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ZOSTAVAX™ in Patients on Chronic/Maintenance Corticosteroids (V211-017) (COMPLETED)

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: NCT00546819
Recruitment Status : Completed
First Posted : October 19, 2007
Results First Posted : August 15, 2011
Last Update Posted : April 12, 2017
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: Zoster Vaccine, Live
Biological: Comparator: Placebo
Enrollment 309
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ZOSTAVAX™ Placebo
Hide Arm/Group Description Participants administered ZOSTAVAX™ on Day 1. Participants administered Placebo on Day 1.
Period Title: Overall Study
Started 207 102
VACCINATED 206 100
Completed 199 96
Not Completed 8 6
Reason Not Completed
Adverse Event             2             3
Lost to Follow-up             2             1
Withdrawal by Subject             4             2
Arm/Group Title ZOSTAVAX™ Placebo Total
Hide Arm/Group Description Participants administered ZOSTAVAX™ on Day 1. Participants administered Placebo on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 207 102 309
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 207 participants 102 participants 309 participants
69.8  (6.9) 69.9  (7.2) 69.8  (7.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 207 participants 102 participants 309 participants
Female
140
  67.6%
80
  78.4%
220
  71.2%
Male
67
  32.4%
22
  21.6%
89
  28.8%
Daily Corticosteroid Dose Stratum  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 207 participants 102 participants 309 participants
5 to 10 mg of prednisone or equivalent 182 88 270
>10 to 20 mg of prednisone or equivalent 25 14 39
1.Primary Outcome
Title Number of Participants With Serious Adverse Events (SAE)
Hide Description A serious adverse event is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement.
Time Frame Up to 182 days postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description

All participants who were vaccinated and had any safety

follow-up were included in the safety analysis.

Arm/Group Title ZOSTAVAX™ Placebo
Hide Arm/Group Description:
Participants administered ZOSTAVAX™ on Day 1.
Participants administered Placebo on Day 1.
Overall Number of Participants Analyzed 204 99
Measure Type: Number
Unit of Measure: Participants
21 11
2.Secondary Outcome
Title Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibodies at 42 Days Postvaccination
Hide Description The Geometric Mean Titer (GMT) of VZV antibodies in participants' serum samples was assessed by a glycoprotein enzyme-linked immunosorbent assay (gpELISA).
Time Frame 42 days postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population: All vaccinated participants who had serology results and who had no protocol deviations that would interfere with the evaluation of VZV-specific gpELISA antibody response.
Arm/Group Title ZOSTAVAX™ Placebo
Hide Arm/Group Description:
Participants administered ZOSTAVAX™ on Day 1.
Participants administered Placebo on Day 1.
Overall Number of Participants Analyzed 167 88
Mean (95% Confidence Interval)
Unit of Measure: gpELISA units/mL
531.1
(453.3 to 622.1)
224.3
(169.8 to 296.2)
3.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) of the VZV Antibody Response From Day 1 to Day 42 Postvaccination.
Hide Description The geometric mean fold rise (GMFR) of the VZV antibodies from Day 1 to Week 6 postvaccination.
Time Frame 42 days postvaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population: All vaccinated participants who had serology results and who had no protocol deviations that would interfere with the evaluation of VZV-specific gpELISA antibody response.
Arm/Group Title ZOSTAVAX™ Placebo
Hide Arm/Group Description:
Participants administered ZOSTAVAX™ on Day 1.
Participants administered Placebo on Day 1.
Overall Number of Participants Analyzed 167 88
Mean (95% Confidence Interval)
Unit of Measure: Ratio
2.3
(2.0 to 2.7)
1.1
(1.0 to 1.2)
Time Frame Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ZOSTAVAX™ Placebo
Hide Arm/Group Description Participants administered ZOSTAVAX™ on Day 1. Participants administered Placebo on Day 1.
All-Cause Mortality
ZOSTAVAX™ Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
ZOSTAVAX™ Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/204 (10.29%)      11/99 (11.11%)    
Cardiac disorders     
Acute myocardial infarction  1  1/204 (0.49%)  1 0/99 (0.00%)  0
Cardiac arrest  1  0/204 (0.00%)  0 1/99 (1.01%)  1
Hypertensive heart disease  1  0/204 (0.00%)  0 1/99 (1.01%)  1
Endocrine disorders     
Goitre  1  0/204 (0.00%)  0 1/99 (1.01%)  1
Gastrointestinal disorders     
Food poisoning  1  1/204 (0.49%)  1 0/99 (0.00%)  0
Inguinal hernia, obstructive  1  1/204 (0.49%)  1 0/99 (0.00%)  0
Large intestine perforation  1  0/204 (0.00%)  0 1/99 (1.01%)  1
Pancreatitis acute  1  0/204 (0.00%)  0 1/99 (1.01%)  1
Upper gastrointestinal haemorrhage  1  1/204 (0.49%)  1 0/99 (0.00%)  0
General disorders     
Chest pain  1  1/204 (0.49%)  1 0/99 (0.00%)  0
Infections and infestations     
Cellulitis  1  1/204 (0.49%)  1 0/99 (0.00%)  0
Cellulitis of male external genital organ  1  0/204 (0.00%)  0 1/99 (1.01%)  1
Gastritis viral  1  0/204 (0.00%)  0 1/99 (1.01%)  1
Gastroenteritis  1  1/204 (0.49%)  1 0/99 (0.00%)  0
Herpes zoster ophthalmic  1  1/204 (0.49%)  1 0/99 (0.00%)  0
Kidney infection  1  1/204 (0.49%)  1 0/99 (0.00%)  0
Pneumonia  1  3/204 (1.47%)  3 2/99 (2.02%)  2
Scrotal abscess  1  0/204 (0.00%)  0 1/99 (1.01%)  1
Injury, poisoning and procedural complications     
Comminuted fracture  1  1/204 (0.49%)  1 0/99 (0.00%)  0
Hip fracture  1  0/204 (0.00%)  0 1/99 (1.01%)  1
Musculoskeletal and connective tissue disorders     
Arthritis  1  1/204 (0.49%)  1 0/99 (0.00%)  0
Musculoskeletal pain  1  1/204 (0.49%)  1 0/99 (0.00%)  0
Osteoarthritis  1  0/204 (0.00%)  0 1/99 (1.01%)  1
Nervous system disorders     
Cerebrovascular accident  1  1/204 (0.49%)  1 1/99 (1.01%)  1
Complex regional pain syndrome  1  1/204 (0.49%)  1 0/99 (0.00%)  0
Psychiatric disorders     
Bipolar disorder  1  0/204 (0.00%)  0 1/99 (1.01%)  1
Renal and urinary disorders     
Renal failure  1  0/204 (0.00%)  0 1/99 (1.01%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  7/204 (3.43%)  9 2/99 (2.02%)  2
Pulmonary embolism  1  1/204 (0.49%)  1 0/99 (0.00%)  0
Pulmonary hypertension  1  1/204 (0.49%)  1 0/99 (0.00%)  0
Pulmonary oedema  1  0/204 (0.00%)  0 1/99 (1.01%)  1
Respiratory failure  1  0/204 (0.00%)  0 1/99 (1.01%)  1
Vascular disorders     
Deep vein thrombosis  1  2/204 (0.98%)  2 0/99 (0.00%)  0
Thrombosis  1  1/204 (0.49%)  1 0/99 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ZOSTAVAX™ Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   43/204 (21.08%)      10/99 (10.10%)    
General disorders     
Injection site erythema  1  36/204 (17.65%)  39 4/99 (4.04%)  4
Injection site pain  1  22/204 (10.78%)  23 8/99 (8.08%)  8
Injection site swelling  1  23/204 (11.27%)  24 5/99 (5.05%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
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. SPONSOR review can be expedited to meet publication guidelines.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00546819    
Other Study ID Numbers: V211-017
2006_557
First Submitted: October 17, 2007
First Posted: October 19, 2007
Results First Submitted: July 20, 2011
Results First Posted: August 15, 2011
Last Update Posted: April 12, 2017