Not applicable as Prevention of herpes zoster ("zoster" or shingles) and herpes zoster-related post-herpetic neuralgia (PHN). MedDRA version: 12.0 Level: LLT Classification code 10019974 Term: Herpes zoster
Conditions
Interventions
Trade Name: Zostavax
Product Name: Zostavax
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Preparation of shingles (herpes zoster) vaccine (live)
CAS Number:
Sponsors
Sanofi Pasteur MSD S.N.C.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject of either gender aged =50 years on day of vaccination 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 4. 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. (In areas where abstinence is not a locally acceptable method of contraception, 2 acceptable methods of birth control must be used for 3 months postvaccination) An acceptable method of birth control is defined as: intrauterine device, oral contraception, diaphragm with spermicide, contraceptive sponge, condom, vasectomy. 5. Subject able to attend all scheduled visits and to comply with all study procedures. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Febrile (oral temperature =38.3°C) within the last 72 hours before vaccination 2. History of hypersensitivity or 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 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. Active untreated tuberculosis 7. Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection 8. Receipt of immunosuppressive therapy or expected to receive immunosuppressive therapy during the study as 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 of prednisone (or equivalent) for > 14 days in the 4 weeks prior to the vaccination 9. Known or suspected immune dysfunction that is caused by a medical condition, or any other cause. - Examples: immune dysfunction including congenital immunodeficiency, human immunodeficiency virus (HIV) infection, organ or bone marrow transplantation, leukaemia, lymphoma, Hodgkin’s disease, multiple myeloma, or generalized malignancy - Exceptions: subjects with prostate or breast cancer with no chemotherapeutic drugs or receiving only hormone blocking drugs, subjects with skin cancer who are not receiving radiation therapy or chemotherapy, and subjects with a history of other malignancies who have been disease-free for at least 6 months can be included 10. Receipt of any other live virus vaccine within = 28 days prior to vaccination, or planned vaccination with any other live virus vaccine during the study 11. Receipt of any inactivated vaccine within = 14 days prior to vaccination, or ,planned vaccination with any inactivated vaccine during the study 12. Receipt of immunoglobulins or any blood products, other than autologous blood transfusion, given during the 5 months prior to vaccination or expected treatment with immunoglobulins or blood products during the study 13. Concomitant use of non-topical antiviral therapy (examples: acyclovir, famciclovir, valacyclovir, ganciclovir, foscarnet, cidofovir, brivudine) or expected to receive non-topical antiviral therapy during the study 14. The subject is at the time of signing informed consent, a user of recreational or illicit drugs or a user who has had a recent history (within the last year) of drug or alcohol abuse or dependence 15. Any other condition or 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) 16. Participation in any other clinical study within 4 weeks prior to study vaccination or planned during the duration of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Two co-primary objectives are: To demonstrate that ZOSTAVAX® administered by intramuscular (IM) route is non-inferior to ZOSTAVAX® administered by subcutaneous (SC) route in terms of 4-week post-vaccination antibody titres as measured by glycoprotein enzyme-linked immunosorbent assay (gpELISA) to varicella-zoster virus (VZV) in subjects =50 years of age. To demonstrate that ZOSTAVAX® administered by IM route induces an acceptable fold-rise of VZV antibody titres (gpELISA) from pre to 4-week post-vaccination in subjects =50 years of age. ;Secondary Objective: The secondary immunogenicity objectives are: To evaluate the immunogenicity as measured by VZV antibody titres (gpELISA) at 4 weeks following ZOSTAVAX® administered by IM or SC route. To evaluate the immune response as measured by a second assay, the VZV IFN-?-ELISPOT at 4 weeks following ZOSTAVAX® administered by IM or SC route. Safety objective To describe the safety profile of ZOSTAVAX® administered by IM or SC route. ;Primary end point(s): PRIMARY EVALUATION ENDPOINTS: Immunogenicity: Two primary endpoints are defined: The 4 week post-vaccination VZV antibody GMT in both groups, The VZV antibody GMFR from pre to 4-week post-vaccination in the IM Group. | — |
Countries
Germany, Spain
Outcome results
None listed