Immunogenicity and Safety Study of ZOSTAVAX Administered by Intramuscular or Subcutaneous Route to Participants Aged From 50 Years Old (V211-045)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

354 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-20

Study Completion Date

2012-10-15

Brief Summary

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PRIMARY OBJECTIVES

Two co-primary objectives are:

* To demonstrate that the immunogenicity of ZOSTAVAX administered by intramuscular route (IM) is non-inferior to ZOSTAVAX administered by subcutaneous route (SC)
* To demonstrate that ZOSTAVAX administered by IM route induces an acceptable fold-rise of varicella zoster virus (VZV) antibody titre from pre to 4-week post-vaccination

SECONDARY OBJECTIVES

Immunogenicity objectives

* To evaluate the immunogenicity as measured by VZV antibody titre at 4 weeks following ZOSTAVAX administered by IM or SC route
* To evaluate the immune response as measured by a second assay, the VZV Interferon gamma Enzyme-linked immunospot (ELISPOT) at 4 weeks following ZOSTAVAX administered by IM or SC route

Safety objective

\- To describe the safety profile of ZOSTAVAX administered by IM or SC route

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Detailed Description

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Conditions

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Herpes Zoster

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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ZOSTAVAX intramuscular (IM) route

Single dose of 0.65 mL via IM injection

Group Type EXPERIMENTAL

ZOSTAVAX

Intervention Type BIOLOGICAL

1 dose 0.65 mL

ZOSTAVAX subcutaneous (SC) route

Single dose of 0.65 mL via SC injection

Group Type ACTIVE_COMPARATOR

ZOSTAVAX

Intervention Type BIOLOGICAL

1 dose 0.65 mL

Interventions

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ZOSTAVAX

1 dose 0.65 mL

Intervention Type BIOLOGICAL

Other Intervention Names

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V211

Eligibility Criteria

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Inclusion Criteria

* Adults aged \>=50 years
* Varicella history-positive or residence for \>30 years in a country with endemic VZV infection

Exclusion Criteria

* Febrile illness
* History of hypersensitivity or anaphylactoid reaction to any of the vaccine components
* Prior herpes zoster episode clinically diagnosed or exposure to varicella or herpes zoster within the 4 weeks prior to vaccination
* Prior receipt of varicella or zoster vaccine
* Active untreated tuberculosis
* Thrombocytopenia, any other coagulation disorder contraindicating intramuscular injection
* Receipt of medication / vaccine that may interfere with study assessments
* Known or suspected immune dysfunction
* User of recreational / illicit drugs or subject with alcohol abuse or dependence within the last year
* Any condition that might interfere with the interpretation of the study,

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes