EUCTR2009-012458-19-DEActive, not recruitingNot Applicable
An open-label, randomised, comparative, multicentre study of theimmunogenicity and safety of ZOSTAVAX® when administered byintramuscular route or subcutaneous route to subjects =50 years of age
Sanofi Pasteur MSD S.N.C.0 sites354 target enrollmentStarted: July 15, 2009Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 354
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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,
- •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
- •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,
- •16. Participation in any other clinical study within 4 weeks prior to study vaccination
- +1 more not shown
Investigators
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