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| Name | Class |
|---|---|
| University of Colorado, Denver | OTHER |
| Duke University | OTHER |
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This study was conducted to obtain safety and immunogenicity data after a booster dose of Zoster Vaccine, Live administered ≥10 years following an initial dose. This information was compared to similar information obtained after Zoster Vaccine, Live administration to age-matched and younger participants who received their first dose of Zoster Vaccine, Live. The study was designed to determine: 1) whether a booster dose of Zoster Vaccine, Live in participants ≥70 years of age induces an antibody response that is noninferior to that of a first dose of Zoster Vaccine, Live in participants matched for age; 2) whether a booster dose of Zoster Vaccine, Live induces an acceptable rise in the level of varicella-zoster virus (VZV) antibodies.
All participants were followed for one year after completion of the 42-day post-vaccination period while Groups 1 and 2 were followed for a total of three years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Booster Dose Participants ≥70 years of age | Experimental | Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 NCT00007501) |
|
| Group 2: First Dose Participants ≥70 years of age | Experimental | Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age |
|
| Group 3: First Dose Participants ≥60 and <70 years of age | Experimental | Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live |
|
| Group 4: First Dose Participants ≥50 and <60 years of age | Experimental | Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoster Vaccine, Live | Biological | Single approximately 0.65-mL subcutaneous injection of Zoster Vaccine, Live on Day 1 of the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV) | VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA) | Day 1 (Baseline) and Week 6 postvaccination |
| Geometric Mean Fold Rise (GMFR) From Day 1 (Baseline) to Week 6 Postvaccination in VZV Antibody Titers | VZV antibody titers were determined by gpELISA. The GMFR measures the rise in VZV antibodies from Day 1 (Baseline) to Week 6 postvaccination. | Day 1 (Baseline) and Week 6 postvaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting One or More Adverse Experiences | 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 study vaccine is also an adverse experience. A serious adverse experience is any AE that results in death, is life threatening, results in persistent disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention. Vaccine-related AEs were those assessed by the investigator as definitely, probably, or possibly related to vaccine administration. This outcome measure applies only to AEs collected after vaccination in Part 1 of the current study. |
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Inclusion Criteria:
All Groups:
Group 1:
Group 2:
Group 3:
Group 4:
Exclusion Criteria:
All Groups:
Groups 2, 3, and 4:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26452397 | Result | Levin MJ, Schmader KE, Pang L, Williams-Diaz A, Zerbe G, Canniff J, Johnson MJ, Caldas Y, Cho A, Lang N, Su SC, Parrino J, Popmihajlov Z, Weinberg A. Cellular and Humoral Responses to a Second Dose of Herpes Zoster Vaccine Administered 10 Years After the First Dose Among Older Adults. J Infect Dis. 2016 Jan 1;213(1):14-22. doi: 10.1093/infdis/jiv480. Epub 2015 Oct 9. | |
| 30165651 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Booster Dose Participants ≥70 Years of Age | Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1. |
| FG001 | Group 2: First Dose Participants ≥70 Years of Age | Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1. |
| FG002 | Group 3: First Dose Participants ≥60 and <70 Years of Age | Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1. |
| FG003 | Group 4: First Dose Participants ≥50 and <60 Years of Age | Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1: Day 1 to Week 52 (1 Year) |
|
| |||||||||||||||||||||
| Part 2: Week 156 (3 Year) Visit |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Booster Dose Participants ≥70 Years of Age | Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1. |
| BG001 |
| 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 Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV) | VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA) | Analysis included all vaccinated participants except those who had protocol deviations that interfered with the assessment of VZV antibody response, who developed varicella or herpes zoster rashes before a blood sample was taken, or who reported exposure to varicella or herpes zoster. The planned analysis included Group 1 versus Group 2 only. | Posted | Geometric Mean | 95% Confidence Interval | gpELISA Units/mL | Day 1 (Baseline) and Week 6 postvaccination |
|
Up to 42 days postvaccination: all AEs; Day 43 to Week 52: SAEs only; Week 156: SAEs only within 24 hours of the Week-156 blood draw (Groups 1 and 2 only)
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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 | Group 1: Booster Dose Participants ≥70 Years of Age | Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection-site erythema | General disorders | MedDRA (15.0) | 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 |
|---|---|
| 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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|
| Up to 42 days postvaccination |
| Weinberg A, Popmihajlov Z, Schmader KE, Johnson MJ, Caldas Y, Salazar AT, Canniff J, McCarson BJ, Martin J, Pang L, Levin MJ. Persistence of Varicella-Zoster Virus Cell-Mediated Immunity After the Administration of a Second Dose of Live Herpes Zoster Vaccine. J Infect Dis. 2019 Jan 7;219(2):335-338. doi: 10.1093/infdis/jiy514. |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Group 2: First Dose Participants ≥70 Years of Age |
Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1. |
| BG002 | Group 3: First Dose Participants ≥60 and <70 Years of Age | Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1. |
| BG003 | Group 4: First Dose Participants ≥50 and <60 Years of Age | Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Group 2: First Dose Participants ≥70 Years of Age | Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1. |
|
|
|
| Primary | Geometric Mean Fold Rise (GMFR) From Day 1 (Baseline) to Week 6 Postvaccination in VZV Antibody Titers | VZV antibody titers were determined by gpELISA. The GMFR measures the rise in VZV antibodies from Day 1 (Baseline) to Week 6 postvaccination. | Analysis included all vaccinated participants except those who had protocol deviations that interfered with the assessment of VZV antibody response, who developed varicella or herpes zoster rashes before a blood sample was taken, or who reported exposure to varicella or herpes zoster. The planned analysis included Group 1 only. | Posted | Geometric Mean | 95% Confidence Interval | Fold Rise | Day 1 (Baseline) and Week 6 postvaccination |
|
|
|
|
| Secondary | Number of Participants Reporting One or More Adverse Experiences | 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 study vaccine is also an adverse experience. A serious adverse experience is any AE that results in death, is life threatening, results in persistent disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention. Vaccine-related AEs were those assessed by the investigator as definitely, probably, or possibly related to vaccine administration. This outcome measure applies only to AEs collected after vaccination in Part 1 of the current study. | Analysis included all vaccinated participants who had any safety follow-up | Posted | Number | Participants | Up to 42 days postvaccination |
|
|
|
| 29 |
| 201 |
| 76 |
| 201 |
| EG001 | Group 2: First Dose Participants ≥70 Years of Age | Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1. | 29 | 199 | 58 | 199 |
| EG002 | Group 3: First Dose Participants ≥60 and <70 Years of Age | Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1. | 6 | 100 | 61 | 100 |
| EG003 | Group 4: First Dose Participants ≥50 and <60 Years of Age | Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1. | 2 | 100 | 62 | 100 |
| Ileus | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Pelvic abscess | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Wound haemorrhage | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Dementia Alzheimer's type | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Cardiovascular disorder | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Femoral hernia | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Large intestinal ulcer haemorrhage | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Localised intraabdominal fluid collection | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pancreatic pseudocyst | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Appendicitis perforated | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Incisional hernia, obstructive | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Chronic lymphocytic leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Lung adenocarcinoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Plasma cell myeloma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Pleural mesothelioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Cervical radiculopathy | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Aortic dissection | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
| Injection-site pain | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Injection-site pruritus | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Injection-site swelling | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (15.0) | 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. Any information identified by the Sponsor as confidential must be deleted prior to submission.
| D007239 | Infections |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |
| Injection-site Adverse Event |
|
| Non-Injection-site Adverse Event |
|
| Serious Adverse Event |
|
| Vaccine-related Serious Adverse Event |
|