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A Study of an Investigational Zoster Vaccine in Subjects With a History of Varicella (Chickenpox) Given Concomitantly With Another Vaccine (V211-011)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00231816
First received: September 30, 2005
Last updated: November 17, 2010
Last verified: November 2010
History of Changes
Results First Received: May 12, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Herpes Zoster
Interventions: Biological: ZOSTAVAX™ (concomitant)
Biological: Comparator: Influenza Vaccine
Biological: ZOSTAVAX™ (Nonconcomitant)

  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

Participants were recruited at 13 sites in the United States and 7 sites in Europe.

First Patient In (FPI): 23-SEP-2005; Last Patient Last Visit (LPLV): 08-MAR-2006

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
Concomitant Group ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
Nonconcomitant Group Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4

Participant Flow:   Overall Study
    Concomitant Group     Nonconcomitant Group  
STARTED     382     381  
Vaccinated at Visit 1     382     380 [1]
Vaccinated at Visit 2     369     371  
COMPLETED     366 [2]   369 [2]
NOT COMPLETED     16     12  
Adverse Event                 1                 0  
Lost to Follow-up                 8                 5  
Protocol Violation                 2                 3  
Withdrawal by Subject                 3                 3  
Not Specified                 2                 1  
[1] One participant was randomized but not vaccinated
[2] Participant received required vaccines and returned completed vaccination report cards at Visits 2&3



  Baseline Characteristics
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Reporting Groups
  Description
Concomitant Group ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
Nonconcomitant Group Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
Total Total of all reporting groups

Baseline Measures
    Concomitant Group     Nonconcomitant Group     Total  
Number of Participants  
[units: participants]
 		  382     380     762  
Age  
[units: years]
Mean ± Standard Deviation 		  63.4  ± 7.99     63.6  ± 8.24     63.5  ± 8.11  
Gender  
[units: participants]
 		     
Female     215     212     427  
Male     167     168     335  
Race/Ethnicity, Customized  
[units: participants]
 		     
African     1     0     1  
Asian     5     4     9  
Black     106     100     206  
Hispanic American     11     11     22  
Indian     0     1     1  
Multiracial     0     2     2  
Native American     1     1     2  
White     258     261     519  



  Outcome Measures
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1.  Primary:   Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody Responses   [ Time Frame: 4 weeks ]
  Show Outcome Measure 1

2.  Other Pre-specified:   Geometric Mean Fold Rise (GMFR) in VZV gpELISA Antibody Titers From Prevaccination to 4 Weeks Postvaccination   [ Time Frame: prevaccination to 4 weeks postvaccination ]
  Show Outcome Measure 2

3.  Other Pre-specified:   Geometric Mean Titers (GMTs) of H1N1 Strain Antibody Responses at 4 Weeks Postvaccination   [ Time Frame: 4 weeks postvaccination ]
  Show Outcome Measure 3

4.  Other Pre-specified:   GMTs of H3N2 Strain Antibody Responses at 4 Weeks Postvaccination   [ Time Frame: 4 weeks postvaccination ]
  Show Outcome Measure 4

5.  Other Pre-specified:   GMTs of B Strain Antibody Responses at 4 Weeks Postvaccination   [ Time Frame: 4 weeks postvaccination ]
  Show Outcome Measure 5


  Serious Adverse Events
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  Other Adverse Events
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  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 of Late Stage Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@spcorp.com


Publications:


Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00231816     History of Changes
Other Study ID Numbers: V211-011, 2005_036
Study First Received: September 30, 2005
Results First Received: May 12, 2010
Last Updated: November 17, 2010
Health Authority: United States: Food and Drug Administration