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

NCT ID: NCT00444860

Last Updated: 2015-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2007-05-31

Brief Summary

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

Conditions

Varicella Virus Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Zostavax

Group Type: EXPERIMENTAL

Zoster Vaccine, Live, (Oka-Merck)

Intervention Type: BIOLOGICAL

A single dose of 0.65 ml of Zostavax injection was given to each study subject

Interventions

Zoster Vaccine, Live, (Oka-Merck)

A single dose of 0.65 ml of Zostavax injection was given to each study subject

Intervention Type: BIOLOGICAL

Other Intervention Names

Zostavax

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Yao CA, Chen LK, Huang KC. The immunogenicity and safety of zoster vaccine in Taiwanese adults. Vaccine. 2015 Mar 24;33(13):1515-7. doi: 10.1016/j.vaccine.2015.01.085. Epub 2015 Feb 11.

Reference Type: RESULT

PMID: 25681662 (View on PubMed)

Other Identifiers

MKV211-019

Identifier Type: -

Identifier Source: secondary_id

2007_008

Identifier Type: -

Identifier Source: secondary_id

V211-019

Identifier Type: -

Identifier Source: org_study_id