Back to resultsImmunogenicity and Safety of a 1-dose Regimen of a Zoster Vaccine Versus Different 2-dose Regimens in Participants ≥ 70 Years of Age. (V211-043)
Primary Purpose
Prevention of : Herpes-Zoster
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Zostavax
Sponsored by
About this trial
This is an interventional prevention trial for Prevention of : Herpes-Zoster
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 70 years
- Varicella history-positive or residence for > 30 years in a country with endemic VZV infection
- Signed informed consent form prior to any study procedure
Exclusion Criteria:
- Febrile illness within the last 72 hours before the first vaccination
- Prior herpes-zoster episode clinically diagnosed by a physician
- Prior receipt of varicella or zoster vaccine
- Exposure to varicella or herpes-zoster within the 4 weeks prior to the first vaccination
- Significant underlying illness preventing completion of the study vaccination schedules,
- Known active tuberculosis,
- Immune deficiency disorder, including active neoplastic disease within the prior 5 years,
- Immune function impairment caused by medical condition or immunosuppressive therapy, or any other cause,
- Receipt of any inactivated vaccine within the 2 weeks prior to the first vaccination,
- Receipt of any other live vaccine within the 4 weeks prior to the first vaccination,
- Receipt of immunoglobulins or blood-derived products within the 5 months prior to the first vaccination,
- Concomitant use of non-topical antiviral therapy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Single Dose of Zostavax
Zostavax - Day 0 and Month 1
Zostavax - Day 0 and Month 3
Arm Description
Zostavax 0.65mL intramuscular injection administered on Day 0
Zostavax 0.65mL intramuscular injection administered on Day 0 and Month 1
Zostavax 0.65mL intramuscular injection administered on Day 0 and Month 3
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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
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.
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.
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.
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.
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
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
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.
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.
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.
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.
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.
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.
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
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,
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
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,
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.
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.
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.
Percentage of Participants Who Died During the Study
The number of participants who died for any reason during the study was summarized.
Full Information
NCT ID
NCT00561080
First Posted
November 19, 2007
Last Updated
December 24, 2018
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00561080
Brief Title
Immunogenicity and Safety of a 1-dose Regimen of a Zoster Vaccine Versus Different 2-dose Regimens in Participants ≥ 70 Years of Age. (V211-043)
Official Title
An Open-label, Randomised, Comparative, Multi-centre Study of the Immunogenicity and Safety of a 1-dose Regimen and Different 2-dose Regimens of a Zoster Vaccine (Live), ZOSTAVAX ®, in Subjects ≥ 70 Years of Age
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 26, 2007 (Actual)
Primary Completion Date
June 3, 2009 (Actual)
Study Completion Date
June 3, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
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
To summarise the VZV antibody titres at 4 weeks post-vaccination after a 1-dose regimen and 4 weeks post-vaccination after each dose of each 2-doses regimen of ZOSTAVAX®.
To compare the VZV antibody titres at 12 months after completion of a 1-dose regimen with the VZV antibody titres at 12 months after completion of each 2-doses regimen of ZOSTAVAX®
To summarise the VZV antibody titres at 24 and 36 months after completion of a 1-dose regimen and at 24 and 36 months after completion of each 2-doses regimen of ZOSTAVAX®
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of : Herpes-Zoster
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
759 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Dose of Zostavax
Arm Type
Experimental
Arm Description
Zostavax 0.65mL intramuscular injection administered on Day 0
Arm Title
Zostavax - Day 0 and Month 1
Arm Type
Experimental
Arm Description
Zostavax 0.65mL intramuscular injection administered on Day 0 and Month 1
Arm Title
Zostavax - Day 0 and Month 3
Arm Type
Experimental
Arm Description
Zostavax 0.65mL intramuscular injection administered on Day 0 and Month 3
Intervention Type
Biological
Intervention Name(s)
Zostavax
Other Intervention Name(s)
Zoster vaccine live
Primary Outcome Measure Information:
Title
Geometric Mean Titer (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks After Each Vaccination: Groups 2 and 3
Description
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).
Time Frame
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 Outcome Measure Information:
Title
Geometric Mean Titer (GMT) of VZV Antibodies 4 Weeks After Vaccination: Group 1
Description
Blood sample taken at 4 weeks post vaccination to determine the geometric mean titer (GMT) of VZV antibodies via gpELISA.
Time Frame
4 weeks post-dose (Month 1)
Title
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
Description
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
Time Frame
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)
Title
Geometric Mean Titre of VZV Antibodies 12 Months Post-last Dose
Description
Blood sample taken at 1 year post last vaccination to determine the geometric mean titer (GMT) of varicella antibodies via gpELISA.
Time Frame
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)
Title
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
Description
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.
Time Frame
predose 1 and 1 year post-last dose (Group 1: Month 12; Group 2: 13 Month 13; and Group 3: Month 15)
Title
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
Description
Blood sample taken at 36 months post last-vaccination to determine the geometric mean titer (GMT) of varicella antibodies via gpELISA.
Time Frame
24 and 36 months post-last dose
Title
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
Description
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.
Time Frame
Predose 1 and 24 and 36 months post-last dose
Title
Percentage of Participants Who Reported a Solicited Injection Site Reaction : Post-dose 1
Description
Participants entered data into daily dairy card regarding previously identified possible injection site reactions of erythema, injection site swelling or injection site pain
Time Frame
up to 4 days after 1st vaccination
Title
Percentage of Participants Who Reported a Solicited Injection Site Reaction: Post-dose 2
Description
Participants entered data into daily dairy card regarding previously identified possible injection site reactions of erythema, injection site swelling or injection site pain
Time Frame
up to 4 days after 2nd vaccination
Title
Percentage of Participants Who Reported an Unsolicited Injection Site Reaction: Post-dose 1
Description
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.
Time Frame
up to 28 days after 1st of study drug
Title
Percentage of Participants Who Reported an Unsolicited Injection Site Reaction: Post-dose 2
Description
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.
Time Frame
up to 28 days post-dose 2
Title
Percentage of Participants Who Reported Herpes Zoster or Zoster-like Rash: Post-dose 1
Description
Percentage of participants who reported herpes zoster or zoster-like rash following the 1st dose of vaccine were recorded.
Time Frame
up to 28 days post-dose 1
Title
Percentage of Participants Who Reported Herpes Zoster or Zoster-like Rash: Post-Dose 2
Description
Percentage of participants who reported herpes zoster or zoster-like rash following the 2nd dose of vaccine were recorded.
Time Frame
up to 28 days post-dose 2
Title
Percentage of Participants Who Reported Varicella or Varicella-like Rash: Post-dose 1
Description
Percentage of participants that reported varicella or varicella-like rash following the 1st dose of vaccine were recorded.
Time Frame
up to 28 days post-dose 1
Title
Percentage of Participants Who Reported Varicella or Varicella-like Rash: Post-dose 2
Description
Percentage of participants that reported varicella or varicella-like rash following the 2nd dose of vaccine were recorded.
Time Frame
up to 28 days post-dose 2
Title
Percentage of Participants Who Reported a Systemic Adverse Event: Post-dose 1
Description
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
Time Frame
up to 28 days after 1st vaccination
Title
Percentage of Participants Who Reported a Systemic Adverse Event: Post-dose 2
Description
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,
Time Frame
up to 28 days after 2nd vaccination
Title
Percentage of Participants Who Reported a Vaccine-related Systemic Adverse Event: Post-dose 1
Description
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
Time Frame
up to 28 days after 1st vaccination
Title
Percentage of Participants Who Reported a Vaccine-related Systemic Adverse Event: Post-dose 2
Description
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,
Time Frame
up to 28 days after 2nd vaccination
Title
Percentage of Participants Who Reported a Serious Adverse Event: Post-dose 1
Description
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.
Time Frame
up to 28 days after 1st vaccination
Title
Percentage of Participants Who Reported a Serious Adverse Event: Post-dose 2
Description
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.
Time Frame
up to 28 days after 2nd vaccination
Title
Percentage of Participants Who Reported a Vaccine-related Serious Adverse Event
Description
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.
Time Frame
up to end of study (approximately 15 months)
Title
Percentage of Participants Who Died During the Study
Description
The number of participants who died for any reason during the study was summarized.
Time Frame
up to end of study (approximately 15 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age ≥ 70 years
Varicella history-positive or residence for > 30 years in a country with endemic VZV infection
Signed informed consent form prior to any study procedure
Exclusion Criteria:
Febrile illness within the last 72 hours before the first vaccination
Prior herpes-zoster episode clinically diagnosed by a physician
Prior receipt of varicella or zoster vaccine
Exposure to varicella or herpes-zoster within the 4 weeks prior to the first vaccination
Significant underlying illness preventing completion of the study vaccination schedules,
Known active tuberculosis,
Immune deficiency disorder, including active neoplastic disease within the prior 5 years,
Immune function impairment caused by medical condition or immunosuppressive therapy, or any other cause,
Receipt of any inactivated vaccine within the 2 weeks prior to the first vaccination,
Receipt of any other live vaccine within the 4 weeks prior to the first vaccination,
Receipt of immunoglobulins or blood-derived products within the 5 months prior to the first vaccination,
Concomitant use of non-topical antiviral therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
23319176
Citation
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.
Results Reference
derived
Learn more about this trial
Immunogenicity and Safety of a 1-dose Regimen of a Zoster Vaccine Versus Different 2-dose Regimens in Participants ≥ 70 Years of Age. (V211-043)
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