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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 (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00231816
First received: September 30, 2005
Last updated: September 2, 2015
Last verified: September 2015
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 
Overall Participants Analyzed 
[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


  More Information