A Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity, Safety and Tolerability of ZOSTAVAX™ in Subjects 50 to 59 Years of Age - ZOSTAVAX™ in Subjects 50 to 59 Years of Age

Conditions: Herpes Zoster
MedDRA version: 9.1Level: LLTClassification code 10019974Term: Herpes zoster

Registration Number: EUCTR2007-004020-20-FI

Lead Sponsor: MSD Finland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20300

Inclusion Criteria

1. Age 50 to 59 years (at time of informed consent).
2. Signed an informed consent form prior to any study procedure.
3. Afebrile (<100.4°F [<38.0°C] oral or equivalent) on day of vaccination.
4. History of varicella or residence in a VZV-endemic area for =30 years.
5. Female subjects who are of reproductive potential must have a negative serum or urine pregnancy test and agree to remain abstinent, or use (or have their partner use) 2 acceptable methods of birth control for 3 months postvaccination.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. A history of hypersensitivity reaction to any vaccine component, including gelatin or neomycin.
2. Prior receipt of any varicella or zoster vaccine.
3. Prior history of HZ.
4. Immunoglobulin or any blood products given 5 months prior to vaccination or expected during the 42 days after vaccination.
5. Any live virus vaccine administered within 4 weeks prevaccination or expected within 42 days postvaccination.
6. Any inactivated vaccine administered within 7 days prevaccination or expected within 7 days postvaccination.
7. Subject is pregnant or breastfeeding.
8. Participation in a clinical study with administration of an investigational drug or vaccine within the last 30 days prior to enrollment.
9. An intercurrent illness that might interfere with the interpretation of the study.
10. Use of immunosuppressive therapy.
11. Known or suspected immune dysfunction.
12. Any concomitant use of nontopical antiviral therapy.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the impact of ZOSTAVAX™ on the development of HZ in subjects 50 to 59 years of age.;Secondary Objective: To determine whether ZOSTAVAX™ is immunogenic when administered to subjects 50 to 59 years of age.<br>To assess the overall safety and tolerability profile of ZOSTAVAX™ in subjects 50 to 59 years of age.;Primary end point(s): The primary efficacy endpoint is the incidence of HZ in the vaccine and placebo groups, defined as the number of confirmed HZ cases per 1000 person-years of follow-up following vaccination. This will be an event-driven study. Subjects will be followed in the study for occurrences of HZ for approximately 1 year or longer, depending on the time required to accrue 96 confirmed cases. <br> <br>

Secondary Outcome Measures