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)

NCT00092417 | Completed Phase 3 Results

• 2 other identifiers: V211-0092004_075
• Study Type: interventional
• Target: 695
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs)

  The incidence of vaccine-related SAEs occurring Day 1 through Day 42 postvaccination. Whether a serious clinical adverse experience occurring Day 1 through Day 42 postvaccination was vaccine-related was determined by the investigator who was a qualified physician . The difference in the risk of developing a vaccine-related SAE between the two groups was compared at the 2-sided 0.05 level.

  Day 1-42 post vaccination

• Number of Participants With Moderate or Severe Injection-site Pain/Tenderness/Soreness or Swelling (> 2 Inches at Largest Diameter)

  Day 1-5 postvaccination

Other Outcomes (3)

• Number of Participants With Varicella or Varicella-like Noninjection-site Rashes, Nondermatomal in Distribution With >100 Lesions

  Day 1-42 postvaccination

• Number of Participants With Herpes Zoster (HZ) or HZ-like Rashes

  Day 1-42 postvaccination

• Number of Participants With Fevers ≥101.0°F [≥38.3°C]

  Day 1-21 postvaccination

Study Arms (2)

1

EXPERIMENTAL

Higher Potency Dose

Biological: Comparator: Varicella Zoster Virus Vaccine

2

EXPERIMENTAL

Lower Potency Dose

Biological: Comparator: Varicella Zoster Virus Vaccine

Interventions

Comparator: Varicella Zoster Virus Vaccine BIOLOGICAL

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

1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy individuals 50 years of age or older with a history of chickenpox who have not had herpes zoster

You may not qualify if:

• Preexisting conditions that might affect vaccine safety such as conditions that inhibit an immune response

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 17227688 BACKGROUND

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2004
• First Posted: September 27, 2004
• Study Start: October 1, 2003
• Primary Completion: June 1, 2004
• Study Completion: June 1, 2004
• Last Updated: October 7, 2015
• Results First Posted: June 10, 2010

Record last verified: 2015-10