A Phase IV Clinical Trial to Evaluate the Safety and Tolerability of ZOSTAVAX™ in Subjects =60 Years of Age

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 12000

Inclusion Criteria

1. Age = 60 years.
2. Signed an informed consent prior to any study procedure.
3. Afebrile (<101.0°F [<38.3°C] oral or equivalent) on day of vaccination.
4. Females must be postmenopausal or have a negative serum or urine pregnancy test.
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. A history of allergic reaction to any vaccine component (including gelatin), or an anaphylactic/anaphylactoid reaction to neomycin (note that subjects/patients with a history of contact dermatitis from neomycin may receive the vaccine).
2. Prior receipt of any varicella or zoster vaccine.
3. Any live virus vaccine administered within 4 weeks prevaccination or scheduled during the 42-day postvaccination period.
4. Any inactivated vaccine, except for influenza vaccine, administered within 7 days prevaccination or scheduled during the 42-day postvaccination period.
5. Subject is pregnant or breastfeeding.
6. Participation in an investigational drug or vaccine study within the last 30 days prior to enrollment or expected during the 42-day postvaccination period.
7. An intercurrent illness (including active untreated tuberculosis) that might interfere with the interpretation of the study or prevent the subject from completion of the study.
8. Use of immunosuppressive therapy. Subjects on corticosteroids should be excluded if they are receiving or are expected to receive, in the period from 4 weeks prior to enrollment until 4 weeks postvaccination, systemic doses greater than required for physiological replacement, i.e., >5 mg of prednisone (or equivalent) and for >2 weeks. Excluded immunosuppressive therapies also include chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation.
9. Known or suspected immune dysfunction that is caused by a medical condition or any other cause. Examples of medical conditions associated with immune dysfunction include congenital immunodeficiency, human immunodeficiency virus (HIV) infection, organ or bone marrow transplantation, leukemia, lymphoma, Hodgkin’s disease, multiple myeloma, or generalized malignancy. Subjects with a history of cancer who are not on active treatment and are not thought to be immunosuppressed at enrollment will be eligible for enrollment.
10. Note: Subjects with prostate or breast cancer who are not on chemotherapeutic drugs (other than 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, will be eligible for enrollment.
11. Any concomitant use of nontopical antiviral therapy with activity against herpesviruses, including but not limited to acyclovir, famciclovir, valacyclovir, ganciclovir, foscarnet, brivudine, and cidofovir.
12. Any other reason that in the opinion of the investigator might interfere with the evaluation required by the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of the study is to evaluate the general safety of ZOSTAVAX™ in subjects =60 years of age.;Secondary Objective: None;<br> Primary end point(s): The primary safety evaluation will be the proportion of subjects reporting serious clinical adverse experiences during the primary safety follow-up period (42 days) in each vaccination group.<br><br>

Secondary Outcome Measures

Name	Time	Method

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Updated 4/3/2023