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 = 70 years of age

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 750

Inclusion Criteria

Subjects will be included in this study if they meet all of the following 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

Subjects will not be included in the study if they meet any of the following non-inclusion criteria:

1. Febrile (oral temperature = 38.3°C) 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 strictly greater than 1 hour of exposure indoors), or hospital contact (in same 2- to 4-bed 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 study 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 inpairment 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 =5 mg/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 first 5 months prior to the first vaccination
13. Concomitant use of non-topical anti-viral 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

There are also a list of temporary contra-indications to further vaccination and definite contra-indications to further vaccination. See Study Protocol Section IV.3 and IV.4.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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