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)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Prevention of : Herpes-Zoster

Treatments: Biological: Zostavax

Study type: Interventional

Funder types: Industry

Identifiers

NCT00561080

X06-Z-305 (Other Identifier)

V211-043

2007-000744-28 (EudraCT Number)

Details and patient eligibility

About

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®

Enrollment: 759 patients

Sex: All

Ages: 70+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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759 participants in 3 patient groups

Single Dose of Zostavax

Experimental group

Description:

Zostavax 0.65mL intramuscular injection administered on Day 0

Treatment:

Biological: Zostavax

Zostavax - Day 0 and Month 1

Experimental group

Description:

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

Treatment:

Biological: Zostavax

Zostavax - Day 0 and Month 3

Experimental group

Description:

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

Treatment:

Biological: Zostavax