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)
October 6, 2015 updated by: Merck Sharp & Dohme LLC
Evaluation of the Safety and Tolerability of a Higher Potency Dose of Varicella Zoster Virus Vaccine Live (Oka/Merck)Among Adults 50 Years of Age or Older
This study compared the safety and tolerability profile of a higher potency investigational vaccine to that of the investigational vaccine at a lower potency dose.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
695
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy individuals 50 years of age or older with a history of chickenpox who have not had herpes zoster
Exclusion Criteria :
- Preexisting conditions that might affect vaccine safety such as conditions that inhibit an immune response
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Higher Potency Dose
|
Single 0.65 mL subcutaneous injection of higher potency zoster vaccine (~207,000 plaque-forming units [PFU]/0.65-mL
dose)
Single 0.65 mL subcutaneous injection of lower potency zoster vaccine (~58,000 plaque-forming units [PFU]/0.65-mL
dose)
|
|
Experimental: 2
Lower Potency Dose
|
Single 0.65 mL subcutaneous injection of higher potency zoster vaccine (~207,000 plaque-forming units [PFU]/0.65-mL
dose)
Single 0.65 mL subcutaneous injection of lower potency zoster vaccine (~58,000 plaque-forming units [PFU]/0.65-mL
dose)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs)
Time Frame: Day 1-42 post vaccination
|
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.
|
Day 1-42 post vaccination
|
|
Number of Participants With Moderate or Severe Injection-site Pain/Tenderness/Soreness or Swelling (> 2 Inches at Largest Diameter)
Time Frame: Day 1-5 postvaccination
|
Day 1-5 postvaccination
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Varicella or Varicella-like Noninjection-site Rashes, Nondermatomal in Distribution With >100 Lesions
Time Frame: Day 1-42 postvaccination
|
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).
|
Day 1-42 postvaccination
|
|
Number of Participants With Herpes Zoster (HZ) or HZ-like Rashes
Time Frame: Day 1-42 postvaccination
|
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).
|
Day 1-42 postvaccination
|
|
Number of Participants With Fevers ≥101.0°F [≥38.3°C]
Time Frame: Day 1-21 postvaccination
|
Maximum reported oral or equivalent temperature ≥101.0°F
[≥38.3°C] was reported Day 1 through Day 21 postvaccination.
|
Day 1-21 postvaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2003
Primary Completion (Actual)
June 1, 2004
Study Completion (Actual)
June 1, 2004
Study Registration Dates
First Submitted
September 22, 2004
First Submitted That Met QC Criteria
September 24, 2004
First Posted (Estimate)
September 27, 2004
Study Record Updates
Last Update Posted (Estimate)
October 7, 2015
Last Update Submitted That Met QC Criteria
October 6, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V211-009
- 2004_075
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.