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

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ClinicalTrials.gov Identifier: NCT01527370
Recruitment Status : Completed
First Posted : February 7, 2012
Results First Posted : December 30, 2013
Last Update Posted : September 18, 2018
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
Enrollment 250

Recruitment Details Ten sites in India enrolled adult participants in the study.
Pre-assignment Details  
Arm/Group Title Zoster Vaccine Live
Hide Arm/Group Description A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
Period Title: Overall Study
Started 250
Completed 244
Not Completed 6
Reason Not Completed
Withdrawal by Subject             4
Physician Decision             1
Death             1
Arm/Group Title Zoster Vaccine Live
Hide Arm/Group Description A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
Overall Number of Baseline Participants 250
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 250 participants
58.6  (7.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 250 participants
Female
66
  26.4%
Male
184
  73.6%
1.Primary Outcome
Title The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination
Hide Description Antibody titers were measured by VZV-specific glycoprotein enzyme-linked immunosorbent assay (gpELISA).
Time Frame Prevaccination up to 6 weeks postvaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This endpoint was analyzed in the per-protocol population which included all participants who were vaccinated and had no major deviations from the protocol procedure. At the week 6 postvaccination timepoint, a total of 7 participants were excluded from the per-protocol immunogenicity analyses.
Arm/Group Title Zoster Vaccine Live
Hide Arm/Group Description:
A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
Overall Number of Participants Analyzed 250
Geometric Mean (95% Confidence Interval)
Unit of Measure: gpELISA units/mL
Prevaccination (n=250)
149.8
(132.6 to 169.2)
6 weeks postvaccination (n=243)
410.8
(373.0 to 452.6)
2.Primary Outcome
Title Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers at 6 Weeks Postvaccination
Hide Description GMFR was analyzed as the geometric mean of the ratio of VZV antibody titer (gpELISA units/mL) at postvaccination week 6 over VZV antibody titer (gpELISA units/mL) at prevaccination day 1.
Time Frame Prevaccination up to 6 weeks postvaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This endpoint was analyzed in the per-protocol population which included all participants who were vaccinated and had no major deviations from the protocol procedure. At the week 6 postvaccination timepoint, a total of 7 participants were excluded from the per-protocol immunogenicity analyses.
Arm/Group Title Zoster Vaccine Live
Hide Arm/Group Description:
A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
Overall Number of Participants Analyzed 243
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
2.8
(2.5 to 3.1)
3.Primary Outcome
Title Number of Participants With Serious Adverse Events
Hide Description A serious adverse event is one that results in death, is life-threatening, results in a persistent or significant disability, results in or prolongs hospitalization, results in a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment.
Time Frame Up to 42 days postvaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This endpoint was analyzed in all participants who were vaccinated and had any safety follow up data.
Arm/Group Title Zoster Vaccine Live
Hide Arm/Group Description:
A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
Overall Number of Participants Analyzed 250
Measure Type: Number
Unit of Measure: Participants
2
Time Frame Day 1 up to day 42 postvaccinaton
Adverse Event Reporting Description Adverse events were collected from all participants who were vaccinated and had any safety follow up data.
 
Arm/Group Title Zoster Vaccine Live
Hide Arm/Group Description A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
All-Cause Mortality
Zoster Vaccine Live
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Zoster Vaccine Live
Affected / at Risk (%) # Events
Total   2/250 (0.80%)    
Gastrointestinal disorders   
Abdominal pain  1/250 (0.40%)  1
Infections and infestations   
Bronchitis  1/250 (0.40%)  1
1
Term from vocabulary, MedDRA version 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Zoster Vaccine Live
Affected / at Risk (%) # Events
Total   47/250 (18.80%)    
General disorders   
Injection site erythema  35/250 (14.00%)  36
Injection site pain  22/250 (8.80%)  24
Injection site swelling  31/250 (12.40%)  33
1
Term from vocabulary, MedDRA version 16.0
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 Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Publications of Results:
Sreenivasamurthy L, Pandey S, Chandra BS, Sharma M, Ranganathaiah SR, Vaidya P, Naik R. Immunogenicity, Safety, and Tolerability of Live Attenuated Varicella-Zoster Virus Vaccine (ZOSTAVAX™) in Healthy Adults in India. J Assoc Physicians India. 2018;66:50-54. http://www.japi.org/july_2018/11_OA_Immunogenicity,%20Safety,%20And%20Tolerability%20Of%20Live%20Attenuated.pdf
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: September 18, 2018