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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Herpes Zoster

Treatments: Biological: ZOSTAVAX

Study type: Interventional

Funder types: Industry

Identifiers

NCT01391546

ZTV03C (Other Identifier)

V211-045 (Other Identifier)

2009-012458-19 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 354 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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,

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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354 participants in 2 patient groups

ZOSTAVAX intramuscular (IM) route

Experimental group

Description:

Single dose of 0.65 mL via IM injection

Treatment:

Biological: ZOSTAVAX

ZOSTAVAX subcutaneous (SC) route

Active Comparator group

Description:

Single dose of 0.65 mL via SC injection

Treatment:

Biological: ZOSTAVAX