ZOSTAVAX™ Safety Study in Subjects ≥ 60 Years of Age (V211-020)

NCT00550745 | Completed Phase 4 Results

• 2 other identifiers: V211-0202007_606
• Study Type: interventional
• Target: 11,999
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to evaluate the general safety of ZOSTAVAX™ in subjects 60 years of age or older as required by the FDA.

Conditions

Herpes Zoster

Outcome Measures

Primary Outcomes (1)

• Serious Adverse Events Reported Within 42 Days Postvaccination

  Only Serious Adverse Events were collected and analyzed for this study. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement.

  42 Days

Secondary Outcomes (1)

• Serious Adverse Events Reported Within 6 Months (Day 1 to 182) Postvaccination

  6 months

Study Arms (2)

1

EXPERIMENTAL

Arm 1: vaccine

Biological: Zoster Vaccine, Live

2

PLACEBO COMPARATOR

Arm 2: Placebo Comparator

Biological: Comparator: placebo

Interventions

Zoster Vaccine, Live BIOLOGICAL

single 0.65 mL Zoster Vaccine, Live injection. 6 month treatment period.

1

Comparator: placebo BIOLOGICAL

single 0.65 mL Placebo injection. 6 month treatment period.

2

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years of Age
• Signed an informed consent prior to the start of study
• Non-Feverish, (less than 101.0°F / 38.3°C) on day of vaccination
• Females must be postmenopausal or have a negative pregnancy test

You may not qualify if:

• A history of allergic reaction to any vaccine component (including gelatin or neomycin)
• Prior receipt of any varicella or zoster vaccine
• Any live virus vaccine administered within 4 weeks before the start of the study or scheduled during the 42 days after vaccination
• Any inactivated virus vaccine, except for flu vaccine, administered within 7 days before the start of the study or scheduled during the 42 days after vaccination
• Subject is pregnant or breastfeeding
• Participation in an investigational drug or vaccine study within the last 30 days prior to the start of the study or expected during the 42 days after vaccination
• An ongoing illness (including active untreated tuberculosis) that might interfere with or prevent the subject from completion of the study
• Use of immunosuppressive therapy. Subjects taking corticosteroids such as prednisone should be excluded. Excluded immunosuppressive therapies also include chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation
• Known or suspected immune dysfunction that is caused by a medical condition or any other cause. Examples of medical conditions associated with immune dysfunction include congenital immunodeficiency, human immunodeficiency virus (HIV) infection, organ or bone marrow transplantation, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, or generalized malignancy. Subjects with a history of cancer who are not on active treatment and are not thought to have a weakened immune system at the time of enrollment will be eligible
• Any active use of non-topical antiviral therapy including but not limited to acyclovir, famciclovir, valacyclovir, ganciclovir, foscarnet, brivudine, and cidofovir

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Murray AV, Reisinger KS, Kerzner B, Stek JE, Sausser TA, Xu J, Wang WW, Chan IS, Annunziato PW, Parrino J. Safety and tolerability of zoster vaccine in adults >/=60 years old. Hum Vaccin. 2011 Nov;7(11):1130-6. doi: 10.4161/hv.7.11.17982. Epub 2011 Nov 1.

  PMID: 22048110 RESULT

MeSH Terms

Conditions

Herpes Zoster

Interventions

Herpes Zoster Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Chickenpox Vaccine; Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

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

ClinicalTrialsDisclosure@merck.com

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 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2007
• First Posted: October 30, 2007
• Study Start: September 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: April 12, 2017
• Results First Posted: February 2, 2010

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share