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)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Healthy

Treatments: Biological: Comparator: Varicella Zoster Virus Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00092417

V211-009

2004_075

Details and patient eligibility

About

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.

Enrollment: 695 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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695 participants in 2 patient groups

1

Experimental group

Description:

Higher Potency Dose

Treatment:

Biological: Comparator: Varicella Zoster Virus Vaccine

Biological: Comparator: Varicella Zoster Virus Vaccine

2

Experimental group

Description:

Lower Potency Dose

Treatment:

Biological: Comparator: Varicella Zoster Virus Vaccine

Biological: Comparator: Varicella Zoster Virus Vaccine