Clinical trial NCT01391546: Immunogenicity and Safety Study of ZOSTAVAX Administered by Intramuscular or Subcutaneous Route to Participants Aged From 50 Years Old (V211-045)
Official title: An Open-label, Randomised, Comparative, Multicentre Study of the Immunogenicity and Safety of ZOSTAVAX When Administered by Intramuscular Route or Subcutaneous Route to Subjects of 50 Years of Age and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Zoster
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-07-12
Enrollment: 354
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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


Eligibility criteria: 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,

Primary outcomes:
measure: Geometric Mean Titre (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks Post-vaccination
timeFrame: 4 week post-vaccination
measure: Geometric Mean Fold Rise (GMFR) in VZV Antibody Titre: IM Route
timeFrame: Pre-vaccination (Day 0) and 4 week post-vaccination
Secondary outcomes:
measure: Geometric Mean Fold Rise (GMFR) in VZV Antibody Titre: SC Route
timeFrame: Pre-vaccination (Day 0) and 4 week post-vaccination
measure: Geometric Mean Count (GMCs) of VZV Interferon Gamma ((IFN-γ) Enzyme-Linked ImmunoSpot (ELISPOT) Antibodies
timeFrame: 4 week post-vaccination
measure: Geometric Mean Fold Rise (GMFR) of IFN-γ ELISPOT Antibodies
timeFrame: Pre-vaccination (Day 0) and 4 week post-vaccination
measure: Percentage of Participants Who Report at Least 1 Injection-site Adverse Reaction
timeFrame: up to 28 days after vaccination
measure: Percentage of Participants Who Report at Least 1 Systemic Adverse Event
timeFrame: up to Day 28 after vaccination
measure: Percentage of Participants Who Report at Least 1 Serious Adverse Event
timeFrame: up to 35 days after vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Diez-Domingo J, Weinke T, Garcia de Lomas J, Meyer CU, Bertrand I, Eymin C, Thomas S, Sadorge C. Comparison of intramuscular and subcutaneous administration of a herpes zoster live-attenuated vaccine in adults aged >/=50 years: a randomised non-inferiority clinical trial. Vaccine. 2015 Feb 4;33(6):789-95. doi: 10.1016/j.vaccine.2014.12.024. Epub 2014 Dec 30.