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)

NCT ID: NCT00092417

Last Updated: 2015-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 695 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2004-06-30

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1

Higher Potency Dose

Group Type: EXPERIMENTAL

Comparator: Varicella Zoster Virus Vaccine

Intervention Type: BIOLOGICAL

Single 0.65 mL subcutaneous injection of higher potency zoster vaccine (\~207,000 plaque-forming units \[PFU\]/0.65-mL dose)

2

Lower Potency Dose

Group Type: EXPERIMENTAL

Comparator: Varicella Zoster Virus Vaccine

Intervention Type: BIOLOGICAL

Single 0.65 mL subcutaneous injection of lower potency zoster vaccine (\~58,000 plaque-forming units \[PFU\]/0.65-mL dose)

Interventions

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)

Intervention Type: 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)

Intervention Type: BIOLOGICAL

Eligibility 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

• 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

Tyring SK, Diaz-Mitoma F, Padget LG, Nunez M, Poland G, Cassidy WM, Bundick ND, Li J, Chan IS, Stek JE, Annunziato PW; Protocol 009 Study Group. Safety and tolerability of a high-potency zoster vaccine in adults >/= 50 or years of age. Vaccine. 2007 Feb 26;25(10):1877-83. doi: 10.1016/j.vaccine.2006.10.027. Epub 2006 Oct 30.

Reference Type: BACKGROUND

PMID: 17227688 (View on PubMed)

Other Identifiers

2004_075

Identifier Type: -

Identifier Source: secondary_id

V211-009

Identifier Type: -

Identifier Source: org_study_id