Herpes zoster [shingles] and post-herpetic neuralgia
Conditions
Interventions
Trade Name: Zostavax®
Product Name: Zostavax
Pharmaceutical Form: Powder and solvent for suspension for injection
Other descriptive name: Varicella-zoster virus (live, attenuated)
Concentration unit:
Sponsors
Sanofi Pasteur MSD S.N.C.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 a 0-3 month schedule in subjects from 70 years of age as measured at 4 weeks post vaccination.;Secondary Objective: 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® administered to subjects = 70 years of age. 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® administered to subjects = 70 years of age. To summarise the VZV antibody titres annually 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® administered to subjects = 70 years of age. To assess the safety profile of a 1-dose regimen and the safety profile of each 2-doses regimen of Zostavax® adminsitered to subjects = 70 years of age. ;Primary end point(s): Immunogenicity The primary criteria defined for immunogenicity are the 4 weeks post-dose 1 and 4 weeks post-dose 2 VZV antibody titres (i.e. GMT in gpELISA units/mL) in group 2 and in group 3. There are a number of secondary criteria defined for immunogenicity. See Study Protocol Section XI.1.2 for a listing of these [Evaluation criteria, Secondary criteria]. | — |
Countries
Finland, Germany, Italy, Netherlands, Spain
Outcome results
None listed