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Trial record 30 of 469 for:    Shingles

A Study to Evaluate Safety, Tolerability, and Immunogenicity of an Investigational Zoster Vaccine In Subjects With a History of Varicella (Chickenpox)(V211-010)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00130793
Recruitment Status : Completed
First Posted : August 16, 2005
Results First Posted : July 3, 2009
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Herpes Zoster
Interventions Biological: Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation
Biological: Comparator: zoster vaccine live (Oka/Merck) frozen formulation
Enrollment 368

Recruitment Details

Patients were recruited at 14 sites in the United States.

First patient randomized: 08Aug2005; Last patient last visit: 28Nov2005

Pre-assignment Details  
Arm/Group Title ZOSTAVAX™ With PGSU ZOSTAVAX™ With PGS
Hide Arm/Group Description ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
Period Title: Overall Study
Started 183 185
Vaccinated 182 [1] 185
Completed 180 [2] 181 [3]
Not Completed 3 4
Reason Not Completed
Lost to Follow-up             1             4
Withdrew consent             2             0
[1]
One subject was allocated but not vaccinated.
[2]
Subject received vaccine, completed blood draws, returned vaccination report card (VRC) at Week 4
[3]
Subject received vaccine, completed blood draws, returned VRC at Week 4
Arm/Group Title ZOSTAVAX™ With PGSU ZOSTAVAX™ With PGS Total
Hide Arm/Group Description ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection Total of all reporting groups
Overall Number of Baseline Participants 182 185 367
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 182 participants 185 participants 367 participants
63.4  (9.25) 63.2  (8.44) 63.35  (8.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 182 participants 185 participants 367 participants
Female
97
  53.3%
106
  57.3%
203
  55.3%
Male
85
  46.7%
79
  42.7%
164
  44.7%
Race/Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 182 participants 185 participants 367 participants
Asian 6 6 12
Asiatic 1 4 5
Black 19 15 34
Hispanic American 30 34 64
Indian 1 0 1
Native American 1 0 1
White 124 126 250
1.Primary Outcome
Title Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination
Hide Description The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at 4 weeks postvaccination in subjects who received ZOSTAVAX™ with PGSU and in subjects who received ZOSTAVAX™ with PGS.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The primary immunogenicity analyses were based on the per-protocol population defined as subjects who had valid results from samples obtained within the prespecified day ranges at Day 1 or at Week 4 postvaccination, and who did not meet any of the protocol violations prespecified in the statistical analysis plan (SAP)
Arm/Group Title ZOSTAVAX™ With PGSU ZOSTAVAX™ With PGS
Hide Arm/Group Description:
ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
Overall Number of Participants Analyzed 176 178
Geometric Mean (95% Confidence Interval)
Unit of Measure: gpELISA units/mL
717.5
(607.3 to 847.7)
844.9
(704.4 to 1013.6)
2.Secondary Outcome
Title Vaccine-Related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination
Hide Description Vaccine-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) serious adverse experiences are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All vaccinated subjects with safety follow-up are included.
Arm/Group Title ZOSTAVAX™ With PGSU ZOSTAVAX™ With PGS
Hide Arm/Group Description:
ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
Overall Number of Participants Analyzed 180 183
Measure Type: Number
Unit of Measure: Participants
With vaccine related SAEs 0 0
Without vaccine related SAEs 180 183
3.Other Pre-specified Outcome
Title Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination
Hide Description GMFR of the VZV antibody response from prevaccination to Week 4 postvaccination
Time Frame From prevaccination (baseline) to 4 weeks postvaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The primary immunogenicity analyses were based on the per-protocol population defined as subjects who had valid results from samples obtained within the prespecified day ranges at Day 1 or at Week 4 postvaccination, and who did not meet any of the protocol violations prespecified in the SAP.
Arm/Group Title ZOSTAVAX™With PGSU ZOSTAVAX™ With PGS
Hide Arm/Group Description:
ZOSTAVAX™with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
Overall Number of Participants Analyzed 174 177
Geometric Mean (95% Confidence Interval)
Unit of Measure: gpELISA units/mL
2.6
(2.2 to 3.0)
2.9
(2.4 to 3.4)
Time Frame Through 28 days post-vaccination.
Adverse Event Reporting Description The AE presentation includes participants who were vaccinated and had safety follow-up.
 
Arm/Group Title ZOSTAVAX™ With PGSU ZOSTAVAX™ With PGS
Hide Arm/Group Description ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
All-Cause Mortality
ZOSTAVAX™ With PGSU ZOSTAVAX™ With PGS
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ZOSTAVAX™ With PGSU ZOSTAVAX™ With PGS
Affected / at Risk (%) Affected / at Risk (%)
Total   1/180 (0.56%)   0/183 (0.00%) 
Infections and infestations     
Gastroenteritis  1/180 (0.56%)  0/183 (0.00%) 
1
Term from vocabulary, MedDRA (8.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ZOSTAVAX™ With PGSU ZOSTAVAX™ With PGS
Affected / at Risk (%) Affected / at Risk (%)
Total   63/180 (35.00%)   84/183 (45.90%) 
General disorders     
Injection site erythema  52/180 (28.89%)  65/183 (35.52%) 
Injection site pain  48/180 (26.67%)  70/183 (38.25%) 
Injection site pruritus  13/180 (7.22%)  16/183 (8.74%) 
Injection site swelling  44/180 (24.44%)  60/183 (32.79%) 
1
Term from vocabulary, MedDRA (8.1)
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.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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: NCT00130793     History of Changes
Other Study ID Numbers: V211-010
2005_035
First Submitted: August 11, 2005
First Posted: August 16, 2005
Results First Submitted: May 11, 2009
Results First Posted: July 3, 2009
Last Update Posted: January 26, 2015