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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00561080
Recruitment Status : Completed
First Posted : November 20, 2007
Results First Posted : December 22, 2017
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Prevention of : Herpes-Zoster
Intervention Biological: Zostavax
Enrollment 759

Recruitment Details A total of 779 participants were screened. Twenty participants were not randomized.
Pre-assignment Details  
Arm/Group Title Group 1: Single Dose of Zostavax Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3
Hide Arm/Group Description Single injection of the 0.65 mL of Zostavax administered on Day 0 0.65 mL of Zostavax administered on Day 0 and Month 1 0.65 mL of Zostavax administered on Day 0 and Month 3
Period Title: Vaccination Period (up to Month 4)
Started 253 255 251
Received at Least 1 Vaccination 253 254 250
Completed 250 229 225
Not Completed 3 26 26
Reason Not Completed
Adverse Event             0             4             6
Definitive Contra-indication             0             2             3
Protocol Violation             0             1             3
Withdrawal by Subject             3             16             13
Lost to Follow-up             0             1             0
Other             0             2             1
Period Title: 12-month Post Last Dose Follow-up
Started 250 229 225
Completed 243 220 215
Not Completed 7 9 10
Reason Not Completed
Adverse Event             3             3             1
Protocol Violation             0             0             4
Withdrawal by Subject             2             6             5
Lost to Follow-up             2             0             0
Period Title: 24-month Post Last Dose Follow-up
Started 0 [1] 0 [1] 0 [1]
Completed 0 0 0
Not Completed 0 0 0
[1]
Study stopped at 1 year post last dose
Period Title: 36 Month Post Last Dose Follow-up
Started 0 [1] 0 [1] 0 [1]
Completed 0 0 0
Not Completed 0 0 0
[1]
Study stopped at 1 year post last dose
Arm/Group Title Group 1: Single Dose of Zostavax Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3 Total
Hide Arm/Group Description Single injection of the 0.65 mL of Zostavax administered on Day 0 0.65 mL of Zostavax administered on Day 0 and Month 1 0.65 mL of Zostavax administered on Day 0 and Month 3 Total of all reporting groups
Overall Number of Baseline Participants 253 255 251 759
Hide Baseline Analysis Population Description
Baseline age missing for 1 participant in Group 2 and 1 participant in Group 3.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 253 participants 254 participants 250 participants 757 participants
76.2  (5.5) 76.0  (5.4) 76.1  (5.3) 76.1  (5.4)
[1]
Measure Analysis Population Description: Baseline age missing for 1 participant in Group 2 and 1 participant in Group 3.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 253 participants 255 participants 251 participants 759 participants
Female
148
  58.5%
138
  54.1%
135
  53.8%
421
  55.5%
Male
105
  41.5%
117
  45.9%
116
  46.2%
338
  44.5%
1.Primary Outcome
Title Geometric Mean Titer (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks After Each Vaccination: Groups 2 and 3
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3
Hide Arm/Group Description:
0.65 mL of Zostavax administered on Day 0 and Month 1
0.65 mL of Zostavax administered on Day 0 and Month 3
Overall Number of Participants Analyzed 203 198
Geometric Mean (95% Confidence Interval)
Unit of Measure: gpELISA units/mL
Post Dose 1
498.8
(438.7 to 567.1)
523.3
(459.0 to 596.7)
Post Dose 2
555.3
(496.6 to 620.9)
410.5
(363.1 to 464.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 2: Zostavax - Day 0 and Month 1
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Superiority was achieved if the lower bound of the 2-sided 95% CI of the GMT ratio was greater than 1.2
Statistical Test of Hypothesis P-Value 0.948
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Titer Ratio (GMTR)
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
1.02 to 1.22
Estimation Comments GMTR = GMT Post Dose 2/GMT Post dose 1
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 3: Zostavax - Day 0 and Month 3
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Superiority was achieved if the lower bound of the 2-sided 95% CI of the GMT ratio was greater than 1.2
Statistical Test of Hypothesis P-Value >0.999
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter GMTR
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.73 to 0.85
Estimation Comments GMTR = GMT Post Dose 2/GMT Post dose 1
2.Secondary Outcome
Title Geometric Mean Titer (GMT) of VZV Antibodies 4 Weeks After Vaccination: Group 1
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Single Dose of Zostavax
Hide Arm/Group Description:
Single injection of the 0.65 mL of Zostavax administered on Day 0
Overall Number of Participants Analyzed 243
Geometric Mean (95% Confidence Interval)
Unit of Measure: gpELISA units/mL
GMT Pre-Dose Number Analyzed 242 participants
233.7
(207.1 to 263.7)
GMT Post Dose Number Analyzed 243 participants
550.0
(489.2 to 618.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: Single Dose of Zostavax
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMFR
Estimated Value 2.35
Confidence Interval (2-Sided) 95%
2.11 to 2.62
Estimation Comments GMFR=GMT Post Dose/GMT Pre Dose
3.Secondary Outcome
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
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Single Dose of Zostavax Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3
Hide Arm/Group Description:
Single injection of the 0.65 mL of Zostavax administered on Day 0
0.65 mL of Zostavax administered on Day 0 and Month 1
0.65 mL of Zostavax administered on Day 0 and Month 3
Overall Number of Participants Analyzed 242 203 198
Geometric Mean (95% Confidence Interval)
Unit of Measure: gpELISA units/mL
GMFR Post Dose 1
2.35
(2.11 to 2.62)
2.37
(2.11 to 2.66)
2.29
(2.05 to 2.57)
GMFR Post Dose 2
NA [1] 
(NA to NA)
2.64
(2.37 to 2.95)
1.80
(1.63 to 1.98)
[1]
Group 1 did not have 2nd vaccination
4.Secondary Outcome
Title Geometric Mean Titre of VZV Antibodies 12 Months Post-last Dose
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Single Dose of Zostavax Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3
Hide Arm/Group Description:
Single injection of the 0.65 mL of Zostavax administered on Day 0
0.65 mL of Zostavax administered on Day 0 and Month 1
0.65 mL of Zostavax administered on Day 0 and Month 3
Overall Number of Participants Analyzed 223 189 204
Geometric Mean (95% Confidence Interval)
Unit of Measure: gpELISA units/mL
246.8
(230.9 to 263.9)
261.1
(242.8 to 280.7)
266.6
(248.6 to 285.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: Single Dose of Zostavax, Group 2: Zostavax - Day 0 and Month 1
Comments 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
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.96 to 1.17
Estimation Comments GMT Ratio = Group 2 GMT/Group 1 GMT
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1: Single Dose of Zostavax, Group 3: Zostavax - Day 0 and Month 3
Comments 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
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.98 to 1.19
Estimation Comments GMT Ratio = GMT Group 3/GMT Group 1
5.Secondary Outcome
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
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Single Dose of Zostavax Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3
Hide Arm/Group Description:
Single injection of the 0.65 mL of Zostavax administered on Day 0
0.65 mL of Zostavax administered on Day 0 and Month 1
0.65 mL of Zostavax administered on Day 0 and Month 3
Overall Number of Participants Analyzed 223 189 204
Geometric Mean (95% Confidence Interval)
Unit of Measure: gpELISA units/mL
1.06
(0.99 to 1.14)
1.16
(1.06 to 1.26)
1.17
(1.07 to 1.27)
6.Secondary Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Single Dose of Zostavax Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3
Hide Arm/Group Description:
Single injection of the 0.65 mL of Zostavax administered on Day 0
0.65 mL of Zostavax administered on Day 0 and Month 1
0.65 mL of Zostavax administered on Day 0 and Month 3
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Single Dose of Zostavax Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3
Hide Arm/Group Description:
Single injection of the 0.65 mL of Zostavax administered on Day 0
0.65 mL of Zostavax administered on Day 0 and Month 1
0.65 mL of Zostavax administered on Day 0 and Month 3
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Percentage of Participants Who Reported a Solicited Injection Site Reaction : Post-dose 1
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Groups 1, 2 and 3 who received the 1st dose of study drug and had follow-up safety data. .
Arm/Group Title Group 1: Single Dose of Zostavax Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3
Hide Arm/Group Description:
Single injection of the 0.65 mL of Zostavax administered on Day 0
0.65 mL of Zostavax administered on Day 0 and Month 1
0.65 mL of Zostavax administered on Day 0 and Month 3
Overall Number of Participants Analyzed 252 248 249
Measure Type: Number
Unit of Measure: Percentage of Participants
47.2 46.0 42.2
9.Secondary Outcome
Title Percentage of Participants Who Reported a Solicited Injection Site Reaction: Post-dose 2
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Groups 2 and 3 who received 2nd dose of study drug and had follow-up safety data.
Arm/Group Title Group 1: Single Dose of Zostavax Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3
Hide Arm/Group Description:
Single injection of the 0.65 mL of Zostavax administered on Day 0
0.65 mL of Zostavax administered on Day 0 and Month 1
0.65 mL of Zostavax administered on Day 0 and Month 3
Overall Number of Participants Analyzed 0 232 221
Measure Type: Number
Unit of Measure: Percentage of Participants
42.2 42.1
10.Secondary Outcome
Title Percentage of Participants Who Reported an Unsolicited Injection Site Reaction: Post-dose 1
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Groups 1, 2, and 3 who received at least 1 dose of study drug and had follow-up safety data. .
Arm/Group Title Group 1: Single Dose of Zostavax Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3
Hide Arm/Group Description:
Single injection of the 0.65 mL of Zostavax administered on Day 0
0.65 mL of Zostavax administered on Day 0 and Month 1
0.65 mL of Zostavax administered on Day 0 and Month 3
Overall Number of Participants Analyzed 252 248 249
Measure Type: Number
Unit of Measure: Percentage of Participants
5.6 4.8 0.8
11.Secondary Outcome
Title Percentage of Participants Who Reported an Unsolicited Injection Site Reaction: Post-dose 2
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Groups 2 and 3 who received 2nd dose of study drug and had follow-up safety data. .
Arm/Group Title Group 1: Single Dose of Zostavax Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3
Hide Arm/Group Description:
Single injection of the 0.65 mL of Zostavax administered on Day 0
0.65 mL of Zostavax administered on Day 0 and Month 1
0.65 mL of Zostavax administered on Day 0 and Month 3
Overall Number of Participants Analyzed 0 232 221
Measure Type: Number
Unit of Measure: Percentage of Participants
1.3 3.2
12.Secondary Outcome
Title Percentage of Participants Who Reported Herpes Zoster or Zoster-like Rash: Post-dose 1
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Single Dose of Zostavax Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3
Hide Arm/Group Description:
Single injection of the 0.65 mL of Zostavax administered on Day 0
0.65 mL of Zostavax administered on Day 0 and Month 1
0.65 mL of Zostavax administered on Day 0 and Month 3
Overall Number of Participants Analyzed 252 248 249
Measure Type: Number
Unit of Measure: Percentage of Participants
0.8 0.0 0.0
13.Secondary Outcome
Title Percentage of Participants Who Reported Herpes Zoster or Zoster-like Rash: Post-Dose 2
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Single Dose of Zostavax Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3
Hide Arm/Group Description:
Single injection of the 0.65 mL of Zostavax administered on Day 0
0.65 mL of Zostavax administered on Day 0 and Month 1
0.65 mL of Zostavax administered on Day 0 and Month 3
Overall Number of Participants Analyzed 0 232 221
Measure Type: Number
Unit of Measure: Percentage of Participants
0.0 0.0
14.Secondary Outcome
Title Percentage of Participants Who Reported Varicella or Varicella-like Rash: Post-dose 1
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Single Dose of Zostavax Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3
Hide Arm/Group Description:
Single injection of the 0.65 mL of Zostavax administered on Day 0
0.65 mL of Zostavax administered on Day 0 and Month 1
0.65 mL of Zostavax administered on Day 0 and Month 3
Overall Number of Participants Analyzed 252 248 249
Measure Type: Number
Unit of Measure: Percentage of Participants
0.0 0.0 0.0
15.Secondary Outcome
Title Percentage of Participants Who Reported Varicella or Varicella-like Rash: Post-dose 2
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Group 1: Single Dose of Zostavax Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3
Hide Arm/Group Description:
Single injection of the 0.65 mL of Zostavax administered on Day 0
0.65 mL of Zostavax administered on Day 0 and Month 1
0.65 mL of Zostavax administered on Day 0 and Month 3
Overall Number of Participants Analyzed 0 232 221
Measure Type: Number
Unit of Measure: Percentage of Participants
0.4 0.5
16.Secondary Outcome
Title Percentage of Participants Who Reported a Systemic Adverse Event: Post-dose 1
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Groups 1, 2, and 3 who received 1st dose of study drug and had follow-up safety data. .
Arm/Group Title Group 1: Single Dose of Zostavax Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3
Hide Arm/Group Description:
Single injection of the 0.65 mL of Zostavax administered on Day 0
0.65 mL of Zostavax administered on Day 0 and Month 1
0.65 mL of Zostavax administered on Day 0 and Month 3
Overall Number of Participants Analyzed 252 248 249
Measure Type: Number
Unit of Measure: Percentage of Participants
25.8 32.7 25.7
17.Secondary Outcome
Title Percentage of Participants Who Reported a Systemic Adverse Event: Post-dose 2
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Groups 2 and 3 who received 2nd dose of study drug and had follow-up safety data.
Arm/Group Title Group 1: Single Dose of Zostavax Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3
Hide Arm/Group Description:
Single injection of the 0.65 mL of Zostavax administered on Day 0
0.65 mL of Zostavax administered on Day 0 and Month 1
0.65 mL of Zostavax administered on Day 0 and Month 3
Overall Number of Participants Analyzed 0 232 221
Measure Type: Number
Unit of Measure: Percentage of Participants
20.7 15.4
18.Secondary Outcome
Title Percentage of Participants Who Reported a Vaccine-related Systemic Adverse Event: Post-dose 1
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Groups 1, 2, and 3 who received 1st dose of study drug and had follow-up safety data. .
Arm/Group Title Group 1: Single Dose of Zostavax Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3
Hide Arm/Group Description:
Single injection of the 0.65 mL of Zostavax administered on Day 0
0.65 mL of Zostavax administered on Day 0 and Month 1
0.65 mL of Zostavax administered on Day 0 and Month 3
Overall Number of Participants Analyzed 252 248 249
Measure Type: Number
Unit of Measure: Percentage of Participants
6.7 4.0 8.4
19.Secondary Outcome
Title Percentage of Participants Who Reported a Vaccine-related Systemic Adverse Event: Post-dose 2
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Groups 2 and 3 who received 2nd dose of study drug and had follow-up safety data.
Arm/Group Title Group 1: Single Dose of Zostavax Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3
Hide Arm/Group Description:
Single injection of the 0.65 mL of Zostavax administered on Day 0
0.65 mL of Zostavax administered on Day 0 and Month 1
0.65 mL of Zostavax administered on Day 0 and Month 3
Overall Number of Participants Analyzed 0 232 221
Measure Type: Number
Unit of Measure: Percentage of Participants
3.4 2.7
20.Secondary Outcome
Title Percentage of Participants Who Reported a Serious Adverse Event: Post-dose 1
Hide 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
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Hide Analysis Population Description
All randomized participants in Groups 1, 2, and 3 who received 1st dose of study drug and had follow-up safety data.
Arm/Group Title Group 1: Single Dose of Zostavax Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3
Hide Arm/Group Description:
Single injection of the 0.65 mL of Zostavax administered on Day 0
0.65 mL of Zostavax administered on Day 0 and Month 1
0.65 mL of Zostavax administered on Day 0 and Month 3
Overall Number of Participants Analyzed 252 248 249
Measure Type: Number
Unit of Measure: Percentage of Participants
0.4 2.8 0.4
21.Secondary Outcome
Title Percentage of Participants Who Reported a Serious Adverse Event: Post-dose 2
Hide 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
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Hide Analysis Population Description
All randomized participants in Groups 2 and 3 who received 2nd dose of study drug and had follow-up safety data.
Arm/Group Title Group 1: Single Dose of Zostavax Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3
Hide Arm/Group Description:
Single injection of the 0.65 mL of Zostavax administered on Day 0
0.65 mL of Zostavax administered on Day 0 and Month 1
0.65 mL of Zostavax administered on Day 0 and Month 3
Overall Number of Participants Analyzed 0 232 221
Measure Type: Number
Unit of Measure: Percentage of Participants
0.9 0.9
22.Secondary Outcome
Title Percentage of Participants Who Reported a Vaccine-related Serious Adverse Event
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Groups 1, 2, and 3 who received 1st dose of study drug and had follow-up safety data.
Arm/Group Title Group 1: Single Dose of Zostavax Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3
Hide Arm/Group Description:
Single injection of the 0.65 mL of Zostavax administered on Day 0
0.65 mL of Zostavax administered on Day 0 and Month 1
0.65 mL of Zostavax administered on Day 0 and Month 3
Overall Number of Participants Analyzed 252 248 249
Measure Type: Number
Unit of Measure: Percentage of Participants
0.0 0.0 0.0
23.Secondary Outcome
Title Percentage of Participants Who Died During the Study
Hide 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants in Groups 1, 2, and 3 who received 1st dose of study drug and had follow-up safety data.
Arm/Group Title Group 1: Single Dose of Zostavax Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3
Hide Arm/Group Description:
Single injection of the 0.65 mL of Zostavax administered on Day 0
0.65 mL of Zostavax administered on Day 0 and Month 1
0.65 mL of Zostavax administered on Day 0 and Month 3
Overall Number of Participants Analyzed 252 248 249
Measure Type: Number
Unit of Measure: Percentage of Participants
1.6 2.0 1.2
Time Frame up to 1 year post-last dose (Group 1: 12 months total; Group 2: 13 months total; Group 3: 14 months total)
Adverse Event Reporting Description Analysis population is all enrolled participants.
 
Arm/Group Title Group 1: Single Dose of Zostavax Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3
Hide Arm/Group Description Single injection of the 0.65 mL of Zostavax administered on Day 0 0.65 mL of Zostavax administered on Day 0 and Month 1 0.65 mL of Zostavax administered on Day 0 and Month 3
All-Cause Mortality
Group 1: Single Dose of Zostavax Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: Single Dose of Zostavax Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/253 (1.58%)      11/255 (4.31%)      4/251 (1.59%)    
Cardiac disorders       
Angina pectoris  1  1/253 (0.40%)  1 0/255 (0.00%)  0 0/251 (0.00%)  0
Atrial fibrillation  1  1/253 (0.40%)  1 1/255 (0.39%)  1 0/251 (0.00%)  0
Cardiac failure  1  1/253 (0.40%)  1 0/255 (0.00%)  0 0/251 (0.00%)  0
Cardiogenic shock  1  0/253 (0.00%)  0 1/255 (0.39%)  1 0/251 (0.00%)  0
Coronary artery disease  1  0/253 (0.00%)  0 0/255 (0.00%)  0 1/251 (0.40%)  1
Myocardial infarction  1  0/253 (0.00%)  0 2/255 (0.78%)  2 0/251 (0.00%)  0
Gastrointestinal disorders       
Ileus  1  0/253 (0.00%)  0 1/255 (0.39%)  1 0/251 (0.00%)  0
Infections and infestations       
Bronchitis  1  0/253 (0.00%)  0 1/255 (0.39%)  1 0/251 (0.00%)  0
Diverticulitis  1  0/253 (0.00%)  0 0/255 (0.00%)  0 1/251 (0.40%)  1
Erysipelas  1  0/253 (0.00%)  0 1/255 (0.39%)  1 0/251 (0.00%)  0
Gastroenteritis  1  0/253 (0.00%)  0 1/255 (0.39%)  1 0/251 (0.00%)  0
Injury, poisoning and procedural complications       
Radius fracture  1  0/253 (0.00%)  0 0/255 (0.00%)  0 1/251 (0.40%)  1
Ulna fracture  1  0/253 (0.00%)  0 0/255 (0.00%)  0 1/251 (0.40%)  1
Metabolism and nutrition disorders       
Dehydration  1  1/253 (0.40%)  1 1/255 (0.39%)  1 0/251 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasm malignant  1  0/253 (0.00%)  0 0/255 (0.00%)  0 1/251 (0.40%)  1
Psychiatric disorders       
Mental disorder due to a general medical condition  1  0/253 (0.00%)  0 1/255 (0.39%)  1 0/251 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  0/253 (0.00%)  0 1/255 (0.39%)  1 0/251 (0.00%)  0
Vascular disorders       
Hypertension  1  0/253 (0.00%)  0 1/255 (0.39%)  1 0/251 (0.00%)  0
Peripheral embolism  1  0/253 (0.00%)  0 1/255 (0.39%)  1 0/251 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1: Single Dose of Zostavax Group 2: Zostavax - Day 0 and Month 1 Group 3: Zostavax - Day 0 and Month 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   122/253 (48.22%)      144/255 (56.47%)      132/251 (52.59%)    
General disorders       
Injection site erythema  1  107/253 (42.29%)  107 125/255 (49.02%)  185 122/251 (48.61%)  181
Injection site pain  1  57/253 (22.53%)  60 75/255 (29.41%)  98 74/251 (29.48%)  101
Injection site swelling  1  69/253 (27.27%)  69 73/255 (28.63%)  106 67/251 (26.69%)  92
Nervous system disorders       
Headache  1  13/253 (5.14%)  16 14/255 (5.49%)  18 10/251 (3.98%)  16
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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).
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00561080     History of Changes
Other Study ID Numbers: V211-043
X06-Z-305 ( Other Identifier: MCMVaccBV (SPMSD) Protocol ID )
2007-000744-28 ( EudraCT Number )
First Submitted: November 19, 2007
First Posted: November 20, 2007
Results First Submitted: October 2, 2017
Results First Posted: December 22, 2017
Last Update Posted: February 16, 2018