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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00130793
First received: August 11, 2005
Last updated: January 16, 2014
Last verified: January 2014
Results First Received: May 11, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Patients were recruited at 14 sites in the United States.

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


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
ZOSTAVAX™ With PGSU ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
ZOSTAVAX™ With PGS ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection

Participant Flow:   Overall Study
    ZOSTAVAX™ With PGSU     ZOSTAVAX™ With PGS  
STARTED     183     185  
Vaccinated     182 [1]   185  
COMPLETED     180 [2]   181 [3]
NOT COMPLETED     3     4  
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



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
ZOSTAVAX™ With PGSU ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
ZOSTAVAX™ With PGS ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
Total Total of all reporting groups

Baseline Measures
    ZOSTAVAX™ With PGSU     ZOSTAVAX™ With PGS     Total  
Number of Participants  
[units: participants]
  182     185     367  
Age  
[units: years]
Mean ± Standard Deviation
  63.4  ± 9.25     63.2  ± 8.44     63.35  ± 8.83  
Gender  
[units: participants]
     
Female     97     106     203  
Male     85     79     164  
Race/Ethnicity  
[units: 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  



  Outcome Measures
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1.  Primary:   Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination   [ Time Frame: 4 weeks ]

2.  Secondary:   Vaccine-Related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination   [ Time Frame: 4 weeks ]

3.  Other Pre-specified:   Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination   [ Time Frame: From prevaccination (baseline) to 4 weeks postvaccination ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00130793     History of Changes
Other Study ID Numbers: V211-010, 2005_035
Study First Received: August 11, 2005
Results First Received: May 11, 2009
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration