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Trial record 46 of 456 for:    Shingles

Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025)

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: NCT01527370
Recruitment Status : Completed
First Posted : February 7, 2012
Results First Posted : December 30, 2013
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Herpes Zoster
Shingles
Intervention: Biological: Zoster Vaccine Live

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Ten sites in India enrolled adult participants in the study.

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
Zoster Vaccine Live A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.

Participant Flow:   Overall Study
    Zoster Vaccine Live
STARTED   250 
COMPLETED   244 
NOT COMPLETED   6 
Withdrawal by Subject                4 
Physician Decision                1 
Death                1 



  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
Zoster Vaccine Live A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.

Baseline Measures
   Zoster Vaccine Live 
Overall Participants Analyzed 
[Units: Participants]
 250 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.6  (7.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      66  26.4% 
Male      184  73.6% 


  Outcome Measures

1.  Primary:   The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination   [ Time Frame: Prevaccination up to 6 weeks postvaccination ]

2.  Primary:   Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers at 6 Weeks Postvaccination   [ Time Frame: Prevaccination up to 6 weeks postvaccination ]

3.  Primary:   Number of Participants With Serious Adverse Events   [ Time Frame: Up to 42 days 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



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01527370     History of Changes
Other Study ID Numbers: V211-025
CTRI/2012/08/002922 ( Registry Identifier: CTRI )
First Submitted: February 2, 2012
First Posted: February 7, 2012
Results First Submitted: November 11, 2013
Results First Posted: December 30, 2013
Last Update Posted: April 12, 2017