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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00231816
First received: September 30, 2005
Last updated: April 29, 2014
Last verified: April 2014
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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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
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 ]

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 ]

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


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