Immunogenicity and Safety of a 1-dose Regimen of a Zoster Vaccine Versus Different 2-dose Regimens in Participants ≥ 70 Years of Age. (V211-043)

NCT00561080 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: V211-043X06-Z-3052007-000744-28
• Study Type: interventional
• Target: 759
• Locations: 0 countries
• Sites: N/A

Brief Summary

Primary objective: Immunogenicity To demonstrate that a second dose of ZOSTAVAX® elicits higher varicella-zoster virus (VZV) antibody titres than a first dose of ZOSTAVAX® whether given as a 0-1 month schedule or as a 0-3 month schedule in subjects ≥70 years of age as measured at 4 weeks post-vaccination Secondary objectives Immunogenicity

• To summarise the VZV antibody titres at 4 weeks post-vaccination after a 1-dose regimen and 4 weeks post-vaccination after each dose of each 2-doses regimen of ZOSTAVAX®.
• To compare the VZV antibody titres at 12 months after completion of a 1-dose regimen with the VZV antibody titres at 12 months after completion of each 2-doses regimen of ZOSTAVAX®
• To summarise the VZV antibody titres at 24 and 36 months after completion of a 1-dose regimen and at 24 and 36 months after completion of each 2-doses regimen of ZOSTAVAX®

Conditions

Prevention of : Herpes-Zoster

Outcome Measures

Primary Outcomes (1)

• Geometric Mean Titer (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks After Each Vaccination: Groups 2 and 3

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

  4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3)

Secondary Outcomes (22)

• Geometric Mean Titer (GMT) of VZV Antibodies 4 Weeks After Vaccination: Group 1

  4 weeks post-dose (Month 1)

• Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-vaccination to 4 Weeks Post-dose 1 in Groups 1, 2 and 3 and 4 Weeks Post-dose 2 in Groups 2 and 3

  Predose and 4 weeks post-dose 1 (Month 1 for all groups) and 4 weeks post-dose 2 (Month 2 for Group 2 and Month 4 for Group 3)

• Geometric Mean Titre of VZV Antibodies 12 Months Post-last Dose

  1 year post final dose for Groups 1, 2, and 3 (Group 1: Month 12; Group 2: 13 Month 13; and Group 3: Month 15)

• Geometric Mean Fold Rise (GMFR) in VZV Antibody Titres From Pre-Vaccination To 12 Months Post-dose 1 in Group 1 And From Pre-Vaccination To 12 Months Post-dose 2 in Groups 2 and 3

  predose 1 and 1 year post-last dose (Group 1: Month 12; Group 2: 13 Month 13; and Group 3: Month 15)

• Geometric Mean Titre (GMT) of VZV Antibodies 24 and 36 Months Post-dose 1 in Group 1 and the 24 and 36 Months Post-dose 2 in Groups 2 and 3

  24 and 36 months post-last dose

Study Arms (3)

Single Dose of Zostavax

EXPERIMENTAL

Zostavax 0.65mL intramuscular injection administered on Day 0

Biological: Zostavax

Zostavax - Day 0 and Month 1

EXPERIMENTAL

Zostavax 0.65mL intramuscular injection administered on Day 0 and Month 1

Biological: Zostavax

Zostavax - Day 0 and Month 3

EXPERIMENTAL

Zostavax 0.65mL intramuscular injection administered on Day 0 and Month 3

Biological: Zostavax

Interventions

Zostavax BIOLOGICAL

Also known as: Zoster vaccine live

Single Dose of Zostavax; Zostavax - Day 0 and Month 1; Zostavax - Day 0 and Month 3

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 70 years
• Varicella history-positive or residence for \> 30 years in a country with endemic VZV infection
• Signed informed consent form prior to any study procedure

You may not qualify if:

• Febrile illness within the last 72 hours before the first vaccination
• Prior herpes-zoster episode clinically diagnosed by a physician
• Prior receipt of varicella or zoster vaccine
• Exposure to varicella or herpes-zoster within the 4 weeks prior to the first vaccination
• Significant underlying illness preventing completion of the study vaccination schedules,
• Known active tuberculosis,
• Immune deficiency disorder, including active neoplastic disease within the prior 5 years,
• Immune function impairment caused by medical condition or immunosuppressive therapy, or any other cause,
• Receipt of any inactivated vaccine within the 2 weeks prior to the first vaccination,
• Receipt of any other live vaccine within the 4 weeks prior to the first vaccination,
• Receipt of immunoglobulins or blood-derived products within the 5 months prior to the first vaccination,
• Concomitant use of non-topical antiviral therapy

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Vesikari T, Hardt R, Rumke HC, Icardi G, Montero J, Thomas S, Sadorge C, Fiquet A. Immunogenicity and safety of a live attenuated shingles (herpes zoster) vaccine (Zostavax(R)) in individuals aged >/= 70 years: a randomized study of a single dose vs. two different two-dose schedules. Hum Vaccin Immunother. 2013 Apr;9(4):858-64. doi: 10.4161/hv.23412. Epub 2013 Jan 14.

  PMID: 23319176 DERIVED

MeSH Terms

Interventions

Herpes Zoster Vaccine

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: November 19, 2007
• First Posted: November 20, 2007
• Study Start: October 26, 2007
• Primary Completion: June 3, 2009
• Study Completion: June 3, 2009
• Last Updated: January 11, 2019
• Results First Posted: December 22, 2017

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share