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

NCT ID: NCT00550745

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 11999 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-01-31

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

Study Design

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

Study Groups

1

Arm 1: vaccine

Group Type: EXPERIMENTAL

Zoster Vaccine, Live

Intervention Type: BIOLOGICAL

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

2

Arm 2: Placebo Comparator

Group Type: PLACEBO_COMPARATOR

Comparator: placebo

Intervention Type: BIOLOGICAL

single 0.65 mL Placebo injection. 6 month treatment period.

Interventions

Zoster Vaccine, Live

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

Intervention Type: BIOLOGICAL

Comparator: placebo

single 0.65 mL Placebo injection. 6 month treatment period.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 60+ 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 60 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

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.

Reference Type: RESULT

PMID: 22048110 (View on PubMed)

Other Identifiers

2007_606

Identifier Type: -

Identifier Source: secondary_id

V211-020

Identifier Type: -

Identifier Source: org_study_id