ZOSTAVAX(R) Local Registration Trial (V211-019)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Varicella Virus Infection

Treatments: Biological: Zoster Vaccine, Live, (Oka-Merck)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00444860

V211-019

MKV211-019

2007_008

Details and patient eligibility

About

The purpose of this study is to obtain safety and immunogenicity data for the refrigerator-stable formulation of ZOSTAVAX(R) in taiwanese adults.

Enrollment: 150 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Subject Is Older Than 50 Years Of Age On Day Of Signing Informed Consent

• All Females Must Be Postmenopausal Or Have A Negative Serum Or Urine Pregnancy Test

  • Postmenopausal Is Defined As 6 Months Of Spontaneous Amenorrhea With Serum Follicle Stimulating Hormone (Fsh) Levels In The Postmenopausal Range As Determined By The Laboratory, Or 12 Months Of Spontaneous Amenorrhea

• A Subject Who Is Of Reproductive Potential Must Agree To Remain Abstinent Or Use (Or Have Her Partner Use) 2 Acceptable Methods Of Birth Control For Three Months After Vaccination

  • Acceptable Methods Of Birth Control Are: Intrauterine Device, Diaphragm With Spermicide, Contraceptive Sponge, Oral Contraceptive Pills, Condom, Tubal Ligation, And Vasectomy

• Subject Must Sign Informed Consent Prior To Any Study Procedure

• Subject Must Be afebrile (<38.3 °C Oral) On Day Of Vaccination

• Any Underlying Chronic Illness Must Be In Stable Condition

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

1

Experimental group

Description:

Zostavax

Treatment:

Biological: Zoster Vaccine, Live, (Oka-Merck)