An open-label, randomised, comparative, multi-centre study of the immunogenicity and safety of a 1-dose regimen and different 2-dose regimens of a Zoster vaccine (Live), ZOSTAVAX , in subjects equal or over 70 years of age - ND

• Conditions: Herpes zoster and post-herpetic neuralgia; Level: PTClassification code 10019974

• Registration Number: EUCTR2007-000744-28-IT
• Lead Sponsor: Sanofi Pasteur MSD S.N.C.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-13
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 750

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

Exclusion Criteria

1.Febrile (oral temperature ≥ 38.3C) within the last 72 hours before the first vaccination
2.History of hypersensitivity/ anaphylactoid reaction to ZOSTAVAX components including gelatin or neomycin
3.Prior herpes-zoster episode clinically diagnosed by a physician
4.Prior receipt of varicella or zoster vaccine
5.Exposure to varicella or herpes-zoster within the 4 weeks prior to the first vaccination by continuous household contact, or non-household contact (generally >1 hour of exposure indoors), or hospital contact (in same 2- to 4-beds room or adjacent beds in a large ward or face-to-face contact with an infectious staff member or subject), or contact with a newborn whose mother had onset of varicella 5 days or less before delivery or within 48 hours after delivery
6.Significant underlying illness preventing completion of the vaccination schedules
7.Known active tuberculosis
8.Immune deficiency disorder, including active neoplastic disease (except local skin cancer) within the prior 5 years
9.Immune function impairment caused by medical condition (congenital immunodeficiency, human immunodeficiency virus (HIV) infection, organ or bone marrow transplantation, leukemia, lymphoma, Hodgkin?s disease, multiple myeloma, generalised malignancy), or immunosuppressive therapy (examples: chemotherapy agents to treat cancer, treatments associated with organ or bone marrow transplantation, daily (or on alternate days) systemic corticosteroids at a dose ≥5mg/day prednisone equivalent for at least 14 days in the 4 weeks prior to the first vaccination), or any other cause
10.Receipt of any inactivated vaccine within the 2 weeks prior to the first vaccination
11.Receipt of any other live vaccine within the 4 weeks prior to the first vaccination
12.Receipt of immunoglobulins or blood-derived products within the 5 months prior to the first vaccination
13.Concomitant use of non-topical antiviral therapy (examples: acyclovir, famciclovir, valacyclovir, ganciclovir, foscarnet, cidofovir, brivudine)
14.History of alcohol or recreational drug abuse which in the opinion of the investigator could interfere with study compliance
15.Any other condition / situation that in the opinion of the investigator could interfere with the interpretation of the study, including possible interference caused by acute intercurrent illness (examples: upper respiratory infection, influenza), or any other cause
16.Participation to any other clinical study that includes an investigational product within the 4 weeks prior to the first vaccination or planned during the duration of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified