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Evaluation of the Safety and Tolerability of a Higher Potency Dose of an Investigational Vaccine Among Adults 50 Years of Age and Older (V211-009)

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ClinicalTrials.gov Identifier: NCT00092417
Recruitment Status : Completed
First Posted : September 27, 2004
Results First Posted : June 10, 2010
Last Update Posted : October 7, 2015
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 Healthy
Intervention Biological: Comparator: Varicella Zoster Virus Vaccine
Enrollment 695
Recruitment Details

Participants were recruited at 18 sites in the United States, Canada, and Europe

Prime Therapy Period: 30-Oct-2003 to 07-Jun-2004

Cutoff date for in-house data: 24-Aug-2004

Pre-assignment Details  
Arm/Group Title Zoster Vaccine Higher Potency Zoster Vaccine Lower Potency
Hide Arm/Group Description Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
Period Title: Overall Study
Started 464 [1] 234 [2]
Vaccinated 461 [3] 234
Completed 459 [4] 233 [5]
Not Completed 5 1
Reason Not Completed
Lost to Follow-up             2             0
Withdrawal by Subject             2             1
Not Specified             1             0
[1]
Started Period Group 1
[2]
Started Period Group 2
[3]
3 participants were allocated,not vaccinated; they are not reported in the Baseline Characteristics
[4]
Received the higher potency zoster vaccine & completed 42 days of safety follow-up post vaccination
[5]
Received the lower potency zoster vaccine & completed 42 days of safety follow-up post vaccination
Arm/Group Title Zoster Vaccine Higher Potency Zoster Vaccine Lower Potency Total
Hide Arm/Group Description Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection Total of all reporting groups
Overall Number of Baseline Participants 461 234 695
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 461 participants 234 participants 695 participants
65.2  (9.16) 65.6  (9.69) 65.4  (9.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 461 participants 234 participants 695 participants
Female
282
  61.2%
134
  57.3%
416
  59.9%
Male
179
  38.8%
100
  42.7%
279
  40.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 461 participants 234 participants 695 participants
Asian 10 6 16
Black 6 4 10
Hispanic American 10 8 18
Multi-Racial 1 2 3
Native American 2 0 2
White 432 214 646
1.Primary Outcome
Title Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs)
Hide Description The incidence of vaccine-related SAEs occurring Day 1 through Day 42 postvaccination. Whether a serious clinical adverse experience occurring Day 1 through Day 42 postvaccination was vaccine-related was determined by the investigator who was a qualified physician . The difference in the risk of developing a vaccine-related SAE between the two groups was compared at the 2-sided 0.05 level.
Time Frame Day 1-42 post vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population for the primary safety analysis consisted of all vaccinated participants who had safety follow-up data.
Arm/Group Title Zoster Vaccine Higher Potency Zoster Vaccine Lower Potency
Hide Arm/Group Description:
Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
Overall Number of Participants Analyzed 459 234
Measure Type: Number
Unit of Measure: Participants
With vaccine-related SAEs 0 0
Without vaccine-related SAEs 459 234
2.Primary Outcome
Title Number of Participants With Moderate or Severe Injection-site Pain/Tenderness/Soreness or Swelling (> 2 Inches at Largest Diameter)
Hide Description [Not Specified]
Time Frame Day 1-5 postvaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population for the primary safety analysis consisted of all vaccinated participants who had safety follow-up data.
Arm/Group Title Zoster Vaccine Higher Potency Zoster Vaccine Lower Potency
Hide Arm/Group Description:
Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
Overall Number of Participants Analyzed 459 234
Measure Type: Number
Unit of Measure: Participants
With moderate or severe injection-site reaction 79 21
Without moderate or severe injection-site reaction 380 213
3.Other Pre-specified Outcome
Title Number of Participants With Varicella or Varicella-like Noninjection-site Rashes, Nondermatomal in Distribution With >100 Lesions
Hide Description Noninjection-site rash Day 1 through Day 42 postvaccination was reported by the participant to the investigator and confirmed to be varicelliform rash by the study physician and polymerase chain reaction (PCR).
Time Frame Day 1-42 postvaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population for the safety analyses consisted of all vaccinated participants who had safety follow-up data.
Arm/Group Title Zoster Vaccine Higher Potency Zoster Vaccine Lower Potency
Hide Arm/Group Description:
Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
Overall Number of Participants Analyzed 459 234
Measure Type: Number
Unit of Measure: Participants
With varicella or rash, varicelliform 0 0
Without varicella or rash, varicelliform 459 234
4.Other Pre-specified Outcome
Title Number of Participants With Herpes Zoster (HZ) or HZ-like Rashes
Hide Description Noninjection-site rash Day 1 through Day 42 postvaccination was reported by the participant to the investigator and confirmed to be zosteriform rash by the study physician and polymerase chain reaction (PCR).
Time Frame Day 1-42 postvaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population for the safety analyses consisted of all vaccinated participants who had safety follow-up data.
Arm/Group Title Zoster Vaccine Higher Potency Zoster Vaccine Lower Potency
Hide Arm/Group Description:
Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
Overall Number of Participants Analyzed 459 234
Measure Type: Number
Unit of Measure: Participants
With zoster or rash, zosteriform 3 3
Without zoster or rash, zosteriform 456 231
5.Other Pre-specified Outcome
Title Number of Participants With Fevers ≥101.0°F [≥38.3°C]
Hide Description Maximum reported oral or equivalent temperature ≥101.0°F [≥38.3°C] was reported Day 1 through Day 21 postvaccination.
Time Frame Day 1-21 postvaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population for the safety analyses consisted of all vaccinated participants who had safety follow-up data. 5 participants in the Zoster Vaccine Higher Potency group and 3 participants in the Zoster Vaccine Lower Potency group were not included in this analysis since these participants were without a follow-up.
Arm/Group Title Zoster Vaccine Higher Potency Zoster Vaccine Lower Potency
Hide Arm/Group Description:
Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
Overall Number of Participants Analyzed 456 231
Measure Type: Number
Unit of Measure: Participants
With max oral temp ≥101.0°F (≥38.3°C) 4 2
With max oral temp <101.0°F (<38.3°C) 452 229
Time Frame Day 1 – 42 postvaccination
Adverse Event Reporting Description

Daily temperature readings, injection-site adverse experiences, rashes, and other adverse experiences were recorded by the participant on a Vaccination Report Card which was reviewed 42 days after vaccination.

Number of participants at risk included randomized participants who had follow-up after at least one dose of vaccination.

 
Arm/Group Title Zoster Vaccine Higher Potency Zoster Vaccine Lower Potency
Hide Arm/Group Description Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
All-Cause Mortality
Zoster Vaccine Higher Potency Zoster Vaccine Lower Potency
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Zoster Vaccine Higher Potency Zoster Vaccine Lower Potency
Affected / at Risk (%) Affected / at Risk (%)
Total   4/459 (0.87%)   1/234 (0.43%) 
Cardiac disorders     
Angina pectoris * 1  1/459 (0.22%)  0/234 (0.00%) 
Coronary artery disease * 1  1/459 (0.22%)  0/234 (0.00%) 
Gastrointestinal disorders     
Enteritis * 1  1/459 (0.22%)  0/234 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Small cell lung cancer stage unspecified * 1  0/459 (0.00%)  1/234 (0.43%) 
Psychiatric disorders     
Depression * 1  1/459 (0.22%)  0/234 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 7.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Zoster Vaccine Higher Potency Zoster Vaccine Lower Potency
Affected / at Risk (%) Affected / at Risk (%)
Total   296/459 (64.49%)   141/234 (60.26%) 
General disorders     
Injection Site Erythema  1  227/459 (49.46%)  111/234 (47.44%) 
Injection Site Pain  1  217/459 (47.28%)  91/234 (38.89%) 
Injection Site Pruritus  1  58/459 (12.64%)  21/234 (8.97%) 
Injection Site Swelling  1  189/459 (41.18%)  77/234 (32.91%) 
Nervous system disorders     
Headache * 1  43/459 (9.37%)  16/234 (6.84%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 7.0
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: NCT00092417     History of Changes
Other Study ID Numbers: V211-009
2004_075
First Submitted: September 22, 2004
First Posted: September 27, 2004
Results First Submitted: May 12, 2010
Results First Posted: June 10, 2010
Last Update Posted: October 7, 2015