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:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092417
First received: September 22, 2004
Last updated: September 6, 2013
Last verified: September 2013
  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 Sharp & Dohme Corp.:

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 ]

Other Outcome Measures:
  • Number of Participants With Varicella or Varicella-like Noninjection-site Rashes, Nondermatomal in Distribution With >100 Lesions [ Time Frame: Day 1-42 postvaccination ] [ Designated as safety issue: Yes ]
    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).

  • Number of Participants With Herpes Zoster (HZ) or HZ-like Rashes [ Time Frame: Day 1-42 postvaccination ] [ Designated as safety issue: Yes ]
    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).

  • Number of Participants With Fevers ≥101.0°F [≥38.3°C] [ Time Frame: Day 1-21 postvaccination ] [ Designated as safety issue: Yes ]
    Maximum reported oral or equivalent temperature ≥101.0°F [≥38.3°C] was reported Day 1 through Day 21 postvaccination.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092417

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  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: September 6, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 28, 2014