |
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Daily Corticosteroid Dose Stratum | Number | Participants |
|
Participants administered Placebo on Day 1. |
|
|
| Secondary | Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibodies at 42 Days Postvaccination | The Geometric Mean Titer (GMT) of VZV antibodies in participants' serum samples was assessed by a glycoprotein enzyme-linked immunosorbent assay (gpELISA). | Per-protocol population: All vaccinated participants who had serology results and who had no protocol deviations that would interfere with the evaluation of VZV-specific gpELISA antibody response. | Posted | Mean | 95% Confidence Interval | gpELISA units/mL | 42 days postvaccination |
|
|
|
| Secondary | Geometric Mean Fold Rise (GMFR) of the VZV Antibody Response From Day 1 to Day 42 Postvaccination. | The geometric mean fold rise (GMFR) of the VZV antibodies from Day 1 to Week 6 postvaccination. | Per-protocol population: All vaccinated participants who had serology results and who had no protocol deviations that would interfere with the evaluation of VZV-specific gpELISA antibody response. | Posted | Mean | 95% Confidence Interval | Ratio | 42 days postvaccination |
|
|
|
| 21 |
| 204 |
| 43 |
| 204 |
| EG001 | Placebo | Participants administered Placebo on Day 1. | 11 | 99 | 10 | 99 |
| Cardiac arrest | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypertensive heart disease | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA 13.0 | Systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Inguinal hernia, obstructive | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Cellulitis of male external genital organ | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Gastritis viral | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Herpes zoster ophthalmic | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Kidney infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Scrotal abscess | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Complex regional pain syndrome | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Bipolar disorder | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 13.0 | Systematic Assessment |
|
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. SPONSOR review can be expedited to meet publication guidelines.
| D007239 | Infections |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |