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| ID | Type | Description | Link |
|---|---|---|---|
| X06-Z-305 | Other Identifier | MCMVaccBV (SPMSD) Protocol ID | |
| 2007-000744-28 | EudraCT Number |
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Primary objective:
Immunogenicity To demonstrate that a second dose of ZOSTAVAX® elicits higher varicella-zoster virus (VZV) antibody titres than a first dose of ZOSTAVAX® whether given as a 0-1 month schedule or as a 0-3 month schedule in subjects ≥70 years of age as measured at 4 weeks post-vaccination
Secondary objectives Immunogenicity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Dose of Zostavax | Experimental | Zostavax 0.65mL intramuscular injection administered on Day 0 |
|
| Zostavax - Day 0 and Month 1 | Experimental | Zostavax 0.65mL intramuscular injection administered on Day 0 and Month 1 |
|
| Zostavax - Day 0 and Month 3 | Experimental | Zostavax 0.65mL intramuscular injection administered on Day 0 and Month 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zostavax | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks After Each Vaccination: Groups 2 and 3 | Blood samples taken at 4 weeks post each vaccination to determine the geometric mean titer (GMT) of VZV antibodies via Glycoprotein Enzyme Linked Immunosorbent Assay (gpELISA). | 4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) of VZV Antibodies 4 Weeks After Vaccination: Group 1 | Blood sample taken at 4 weeks post vaccination to determine the geometric mean titer (GMT) of VZV antibodies via gpELISA. | 4 weeks post-dose (Month 1) |
| Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-vaccination to 4 Weeks Post-dose 1 in Groups 1, 2 and 3 and 4 Weeks Post-dose 2 in Groups 2 and 3 |
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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 |
|---|---|---|---|
| 23319176 | Derived | Vesikari T, Hardt R, Rumke HC, Icardi G, Montero J, Thomas S, Sadorge C, Fiquet A. Immunogenicity and safety of a live attenuated shingles (herpes zoster) vaccine (Zostavax(R)) in individuals aged >/= 70 years: a randomized study of a single dose vs. two different two-dose schedules. Hum Vaccin Immunother. 2013 Apr;9(4):858-64. doi: 10.4161/hv.23412. Epub 2013 Jan 14. |
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A total of 779 participants were screened. Twenty participants were not randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Single Dose of Zostavax | Single injection of the 0.65 mL of Zostavax administered on Day 0 |
| FG001 | Group 2: Zostavax - Day 0 and Month 1 | 0.65 mL of Zostavax administered on Day 0 and Month 1 |
| FG002 | Group 3: Zostavax - Day 0 and Month 3 | 0.65 mL of Zostavax administered on Day 0 and Month 3 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vaccination Period (up to Month 4) |
|
| ||||||||||||||||||||||||
| 12-month Post Last Dose Follow-up |
| |||||||||||||||||||||||||
| 24-month Post Last Dose Follow-up |
| |||||||||||||||||||||||||
| 36 Month Post Last Dose Follow-up |
|
Baseline age missing for 1 participant in Group 2 and 1 participant in Group 3.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Single Dose of Zostavax | Single injection of the 0.65 mL of Zostavax administered on Day 0 |
| BG001 | Group 2: Zostavax - Day 0 and Month 1 | 0.65 mL of Zostavax administered on Day 0 and Month 1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline age missing for 1 participant in Group 2 and 1 participant in Group 3. |
| 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) Antibodies 4 Weeks After Each Vaccination: Groups 2 and 3 | Blood samples taken at 4 weeks post each vaccination to determine the geometric mean titer (GMT) of VZV antibodies via Glycoprotein Enzyme Linked Immunosorbent Assay (gpELISA). | All randomized participants in Groups 2 and 3 who received at least 1 dose of the study vaccine, had post-vaccination immunogenicity evaluation and excluded those with protocol violation which may have interfered with the immunogenicity evaluation or participants with herpes zoster (HZ) onset before the time point for analysis. | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | 4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3) |
|
up to 1 year post-last dose (Group 1: 12 months total; Group 2: 13 months total; Group 3: 14 months total)
Analysis population is all enrolled participants.
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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: Single Dose of Zostavax | Single injection of the 0.65 mL of Zostavax administered on Day 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA Version 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA Version 10.0 | 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 |
|---|---|
| D053061 | Herpes Zoster Vaccine |
| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
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Blood sample taken at predose (Day 0) and 4 weeks post each vaccination to determine the geometric mean titer (GMT) of VZV antibodies via gpELISA. The GMFR was calculated following each vaccination as GMT Post-dose/GMT Pre-vaccination |
| Predose and 4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3) |
| Geometric Mean Titre of VZV Antibodies 12 Months Post-last Dose | Blood sample taken at 1 year post last vaccination to determine the geometric mean titer (GMT) of varicella antibodies via gpELISA. | 1 year post final dose for Groups 1, 2, and 3 (Group 1: Month 12; Group 2: 13 Month 13; and Group 3: Month 15) |
| Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-Vaccination To 12 Months Post-dose 1 in Group 1 And From Pre-Vaccination To 12 Months Post-dose 2 in Groups 2 and 3 | Blood sample taken at predose and 1 year post last vaccination to determine the GMFR of varicella antibodies via gpELISA. Geometric mean fold rise was calculated for each arm as GMT 12-month post last dose divided by pre-vaccination GMT. | predose 1 and 1 year post-last dose (Group 1: Month 12; Group 2: 13 Month 13; and Group 3: Month 15) |
| Geometric Mean Titre (GMT) of VZV Antibodies 24 and 36 Months Post-dose 1 in Group 1 and the 24 and 36 Months Post-dose 2 in Groups 2 and 3 | Blood sample taken at 36 months post last-vaccination to determine the geometric mean titer (GMT) of varicella antibodies via gpELISA. | 24 and 36 months post-last dose |
| Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-Vaccination To 24 And 36 Months Post-dose 1 in Group 1 and From Pre-vaccination To 24 And 36 Months Post-dose 2 in Groups 2 and 3 | Blood samples were to be taken at predose and 24 months post- last vaccination in Groups 1 , 2, and 3 to determine the GMFR of varicella antibodies via gpELISA. Geometric mean fold rise was to be calculated for each arm as GMT 24-month post last dose divided by pre-vaccination GMT. | Predose 1 and 24 and 36 months post-last dose |
| Percentage of Participants Who Reported a Solicited Injection Site Reaction : Post-dose 1 | Participants entered data into daily dairy card regarding previously identified possible injection site reactions of erythema, injection site swelling or injection site pain | up to 4 days after 1st vaccination |
| Percentage of Participants Who Reported a Solicited Injection Site Reaction: Post-dose 2 | Participants entered data into daily dairy card regarding previously identified possible injection site reactions of erythema, injection site swelling or injection site pain | up to 4 days after 2nd vaccination |
| Percentage of Participants Who Reported an Unsolicited Injection Site Reaction: Post-dose 1 | The percentage of participants who reported an injection site reaction that was not specifically prompted by the diary card within 28 day of 1st vaccination was recorded. | up to 28 days after 1st of study drug |
| Percentage of Participants Who Reported an Unsolicited Injection Site Reaction: Post-dose 2 | The percentage of participants that reported an injection site reaction that was not specifically prompted by the diary card within 28 days post-dose 2 was recorded. | up to 28 days post-dose 2 |
| Percentage of Participants Who Reported Herpes Zoster or Zoster-like Rash: Post-dose 1 | Percentage of participants who reported herpes zoster or zoster-like rash following the 1st dose of vaccine were recorded. | up to 28 days post-dose 1 |
| Percentage of Participants Who Reported Herpes Zoster or Zoster-like Rash: Post-Dose 2 | Percentage of participants who reported herpes zoster or zoster-like rash following the 2nd dose of vaccine were recorded. | up to 28 days post-dose 2 |
| Percentage of Participants Who Reported Varicella or Varicella-like Rash: Post-dose 1 | Percentage of participants that reported varicella or varicella-like rash following the 1st dose of vaccine were recorded. | up to 28 days post-dose 1 |
| Percentage of Participants Who Reported Varicella or Varicella-like Rash: Post-dose 2 | Percentage of participants that reported varicella or varicella-like rash following the 2nd dose of vaccine were recorded. | up to 28 days post-dose 2 |
| Percentage of Participants Who Reported a Systemic Adverse Event: Post-dose 1 | 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 | up to 28 days after 1st vaccination |
| Percentage of Participants Who Reported a Systemic Adverse Event: Post-dose 2 | 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, | up to 28 days after 2nd vaccination |
| Percentage of Participants Who Reported a Vaccine-related Systemic Adverse Event: Post-dose 1 | 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) and were reported as at least possibly related to the vaccine were summarized | up to 28 days after 1st vaccination |
| Percentage of Participants Who Reported a Vaccine-related Systemic Adverse Event: Post-dose 2 | 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) and were reported as at least possibly related to the vaccine were summarized, | up to 28 days after 2nd vaccination |
| Percentage of Participants Who Reported a Serious Adverse Event: Post-dose 1 | 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 28 days of 1st dose of vaccine were recorded. | up to 28 days after 1st vaccination |
| Percentage of Participants Who Reported a Serious Adverse Event: Post-dose 2 | 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 28 days of 1st dose of vaccine were recorded. | up to 28 days after 2nd vaccination |
| Percentage of Participants Who Reported a Vaccine-related 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 during the entire study period that was considered at least possibly -related to the vaccine were recorded. | up to end of study (approximately 15 months) |
| Percentage of Participants Who Died During the Study | The number of participants who died for any reason during the study was summarized. | up to end of study (approximately 15 months) |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Other |
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Group 3: Zostavax - Day 0 and Month 3 | 0.65 mL of Zostavax administered on Day 0 and Month 3 |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Group 3: Zostavax - Day 0 and Month 3 | 0.65 mL of Zostavax administered on Day 0 and Month 3 |
|
|
|
| Secondary | Geometric Mean Titer (GMT) of VZV Antibodies 4 Weeks After Vaccination: Group 1 | Blood sample taken at 4 weeks post vaccination to determine the geometric mean titer (GMT) of VZV antibodies via gpELISA. | All randomized participants in Group 1 who received study vaccine, had post-vaccination immunogenicity evaluation and excluded those with protocol violation which may have interfered with the immunogenicity evaluation or participants with herpes zoster (HZ) onset before the time point for analysis. | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | 4 weeks post-dose (Month 1) |
|
|
|
|
| Secondary | Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-vaccination to 4 Weeks Post-dose 1 in Groups 1, 2 and 3 and 4 Weeks Post-dose 2 in Groups 2 and 3 | Blood sample taken at predose (Day 0) and 4 weeks post each vaccination to determine the geometric mean titer (GMT) of VZV antibodies via gpELISA. The GMFR was calculated following each vaccination as GMT Post-dose/GMT Pre-vaccination | All randomized participants in who received at least 1 dose of the study vaccine, had pre-dose 1 evaluation and had post-vaccination immunogenicity evaluation. Excluded those with protocol violation which may have interfered with the immunogenicity evaluation or participants with herpes zoster (HZ) onset before the time point for analysis. | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | Predose and 4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3) |
|
|
|
| Secondary | Geometric Mean Titre of VZV Antibodies 12 Months Post-last Dose | Blood sample taken at 1 year post last vaccination to determine the geometric mean titer (GMT) of varicella antibodies via gpELISA. | All randomized participants in who received at least 1 dose of the study vaccine, had 12-month post-vaccination immunogenicity evaluation and excluded those with protocol violation which may have interfered with the immunogenicity evaluation or participants with herpes zoster (HZ) onset before the time point for analysis. | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | 1 year post final dose for Groups 1, 2, and 3 (Group 1: Month 12; Group 2: 13 Month 13; and Group 3: Month 15) |
|
|
|
|
| Secondary | Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-Vaccination To 12 Months Post-dose 1 in Group 1 And From Pre-Vaccination To 12 Months Post-dose 2 in Groups 2 and 3 | Blood sample taken at predose and 1 year post last vaccination to determine the GMFR of varicella antibodies via gpELISA. Geometric mean fold rise was calculated for each arm as GMT 12-month post last dose divided by pre-vaccination GMT. | All randomized participants who received at least 1 dose of the study vaccine, had 12-month post-vaccination immunogenicity evaluation and excluded those with protocol violation which may have interfered with the immunogenicity evaluation or participants with herpes zoster (HZ) onset before the time point for analysis. | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | predose 1 and 1 year post-last dose (Group 1: Month 12; Group 2: 13 Month 13; and Group 3: Month 15) |
|
|
|
| Secondary | Geometric Mean Titre (GMT) of VZV Antibodies 24 and 36 Months Post-dose 1 in Group 1 and the 24 and 36 Months Post-dose 2 in Groups 2 and 3 | Blood sample taken at 36 months post last-vaccination to determine the geometric mean titer (GMT) of varicella antibodies via gpELISA. | Study stopped after 12 months. As per protocol, the study was stopped after the 12-month follow-up since there was no statistical evidence or clinical trend for superiority of any of the 2-dose regimens compared with the 1-dose regimen. 24 and 36 month data not obtained. | Posted | 24 and 36 months post-last dose |
|
|
| Secondary | Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-Vaccination To 24 And 36 Months Post-dose 1 in Group 1 and From Pre-vaccination To 24 And 36 Months Post-dose 2 in Groups 2 and 3 | Blood samples were to be taken at predose and 24 months post- last vaccination in Groups 1 , 2, and 3 to determine the GMFR of varicella antibodies via gpELISA. Geometric mean fold rise was to be calculated for each arm as GMT 24-month post last dose divided by pre-vaccination GMT. | Study stopped after 12 months. As per protocol, the study was stopped after the 12-month follow-up since there was no statistical evidence or clinical trend for superiority of any of the 2-dose regimens compared with the 1-dose regimen. 24 and 36 month data not obtained. | Posted | Predose 1 and 24 and 36 months post-last dose |
|
|
| Secondary | Percentage of Participants Who Reported a Solicited Injection Site Reaction : Post-dose 1 | Participants entered data into daily dairy card regarding previously identified possible injection site reactions of erythema, injection site swelling or injection site pain | All randomized participants in Groups 1, 2 and 3 who received the 1st dose of study drug and had follow-up safety data. . | Posted | Number | Percentage of Participants | up to 4 days after 1st vaccination |
|
|
|
| Secondary | Percentage of Participants Who Reported a Solicited Injection Site Reaction: Post-dose 2 | Participants entered data into daily dairy card regarding previously identified possible injection site reactions of erythema, injection site swelling or injection site pain | All randomized participants in Groups 2 and 3 who received 2nd dose of study drug and had follow-up safety data. | Posted | Number | Percentage of Participants | up to 4 days after 2nd vaccination |
|
|
|
| Secondary | Percentage of Participants Who Reported an Unsolicited Injection Site Reaction: Post-dose 1 | The percentage of participants who reported an injection site reaction that was not specifically prompted by the diary card within 28 day of 1st vaccination was recorded. | All randomized participants in Groups 1, 2, and 3 who received at least 1 dose of study drug and had follow-up safety data. . | Posted | Number | Percentage of Participants | up to 28 days after 1st of study drug |
|
|
|
| Secondary | Percentage of Participants Who Reported an Unsolicited Injection Site Reaction: Post-dose 2 | The percentage of participants that reported an injection site reaction that was not specifically prompted by the diary card within 28 days post-dose 2 was recorded. | All randomized participants in Groups 2 and 3 who received 2nd dose of study drug and had follow-up safety data. . | Posted | Number | Percentage of Participants | up to 28 days post-dose 2 |
|
|
|
| Secondary | Percentage of Participants Who Reported Herpes Zoster or Zoster-like Rash: Post-dose 1 | Percentage of participants who reported herpes zoster or zoster-like rash following the 1st dose of vaccine were recorded. | All randomized participants in Groups 1, 2, and 3 who received 1st dose of the study drug and who have safety follow-up data for post-dose 1. | Posted | Number | Percentage of Participants | up to 28 days post-dose 1 |
|
|
|
| Secondary | Percentage of Participants Who Reported Herpes Zoster or Zoster-like Rash: Post-Dose 2 | Percentage of participants who reported herpes zoster or zoster-like rash following the 2nd dose of vaccine were recorded. | All randomized participants in Groups 2 and 3 who received 2nd dose of the study drug and who have safety follow-up data for post-dose 2. | Posted | Number | Percentage of Participants | up to 28 days post-dose 2 |
|
|
|
| Secondary | Percentage of Participants Who Reported Varicella or Varicella-like Rash: Post-dose 1 | Percentage of participants that reported varicella or varicella-like rash following the 1st dose of vaccine were recorded. | All randomized participants in Groups 1, 2 and 3 who received 1st dose of the study drug and who have safety follow-up data for post-dose 1. | Posted | Number | Percentage of Participants | up to 28 days post-dose 1 |
|
|
|
| Secondary | Percentage of Participants Who Reported Varicella or Varicella-like Rash: Post-dose 2 | Percentage of participants that reported varicella or varicella-like rash following the 2nd dose of vaccine were recorded. | All randomized participants in Groups 2 and 3 who received 2nd dose of the study drug and who have safety follow-up data for post-dose 2. | Posted | Number | Percentage of Participants | up to 28 days post-dose 2 |
|
|
|
| Secondary | Percentage of Participants Who Reported a Systemic Adverse Event: Post-dose 1 | 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 | All randomized participants in Groups 1, 2, and 3 who received 1st dose of study drug and had follow-up safety data. . | Posted | Number | Percentage of Participants | up to 28 days after 1st vaccination |
|
|
|
| Secondary | Percentage of Participants Who Reported a Systemic Adverse Event: Post-dose 2 | 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, | All randomized participants in Groups 2 and 3 who received 2nd dose of study drug and had follow-up safety data. | Posted | Number | Percentage of Participants | up to 28 days after 2nd vaccination |
|
|
|
| Secondary | Percentage of Participants Who Reported a Vaccine-related Systemic Adverse Event: Post-dose 1 | 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) and were reported as at least possibly related to the vaccine were summarized | All randomized participants in Groups 1, 2, and 3 who received 1st dose of study drug and had follow-up safety data. . | Posted | Number | Percentage of Participants | up to 28 days after 1st vaccination |
|
|
|
| Secondary | Percentage of Participants Who Reported a Vaccine-related Systemic Adverse Event: Post-dose 2 | 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) and were reported as at least possibly related to the vaccine were summarized, | All randomized participants in Groups 2 and 3 who received 2nd dose of study drug and had follow-up safety data. | Posted | Number | Percentage of Participants | up to 28 days after 2nd vaccination |
|
|
|
| Secondary | Percentage of Participants Who Reported a Serious Adverse Event: Post-dose 1 | 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 28 days of 1st dose of vaccine were recorded. | All randomized participants in Groups 1, 2, and 3 who received 1st dose of study drug and had follow-up safety data. | Posted | Number | Percentage of Participants | up to 28 days after 1st vaccination |
|
|
|
| Secondary | Percentage of Participants Who Reported a Serious Adverse Event: Post-dose 2 | 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 28 days of 1st dose of vaccine were recorded. | All randomized participants in Groups 2 and 3 who received 2nd dose of study drug and had follow-up safety data. | Posted | Number | Percentage of Participants | up to 28 days after 2nd vaccination |
|
|
|
| Secondary | Percentage of Participants Who Reported a Vaccine-related 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 during the entire study period that was considered at least possibly -related to the vaccine were recorded. | All randomized participants in Groups 1, 2, and 3 who received 1st dose of study drug and had follow-up safety data. | Posted | Number | Percentage of Participants | up to end of study (approximately 15 months) |
|
|
|
| Secondary | Percentage of Participants Who Died During the Study | The number of participants who died for any reason during the study was summarized. | All randomized participants in Groups 1, 2, and 3 who received 1st dose of study drug and had follow-up safety data. | Posted | Number | Percentage of Participants | up to end of study (approximately 15 months) |
|
|
|
| 4 |
| 253 |
| 122 |
| 253 |
| EG001 | Group 2: Zostavax - Day 0 and Month 1 | 0.65 mL of Zostavax administered on Day 0 and Month 1 | 11 | 255 | 144 | 255 |
| EG002 | Group 3: Zostavax - Day 0 and Month 3 | 0.65 mL of Zostavax administered on Day 0 and Month 3 | 4 | 251 | 132 | 251 |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Version 10.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA Version 10.0 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA Version 10.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA Version 10.0 | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA Version 10.0 | Systematic Assessment |
|
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA Version 10.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 10.0 | Systematic Assessment |
|
| Mental disorder due to a general medical condition | Psychiatric disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Peripheral embolism | Vascular disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
|
Investigators must first obtain written consent from Sanofi Pasteur MSD. If consent is given, all abstracts manuscripts, texts, or presentation, etc... shall be sent to Sanofi Pasteur MSD for review and approval prior to their publication or presentation. Sanofi Pasteur MSD 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).
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |
| Male |
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ANCOVA model includes country and age at first vaccination as independent variables and baseline antibody titre as covariate. The GMT 12-month post-last dose is the GMT adjusted from the ANCOVA model |
| GMT Ratio |
| 1.08 |
| 2-Sided |
| 95 |
| 0.98 |
| 1.19 |
GMT Ratio = GMT Group 3/GMT Group 1 |
| Superiority or Other |