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This study will determine whether ZOSTAVAXâ„¢ made with an alternative manufacturing process [ZOSTAVAXâ„¢ (AMP)] is well tolerated and immunogenic, and has a comparable immune response to ZOSTAVAXâ„¢.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZOSTAVAXâ„¢ (AMP) | Experimental | ZOSTAVAXâ„¢ manufactured with an alternative process |
|
| ZOSTAVAXâ„¢ | Active Comparator | ZOSTAVAXâ„¢ manufactured with the current process |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoster Vaccine, Live (AMP) | Biological | One approximately 0.65-mL injection subcutaneously on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibody | VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA) | Day 1 and Week 6 postvaccination |
| Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers | VZV antibody titers were determined by gpELISA. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 6 / Day 1 (Baseline). | Day 1 (Baseline) to Week 6 postvaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Adverse Experiences (AEs) | 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 study vaccine is also an adverse experience. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37781954 | Derived | de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5. |
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One participant in the ZOSTAVAXâ„¢ (AMP) group was randomized but not vaccinated, making the number of participants vaccinated in this group 331
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| ID | Title | Description |
|---|---|---|
| FG000 | ZOSTAVAXâ„¢ (AMP) | Zoster Vaccine, Live Alternative Manufacturing Process (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1 |
| FG001 | ZOSTAVAXâ„¢ | Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1 Through Day 42 Follow-up |
|
| ||||||||||||||||||||||||
| Day 43 Through Day 182 Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ZOSTAVAXâ„¢ (AMP) | Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1 |
| BG001 | ZOSTAVAXâ„¢ | Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously 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 Titer (GMT) of Varicella-Zoster Virus (VZV) Antibody | 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 antibody response, developed suspected varicella or herpes zoster rashes before blood sampling, or reported an exposure to varicella or herpes zoster | Posted | Geometric Mean | 95% Confidence Interval | Units/mL | Day 1 and Week 6 postvaccination |
|
Serious Adverse Events: Day 1 to Day 182 postvaccination; Other Adverse Events: Day 1 to Day 42 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 | ZOSTAVAXâ„¢ (AMP) | Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bile duct stone | Hepatobiliary disorders | MedDRA (15.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection-site erythema | General disorders | MedDRA (15.0) |
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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 |
| D000249 | Adenosine Monophosphate |
| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
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| Zoster Vaccine, Live | Biological | One approximately 0.65-mL injection subcutaneously on Day 1 |
|
|
| Day 1 to Day 42 postvaccination |
| Number of Participants With One or More Serious Adverse Experience (SAE) Day 1 to 42 Postvaccination | An SAE 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 | Day 1 to Day 42 postvaccination |
| Number of Participants With One or More Serious Adverse Experience Day 1 to 182 Postvaccination | An SAE 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 | Day 1 to Day 182 postvaccination |
| Withdrawal by Subject |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
|
|
|
| Primary | Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers | VZV antibody titers were determined by gpELISA. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 6 / Day 1 (Baseline). | Analysis included all vaccinated participants except those who had protocol deviations that interfered with the assessment of antibody response, developed suspected varicella or herpes zoster rashes before blood sampling, or reported an exposure to varicella or herpes zoster. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Day 1 (Baseline) to Week 6 postvaccination |
|
|
|
|
| Secondary | Number of Participants With One or More Adverse Experiences (AEs) | 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 study vaccine is also an adverse experience. | Analysis included all vaccinated participants with safety follow-up data. One participant in the AMP vaccine group was vaccinated but lost to follow-up without safety follow-up. | Posted | Number | Participants | Day 1 to Day 42 postvaccination |
|
|
|
| Secondary | Number of Participants With One or More Serious Adverse Experience (SAE) Day 1 to 42 Postvaccination | An SAE 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 | Analysis included all vaccinated participants with safety follow-up data. One participant in the AMP vaccine group was vaccinated but lost to follow-up without safety follow-up. | Posted | Number | Participants | Day 1 to Day 42 postvaccination |
|
|
|
| Secondary | Number of Participants With One or More Serious Adverse Experience Day 1 to 182 Postvaccination | An SAE 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 | Analysis included all vaccinated participants with safety follow-up data. One participant in the AMP vaccine group was vaccinated but lost to follow-up without safety follow-up. | Posted | Number | Participants | Day 1 to Day 182 postvaccination |
|
|
|
| 4 |
| 330 |
| 186 |
| 330 |
| EG001 | ZOSTAVAXâ„¢ | Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1 | 8 | 166 | 85 | 166 |
| Traumatic liver injury | Injury, poisoning and procedural complications | MedDRA (15.0) |
|
| Psychotic disorder | Psychiatric disorders | MedDRA (15.0) |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (15.0) |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (15.0) |
|
| Acquired oesophageal web | Gastrointestinal disorders | MedDRA (15.0) |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (15.0) |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA (15.0) |
|
| Cholangitis | Hepatobiliary disorders | MedDRA (15.0) |
|
| Gallbladder perforation | Hepatobiliary disorders | MedDRA (15.0) |
|
| Enterocolitis infectious | Infections and infestations | MedDRA (15.0) |
|
| Gastroenteritis salmonella | Infections and infestations | MedDRA (15.0) |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA (15.0) |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (15.0) |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) |
|
| Depression | Psychiatric disorders | MedDRA (15.0) |
|
| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) |
|
| Injection-site pain | General disorders | MedDRA (15.0) |
|
| Injection-site pruritus | General disorders | MedDRA (15.0) |
|
| Injection-site swelling | General disorders | MedDRA (15.0) |
|
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 |
| D000227 | Adenine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |