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| ID | Type | Description | Link |
|---|---|---|---|
| CTRI/2012/08/002922 | Registry Identifier | CTRI |
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This study will determine if ZOSTAVAX™ is safe, tolerable, and immunogenic in healthy adults in India.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zoster Vaccine Live | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoster Vaccine Live | Biological | One approximately 0.65 mL injection subcutaneously on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination | Antibody titers were measured by VZV-specific glycoprotein enzyme-linked immunosorbent assay (gpELISA). | Prevaccination up to 6 weeks postvaccination |
| Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers at 6 Weeks Postvaccination | GMFR was analyzed as the geometric mean of the ratio of VZV antibody titer (gpELISA units/mL) at postvaccination week 6 over VZV antibody titer (gpELISA units/mL) at prevaccination day 1. | Prevaccination up to 6 weeks postvaccination |
| Number of Participants With Serious Adverse Events | A serious adverse event is one that results in death, is life-threatening, results in a persistent or significant disability, results in or prolongs hospitalization, results in a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment. | Up to 42 days postvaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31325263 | Result | Sreenivasamurthy L, Pandey S, Chandra BS, Sharma M, Ranganathaiah SR, Vaidya P, Naik R. Immunogenicity, Safety, and Tolerability of Live Attenuated VaricellaZoster Virus Vaccine (ZOSTAVAX) in Healthy Adults in India. J Assoc Physicians India. 2018 Jul;66(7):50-54. |
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Ten sites in India enrolled adult participants in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Zoster Vaccine Live | A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Zoster Vaccine Live | A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity. |
| 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 | The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination | Antibody titers were measured by VZV-specific glycoprotein enzyme-linked immunosorbent assay (gpELISA). | This endpoint was analyzed in the per-protocol population which included all participants who were vaccinated and had no major deviations from the protocol procedure. At the week 6 postvaccination timepoint, a total of 7 participants were excluded from the per-protocol immunogenicity analyses. | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | Prevaccination up to 6 weeks postvaccination |
|
Day 1 up to day 42 postvaccinaton
Adverse events were collected from all participants who were vaccinated and had any safety follow up data.
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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 | Zoster Vaccine Live | A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 16.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA version 16.0 |
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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 |
| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
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| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers at 6 Weeks Postvaccination | GMFR was analyzed as the geometric mean of the ratio of VZV antibody titer (gpELISA units/mL) at postvaccination week 6 over VZV antibody titer (gpELISA units/mL) at prevaccination day 1. | This endpoint was analyzed in the per-protocol population which included all participants who were vaccinated and had no major deviations from the protocol procedure. At the week 6 postvaccination timepoint, a total of 7 participants were excluded from the per-protocol immunogenicity analyses. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Prevaccination up to 6 weeks postvaccination |
|
|
|
| Primary | Number of Participants With Serious Adverse Events | A serious adverse event is one that results in death, is life-threatening, results in a persistent or significant disability, results in or prolongs hospitalization, results in a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment. | This endpoint was analyzed in all participants who were vaccinated and had any safety follow up data. | Posted | Number | Participants | Up to 42 days postvaccination |
|
|
|
| 2 |
| 250 |
| 47 |
| 250 |
| Bronchitis | Infections and infestations | MedDRA version 16.0 |
|
| Injection site pain | General disorders | MedDRA version 16.0 |
|
| Injection site swelling | General disorders | MedDRA version 16.0 |
|
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. Sponsor review can be expedited to meet publication timelines.
| D007239 | Infections |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |