An open-label, randomised, comparative, multicentre study of the immunogenicity and safety of ZOSTAVAX® when administered by intramuscular route or subcutaneous route to subjects =50 years of age

• Register: EUCTR
• Last refreshed on: 14 October 2013
• Main ID: EUCTR2009-012458-19-DE
• Date of registration: 15/07/2009
• Prospective Registration: Yes
• Primary sponsor: Sanofi Pasteur MSD S.N.C.
• Public title: An open-label, randomised, comparative, multicentre study of the immunogenicity and safety of ZOSTAVAX® when administered by intramuscular route or subcutaneous route to subjects =50 years of age
• Scientific title: An open-label, randomised, comparative, multicentre study of the immunogenicity and safety of ZOSTAVAX® when administered by intramuscular route or subcutaneous route to subjects =50 years of age
• Date of first enrolment: 15/10/2009
• Target sample size: 354
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-012458-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: administration of vaccine by SC route as per SmPC

Countries of recruitment

Germany, Spain

Key inclusion & exclusion 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:
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


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

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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: NA
Other descriptive name: VARICELLA VIRUS OKA/MERCK STRAIN (LIVE, ATTENUATED)
Concentration unit: PFU plaque forming unit
Concentration type: not less then
Concentration number: 19400-

Primary Outcome(s)

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.

Secondary ID(s)

ZTV03C