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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-004020-20-DE

Enrollment

20300

Registered

2007-09-28

Start date

2007-12-10

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes Zoster MedDRA version: 9.1 Level: LLT Classification code 10019974 Term: Herpes zoster

Interventions

Trade Name: ZOSTAVAX Product Code: V211 Pharmaceutical Form: Injection* INN or Proposed INN: Varicella-zoster live virus Current Sponsor code: V211 Concentration unit: ml millilitre(s) Concentration t

Eligibility

Sex/Gender

All

Inclusion criteria

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 (=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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. 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.	—

Measure

Time frame

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. 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.

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Countries

Finland, Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026