ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of an Investigational Zoster Vaccine, in Subjects With a History of Herpes Zoster (V211-014)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00322231
Recruitment Status : Completed
First Posted : May 5, 2006
Results First Posted : December 15, 2010
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: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition: Herpes Zoster
Interventions: Biological: zoster vaccine live (ZOSTAVAX™)
Biological: Comparator: Placebo

  Participant Flow

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 9 sites in the United States.

First patient enrolled: May-2006; Last patient last visit: July – 2007


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™ / Placebo 0.65mL of Zoster vaccine live injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of placebo injected subcutaneously at Week 4 (Period 2)
Placebo / ZOSTAVAX™ 0.65mL of placebo injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of Zoster vaccine live injected subcutaneously at Week 4 (Period 2)

Participant Flow for 2 periods

Period 1:   Period 1
    ZOSTAVAX™ / Placebo   Placebo / ZOSTAVAX™
STARTED   51   50 
COMPLETED   51   50 
NOT COMPLETED   0   0 

Period 2:   Period 2
    ZOSTAVAX™ / Placebo   Placebo / ZOSTAVAX™
STARTED   51   49 [1] 
COMPLETED   51   49 
NOT COMPLETED   0   0 
[1] One participant was lost between Period 1 and Period 2



  Baseline Characteristics

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™ / Placebo 0.65mL of Zoster vaccine live injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of placebo injected subcutaneously at Week 4 (Period 2)
Placebo / ZOSTAVAX™ 0.65mL of placebo injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of Zoster vaccine live injected subcutaneously at Week 4 (Period 2)
Total Total of all reporting groups

Baseline Measures
   ZOSTAVAX™ / Placebo   Placebo / ZOSTAVAX™   Total 
Overall Participants Analyzed 
[Units: Participants]
 51   50   101 
Age, Customized 
[Units: Participants]
     
50 to 59 Years of age   10   10   20 
≥ 60 Years of age   41   40   81 
Gender 
[Units: Participants]
     
Female   36   24   60 
Male   15   26   41 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian   1   3   4 
Black   3   3   6 
Hispanic American   0   2   2 
White   47   42   89 


  Outcome Measures

1.  Primary:   Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination   [ Time Frame: To Day 28 postvaccination ]

2.  Secondary:   Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination   [ Time Frame: 4 weeks postvaccination ]

3.  Secondary:   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


  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.


  More Information

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.


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


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00322231     History of Changes
Other Study ID Numbers: V211-014
2006_010
First Submitted: May 2, 2006
First Posted: May 5, 2006
Results First Submitted: May 12, 2010
Results First Posted: December 15, 2010
Last Update Posted: January 26, 2015