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Trial record 2 of 8 for:    merck v212

A Study to Evaluate the Safety and Efficacy of Inactivated Varicella-zoster Vaccine (VZV) as a Preventative Treatment for Herpes Zoster (HZ) and HZ-related Complications in Adult Participants With Solid Tumor or Hematologic Malignancy (V212-011)

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ClinicalTrials.gov Identifier: NCT01254630
Recruitment Status : Completed
First Posted : December 6, 2010
Results First Posted : April 13, 2018
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition: Herpes Zoster
Interventions: Biological: V212
Biological: 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
Adult participants with a diagnosis of solid tumor malignancy (STM) or hematologic malignancy (HM) were enrolled from 328 sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 5507 screened participants, 5305 were randomized. Twenty randomized participants were not included in analyses: 19 participants from a single site identified to have major Good Clinical Practice compliance issues and 1 participant that was not vaccinated. Thus, a total of 5285 were included in analyses.

Reporting Groups
  Description
V212-STM Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.
V212-HM Participants with HM randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.
Placebo-STM Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.
Placebo-HM Participants with HM randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.

Participant Flow:   Overall Study
    V212-STM   V212-HM   Placebo-STM   Placebo-HM
STARTED   1348   1288   1364   1285 
Received Vaccination 1   1328   1277   1350   1275 
Received Vaccination 2   1255   1217   1286   1226 
Received Vaccination 3   1198   1178   1247   1194 
Received Vaccination 4   1155   1145   1212   1160 
COMPLETED   546   0   552   0 
NOT COMPLETED   802   1288   812   1285 
Adverse Event                36                15                40                8 
Death                461                151                478                139 
Lost to Follow-up                80                26                89                32 
Physician Decision                24                8                16                7 
Withdrawal by Subject                201                94                188                89 
Study terminated by sponsor                0                994                0                1010 
Status not recorded                0                0                1                0 



  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.
All randomized participants included in study analyses. Twenty randomized participants were not included in baseline analyses: 19 participants from a single site identified to have major Good Clinical Practice compliance issues and 1 participant that was not vaccinated.

Reporting Groups
  Description
V212-STM Participants with STM receiving chemotherapy randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.
V212-HM Participants with HM randomized to receive V212 vaccine given as a 4-dose regimen administered ~30 days apart.
Placebo-STM Participants with STM receiving chemotherapy randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.
Placebo-HM Participants with HM randomized to receive placebo to V212 vaccine given as a 4-dose regimen administered ~30 days apart.
Total Total of all reporting groups

Baseline Measures
   V212-STM   V212-HM   Placebo-STM   Placebo-HM   Total 
Overall Participants Analyzed 
[Units: Participants]
 1348   1288   1364   1285   5285 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.6  (11.5)   61.0  (14.9)   57.7  (11.5)   61.4  (14.5)   59.4  (13.3) 
Age, Customized 
[Units: Participants]
         
Adults (between 18 and 64 years)   965   705   981   673   3324 
From 65 to 84 years   379   558   378   589   1904 
85 years and over   4   25   5   23   57 
Age, Customized 
[Units: Participants]
         
<50 years   299   235   320   223   1077 
≥50 years   1049   1053   1044   1062   4208 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      867  64.3%      528  41.0%      892  65.4%      523  40.7%      2810  53.2% 
Male      481  35.7%      760  59.0%      472  34.6%      762  59.3%      2475  46.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      17   1.3%      2   0.2%      14   1.0%      2   0.2%      35   0.7% 
Asian      55   4.1%      110   8.5%      64   4.7%      94   7.3%      323   6.1% 
Native Hawaiian or Other Pacific Islander      2   0.1%      2   0.2%      3   0.2%      2   0.2%      9   0.2% 
Black or African American      86   6.4%      41   3.2%      92   6.7%      57   4.4%      276   5.2% 
White      1044  77.4%      976  75.8%      1031  75.6%      986  76.7%      4037  76.4% 
More than one race      144  10.7%      157  12.2%      159  11.7%      141  11.0%      601  11.4% 
Unknown or Not Reported      0   0.0%      0   0.0%      1   0.1%      3   0.2%      4   0.1% 


  Outcome Measures

1.  Primary:   Incidence of Confirmed Herpes-Zoster   [ Time Frame: Up to approximately 5 years ]

2.  Primary:   Percentage of Participants With One or More Serious Adverse Events   [ Time Frame: Up to 28 days after vaccination 4 (up to approximately 118 days) ]

3.  Secondary:   Incidence of Moderate to Severe Herpes-Zoster-Associated Pain   [ Time Frame: Up to 6 months after onset of HZ (up to approximately 5 years) ]

4.  Secondary:   Incidence of Herpes-Zoster Complications   [ Time Frame: Up to 6 months after onset of HZ (up to approximately 5 years) ]

5.  Secondary:   Incidence of Postherpetic Neuralgia   [ Time Frame: Up to 6 months after onset of HZ (up to approximately 5 years) ]

6.  Other Pre-specified:   Percentage of Participants With Study Medication Withdrawn Due to an Adverse Event   [ Time Frame: Up to 28 days after vaccination 4 (up to approximately 118 days) ]


  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: NCT01254630     History of Changes
Other Study ID Numbers: V212-011
CTRI/2012/05/002673 ( Registry Identifier: CTRI )
2010-023156-89 ( EudraCT Number )
V212-011 ( Other Identifier: Merck Protocol Number )
First Submitted: December 3, 2010
First Posted: December 6, 2010
Results First Submitted: March 14, 2018
Results First Posted: April 13, 2018
Last Update Posted: April 13, 2018