A Study to Evaluate Safety, Tolerability, and Immunogenicity of an Investigational Zoster Vaccine In Subjects With a History of Varicella (Chickenpox)(V211-010)(COMPLETED)

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 3

Conditions

Herpes Zoster

Treatments

Biological: Comparator: zoster vaccine live (Oka/Merck) frozen formulation
Biological: Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation

Study type

Interventional

Funder types

Industry

Identifiers

NCT00130793
V211-010
2005_035

Details and patient eligibility

About

The purpose of this study is to determine whether the refrigerator-stable formulation of an investigational vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile to that of the freezer-stable formulation of the vaccine.

Full description

The duration of treatment is 4 weeks.

Enrollment

368 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Individuals who are at least 50 years of age or older with a history of varicella (chicken pox)

Exclusion criteria

  • Prior history of herpes zoster (shingles)
  • Prior receipt of varicella or zoster vaccine
  • Immunosuppressed

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

368 participants in 2 patient groups

zoster vaccine live (Oka/Merck) refrigerated formulation
Experimental group
Description:
ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
Treatment:
Biological: Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation
zoster vaccine live (Oka/Merck) frozen formulation
Active Comparator group
Description:
ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
Treatment:
Biological: Comparator: zoster vaccine live (Oka/Merck) frozen formulation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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