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Trial record 27 of 469 for:    Shingles

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

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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
Enrollment 101

Recruitment Details

Patients were recruited at 9 sites in the United States.

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

Pre-assignment Details  
Arm/Group Title ZOSTAVAX™ / Placebo Placebo / ZOSTAVAX™
Hide Arm/Group Description 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) 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)
Period Title: Period 1
Started 51 50
Completed 51 50
Not Completed 0 0
Period Title: Period 2
Started 51 49 [1]
Completed 51 49
Not Completed 0 0
[1]
One participant was lost between Period 1 and Period 2
Arm/Group Title ZOSTAVAX™ / Placebo Placebo / ZOSTAVAX™ Total
Hide Arm/Group Description 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) 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 of all reporting groups
Overall Number of Baseline Participants 51 50 101
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 51 participants 50 participants 101 participants
50 to 59 Years of age 10 10 20
≥ 60 Years of age 41 40 81
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 50 participants 101 participants
Female
36
  70.6%
24
  48.0%
60
  59.4%
Male
15
  29.4%
26
  52.0%
41
  40.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 51 participants 50 participants 101 participants
Asian 1 3 4
Black 3 3 6
Hispanic American 0 2 2
White 47 42 89
1.Primary Outcome
Title Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination
Hide Description SAEs are AEs at any dose that: Results in death or persistent/significant disability/incapacity; or prolongs an existing inpatient hospitalization or Is life threatening; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose or Is an other important medical event
Time Frame To Day 28 postvaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All vaccinated participants were evaluated for safety. This was a crossover study. All participants received one dose each of ZOSTAVAX™ and placebo. Data below reflect SAEs reported after receipt of ZOSTAVAX™ or placebo.
Arm/Group Title ZOSTAVAX™ Placebo
Hide Arm/Group Description:
Participants who received ZOSTAVAX™ in the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group (see participant flow section) are included
Participants who received placebo in the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ Group (see participant flow section) are included.
Overall Number of Participants Analyzed 100 101
Measure Type: Number
Unit of Measure: Participants
With Vaccine-related SAEs 0 0
Without Vaccine-related SAEs 100 101
2.Secondary Outcome
Title Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination
Hide Description The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at the prespecified day ranges at prevaccination and 4 weeks postvaccination
Time Frame 4 weeks postvaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population
Arm/Group Title ZOSTAVAX™ Placebo
Hide Arm/Group Description:
Participants who received ZOSTAVAX™ in both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group (see participant flow section) are included.
Participants who received placebo (at Day 1) in Placebo / ZOSTAVAX™ group. Participants who received ZOSTAVAX™ at (Day 1) in the ZOSTAVAX™ / Placebo group were excluded to avoid a possible carry-over effect of ZOSTAVAX™ on immunogenicity measurements.
Overall Number of Participants Analyzed 100 50
Geometric Mean (95% Confidence Interval)
Unit of Measure: gpELISA units/mL
810.1
(688.3 to 953.4)
391.1
(291.9 to 523.9)
3.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination
Hide Description GMFR of the VZV antibody response at the prespecified day ranges prevaccination and 4 weeks postvaccination
Time Frame From prevaccination (baseline) to 4 weeks postvaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population
Arm/Group Title ZOSTAVAX™ Placebo
Hide Arm/Group Description:
Participants who received ZOSTAVAX™ in both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group are included. In addition, 5 participants from the Placebo / ZOSTAVAX™ group were excluded in the prevaccination summaries (since their specimens were damaged or collected out of day range), and are not in the analysis.
Participants included in this analysis were those who received Placebo in Placebo /ZOSTAVAX™ group (on Day 1). Participants who received ZOSTAVAX™ in the ZOSTAVAX™ / Placebo group were excluded in order to avoid a possible carry-over effect of ZOSTAVAX™ on immunogenicity measurements. In addition, 5 participants from the Placebo / ZOSTAVAX™ group were excluded in the prevaccination summaries (since their specimens were damaged or collected out of day range), and are not in the analysis.
Overall Number of Participants Analyzed 95 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Geometric mean fold rise
2.1
(1.8 to 2.4)
1.0
(0.9 to 1.1)
Time Frame Day 1 - 28 following each vaccination
Adverse Event Reporting Description

Injection-site adverse experiences (AEs), rashes, oral temperatures (if the participant felt febrile), and other AEs were recorded by the participant on a Vaccination Report Card which was reviewed by the study site personnel at the end of each 28-day follow-up period.

The participants at risk are ITT population with follow-up.

 
Arm/Group Title ZOSTAVAX™ Placebo
Hide Arm/Group Description All participants that received ZOSTAVAX™ from both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group. Two participants that received ZOSTAVAX™ were lost to follow up and not included in the analysis. All participants that received Placebo in both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™. Five participants that received placebo were lost to follow up and not included in the analysis.
All-Cause Mortality
ZOSTAVAX™ Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ZOSTAVAX™ Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/98 (0.00%)   0/96 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ZOSTAVAX™ Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   45/98 (45.92%)   4/96 (4.17%) 
General disorders     
Injection Site Erythema  1  33/98 (33.67%)  3/96 (3.13%) 
Injection Site Pain  1  36/98 (36.73%)  1/96 (1.04%) 
Injection Site Pruritus  1  5/98 (5.10%)  0/96 (0.00%) 
Injection Site Swelling  1  26/98 (26.53%)  2/96 (2.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
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.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
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