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
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 April 14, 2014