An open-label, single-arm, phase IV study assessing the immunogenicity and safety of ZOSTAVAX? at minimum release specification approaching expiry potency in subjects =50 years old

• Register: EUCTR
• Last refreshed on: 4 April 2022
• Main ID: EUCTR2007-006532-66-FR
• Date of registration: 24/01/2008
• Prospective Registration: Yes
• Primary sponsor: Sanofi Pasteur MSD SNC
• Public title: An open-label, single-arm, phase IV study assessing the immunogenicity and safety of ZOSTAVAX? at minimum release specification approaching expiry potency in subjects =50 years old
• Scientific title: An open-label, single-arm, phase IV study assessing the immunogenicity and safety of ZOSTAVAX? at minimum release specification approaching expiry potency in subjects =50 years old
• Date of first enrolment: 25/03/2008
• Target sample size: 95
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-006532-66
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

France

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subject of either gender aged =50 years on day of signing informed consent
2. Positive history of varicella or residence for >30 years in a country with endemic VZV infection
3. Subject affiliated to a health social security system
4. Subject having signed the informed consent form prior to any study procedure
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. Subject febrile (oral temperature =38.3°C) within 72 hours prior to vaccination
2. Subject with a prior history of Herpes Zoster clinically diagnosed by a physician
3. Subject has previously received a varicella or zoster vaccine
4. Exposure to varicella or herpes-zoster within 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-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
5. Subject received any other live virus vaccine within 4 weeks prior to vaccination, or is expected to receive any other live virus vaccine during the study
6. Subject received any inactivated vaccine within 14 days prior to vaccination, or is expected to receive any inactivated vaccine during the study
7. Subject is treated with immunoglobulins or any blood products, other than autologous blood transfusion, given during the 5 months prior to vaccination or expected during the study
8. Subject is taking any nontopical antiviral therapy with activity against herpesviruses, (including but not limited to acyclovir, famciclovir, valacyclovir, ganciclovir, foscarnet, cidofovir, brivudine)
9. Subject is on 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 vaccination until the end of the study, systemic doses greater than required for physiological replacement, i.e., >5 mg of prednisone (or equivalent) for >2 weeks.
• Excluded immunosuppressive therapies also involve chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation.
10. Subject has 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
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 5 years will be eligible for enrollment.
11. Subject has a history of hypersensitivity reaction or anaphylactoid reaction to any vaccine component, including gelatin or neomycin
12. Subject with known active tuberculosis
13. Subject with significant underlying illness preventing completion of the study
14. Subject is currently participating or has participated in a study with an investigational compound or device within 4 weeks of signing informed consent.
15. Subject is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence
16. Any other reason that in the opinion of the investigator might interfere with the study
17. Volunteer having been paid more than 4500€ to take part in biomedical researches over the previous 12 months



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Not applicable_Healthy volunteers_Up to 50 years of age

Intervention(s)

Trade Name: Zostavax
Product Name: Zostavax
Product Code: J07BK02
Pharmaceutical Form: Powder and solvent for suspension for injection
Other descriptive name: Varicella-zoster virus (live, attenuated)
Concentration unit: PFU plaque forming unit
Concentration type: not less then
Concentration number: 19400-

Primary Outcome(s)

Secondary Objective: To describe the safety profile of ZOSTAVAX® at minimum release specification and approaching expiry potency

Primary end point(s): Immunogenicity:
The geometric mean fold rise of VZV antibody titres from pre to post-vaccination (i.e. GMFR)

Main Objective: To demonstrate whether or not ZOSTAVAX® at minimum release specification and approaching expiry potency elicits an acceptable VZV antibody fold rise (gpELISA) from pre-vaccination to 4 weeks post-vaccination

Secondary ID(s)

ZTV02C

Ethics review

Status: Approved
Approval date: 25/03/2008
Contact:

Results

• Results available: Yes
• Date Posted: 12/03/2015
• Date Completed: 25/06/2008
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-006532-66/results