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)(COMPLETED)
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00092417
First received: September 22, 2004
Last updated: December 17, 2010
Last verified: December 2010
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Biological: Comparator: Varicella Zoster Virus Vaccine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs) [ Time Frame: Day 1-42 post vaccination ] [ Designated as safety issue: Yes ]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.
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 695 |
| Study Start Date: | October 2003 |
| Study Completion Date: | August 2004 |
| Primary Completion Date: | June 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Higher Potency Dose
|
Biological: Comparator: Varicella Zoster Virus Vaccine
Single 0.65 mL subcutaneous injection of higher potency zoster vaccine (~207,000 plaque-forming units [PFU]/0.65-mL dose)
|
|
Experimental: 2
Lower Potency Dose
|
Biological: Comparator: Varicella Zoster Virus Vaccine
Single 0.65 mL subcutaneous injection of lower potency zoster vaccine (~58,000 plaque-forming units [PFU]/0.65-mL dose)
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations More Information
Publications:
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00092417 History of Changes |
| Other Study ID Numbers: | V211-009, 2004_075 |
| Study First Received: | September 22, 2004 |
| Results First Received: | May 12, 2010 |
| Last Updated: | December 17, 2010 |
| Health Authority: | United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on May 19, 2013