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| ID | Type | Description | Link |
|---|---|---|---|
| ZTV03C | Other Identifier | MCMVaccBV (SPMSD) Protocol Number | |
| V211-045 | Other Identifier | Merck Protocol Number | |
| 2009-012458-19 | EudraCT Number |
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PRIMARY OBJECTIVES
Two co-primary objectives are:
SECONDARY OBJECTIVES
Immunogenicity objectives
Safety objective
- To describe the safety profile of ZOSTAVAX administered by IM or SC route
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZOSTAVAX intramuscular (IM) route | Experimental | Single dose of 0.65 mL via IM injection |
|
| ZOSTAVAX subcutaneous (SC) route | Active Comparator | Single dose of 0.65 mL via SC injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZOSTAVAX | Biological | 1 dose 0.65 mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titre (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks Post-vaccination | Blood samples taken at 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via Glycoprotein Enzyme Linked Immunosorbent Assay (gpELISA). | 4 week post-vaccination |
| Geometric Mean Fold Rise (GMFR) in VZV Antibody Titre: IM Route | Blood sample taken at predose (Day 0) and 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination | Pre-vaccination (Day 0) and 4 week post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) in VZV Antibody Titre: SC Route | Blood sample taken at predose (Day 0) and 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-vaccination/GMT Pre-vaccination | Pre-vaccination (Day 0) and 4 week post-vaccination |
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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 |
|---|---|---|---|
| 25555381 | Result | Diez-Domingo J, Weinke T, Garcia de Lomas J, Meyer CU, Bertrand I, Eymin C, Thomas S, Sadorge C. Comparison of intramuscular and subcutaneous administration of a herpes zoster live-attenuated vaccine in adults aged >/=50 years: a randomised non-inferiority clinical trial. Vaccine. 2015 Feb 4;33(6):789-95. doi: 10.1016/j.vaccine.2014.12.024. Epub 2014 Dec 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ZOSTAVAX Intramuscular (IM) Route | Single dose of 0.65 mL via IM injection |
| FG001 | ZOSTAVAX Subcutaneous (SC) Route | Single dose of 0.65 mL via SC injection |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ZOSTAVAX Intramuscular (IM) Route | Single dose of 0.65 mL via IM injection |
| BG001 | ZOSTAVAX Subcutaneous (SC) Route | Single dose of 0.65 mL via SC injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 Titre (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks Post-vaccination | Blood samples taken at 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via Glycoprotein Enzyme Linked Immunosorbent Assay (gpELISA). | All randomised participants who had received the study vaccine, had at least one valid immunogenicity evaluation for VZV antibody and had post-vaccination data available for endpoint. | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | 4 week post-vaccination |
|
up to 35 days
Safety population included all participants who received vaccine and had safety follow-up data available.
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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 Intramuscular (IM) Route | Single dose of 0.65 mL via IM injection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hernia obstructive | General disorders | MedDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA 14.1 | 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 |
|---|---|
| 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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| Geometric Mean Count (GMCs) of VZV Interferon Gamma ((IFN-γ) Enzyme-Linked ImmunoSpot (ELISPOT) Antibodies |
Blood samples taken 4 weeks post-vaccination to determine the IFN-γ ELISPOT GMC's. Results were reported as ELISPOT count/10^6 Peripheral Blood Mononuclear Cells (PBMC) |
| 4 week post-vaccination |
| Geometric Mean Fold Rise (GMFR) of IFN-γ ELISPOT Antibodies | Blood samples taken pre-vaccination and 4 weeks post-vaccination to determine the IFN-γ ELISPOT GMFR. | Pre-vaccination (Day 0) and 4 week post-vaccination |
| Percentage of Participants Who Report at Least 1 Injection-site Adverse Reaction | Participants entered data into daily diary card regarding previously identified possible injection site reactions of erythema, injection site swelling or injection site pain for 1st 4 days post-vaccination. Additionally, injection site reactions not prompted on diary card (unsolicited) were collected up 28 days post-vaccination. All injection site reactions (solicited or unsolicited) were recorded. | up to 28 days after vaccination |
| Percentage of Participants Who Report at Least 1 Systemic Adverse Event | An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Adverse events that were considered systemic (not localized) were summarized. These events included rashes of interest: i.e. Varicella, Varicella-like rashes, Herpes zoster or shingles and Herpes zoster-like rashes and other systemic adverse events. | up to Day 28 after vaccination |
| Percentage of Participants Who Report at Least 1 Serious Adverse Event | A serious adverse event (SAE) is 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. The percentage of participants who reported an SAE within 35 days of vaccination were recorded. | up to 35 days after vaccination |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Age at Vaccination | Age of all vaccinated participants at Day 0 (time of vaccination) | One enrolled participant in IM arm withdrew prior to vaccination | Mean | Standard Deviation | Years of Age |
|
Single dose of 0.65 mL via SC injection
|
|
|
| Primary | Geometric Mean Fold Rise (GMFR) in VZV Antibody Titre: IM Route | Blood sample taken at predose (Day 0) and 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination | All randomised participants who had received the study vaccine via IM route, had at least one valid immunogenicity evaluation for VZV antibody and had post-vaccination data available for endpoint. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Pre-vaccination (Day 0) and 4 week post-vaccination |
|
|
|
|
| Secondary | Geometric Mean Fold Rise (GMFR) in VZV Antibody Titre: SC Route | Blood sample taken at predose (Day 0) and 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-vaccination/GMT Pre-vaccination | All randomised participants who had received the study vaccine via SC route, had at least one valid immunogenicity evaluation for VZV antibody and had post-vaccination data available for endpoint. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Pre-vaccination (Day 0) and 4 week post-vaccination |
|
|
|
| Secondary | Geometric Mean Count (GMCs) of VZV Interferon Gamma ((IFN-γ) Enzyme-Linked ImmunoSpot (ELISPOT) Antibodies | Blood samples taken 4 weeks post-vaccination to determine the IFN-γ ELISPOT GMC's. Results were reported as ELISPOT count/10^6 Peripheral Blood Mononuclear Cells (PBMC) | All randomised participants in the ELISPOT subset (predetermined protocol-defined sites) who had received the study vaccine and had valid post-vaccination data for endpoint. | Posted | Geometric Mean | 95% Confidence Interval | ELISPOT count/10^6 PBMC | 4 week post-vaccination |
|
|
|
| Secondary | Geometric Mean Fold Rise (GMFR) of IFN-γ ELISPOT Antibodies | Blood samples taken pre-vaccination and 4 weeks post-vaccination to determine the IFN-γ ELISPOT GMFR. | All randomised participants in the ELISPOT subset (predetermined protocol-defined sites) who had received the study vaccine and had valid pre- and post-vaccination data for endpoint. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Pre-vaccination (Day 0) and 4 week post-vaccination |
|
|
|
| Secondary | Percentage of Participants Who Report at Least 1 Injection-site Adverse Reaction | Participants entered data into daily diary card regarding previously identified possible injection site reactions of erythema, injection site swelling or injection site pain for 1st 4 days post-vaccination. Additionally, injection site reactions not prompted on diary card (unsolicited) were collected up 28 days post-vaccination. All injection site reactions (solicited or unsolicited) were recorded. | All vaccinated participants who had follow-up safety data. | Posted | Number | 95% Confidence Interval | Percentage of Participants | up to 28 days after vaccination |
|
|
|
| Secondary | Percentage of Participants Who Report at Least 1 Systemic Adverse Event | An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Adverse events that were considered systemic (not localized) were summarized. These events included rashes of interest: i.e. Varicella, Varicella-like rashes, Herpes zoster or shingles and Herpes zoster-like rashes and other systemic adverse events. | All vaccinated participants who had follow-up safety data. | Posted | Number | 95% Confidence Interval | Percentage of Participants | up to Day 28 after vaccination |
|
|
|
| Secondary | Percentage of Participants Who Report at Least 1 Serious Adverse Event | A serious adverse event (SAE) is 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. The percentage of participants who reported an SAE within 35 days of vaccination were recorded. | Posted | Number | Percentage of Participants | up to 35 days after vaccination |
|
|
|
| 1 |
| 176 |
| 59 |
| 176 |
| EG001 | ZOSTAVAX Subcutaneous (SC) Route | Single dose of 0.65 mL via SC injection | 2 | 177 | 112 | 177 |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 14.1 | Systematic Assessment |
|
Investigators must first obtain written consent from Sponsor. If consent is given, all abstracts manuscripts, texts, or presentation, etc. will be sent to Sponsor for review and approval prior to their publication or presentation. Sponsor shall have sixty days to review these documents and may refuse to give its consent in part or whole for confidential reasons (including but not limited to intellectual property rights, whether patentable or not).
| D007239 | Infections |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |