Immunogenicity and Safety Study of ZOSTAVAX Administered by Intramuscular or Subcutaneous Route to Subjects Aged From 50 Years Old

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT01391546
First received: July 7, 2011
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

PRIMARY OBJECTIVES

Two co-primary objectives are:

  • To demonstrate that 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 titres from pre to 4-week post-vaccination

SECONDARY OBJECTIVES

Immunogenicity objectives

  • To evaluate the immunogenicity as measured by VZV antibody titres 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


Condition Intervention Phase
Herpes Zoster
Biological: 1 dose at Day 0
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Sanofi Pasteur MSD:

Primary Outcome Measures:
  • VZV Glycoprotein enzyme-linked immunosorbent assay (gpELISA) antibody Geometric Mean of Titres (GMT) [ Time Frame: 4 week post-vaccination ] [ Designated as safety issue: No ]
  • VZV gpELISA antibody Geometric Mean Fold Rise (GMFR) in the intramuscular arm [ Time Frame: Pre-vaccination (Day 0) and 4 week post-vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • VZV gpELISA antibody GMFR in the subcutaneous arm [ Time Frame: Pre-vaccination (Day 0) and 4 week post-vaccination ] [ Designated as safety issue: No ]
  • VZV interferon gamma ELISPOT Geometric Mean Count (GMCs) [ Time Frame: 4 week post-vaccination ] [ Designated as safety issue: No ]
  • VZV interferon gamma ELISPOT GMFR [ Time Frame: Pre-vaccination (Day 0) and 4 week post-vaccination ] [ Designated as safety issue: No ]
  • Number and percentage of subjects with injection-site adverse reactions [ Time Frame: From Day 0 to Day 4 after vaccination ] [ Designated as safety issue: Yes ]
    Injection-site adverse reactions: Solicited (erythema, swelling, pain) or unsolicited

  • Number and percentage of subjects with systemic adverse events [ Time Frame: From Day 0 to Day 28 after vaccination ] [ Designated as safety issue: Yes ]
    Rashes of interest: i.e. Varicella, Varicella-like rashes, Herpes zoster or shingles and Herpes zoster-like rashes and other systemic adverse events

  • Number and percentage of subjects with serious adverse events [ Time Frame: From the signature of the informed consent to 35 days after vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 354
Study Start Date: June 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ZOSTAVAX intramuscular (IM) route Biological: 1 dose at Day 0
1 dose 0.65 mL
Active Comparator: ZOSTAVAX subcutaneous (SC) route Biological: 1 dose at Day 0
1 dose 0.65 mL

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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,
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01391546

Locations
Germany
Sanofi Pasteur MSD Investigational Site 02
Dulmen, Germany
Sanofi Pasteur MSD Investigational Site 04
Hamburg, Germany
Sanofi Pasteur MSD Investigational Site 03
Hamburg, Germany
Sanofi Pasteur MSD Investigational Site 07
Mainz, Germany
Sanofi Pasteur MSD Investigational Site 01
Postdam, Germany
Sanofi Pasteur MSD Investigational Site 06
Riesa, Germany
Sanofi Pasteur MSD Investigational Site 05
Straubing, Germany
Spain
Sanofi Pasteur MSD Investigational Site 08
Valencia, Spain
Sanofi Pasteur MSD Investigational Site 09
Valencia, Spain
Sanofi Pasteur MSD Investigational Site 10
Valencia, Spain
Sponsors and Collaborators
Sanofi Pasteur MSD
  More Information

No publications provided

Responsible Party: Sanofi Pasteur MSD
ClinicalTrials.gov Identifier: NCT01391546     History of Changes
Other Study ID Numbers: ZTV03C
Study First Received: July 7, 2011
Last Updated: July 15, 2013
Health Authority: Germany: Paul-Ehrlich-Institut
Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on September 16, 2014