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

NCT01391546 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: V211-045ZTV03C2009-012458-19
• Study Type: interventional
• Target: 354
• Locations: 0 countries
• Sites: N/A

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

Conditions

Herpes Zoster

Outcome Measures

Primary Outcomes (2)

• Geometric Mean Titre (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks Post-vaccination

  Blood samples taken at 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via Glycoprotein Enzyme Linked Immunosorbent Assay (gpELISA).

  4 week post-vaccination

• Geometric Mean Fold Rise (GMFR) in VZV Antibody Titre: IM Route

  Blood sample taken at predose (Day 0) and 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination

  Pre-vaccination (Day 0) and 4 week post-vaccination

Secondary Outcomes (6)

• Geometric Mean Fold Rise (GMFR) in VZV Antibody Titre: SC Route

  Pre-vaccination (Day 0) and 4 week post-vaccination

• Geometric Mean Count (GMCs) of VZV Interferon Gamma ((IFN-γ) Enzyme-Linked ImmunoSpot (ELISPOT) Antibodies

  4 week post-vaccination

• Geometric Mean Fold Rise (GMFR) of IFN-γ ELISPOT Antibodies

  Pre-vaccination (Day 0) and 4 week post-vaccination

• Percentage of Participants Who Report at Least 1 Injection-site Adverse Reaction

  up to 28 days after vaccination

• Percentage of Participants Who Report at Least 1 Systemic Adverse Event

  up to Day 28 after vaccination

Study Arms (2)

ZOSTAVAX intramuscular (IM) route

EXPERIMENTAL

Single dose of 0.65 mL via IM injection

Biological: ZOSTAVAX

ZOSTAVAX subcutaneous (SC) route

ACTIVE COMPARATOR

Single dose of 0.65 mL via SC injection

Biological: ZOSTAVAX

Interventions

ZOSTAVAX BIOLOGICAL

1 dose 0.65 mL

Also known as: V211

ZOSTAVAX intramuscular (IM) route; ZOSTAVAX subcutaneous (SC) route

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 25555381 RESULT

MeSH Terms

Conditions

Herpes Zoster

Interventions

Herpes Zoster Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Chickenpox Vaccine; Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: July 12, 2011
• Study Start: June 20, 2011
• Primary Completion: October 15, 2012
• Study Completion: October 15, 2012
• Last Updated: January 9, 2019
• Results First Posted: November 20, 2017

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share