EUCTR2007-006532-66-FR
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ot applicable_Healthy volunteers_Up to 50 years of age
- Sponsor
- Sanofi Pasteur MSD SNC
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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